PREGABALIN

Disclaimer:

Medidex is not a provider of medical services and all information is provided for the convenience of the user. No medical decisions should be made based on the information provided on this website without first consulting a licensed healthcare provider.This website is intended for persons 18 years or older. No person under 18 should consult this website without the permission of a parent or guardian.

Overview

What is PREGABALIN?

Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is:

Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35.

LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide.

LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients.

What does PREGABALIN look like?

What are the available doses of PREGABALIN?

Capsules: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg

Oral Solution: 20 mg/mL

What should I talk to my health care provider before I take PREGABALIN?

8.1 Pregnancy

Pregnancy Category C. Increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity, including lethality, growth retardation, and nervous and reproductive system functional impairment, were observed in the offspring of rats and rabbits given pregabalin during pregnancy, at doses that produced plasma pregabalin exposures (AUC) ≥5 times human exposure at the maximum recommended dose (MRD) of 600 mg/day.

When pregnant rats were given pregabalin (500, 1250, or 2500 mg/kg) orally throughout the period of organogenesis, incidences of specific skull alterations attributed to abnormally advanced ossification (premature fusion of the jugal and nasal sutures) were increased at ≥1250 mg/kg, and incidences of skeletal variations and retarded ossification were increased at all doses. Fetal body weights were decreased at the highest dose. The low dose in this study was associated with a plasma exposure (AUC) approximately 17 times human exposure at the MRD of 600 mg/day. A no-effect dose for rat embryo-fetal developmental toxicity was not established.

When pregnant rabbits were given LYRICA (250, 500, or 1250 mg/kg) orally throughout the period of organogenesis, decreased fetal body weight and increased incidences of skeletal malformations, visceral variations, and retarded ossification were observed at the highest dose. The no-effect dose for developmental toxicity in rabbits (500 mg/kg) was associated with a plasma exposure approximately 16 times human exposure at the MRD.

In a study in which female rats were dosed with LYRICA (50, 100, 250, 1250, or 2500 mg/kg) throughout gestation and lactation, offspring growth was reduced at ≥ 100 mg/kg and offspring survival was decreased at ≥250 mg/kg. The effect on offspring survival was pronounced at doses ≥1250 mg/kg, with 100% mortality in high-dose litters. When offspring were tested as adults, neurobehavioral abnormalities (decreased auditory startle responding) were observed at ≥250 mg/kg and reproductive impairment (decreased fertility and litter size) was seen at 1250 mg/kg. The no-effect dose for pre- and postnatal developmental toxicity in rats (50 mg/kg) produced a plasma exposure approximately 2 times human exposure at the MRD.

There are no adequate and well-controlled studies in pregnant women. Use LYRICA during pregnancy only if the potential benefit justifies the potential risk to the fetus.

To provide information regarding the effects of in utero exposure to LYRICA, physicians are advised to recommend that pregnant patients taking LYRICA enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.

8.2 Labor and Delivery

The effects of LYRICA on labor and delivery in pregnant women are unknown. In the prenatal-postnatal study in rats, pregabalin prolonged gestation and induced dystocia at exposures ≥50 times the mean human exposure (AUC (0–24) of 123 µg∙hr/mL) at the maximum recommended clinical dose of 600 mg/day.

8.3 Nursing Mothers

It is not known if pregabalin is excreted in human milk; it is, however, present in the milk of rats. Because many drugs are excreted in human milk, and because of the potential for tumorigenicity shown for pregabalin in animal studies, decide whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4 Pediatric Use

The safety and efficacy of pregabalin in pediatric patients have not been established.

In studies in which pregabalin (50 to 500 mg/kg) was orally administered to young rats from early in the postnatal period (Postnatal Day 7) through sexual maturity, neurobehavioral abnormalities (deficits in learning and memory, altered locomotor activity, decreased auditory startle responding and habituation) and reproductive impairment (delayed sexual maturation and decreased fertility in males and females) were observed at doses ≥50 mg/kg. The neurobehavioral changes of acoustic startle persisted at ≥250 mg/kg and locomotor activity and water maze performance at ≥500 mg/kg in animals tested after cessation of dosing and, thus, were considered to represent long-term effects. The low effect dose for developmental neurotoxicity and reproductive impairment in juvenile rats (50 mg/kg) was associated with a plasma pregabalin exposure (AUC) approximately equal to human exposure at the maximum recommended dose of 600 mg/day. A no-effect dose was not established.

8.5 Geriatric Use

In controlled clinical studies of LYRICA in neuropathic pain associated with diabetic peripheral neuropathy, 246 patients were 65 to 74 years of age, and 73 patients were 75 years of age or older.

In controlled clinical studies of LYRICA in neuropathic pain associated with postherpetic neuralgia, 282 patients were 65 to 74 years of age, and 379 patients were 75 years of age or older.

In controlled clinical studies of LYRICA in epilepsy, there were only 10 patients 65 to 74 years of age, and 2 patients who were 75 years of age or older.

No overall differences in safety and efficacy were observed between these patients and younger patients.

In controlled clinical studies of LYRICA in fibromyalgia, 106 patients were 65 years of age or older. Although the adverse reaction profile was similar between the two age groups, the following neurological adverse reactions were more frequent in patients 65 years of age or older: dizziness, vision blurred, balance disorder, tremor, confusional state, coordination abnormal, and lethargy.

LYRICA is known to be substantially excreted by the kidney, and the risk of toxic reactions to LYRICA may be greater in patients with impaired renal function. Because LYRICA is eliminated primarily by renal excretion, adjust the dose for elderly patients with renal impairment [see ].

