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OMEPRAZOLE DR
Overview
What is OMEPRAZOLE DR?
The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:
Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions.
Omeprazole Delayed-Release Capsules meet USP Dissolution Test 2.
Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: magnesium hydroxide, mannitol, methacrylic acid copolymer dispersion, povidone and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, red iron oxide and titanium dioxide. The capsule imprinting ink contains ammonium hydroxide, black iron oxide, ethyl alcohol, isopropyl alcohol, n-butyl alcohol, potassium hydroxide, propylene glycol and shellac.
What does OMEPRAZOLE DR look like?
What are the available doses of OMEPRAZOLE DR?
Omeprazole delayed-release capsules, USP 10 mg are hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 010” is imprinted on each capsule in black ink.
Omeprazole delayed-release capsules, USP 20 mg are hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink.
Omeprazole delayed-release capsules, USP 40 mg are hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 040” is imprinted on each capsule in black ink.
What should I talk to my health care provider before I take OMEPRAZOLE DR?
8.1 Pregnancy
Pregnancy Category C
Risk Summary
There are no adequate and well-controlled studies with omeprazole in pregnant women. Available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use. Reproduction studies in rats and rabbits resulted in dose-dependent embryolethality at omeprazole doses that were approximately 5.5 to 56 times higher than the human dose. Omeprazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Human Data
Four epidemiological studies compared the frequency of congenital abnormalities among infants born to women who used omeprazole during pregnancy with the frequency of abnormalities among infants of women exposed to H2-receptor antagonists or other controls.
A population-based retrospective cohort epidemiological study from the Swedish Medical Birth Registry, covering approximately 99% of pregnancies, from 1995 to 99, reported on 955 infants (824 exposed during the first trimester with 39 of these exposed beyond first trimester, and 131 exposed after the first trimester) whose mothers used omeprazole during pregnancy. The number of infants exposed in utero to omeprazole that had any malformation, low birth weight, low Apgar score, or hospitalization was similar to the number observed in this population. The number of infants born with ventricular septal defects and the number of stillborn infants was slightly higher in the omeprazole-exposed infants than the expected number in this population.
A population-based retrospective cohort study covering all live births in Denmark from 1996 to 2009, reported on 1,800 live births whose mothers used omeprazole during the first trimester of pregnancy and 837, 317 live births whose mothers did not use any proton pump inhibitor. The overall rate of birth defects in infants born to mothers with first trimester exposure to omeprazole was 2.9% and 2.6% in infants born to mothers not exposed to any proton pump inhibitor during the first trimester.
A retrospective cohort study reported on 689 pregnant women exposed to either H2-blockers or omeprazole in the first trimester (134 exposed to omeprazole) and 1,572 pregnant women unexposed to either during the first trimester. The overall malformation rate in offspring born to mothers with first trimester exposure to omeprazole, an H2-blocker, or were unexposed was 3.6%, 5.5%, and 4.1% respectively.
A small prospective observational cohort study followed 113 women exposed to omeprazole during pregnancy (89% first trimester exposures). The reported rate of major congenital malformations was 4% in the omeprazole group, 2% in controls exposed to non-teratogens, and 2.8% in disease-paired controls. Rates of spontaneous and elective abortions, preterm deliveries, gestational age at delivery, and mean birth weight were similar among the groups.
Several studies have reported no apparent adverse short-term effects on the infant when single dose oral or intravenous omeprazole was administered to over 200 pregnant women as premedication for cesarean section under general anesthesia.
Animal Data
Reproductive studies conducted with omeprazole in rats at oral doses up to 138 mg/kg/day (about 56 times the human dose on a body surface area basis) and in rabbits at doses up to 69 mg/kg/day (about 56 times the human dose on a body surface area basis) did not disclose any evidence for a teratogenic potential of omeprazole. In rabbits, omeprazole in a dose range of 6.9 to 69.1 mg/kg/day (about 5.5 to 56 times the human dose on a body surface area basis) produced dose-related increases in embryo-lethality, fetal resorptions, and pregnancy disruptions. In rats, dose-related embryo/fetal toxicity and postnatal developmental toxicity were observed in offspring resulting from parents treated with omeprazole at 13.8 to 138.0 mg/kg/day (about 5.6 to 56 times the human doses on a body surface area basis).