How should I use PREGABALIN?

LYRICA is indicated for:

LYRICA is given orally with or without food.

When discontinuing LYRICA, taper gradually over a minimum of 1 week.

2.1 Neuropathic Pain Associated with Diabetic Peripheral Neuropathy

The maximum recommended dose of LYRICA is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Begin dosing at 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Because LYRICA is eliminated primarily by renal excretion, adjust the dose in patients with reduced renal function [see ].

Although LYRICA was also studied at 600 mg/day, there is no evidence that this dose confers additional significant benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions, treatment with doses above 300 mg/day is not recommended [see ].

2.2 Postherpetic Neuralgia

The recommended dose of LYRICA is 75 to 150 mg two times a day, or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Begin dosing at 75 mg two times a day, or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Because LYRICA is eliminated primarily by renal excretion, adjust the dose in patients with reduced renal function [see ].

Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day, and who are able to tolerate LYRICA, may be treated with up to 300 mg two times a day, or 200 mg three times a day (600 mg/day). In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, reserve dosing above 300 mg/day for those patients who have on-going pain and are tolerating 300 mg daily [see ].

2.3 Adjunctive Therapy for Adult Patients with Partial Onset Seizures

LYRICA at doses of 150 to 600 mg/day has been shown to be effective as adjunctive therapy in the treatment of partial onset seizures in adults. Both the efficacy and adverse event profiles of LYRICA have been shown to be dose-related. Administer the total daily dose in two or three divided doses. In general, it is recommended that patients be started on a total daily dose no greater than 150 mg/day (75 mg two times a day, or 50 mg three times a day). Based on individual patient response and tolerability, the dose may be increased to a maximum dose of 600 mg/day.

Because LYRICA is eliminated primarily by renal excretion, adjust the dose in patients with reduced renal function [see ].

The effect of dose escalation rate on the tolerability of LYRICA has not been formally studied.

The efficacy of add-on LYRICA in patients taking gabapentin has not been evaluated in controlled trials. Consequently, dosing recommendations for the use of LYRICA with gabapentin cannot be offered.

2.4 Management of Fibromyalgia

The recommended dose of LYRICA for fibromyalgia is 300 to 450 mg/day. Begin dosing at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day). Although LYRICA was also studied at 600 mg/day, there is no evidence that this dose confers additional benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions, treatment with doses above 450 mg/day is not recommended [see ]. Because LYRICA is eliminated primarily by renal excretion, adjust the dose in patients with reduced renal function [see ].

2.5 Neuropathic Pain Associated with Spinal Cord Injury

The recommended dose range of LYRICA for the treatment of neuropathic pain associated with spinal cord injury is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate LYRICA may be treated with up to 300 mg two times a day [see ]. Because LYRICA is eliminated primarily by renal excretion, adjust the dose in patients with reduced renal function [see ].

2.6 Patients with Renal Impairment

In view of dose-dependent adverse reactions and since LYRICA is eliminated primarily by renal excretion, adjust the dose in patients with reduced renal function. Base the dose adjustment in patients with renal impairment on creatinine clearance (CLcr), as indicated in Table 1. To use this dosing table, an estimate of the patient's CLcr in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the Cockcroft and Gault equation:

Next, refer to the Dosage and Administration section to determine the recommended total daily dose based on indication, for a patient with normal renal function (CLcr ≥60 mL/min). Then refer to Table 1 to determine the corresponding renal adjusted dose.

(For example: A patient initiating LYRICA therapy for postherpetic neuralgia with normal renal function (CLcr ≥60 mL/min), receives a total daily dose of 150 mg/day pregabalin. Therefore, a renal impaired patient with a CLcr of 50 mL/min would receive a total daily dose of 75 mg/day pregabalin administered in two or three divided doses.)

For patients undergoing hemodialysis, adjust the pregabalin daily dose based on renal function. In addition to the daily dose adjustment, administer a supplemental dose immediately following every 4-hour hemodialysis treatment (see ).

2.7 Oral Solution Concentration and Dispensing

The oral solution is 20 mg pregabalin per milliliter (mL) and prescriptions should be written in milligrams (mg). The pharmacist will calculate the applicable dose in mL for dispensing (e.g., 150 mg equals 7.5 mL oral solution).

What interacts with PREGABALIN?

Sorry No Records found

What are the warnings of PREGABALIN?

Sorry No Records found

What are the precautions of PREGABALIN?

Sorry No Records found

What are the side effects of PREGABALIN?

Sorry No records found

What should I look out for while using PREGABALIN?

What might happen if I take too much PREGABALIN?

Signs, Symptoms and Laboratory Findings of Acute Overdosage in Humans

There is limited experience with overdose of LYRICA. The highest reported accidental overdose of LYRICA during the clinical development program was 8000 mg, and there were no notable clinical consequences.

Treatment or Management of Overdose

There is no specific antidote for overdose with LYRICA. If indicated, elimination of unabsorbed drug may be attempted by emesis or gastric lavage; observe usual precautions to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient. Contact a Certified Poison Control Center for up-to-date information on the management of overdose with LYRICA.

Although hemodialysis has not been performed in the few known cases of overdose, it may be indicated by the patient's clinical state or in patients with significant renal impairment. Standard hemodialysis procedures result in significant clearance of pregabalin (approximately 50% in 4 hours).

How should I store and handle PREGABALIN?

Store at 20°C to 25°C (68°F to 77°F) [See USP controlled room temperature]. Protect from moisture.25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).25 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:Bottles of 90: NDC 0071-1012-6850 mg capsules:White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:Bottles of 90: NDC 0071-1013-68Unit-Dose Blister Packages of 100: NDC 0071-1013-4175 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:Bottles of 90: NDC 0071-1014-68Unit-Dose Blister Packages of 100: NDC 0071-1014-41100 mg capsules:Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:Bottles of 90: NDC 0071-1015-68Unit-Dose Blister Packages of 100: NDC 0071-1015-41150 mg capsules:White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:Bottles of 90: NDC 0071-1016-68Unit-Dose Blister Packages of 100: NDC 0071-1016-41200 mg capsules:Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:Bottles of 90: NDC 0071-1017-68225 mg capsules:White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:Bottles of 90: NDC 0071-1019-68300 mg capsules:White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:Bottles of 90: NDC 0071-1018-6820 mg/mL oral solution:16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:16 fluid ounce bottle NDC 0071-1020-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).

Clinical Information

Chemical Structure

No Image found

Clinical Pharmacology

12.1 Mechanism of Action

LYRICA (pregabalin) binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. Although the mechanism of action of pregabalin has not been fully elucidated, results with genetically modified mice and with compounds structurally related to pregabalin (such as gabapentin) suggest that binding to the alpha2-delta subunit may be involved in pregabalin's anti-nociceptive and antiseizure effects in animals. In animal models of nerve damage, pregabalin has been shown to reduce calcium-dependent release of pro-nociceptive neurotransmitters in the spinal cord, possibly by disrupting alpha2-delta containing-calcium channel trafficking and/or reducing calcium currents. Evidence from other animal models of nerve damage and persistent pain suggest the anti-nociceptive activities of pregabalin may also be mediated through interactions with descending noradrenergic and serotonergic pathways originating from the brainstem that modulate pain transmission in the spinal cord.

While pregabalin is a structural derivative of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), it does not bind directly to GABAA, GABAB, or benzodiazepine receptors, does not augment GABAA responses in cultured neurons, does not alter rat brain GABA concentration or have acute effects on GABA uptake or degradation. However, in cultured neurons prolonged application of pregabalin increases the density of GABA transporter protein and increases the rate of functional GABA transport. Pregabalin does not block sodium channels, is not active at opiate receptors, and does not alter cyclooxygenase enzyme activity. It is inactive at serotonin and dopamine receptors and does not inhibit dopamine, serotonin, or noradrenaline reuptake.

12.3 Pharmacokinetics

Pregabalin is well absorbed after oral administration, is eliminated largely by renal excretion, and has an elimination half-life of about 6 hours.

Absorption and Distribution

Following oral administration of LYRICA capsules under fasting conditions, peak plasma concentrations occur within 1.5 hours. Pregabalin oral bioavailability is ≥90% and is independent of dose. Following single- (25 to 300 mg) and multiple- dose (75 to 900 mg/day) administration, maximum plasma concentrations (Cmax) and area under the plasma concentration-time curve (AUC) values increase linearly. Following repeated administration, steady state is achieved within 24 to 48 hours. Multiple-dose pharmacokinetics can be predicted from single-dose data.

The rate of pregabalin absorption is decreased when given with food, resulting in a decrease in Cmax of approximately 25% to 30% and an increase in Tmax to approximately 3 hours. However, administration of pregabalin with food has no clinically relevant effect on the total absorption of pregabalin. Therefore, pregabalin can be taken with or without food.

Pregabalin does not bind to plasma proteins. The apparent volume of distribution of pregabalin following oral administration is approximately 0.5 L/kg. Pregabalin is a substrate for system L transporter which is responsible for the transport of large amino acids across the blood brain barrier. Although there are no data in humans, pregabalin has been shown to cross the blood brain barrier in mice, rats, and monkeys. In addition, pregabalin has been shown to cross the placenta in rats and is present in the milk of lactating rats.

Metabolism and Elimination

Pregabalin undergoes negligible metabolism in humans. Following a dose of radiolabeled pregabalin, approximately 90% of the administered dose was recovered in the urine as unchanged pregabalin. The N-methylated derivative of pregabalin, the major metabolite of pregabalin found in urine, accounted for 0.9% of the dose. In preclinical studies, pregabalin (S-enantiomer) did not undergo racemization to the R-enantiomer in mice, rats, rabbits, or monkeys.

Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug with a mean elimination half-life of 6.3 hours in subjects with normal renal function. Mean renal clearance was estimated to be 67.0 to 80.9 mL/min in young healthy subjects. Because pregabalin is not bound to plasma proteins this clearance rate indicates that renal tubular reabsorption is involved. Pregabalin elimination is nearly proportional to creatinine clearance (CLcr) [see ].

Pharmacokinetics in Special Populations

Race

In population pharmacokinetic analyses of the clinical studies in various populations, the pharmacokinetics of LYRICA were not significantly affected by race (Caucasians, Blacks, and Hispanics).

Gender

Population pharmacokinetic analyses of the clinical studies showed that the relationship between daily dose and LYRICA drug exposure is similar between genders.

Renal Impairment and Hemodialysis

Pregabalin clearance is nearly proportional to creatinine clearance (CLcr). Dosage reduction in patients with renal dysfunction is necessary. Pregabalin is effectively removed from plasma by hemodialysis. Following a 4-hour hemodialysis treatment, plasma pregabalin concentrations are reduced by approximately 50%. For patients on hemodialysis, dosing must be modified [see ].

Elderly

Pregabalin oral clearance tended to decrease with increasing age. This decrease in pregabalin oral clearance is consistent with age-related decreases in CLcr. Reduction of pregabalin dose may be required in patients who have age-related compromised renal function [see ].