8.3 Nursing Mothers
Omeprazole is present in human milk. Omeprazole concentrations were measured in breast milk of a woman following oral administration of 20 mg. The peak concentration of omeprazole in breast milk was less than 7% of the peak serum concentration. This concentration would correspond to 0.004 mg of omeprazole in 200 mL of milk. Caution should be exercised when omeprazole is administered to a nursing woman.
8.4 Pediatric Use
Use of omeprazole in pediatric and adolescent patients 2 to 16 years of age for the treatment of GERD and maintenance of healing of erosive esophagitis is supported by a) extrapolation of results from adequate and well-controlled studies that supported the approval of omeprazole for adults, and b) safety and pharmacokinetic studies performed in pediatric and adolescent patients. [See Clinical Pharmacology, Pharmacokinetics, Pediatric for pharmacokinetic information (12.3) and Dosage and Administration (2), Adverse Reactions (6.1) and Clinical Studies, (14.6)]. The safety and effectiveness of omeprazole for the treatment of GERD in patients <1 year of age have not been established. The safety and effectiveness of omeprazole for other pediatric uses have not been established.
8.5 Geriatric Use
Omeprazole was administered to over 2000 elderly individuals (≥ 65 years of age) in clinical trials in the U.S. and Europe. There were no differences in safety and effectiveness between the elderly and younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.
Pharmacokinetic studies have shown the elimination rate was somewhat decreased in the elderly and bioavailability was increased. The plasma clearance of omeprazole was 250 mL/min (about half that of young volunteers) and its plasma half-life averaged one hour, about twice that of young healthy volunteers. However, no dosage adjustment is necessary in the elderly. [See Clinical Pharmacology (12.3)]
8.6 Hepatic Impairment
Consider dose reduction, particularly for maintenance of healing of erosive esophagitis. [See Clinical Pharmacology (12.3)]
8.7 Renal Impairment
No dosage reduction is necessary. [See Clinical Pharmacology (12.3)]
8.8 Asian Population
Consider dose reduction, particularly for maintenance of healing of erosive esophagitis. [See Clinical Pharmacology (12.3)]
How should I use OMEPRAZOLE DR?
1.1 Duodenal Ulcer (adults)
Omeprazole delayed-release capsules, USP are indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.
Omeprazole delayed-release capsules, USP, in combination with clarithromycin and amoxicillin, are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate H. pylori in adults.
Omeprazole delayed-release capsules, USP, in combination with clarithromycin are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori in adults.
Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.1) and Dosage and Administration (2)].
Among patients who fail therapy, omeprazole delayed-release capsules with clarithromycin are more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted. [See Microbiology section (12.4)], and the clarithromycin package insert, Microbiology section.)
1.2 Gastric Ulcer (adults)
Omeprazole delayed-release capsules, USP are indicated for short-term treatment (4 to 8 weeks) of active benign gastric ulcer in adults. [See Clinical Studies (14.2)]
1.3 Treatment of Gastroesophageal Reflux Disease (GERD) (adults and pediatric patients)
Symptomatic GERD
Omeprazole delayed-release capsules, USP are indicated for the treatment of heartburn and other symptoms associated with GERD in pediatric patients and adults.
Erosive Esophagitis
Omeprazole delayed-release capsules, USP are indicated for the short-term treatment (4 to 8 weeks) of erosive esophagitis that has been diagnosed by endoscopy in pediatric patients and adults. [See Clinical Studies (14.4)]
The efficacy of omeprazole delayed-release capsules, USP used for longer than 8 weeks in these patients has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of erosive esophagitis or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of omeprazole may be considered.
1.4 Maintenance of Healing of Erosive Esophagitis (adults)
Omeprazole delayed-release capsules, USP are indicated to maintain healing of erosive esophagitis in pediatric patients and adults.
Controlled studies do not extend beyond 12 months. [See Clinical Studies (14.4)]
1.5 Pathological Hypersecretory Conditions
Omeprazole delayed-release capsules, USP are indicated for the long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults.
Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.
Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.
For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and Administration (2.8)].