Pediatric Pharmacokinetics

Pharmacokinetics of pregabalin have not been adequately studied in pediatric patients.

Drug Interactions

In Vitro Studies

Pregabalin, at concentrations that were, in general, 10-times those attained in clinical trials, does not inhibit human CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4 enzyme systems. In vitro drug interaction studies demonstrate that pregabalin does not induce CYP1A2 or CYP3A4 activity. Therefore, an increase in the metabolism of coadministered CYP1A2 substrates (e.g. theophylline, caffeine) or CYP 3A4 substrates (e.g., midazolam, testosterone) is not anticipated.

In Vivo Studies

The drug interaction studies described in this section were conducted in healthy adults, and across various patient populations.

Gabapentin

The pharmacokinetic interactions of pregabalin and gabapentin were investigated in 12 healthy subjects following concomitant single-dose administration of 100-mg pregabalin and 300-mg gabapentin and in 18 healthy subjects following concomitant multiple-dose administration of 200-mg pregabalin every 8 hours and 400-mg gabapentin every 8 hours. Gabapentin pharmacokinetics following single- and multiple-dose administration were unaltered by pregabalin coadministration. The extent of pregabalin absorption was unaffected by gabapentin coadministration, although there was a small reduction in rate of absorption.

Oral Contraceptive

Pregabalin coadministration (200 mg three times a day) had no effect on the steady-state pharmacokinetics of norethindrone and ethinyl estradiol (1 mg/35 µg, respectively) in healthy subjects.

Lorazepam

Multiple-dose administration of pregabalin (300 mg twice a day) in healthy subjects had no effect on the rate and extent of lorazepam single-dose pharmacokinetics and single-dose administration of lorazepam (1 mg) had no effect on the steady-state pharmacokinetics of pregabalin.

Oxycodone

Multiple-dose administration of pregabalin (300 mg twice a day) in healthy subjects had no effect on the rate and extent of oxycodone single-dose pharmacokinetics. Single-dose administration of oxycodone (10 mg) had no effect on the steady-state pharmacokinetics of pregabalin.

Ethanol

Multiple-dose administration of pregabalin (300 mg twice a day) in healthy subjects had no effect on the rate and extent of ethanol single-dose pharmacokinetics and single-dose administration of ethanol (0.7 g/kg) had no effect on the steady-state pharmacokinetics of pregabalin.

Phenytoin, carbamazepine, valproic acid, and lamotrigine

Steady-state trough plasma concentrations of phenytoin, carbamazepine and carbamazepine 10,11 epoxide, valproic acid, and lamotrigine were not affected by concomitant pregabalin (200 mg three times a day) administration.

Population pharmacokinetic analyses in patients treated with pregabalin and various concomitant medications suggest the following:

Non-Clinical Toxicology

LYRICA is contraindicated in patients with known hypersensitivity to pregabalin or any of its components. Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy.

Antacids containing magnesium trisilicate, when administered concomitantly with nitrofurantoin, reduce both the rate and extent of absorption. The mechanism for this interaction probably is adsorption of nitrofurantoin onto the surface of magnesium trisilicate.

Uricosuric drugs, such as probenecid and sulfinpyrazone, can inhibit renal tubular secretion of nitrofurantoin. The resulting increase in nitrofurantoin serum levels may increase toxicity, and the decreased urinary levels could lessen its efficacy as a urinary tract antibacterial.

5.1 Angioedema

There have been postmarketing reports of angioedema in patients during initial and chronic treatment with LYRICA. Specific symptoms included swelling of the face, mouth (tongue, lips, and gums), and neck (throat and larynx). There were reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. Discontinue LYRICA immediately in patients with these symptoms.

Exercise caution when prescribing LYRICA to patients who have had a previous episode of angioedema. In addition, patients who are taking other drugs associated with angioedema (e.g., angiotensin converting enzyme inhibitors [ACE-inhibitors]) may be at increased risk of developing angioedema.

5.2 Hypersensitivity

There have been postmarketing reports of hypersensitivity in patients shortly after initiation of treatment with LYRICA. Adverse reactions included skin redness, blisters, hives, rash, dyspnea, and wheezing. Discontinue LYRICA immediately in patients with these symptoms.

5.3 Withdrawal of Antiepileptic Drugs (AEDs)

As with all AEDs, withdraw LYRICA gradually to minimize the potential of increased seizure frequency in patients with seizure disorders. If LYRICA is discontinued, taper the drug gradually over a minimum of 1 week.

5.4 Suicidal Behavior and Ideation

Antiepileptic drugs (AEDs), including LYRICA, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Monitor patients treated with any AED for any indication for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.

The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.

The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5–100 years) in the clinical trials analyzed.

Table 2 shows absolute and relative risk by indication for all evaluated AEDs.

The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.

Anyone considering prescribing LYRICA or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

Inform patients, their caregivers, and families that LYRICA and other AEDs increase the risk of suicidal thoughts and behavior and advise them of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Report behaviors of concern immediately to healthcare providers.

5.5 Peripheral Edema

LYRICA treatment may cause peripheral edema. In short-term trials of patients without clinically significant heart or peripheral vascular disease, there was no apparent association between peripheral edema and cardiovascular complications such as hypertension or congestive heart failure. Peripheral edema was not associated with laboratory changes suggestive of deterioration in renal or hepatic function.

In controlled clinical trials the incidence of peripheral edema was 6% in the LYRICA group compared with 2% in the placebo group. In controlled clinical trials, 0.5% of LYRICA patients and 0.2% placebo patients withdrew due to peripheral edema.

Higher frequencies of weight gain and peripheral edema were observed in patients taking both LYRICA and a thiazolidinedione antidiabetic agent compared to patients taking either drug alone. The majority of patients using thiazolidinedione antidiabetic agents in the overall safety database were participants in studies of pain associated with diabetic peripheral neuropathy. In this population, peripheral edema was reported in 3% (2/60) of patients who were using thiazolidinedione antidiabetic agents only, 8% (69/859) of patients who were treated with LYRICA only, and 19% (23/120) of patients who were on both LYRICA and thiazolidinedione antidiabetic agents. Similarly, weight gain was reported in 0% (0/60) of patients on thiazolidinediones only; 4% (35/859) of patients on LYRICA only; and 7.5% (9/120) of patients on both drugs.

As the thiazolidinedione class of antidiabetic drugs can cause weight gain and/or fluid retention, possibly exacerbating or leading to heart failure, exercise caution when co-administering LYRICA and these agents.

Because there are limited data on congestive heart failure patients with New York Heart Association (NYHA) Class III or IV cardiac status, exercise caution when using LYRICA in these patients.

5.6 Dizziness and Somnolence

LYRICA may cause dizziness and somnolence. Inform patients that LYRICA-related dizziness and somnolence may impair their ability to perform tasks such as driving or operating machinery [see ].

In the LYRICA controlled trials, dizziness was experienced by 30% of LYRICA-treated patients compared to 8% of placebo-treated patients; somnolence was experienced by 23% of LYRICA-treated patients compared to 8% of placebo-treated patients. Dizziness and somnolence generally began shortly after the initiation of LYRICA therapy and occurred more frequently at higher doses. Dizziness and somnolence were the adverse reactions most frequently leading to withdrawal (4% each) from controlled studies. In LYRICA-treated patients reporting these adverse reactions in short-term, controlled studies, dizziness persisted until the last dose in 30% and somnolence persisted until the last dose in 42% of patients [see ].

5.7 Weight Gain

LYRICA treatment may cause weight gain. In LYRICA controlled clinical trials of up to 14 weeks, a gain of 7% or more over baseline weight was observed in 9% of LYRICA-treated patients and 2% of placebo-treated patients. Few patients treated with LYRICA (0.3%) withdrew from controlled trials due to weight gain. LYRICA associated weight gain was related to dose and duration of exposure, but did not appear to be associated with baseline BMI, gender, or age. Weight gain was not limited to patients with edema [see ].

Although weight gain was not associated with clinically important changes in blood pressure in short-term controlled studies, the long-term cardiovascular effects of LYRICA-associated weight gain are unknown.

Among diabetic patients, LYRICA-treated patients gained an average of 1.6 kg (range: -16 to 16 kg), compared to an average 0.3 kg (range: -10 to 9 kg) weight gain in placebo patients. In a cohort of 333 diabetic patients who received LYRICA for at least 2 years, the average weight gain was 5.2 kg.

While the effects of LYRICA-associated weight gain on glycemic control have not been systematically assessed, in controlled and longer-term open label clinical trials with diabetic patients, LYRICA treatment did not appear to be associated with loss of glycemic control (as measured by HbA1C).

5.8 Abrupt or Rapid Discontinuation

Following abrupt or rapid discontinuation of LYRICA, some patients reported symptoms including insomnia, nausea, headache, anxiety, hyperhidrosis, and diarrhea. Taper LYRICA gradually over a minimum of 1 week rather than discontinuing the drug abruptly.

5.9 Tumorigenic Potential

In standard preclinical in vivo lifetime carcinogenicity studies of LYRICA, an unexpectedly high incidence of hemangiosarcoma was identified in two different strains of mice [see ]. The clinical significance of this finding is unknown. Clinical experience during LYRICA's premarketing development provides no direct means to assess its potential for inducing tumors in humans.

In clinical studies across various patient populations, comprising 6396 patient-years of exposure in patients >12 years of age, new or worsening-preexisting tumors were reported in 57 patients. Without knowledge of the background incidence and recurrence in similar populations not treated with LYRICA, it is impossible to know whether the incidence seen in these cohorts is or is not affected by treatment.

5.10 Ophthalmological Effects

In controlled studies, a higher proportion of patients treated with LYRICA reported blurred vision (7%) than did patients treated with placebo (2%), which resolved in a majority of cases with continued dosing. Less than 1% of patients discontinued LYRICA treatment due to vision-related events (primarily blurred vision).

Prospectively planned ophthalmologic testing, including visual acuity testing, formal visual field testing and dilated funduscopic examination, was performed in over 3600 patients. In these patients, visual acuity was reduced in 7% of patients treated with LYRICA, and 5% of placebo-treated patients. Visual field changes were detected in 13% of LYRICA-treated, and 12% of placebo-treated patients. Funduscopic changes were observed in 2% of LYRICA-treated and 2% of placebo-treated patients.

Although the clinical significance of the ophthalmologic findings is unknown, inform patients to notify their physician if changes in vision occur. If visual disturbance persists, consider further assessment. Consider more frequent assessment for patients who are already routinely monitored for ocular conditions [see ].

5.11 Creatine Kinase Elevations

LYRICA treatment was associated with creatine kinase elevations. Mean changes in creatine kinase from baseline to the maximum value were 60 U/L for LYRICA-treated patients and 28 U/L for the placebo patients. In all controlled trials across multiple patient populations, 1.5% of patients on LYRICA and 0.7% of placebo patients had a value of creatine kinase at least three times the upper limit of normal. Three LYRICA treated subjects had events reported as rhabdomyolysis in premarketing clinical trials. The relationship between these myopathy events and LYRICA is not completely understood because the cases had documented factors that may have caused or contributed to these events. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if these muscle symptoms are accompanied by malaise or fever. Discontinue treatment with LYRICA if myopathy is diagnosed or suspected or if markedly elevated creatine kinase levels occur.