2.1 Short-Term Treatment of Active Duodenal Ulcer
The recommended adult oral dose of omeprazole delayed-release capsules are 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.
2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence
Triple Therapy (omeprazole/clarithromycin/amoxicillin)
The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.
Dual Therapy (omeprazole/clarithromycin)
The recommended adult oral regimen is omeprazoledelayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.
2.3 Gastric Ulcer
The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.
2.4 Gastroesophageal Reflux Disease (GERD
The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.
2.5 Maintenance of Healing of Erosive Esophagitis
The recommended adult oral dose is 20 mg daily. [See Clinical Studies (14.4)]
2.6 Pathological Hypersecretory Conditions
The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.
2.7 Pediatric Patients
For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:
On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.
Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].
2.8 Alternative Administration Options
Omeprazole is available as a delayed-release capsule.
For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce.
One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.
What interacts with OMEPRAZOLE DR?
Omeprazole delayed-release capsules are contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, and urticaria [See Adverse Reactions (6)].
For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with omeprazole, refer to the section of their package inserts.
What are the warnings of OMEPRAZOLE DR?
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What are the precautions of OMEPRAZOLE DR?
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What are the side effects of OMEPRAZOLE DR?
6.1 Clinical Trials Experience with Omeprazole Monotherapy
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.
The safety data described below reflects exposure to omeprazole delayed-release capsules in 3096 patients from worldwide clinical trials (465 patients from US studies and 2,631 patients from international studies). Indications clinically studied in US trials included duodenal ulcer, resistant ulcer, and Zollinger-Ellison syndrome. The international clinical trials were double blind and open-label in design. The most common adverse reactions reported (i.e., with an incidence rate ≥ 2%) from omeprazole-treated patients enrolled in these studies included headache (6.9%), abdominal pain (5.2%), nausea (4.0%), diarrhea (3.7%), vomiting (3.2%), and flatulence (2.7%).
Additional adverse reactions that were reported with an incidence ≥1% included acid regurgitation (1.9%), upper respiratory infection (1.9%), constipation (1.5%), dizziness (1.5%), rash (1.5%), asthenia (1.3%), back pain (1.1%), and cough (1.1%).
The clinical trial safety profile in patients greater than 65 years of age was similar to that in patients 65 years of age or less. The clinical trial safety profile in pediatric patients who received omeprazole delayed-release capsules was similar to that in adult patients. Unique to the pediatric population, however, adverse reactions of the respiratory system were most frequently reported in the 2 to 16 year age group (18.5%). Similarly, accidental injuries were reported frequently in the 2 to 16 year age group (3.8%). [See Use in Specific Populations (8.4)]
6.2 Clinical Trials Experience with Omeprazole in Combination Therapy for H. pylori Eradication
In clinical trials using either dual therapy with omeprazole and clarithromycin, or triple therapy with omeprazole, clarithromycin, and amoxicillin, no adverse reactions unique to these drug combinations were observed. Adverse reactions observed were limited to those previously reported with omeprazole, clarithromycin, or amoxicillin alone.
Dual Therapy (omeprazole/clarithromycin)
Adverse reactions observed in controlled clinical trials using combination therapy with omeprazole and clarithromycin (n = 346) that differed from those previously described for omeprazole alone were taste perversion (15%), tongue discoloration (2%), rhinitis (2%), pharyngitis (1%) and flu-syndrome (1%). (For more information on clarithromycin, refer to the clarithromycin prescribing information, Adverse Reactions section).
Triple Therapy (omeprazole/clarithromycin/amoxicillin)
The most frequent adverse reactions observed in clinical trials using combination therapy with omeprazole, clarithromycin, and amoxicillin (n = 274) were diarrhea (14%), taste perversion (10%), and headache (7%). None of these occurred at a higher frequency than that reported by patients taking antimicrobial agents alone. (For more information on clarithromycin or amoxicillin, refer to the respective prescribing information, Adverse Reactions sections).
6.3 Post-marketing Experience
The following adverse reactions have been identified during post-approval use of omeprazole delayed-release capsules. Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their actual frequency or establish a causal relationship to drug exposure.