5.12 Decreased Platelet Count

LYRICA treatment was associated with a decrease in platelet count. LYRICA-treated subjects experienced a mean maximal decrease in platelet count of 20 × 103/µL, compared to 11 × 103/µL in placebo patients. In the overall database of controlled trials, 2% of placebo patients and 3% of LYRICA patients experienced a potentially clinically significant decrease in platelets, defined as 20% below baseline value and <150 × 103/µL. A single LYRICA treated subject developed severe thrombocytopenia with a platelet count less than 20 × 103/ µL. In randomized controlled trials, LYRICA was not associated with an increase in bleeding-related adverse reactions.

5.13 PR Interval Prolongation

LYRICA treatment was associated with PR interval prolongation. In analyses of clinical trial ECG data, the mean PR interval increase was 3–6 msec at LYRICA doses ≥300 mg/day. This mean change difference was not associated with an increased risk of PR increase ≥25% from baseline, an increased percentage of subjects with on-treatment PR >200 msec, or an increased risk of adverse reactions of second or third degree AV block.

Subgroup analyses did not identify an increased risk of PR prolongation in patients with baseline PR prolongation or in patients taking other PR prolonging medications. However, these analyses cannot be considered definitive because of the limited number of patients in these categories.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In all controlled and uncontrolled trials across various patient populations during the premarketing development of LYRICA, more than 10,000 patients have received LYRICA. Approximately 5000 patients were treated for 6 months or more, over 3100 patients were treated for 1 year or longer, and over 1400 patients were treated for at least 2 years.

Adverse Reactions Most Commonly Leading to Discontinuation in All Premarketing Controlled Clinical Studies

In premarketing controlled trials of all populations combined, 14% of patients treated with LYRICA and 7% of patients treated with placebo discontinued prematurely due to adverse reactions. In the LYRICA treatment group, the adverse reactions most frequently leading to discontinuation were dizziness (4%) and somnolence (4%). In the placebo group, 1% of patients withdrew due to dizziness and <1% withdrew due to somnolence. Other adverse reactions that led to discontinuation from controlled trials more frequently in the LYRICA group compared to the placebo group were ataxia, confusion, asthenia, thinking abnormal, blurred vision, incoordination, and peripheral edema (1% each).

Most Common Adverse Reactions in All Premarketing Controlled Clinical Studies

In premarketing controlled trials of all patient populations combined, dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and "thinking abnormal" (primarily difficulty with concentration/attention) were more commonly reported by subjects treated with LYRICA than by subjects treated with placebo (≥5% and twice the rate of that seen in placebo).

Controlled Studies with Neuropathic Pain Associated with Diabetic Peripheral Neuropathy

Adverse Reactions Leading to Discontinuation

In clinical trials in patients with neuropathic pain associated with diabetic peripheral neuropathy, 9% of patients treated with LYRICA and 4% of patients treated with placebo discontinued prematurely due to adverse reactions. In the LYRICA treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (3%) and somnolence (2%). In comparison, <1% of placebo patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring with greater frequency in the LYRICA group than in the placebo group, were asthenia, confusion, and peripheral edema. Each of these events led to withdrawal in approximately 1% of patients.

Most Common Adverse Reactions

Table 3 lists all adverse reactions, regardless of causality, occurring in ≥1% of patients with neuropathic pain associated with diabetic neuropathy in the combined LYRICA group for which the incidence was greater in this combined LYRICA group than in the placebo group. A majority of pregabalin-treated patients in clinical studies had adverse reactions with a maximum intensity of "mild" or "moderate".

Controlled Studies in Postherpetic Neuralgia

Adverse Reactions Leading to Discontinuation

In clinical trials in patients with postherpetic neuralgia, 14% of patients treated with LYRICA and 7% of patients treated with placebo discontinued prematurely due to adverse reactions. In the LYRICA treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (4%) and somnolence (3%). In comparison, less than 1% of placebo patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring in greater frequency in the LYRICA group than in the placebo group, were confusion (2%), as well as peripheral edema, asthenia, ataxia, and abnormal gait (1% each).

Most Common Adverse Reactions

Table 4 lists all adverse reactions, regardless of causality, occurring in ≥ 1% of patients with neuropathic pain associated with postherpetic neuralgia in the combined LYRICA group for which the incidence was greater in this combined LYRICA group than in the placebo group. In addition, an event is included, even if the incidence in the all LYRICA group is not greater than in the placebo group, if the incidence of the event in the 600 mg/day group is more than twice that in the placebo group. A majority of pregabalin-treated patients in clinical studies had adverse reactions with a maximum intensity of "mild" or "moderate". Overall, 12.4% of all pregabalin-treated patients and 9.0% of all placebo-treated patients had at least one severe event while 8% of pregabalin-treated patients and 4.3% of placebo-treated patients had at least one severe treatment-related adverse event.