Body As a Whole:
Cardiovascular:
Endocrine
Gastrointestinal:
Hepatic:
Infections and Infestations:
Metabolism and Nutritional disorders:
Musculoskeletal:
Nervous System/Psychiatric:
Respiratory
Skin:
Special Senses:
Ocular
Urogenital:
Hematologic:
What should I look out for while using OMEPRAZOLE DR?
Omeprazole delayed-release capsules are contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, and urticaria [See Adverse Reactions (6)].
For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with omeprazole, refer to the
section of their package inserts.
What might happen if I take too much OMEPRAZOLE DR?
Reports have been received of overdosage with omeprazole in humans. Doses ranged up to 2400 mg (120 times the usual recommended clinical dose). Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, vomiting, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen in normal clinical experience. [See Adverse Reactions (6)] Symptoms were transient, and no serious clinical outcome has been reported when omeprazole was taken alone. No specific antidote for omeprazole overdosage is known. Omeprazole is extensively protein bound and is, therefore, not readily dialyzable. In the event of overdosage, treatment should be symptomatic and supportive.
As with the management of any overdose, the possibility of multiple drug ingestion should be considered. For current information on treatment of any drug overdose, contact a Poison Control Center at 1-800-222-1222.
Single oral doses of omeprazole at 1350, 1339, and 1200 mg/kg were lethal to mice, rats, and dogs, respectively. Animals given these doses showed sedation, ptosis, tremors, convulsions, and decreased activity, body temperature, and respiratory rate and increased depth of respiration.
How should I store and handle OMEPRAZOLE DR?
One-vial formulation (Injection)Store between 15°C and 25°C (59°F and 77°F); Retain in the original package to protect from light. Freezing does not adversely affect the product.After initial puncture, Docetaxel Injection multiple dose vials are stable for 28 days when stored at room temperature, with protection from light.One-vial formulation (Injection)Store between 15°C and 25°C (59°F and 77°F); Retain in the original package to protect from light. Freezing does not adversely affect the product.After initial puncture, Docetaxel Injection multiple dose vials are stable for 28 days when stored at room temperature, with protection from light.One-vial formulation (Injection)Store between 15°C and 25°C (59°F and 77°F); Retain in the original package to protect from light. Freezing does not adversely affect the product.After initial puncture, Docetaxel Injection multiple dose vials are stable for 28 days when stored at room temperature, with protection from light.Omeprazole delayed-release capsules, USP 10 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 010” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0145-0) Bottles of 100 (NDC 60505-0145-2) Bottles of 1000 (NDC 60505-0145-1) Blisters of 70 (NDC 60505-0145-3) Blisters of 100 (NDC 60505-0145-7)Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0065-0) Bottles of 100 (NDC 60505-0065-2) Bottles of 500 (NDC 60505-0065-5) Bottles of 1000 (NDC 60505-0065-1) Bottles of 5000 (NDC 60505-0065-8) Blisters of 70 (NDC 60505-0065-3) Blisters of 100 (NDC 60505-0065-7)Omeprazole delayed-release capsules, USP 40 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 040” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0146-0) Bottles of 90 (NDC 60505-0146-9) Bottles of 100 (NDC 60505-0146-2) Bottles of 500 (NDC 60505-0146-1)StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 010” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0145-0) Bottles of 100 (NDC 60505-0145-2) Bottles of 1000 (NDC 60505-0145-1) Blisters of 70 (NDC 60505-0145-3) Blisters of 100 (NDC 60505-0145-7)Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0065-0) Bottles of 100 (NDC 60505-0065-2) Bottles of 500 (NDC 60505-0065-5) Bottles of 1000 (NDC 60505-0065-1) Bottles of 5000 (NDC 60505-0065-8) Blisters of 70 (NDC 60505-0065-3) Blisters of 100 (NDC 60505-0065-7)Omeprazole delayed-release capsules, USP 40 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 040” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0146-0) Bottles of 90 (NDC 60505-0146-9) Bottles of 100 (NDC 60505-0146-2) Bottles of 500 (NDC 60505-0146-1)StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 010” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0145-0) Bottles of 100 (NDC 60505-0145-2) Bottles of 1000 (NDC 60505-0145-1) Blisters of 70 (NDC 60505-0145-3) Blisters of 100 (NDC 60505-0145-7)Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0065-0) Bottles of 100 (NDC 60505-0065-2) Bottles of 500 (NDC 60505-0065-5) Bottles of 1000 (NDC 60505-0065-1) Bottles of 5000 (NDC 60505-0065-8) Blisters of 70 (NDC 60505-0065-3) Blisters of 100 (NDC 60505-0065-7)Omeprazole delayed-release capsules, USP 40 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 040” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0146-0) Bottles of 90 (NDC 60505-0146-9) Bottles of 100 (NDC 60505-0146-2) Bottles of 500 (NDC 60505-0146-1)StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 010” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0145-0) Bottles of 100 (NDC 60505-0145-2) Bottles of 1000 (NDC 60505-0145-1) Blisters of 70 (NDC 60505-0145-3) Blisters of 100 (NDC 60505-0145-7)Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0065-0) Bottles of 100 (NDC 60505-0065-2) Bottles of 500 (NDC 60505-0065-5) Bottles of 1000 (NDC 60505-0065-1) Bottles of 5000 (NDC 60505-0065-8) Blisters of 70 (NDC 60505-0065-3) Blisters of 100 (NDC 60505-0065-7)Omeprazole delayed-release capsules, USP 40 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 040” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0146-0) Bottles of 90 (NDC 60505-0146-9) Bottles of 100 (NDC 60505-0146-2) Bottles of 500 (NDC 60505-0146-1)StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 010” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0145-0) Bottles of 100 (NDC 60505-0145-2) Bottles of 1000 (NDC 60505-0145-1) Blisters of 70 (NDC 60505-0145-3) Blisters of 100 (NDC 60505-0145-7)Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0065-0) Bottles of 100 (NDC 60505-0065-2) Bottles of 500 (NDC 60505-0065-5) Bottles of 1000 (NDC 60505-0065-1) Bottles of 5000 (NDC 60505-0065-8) Blisters of 70 (NDC 60505-0065-3) Blisters of 100 (NDC 60505-0065-7)Omeprazole delayed-release capsules, USP 40 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 040” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0146-0) Bottles of 90 (NDC 60505-0146-9) Bottles of 100 (NDC 60505-0146-2) Bottles of 500 (NDC 60505-0146-1)StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 010” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0145-0) Bottles of 100 (NDC 60505-0145-2) Bottles of 1000 (NDC 60505-0145-1) Blisters of 70 (NDC 60505-0145-3) Blisters of 100 (NDC 60505-0145-7)Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0065-0) Bottles of 100 (NDC 60505-0065-2) Bottles of 500 (NDC 60505-0065-5) Bottles of 1000 (NDC 60505-0065-1) Bottles of 5000 (NDC 60505-0065-8) Blisters of 70 (NDC 60505-0065-3) Blisters of 100 (NDC 60505-0065-7)Omeprazole delayed-release capsules, USP 40 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 040” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0146-0) Bottles of 90 (NDC 60505-0146-9) Bottles of 100 (NDC 60505-0146-2) Bottles of 500 (NDC 60505-0146-1)StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 010” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0145-0) Bottles of 100 (NDC 60505-0145-2) Bottles of 1000 (NDC 60505-0145-1) Blisters of 70 (NDC 60505-0145-3) Blisters of 100 (NDC 60505-0145-7)Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0065-0) Bottles of 100 (NDC 60505-0065-2) Bottles of 500 (NDC 60505-0065-5) Bottles of 1000 (NDC 60505-0065-1) Bottles of 5000 (NDC 60505-0065-8) Blisters of 70 (NDC 60505-0065-3) Blisters of 100 (NDC 60505-0065-7)Omeprazole delayed-release capsules, USP 40 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 040” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0146-0) Bottles of 90 (NDC 60505-0146-9) Bottles of 100 (NDC 60505-0146-2) Bottles of 500 (NDC 60505-0146-1)StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 010” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0145-0) Bottles of 100 (NDC 60505-0145-2) Bottles of 1000 (NDC 60505-0145-1) Blisters of 70 (NDC 60505-0145-3) Blisters of 100 (NDC 60505-0145-7)Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0065-0) Bottles of 100 (NDC 60505-0065-2) Bottles of 500 (NDC 60505-0065-5) Bottles of 1000 (NDC 60505-0065-1) Bottles of 5000 (NDC 60505-0065-8) Blisters of 70 (NDC 60505-0065-3) Blisters of 100 (NDC 60505-0065-7)Omeprazole delayed-release capsules, USP 40 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 040” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0146-0) Bottles of 90 (NDC 60505-0146-9) Bottles of 100 (NDC 60505-0146-2) Bottles of 500 (NDC 60505-0146-1)StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 010” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0145-0) Bottles of 100 (NDC 60505-0145-2) Bottles of 1000 (NDC 60505-0145-1) Blisters of 70 (NDC 60505-0145-3) Blisters of 100 (NDC 60505-0145-7)Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0065-0) Bottles of 100 (NDC 60505-0065-2) Bottles of 500 (NDC 60505-0065-5) Bottles of 1000 (NDC 60505-0065-1) Bottles of 5000 (NDC 60505-0065-8) Blisters of 70 (NDC 60505-0065-3) Blisters of 100 (NDC 60505-0065-7)Omeprazole delayed-release capsules, USP 40 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 040” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0146-0) Bottles of 90 (NDC 60505-0146-9) Bottles of 100 (NDC 60505-0146-2) Bottles of 500 (NDC 60505-0146-1)StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 010” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0145-0) Bottles of 100 (NDC 60505-0145-2) Bottles of 1000 (NDC 60505-0145-1) Blisters of 70 (NDC 60505-0145-3) Blisters of 100 (NDC 60505-0145-7)Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0065-0) Bottles of 100 (NDC 60505-0065-2) Bottles of 500 (NDC 60505-0065-5) Bottles of 1000 (NDC 60505-0065-1) Bottles of 5000 (NDC 60505-0065-8) Blisters of 70 (NDC 60505-0065-3) Blisters of 100 (NDC 60505-0065-7)Omeprazole delayed-release capsules, USP 40 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 040” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0146-0) Bottles of 90 (NDC 60505-0146-9) Bottles of 100 (NDC 60505-0146-2) Bottles of 500 (NDC 60505-0146-1)StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 010” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0145-0) Bottles of 100 (NDC 60505-0145-2) Bottles of 1000 (NDC 60505-0145-1) Blisters of 70 (NDC 60505-0145-3) Blisters of 100 (NDC 60505-0145-7)Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0065-0) Bottles of 100 (NDC 60505-0065-2) Bottles of 500 (NDC 60505-0065-5) Bottles of 1000 (NDC 60505-0065-1) Bottles of 5000 (NDC 60505-0065-8) Blisters of 70 (NDC 60505-0065-3) Blisters of 100 (NDC 60505-0065-7)Omeprazole delayed-release capsules, USP 40 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 040” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0146-0) Bottles of 90 (NDC 60505-0146-9) Bottles of 100 (NDC 60505-0146-2) Bottles of 500 (NDC 60505-0146-1)StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 010” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0145-0) Bottles of 100 (NDC 60505-0145-2) Bottles of 1000 (NDC 60505-0145-1) Blisters of 70 (NDC 60505-0145-3) Blisters of 100 (NDC 60505-0145-7)Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0065-0) Bottles of 100 (NDC 60505-0065-2) Bottles of 500 (NDC 60505-0065-5) Bottles of 1000 (NDC 60505-0065-1) Bottles of 5000 (NDC 60505-0065-8) Blisters of 70 (NDC 60505-0065-3) Blisters of 100 (NDC 60505-0065-7)Omeprazole delayed-release capsules, USP 40 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 040” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0146-0) Bottles of 90 (NDC 60505-0146-9) Bottles of 100 (NDC 60505-0146-2) Bottles of 500 (NDC 60505-0146-1)StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 010” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0145-0) Bottles of 100 (NDC 60505-0145-2) Bottles of 1000 (NDC 60505-0145-1) Blisters of 70 (NDC 60505-0145-3) Blisters of 100 (NDC 60505-0145-7)Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0065-0) Bottles of 100 (NDC 