Controlled Add-On Studies in Adjunctive Therapy for Adult Patients with Partial Onset Seizures

Adverse Reactions Leading to Discontinuation

Approximately 15% of patients receiving LYRICA and 6% of patients receiving placebo in add-on epilepsy trials discontinued prematurely due to adverse reactions. In the LYRICA treatment group, the adverse reactions most frequently leading to discontinuation were dizziness (6%), ataxia (4%), and somnolence (3%). In comparison, <1% of patients in the placebo group withdrew due to each of these events. Other adverse reactions that led to discontinuation of at least 1% of patients in the LYRICA group and at least twice as frequently compared to the placebo group were asthenia, diplopia, blurred vision, thinking abnormal, nausea, tremor, vertigo, headache, and confusion (which each led to withdrawal in 2% or less of patients).

Most Common Adverse Reactions

Table 5 lists all dose-related adverse reactions occurring in at least 2% of all LYRICA-treated patients. Dose-relatedness was defined as the incidence of the adverse event in the 600 mg/day group was at least 2% greater than the rate in both the placebo and 150 mg/day groups. In these studies, 758 patients received LYRICA and 294 patients received placebo for up to 12 weeks. Because patients were also treated with 1 to 3 other AEDs, it is not possible to determine whether the following adverse reactions can be ascribed to LYRICA alone, or the combination of LYRICA and other AEDs. A majority of pregabalin-treated patients in clinical studies had adverse reactions with a maximum intensity of "mild" or "moderate".

Controlled Studies with Fibromyalgia

Adverse Reactions Leading to Discontinuation

In clinical trials of patients with fibromyalgia, 19% of patients treated with pregabalin (150–600 mg/day) and 10% of patients treated with placebo discontinued prematurely due to adverse reactions. In the pregabalin treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (6%) and somnolence (3%). In comparison, <1% of placebo-treated patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring with greater frequency in the pregabalin treatment group than in the placebo treatment group, were fatigue, headache, balance disorder, and weight increased. Each of these adverse reactions led to withdrawal in approximately 1% of patients.

Most Common Adverse Reactions

Table 6 lists all adverse reactions, regardless of causality, occurring in ≥2% of patients with fibromyalgia in the 'all pregabalin' treatment group for which the incidence was greater than in the placebo treatment group. A majority of pregabalin-treated patients in clinical studies experienced adverse reactions with a maximum intensity of "mild" or "moderate".

Controlled Studies in Neuropathic Pain Associated with Spinal Cord Injury

Adverse Reactions Leading to Discontinuation

In clinical trials of patients with neuropathic pain associated with spinal cord injury, 13% of patients treated with pregabalin and 10% of patients treated with placebo discontinued prematurely due to adverse reactions. In the pregabalin treatment group, the most common reasons for discontinuation due to adverse reactions were somnolence (3%) and edema (2%). In comparison, none of the placebo-treated patients withdrew due to somnolence and edema. Other reasons for discontinuation from the trials, occurring with greater frequency in the pregabalin treatment group than in the placebo treatment group, were fatigue and balance disorder. Each of these adverse reactions led to withdrawal in less than 2% of patients.

Most Common Adverse Reactions

Table 7 lists all adverse reactions, regardless of causality, occurring in ≥2% of patients with neuropathic pain associated with spinal cord injury in the controlled trials. A majority of pregabalin-treated patients in clinical studies experienced adverse reactions with a maximum intensity of "mild" or "moderate".

Other Adverse Reactions Observed During the Clinical Studies of LYRICA

Following is a list of treatment-emergent adverse reactions reported by patients treated with LYRICA during all clinical trials. The listing does not include those events already listed in the previous tables or elsewhere in labeling, those events for which a drug cause was remote, those events which were so general as to be uninformative, and those events reported only once which did not have a substantial probability of being acutely life-threatening.

Events are categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse reactions are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1000 patients; rare reactions are those occurring in fewer than 1/1000 patients. Events of major clinical importance are described in the Warnings and Precautions section (5).

Body as a Whole – Frequent: Abdominal pain, Allergic reaction, Fever, Infrequent: Abscess, Cellulitis, Chills, Malaise, Neck rigidity, Overdose, Pelvic pain, Photosensitivity reaction, Rare: Anaphylactoid reaction, Ascites, Granuloma, Hangover effect, Intentional Injury, Retroperitoneal Fibrosis, Shock

Cardiovascular System – Infrequent: Deep thrombophlebitis, Heart failure, Hypotension, Postural hypotension, Retinal vascular disorder, Syncope; Rare: ST Depressed, Ventricular Fibrillation

Digestive System – Frequent: Gastroenteritis, Increased appetite; Infrequent: Cholecystitis, Cholelithiasis, Colitis, Dysphagia, Esophagitis, Gastritis, Gastrointestinal hemorrhage, Melena, Mouth ulceration, Pancreatitis, Rectal hemorrhage, Tongue edema; Rare: Aphthous stomatitis, Esophageal Ulcer, Periodontal abscess

Hemic and Lymphatic System – Frequent: Ecchymosis; Infrequent: Anemia, Eosinophilia, Hypochromic anemia, Leukocytosis, Leukopenia, Lymphadenopathy, Thrombocytopenia; Rare: Myelofibrosis, Polycythemia, Prothrombin decreased, Purpura, Thrombocythemia

Metabolic and Nutritional Disorders – Rare: Glucose Tolerance Decreased, Urate Crystalluria

Musculoskeletal System – Frequent: Arthralgia, Leg cramps, Myalgia, Myasthenia; Infrequent: Arthrosis; Rare: Chondrodystrophy, Generalized Spasm

Nervous System – Frequent: Anxiety, Depersonalization, Hypertonia, Hypoesthesia, Libido decreased, Nystagmus, Paresthesia, Sedation, Stupor, Twitching; Infrequent: Abnormal dreams, Agitation, Apathy, Aphasia, Circumoral paresthesia, Dysarthria, Hallucinations, Hostility, Hyperalgesia, Hyperesthesia, Hyperkinesia, Hypokinesia, Hypotonia, Libido increased, Myoclonus, Neuralgia, Rare: Addiction, Cerebellar syndrome, Cogwheel rigidity, Coma, Delirium, Delusions, Dysautonomia, Dyskinesia, Dystonia, Encephalopathy, Extrapyramidal syndrome, Guillain-Barré syndrome, Hypalgesia, Intracranial hypertension, Manic reaction, Paranoid reaction, Peripheral neuritis, Personality disorder, Psychotic depression, Schizophrenic reaction, Sleep disorder, Torticollis, Trismus

Respiratory System – Rare: Apnea, Atelectasis, Bronchiolitis, Hiccup, Laryngismus, Lung edema, Lung fibrosis, Yawn

Skin and Appendages – Frequent: Pruritus, Infrequent: Alopecia, Dry skin, Eczema, Hirsutism, Skin ulcer, Urticaria, Vesiculobullous rash; Rare: Angioedema, Exfoliative dermatitis, Lichenoid dermatitis, Melanosis, Nail Disorder, Petechial rash, Purpuric rash, Pustular rash, Skin atrophy, Skin necrosis, Skin nodule, Stevens-Johnson syndrome, Subcutaneous nodule

Special senses – Frequent: Conjunctivitis, Diplopia, Otitis media, Tinnitus; Infrequent: Abnormality of accommodation, Blepharitis, Dry eyes, Eye hemorrhage, Hyperacusis, Photophobia, Retinal edema, Taste loss, Taste perversion; Rare: Anisocoria, Blindness, Corneal ulcer, Exophthalmos, Extraocular palsy, Iritis, Keratitis, Keratoconjunctivitis, Miosis, Mydriasis, Night blindness, Ophthalmoplegia, Optic atrophy, Papilledema, Parosmia, Ptosis, Uveitis

Urogenital System – Frequent: Anorgasmia, Impotence, Urinary frequency, Urinary incontinence; Infrequent: Abnormal ejaculation, Albuminuria, Amenorrhea, Dysmenorrhea, Dysuria, Hematuria, Kidney calculus, Leukorrhea, Menorrhagia, Metrorrhagia, Nephritis, Oliguria, Urinary retention, Urine abnormality; Rare: Acute kidney failure, Balanitis, Bladder Neoplasm, Cervicitis, Dyspareunia, Epididymitis, Female lactation, Glomerulitis, Ovarian disorder, Pyelonephritis

Comparison of Gender and Race

The overall adverse event profile of pregabalin was similar between women and men. There are insufficient data to support a statement regarding the distribution of adverse experience reports by race.

6.2 Post-marketing Experience

The following adverse reactions have been identified during postapproval use of LYRICA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Nervous System Disorders – Headache

Gastrointestinal Disorders – Nausea, Diarrhea

Reproductive System and Breast Disorders – Gynecomastia, Breast Enlargement

In addition, there are post-marketing reports of events related to reduced lower gastrointestinal tract function (e.g., intestinal obstruction, paralytic ileus, constipation) when LYRICA was co-administered with medications that have the potential to produce constipation, such as opioid analgesics. There are also post-marketing reports of respiratory failure and coma in patients taking pregabalin and other CNS depressant medications.

Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

Review

Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

Tips

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

Disclaimer:

PREGABALIN

Overview

What is PREGABALIN?

What does PREGABALIN look like?

What are the available doses of PREGABALIN?

What should I talk to my health care provider before I take PREGABALIN?

How should I use PREGABALIN?

What interacts with PREGABALIN?

What are the warnings of PREGABALIN?

What are the precautions of PREGABALIN?

What are the side effects of PREGABALIN?

What should I look out for while using PREGABALIN?

What might happen if I take too much PREGABALIN?

How should I store and handle PREGABALIN?

Clinical Information

Chemical Structure

Clinical Pharmacology

Non-Clinical Toxicology

Reference

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

Review

Rate this treatment and share your opinion

Helpful tips to write a good review:

Reason for Taking This Treatment

Click the stars to rate this treatment

Effectiveness (required)

Ease of Use (required)

Satisfaction (required)

Write a brief description of your experience with this treatment:

Optional Information

User Reviews & Ratings - losartan oral

«losartan oral Information

Overall User Ratings

User Reviews
Learn about User Reviews

Related to losartan oral

Professional

Tips

Interactions

Follow Us Here

Disclaimer:

PREGABALIN

Overview

What is PREGABALIN?

What does PREGABALIN look like?

What are the available doses of PREGABALIN?

What should I talk to my health care provider before I take PREGABALIN?

How should I use PREGABALIN?

What interacts with PREGABALIN?

What are the warnings of PREGABALIN?

What are the precautions of PREGABALIN?

What are the side effects of PREGABALIN?

What should I look out for while using PREGABALIN?

What might happen if I take too much PREGABALIN?

How should I store and handle PREGABALIN?

Clinical Information

Chemical Structure

Clinical Pharmacology

Non-Clinical Toxicology

Reference

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

Review

Rate this treatment and share your opinion

Helpful tips to write a good review:

Reason for Taking This Treatment

Click the stars to rate this treatment

Effectiveness (required)

Ease of Use (required)

Satisfaction (required)

Write a brief description of your experience with this treatment:

Optional Information

User Reviews & Ratings - losartan oral

«losartan oral Information

Overall User Ratings

User Reviews Learn about User Reviews

Related to losartan oral

Professional

Tips

Interactions

Follow Us Here

User Reviews
Learn about User Reviews