60505-0065-2) Bottles of 500 (NDC 60505-0065-5) Bottles of 1000 (NDC 60505-0065-1) Bottles of 5000 (NDC 60505-0065-8) Blisters of 70 (NDC 60505-0065-3) Blisters of 100 (NDC 60505-0065-7)Omeprazole delayed-release capsules, USP 40 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 040” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0146-0) Bottles of 90 (NDC 60505-0146-9) Bottles of 100 (NDC 60505-0146-2) Bottles of 500 (NDC 60505-0146-1)StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 010” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0145-0) Bottles of 100 (NDC 60505-0145-2) Bottles of 1000 (NDC 60505-0145-1) Blisters of 70 (NDC 60505-0145-3) Blisters of 100 (NDC 60505-0145-7)Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0065-0) Bottles of 100 (NDC 60505-0065-2) Bottles of 500 (NDC 60505-0065-5) Bottles of 1000 (NDC 60505-0065-1) Bottles of 5000 (NDC 60505-0065-8) Blisters of 70 (NDC 60505-0065-3) Blisters of 100 (NDC 60505-0065-7)Omeprazole delayed-release capsules, USP 40 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 040” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0146-0) Bottles of 90 (NDC 60505-0146-9) Bottles of 100 (NDC 60505-0146-2) Bottles of 500 (NDC 60505-0146-1)StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 010” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0145-0) Bottles of 100 (NDC 60505-0145-2) Bottles of 1000 (NDC 60505-0145-1) Blisters of 70 (NDC 60505-0145-3) Blisters of 100 (NDC 60505-0145-7)Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0065-0) Bottles of 100 (NDC 60505-0065-2) Bottles of 500 (NDC 60505-0065-5) Bottles of 1000 (NDC 60505-0065-1) Bottles of 5000 (NDC 60505-0065-8) Blisters of 70 (NDC 60505-0065-3) Blisters of 100 (NDC 60505-0065-7)Omeprazole delayed-release capsules, USP 40 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 040” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0146-0) Bottles of 90 (NDC 60505-0146-9) Bottles of 100 (NDC 60505-0146-2) Bottles of 500 (NDC 60505-0146-1)StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 010” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0145-0) Bottles of 100 (NDC 60505-0145-2) Bottles of 1000 (NDC 60505-0145-1) Blisters of 70 (NDC 60505-0145-3) Blisters of 100 (NDC 60505-0145-7)Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0065-0) Bottles of 100 (NDC 60505-0065-2) Bottles of 500 (NDC 60505-0065-5) Bottles of 1000 (NDC 60505-0065-1) Bottles of 5000 (NDC 60505-0065-8) Blisters of 70 (NDC 60505-0065-3) Blisters of 100 (NDC 60505-0065-7)Omeprazole delayed-release capsules, USP 40 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 040” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0146-0) Bottles of 90 (NDC 60505-0146-9) Bottles of 100 (NDC 60505-0146-2) Bottles of 500 (NDC 60505-0146-1)StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 010” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0145-0) Bottles of 100 (NDC 60505-0145-2) Bottles of 1000 (NDC 60505-0145-1) Blisters of 70 (NDC 60505-0145-3) Blisters of 100 (NDC 60505-0145-7)Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0065-0) Bottles of 100 (NDC 60505-0065-2) Bottles of 500 (NDC 60505-0065-5) Bottles of 1000 (NDC 60505-0065-1) Bottles of 5000 (NDC 60505-0065-8) Blisters of 70 (NDC 60505-0065-3) Blisters of 100 (NDC 60505-0065-7)Omeprazole delayed-release capsules, USP 40 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 040” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0146-0) Bottles of 90 (NDC 60505-0146-9) Bottles of 100 (NDC 60505-0146-2) Bottles of 500 (NDC 60505-0146-1)StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 010” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0145-0) Bottles of 100 (NDC 60505-0145-2) Bottles of 1000 (NDC 60505-0145-1) Blisters of 70 (NDC 60505-0145-3) Blisters of 100 (NDC 60505-0145-7)Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0065-0) Bottles of 100 (NDC 60505-0065-2) Bottles of 500 (NDC 60505-0065-5) Bottles of 1000 (NDC 60505-0065-1) Bottles of 5000 (NDC 60505-0065-8) Blisters of 70 (NDC 60505-0065-3) Blisters of 100 (NDC 60505-0065-7)Omeprazole delayed-release capsules, USP 40 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 040” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0146-0) Bottles of 90 (NDC 60505-0146-9) Bottles of 100 (NDC 60505-0146-2) Bottles of 500 (NDC 60505-0146-1)StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 010” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0145-0) Bottles of 100 (NDC 60505-0145-2) Bottles of 1000 (NDC 60505-0145-1) Blisters of 70 (NDC 60505-0145-3) Blisters of 100 (NDC 60505-0145-7)Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0065-0) Bottles of 100 (NDC 60505-0065-2) Bottles of 500 (NDC 60505-0065-5) Bottles of 1000 (NDC 60505-0065-1) Bottles of 5000 (NDC 60505-0065-8) Blisters of 70 (NDC 60505-0065-3) Blisters of 100 (NDC 60505-0065-7)Omeprazole delayed-release capsules, USP 40 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 040” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0146-0) Bottles of 90 (NDC 60505-0146-9) Bottles of 100 (NDC 60505-0146-2) Bottles of 500 (NDC 60505-0146-1)StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 010” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0145-0) Bottles of 100 (NDC 60505-0145-2) Bottles of 1000 (NDC 60505-0145-1) Blisters of 70 (NDC 60505-0145-3) Blisters of 100 (NDC 60505-0145-7)Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0065-0) Bottles of 100 (NDC 60505-0065-2) Bottles of 500 (NDC 60505-0065-5) Bottles of 1000 (NDC 60505-0065-1) Bottles of 5000 (NDC 60505-0065-8) Blisters of 70 (NDC 60505-0065-3) Blisters of 100 (NDC 60505-0065-7)Omeprazole delayed-release capsules, USP 40 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 040” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0146-0) Bottles of 90 (NDC 60505-0146-9) Bottles of 100 (NDC 60505-0146-2) Bottles of 500 (NDC 60505-0146-1)StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 010” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0145-0) Bottles of 100 (NDC 60505-0145-2) Bottles of 1000 (NDC 60505-0145-1) Blisters of 70 (NDC 60505-0145-3) Blisters of 100 (NDC 60505-0145-7)Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0065-0) Bottles of 100 (NDC 60505-0065-2) Bottles of 500 (NDC 60505-0065-5) Bottles of 1000 (NDC 60505-0065-1) Bottles of 5000 (NDC 60505-0065-8) Blisters of 70 (NDC 60505-0065-3) Blisters of 100 (NDC 60505-0065-7)Omeprazole delayed-release capsules, USP 40 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 040” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0146-0) Bottles of 90 (NDC 60505-0146-9) Bottles of 100 (NDC 60505-0146-2) Bottles of 500 (NDC 60505-0146-1)StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Omeprazole delayed-release capsules, USP 10 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 010” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0145-0) Bottles of 100 (NDC 60505-0145-2) Bottles of 1000 (NDC 60505-0145-1) Blisters of 70 (NDC 60505-0145-3) Blisters of 100 (NDC 60505-0145-7)Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0065-0) Bottles of 100 (NDC 60505-0065-2) Bottles of 500 (NDC 60505-0065-5) Bottles of 1000 (NDC 60505-0065-1) Bottles of 5000 (NDC 60505-0065-8) Blisters of 70 (NDC 60505-0065-3) Blisters of 100 (NDC 60505-0065-7)Omeprazole delayed-release capsules, USP 40 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 040” is imprinted on each capsule in black ink. They are supplied as follows:Bottles of 30 (NDC 60505-0146-0) Bottles of 90 (NDC 60505-0146-9) Bottles of 100 (NDC 60505-0146-2) Bottles of 500 (NDC 60505-0146-1)StorageStore omeprazole delayed-release capsules in a tight container protected from light and moisture.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
12.1 Mechanism of Action
Omeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, omeprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose-related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus. Animal studies indicate that after rapid disappearance from plasma, omeprazole can be found within the gastric mucosa for a day or more.
12.2 Pharmacodynamics
Antisecretory Activity
After oral administration, the onset of the antisecretory effect of omeprazole occurs within one hour, with the maximum effect occurring within two hours. Inhibition of secretion is about 50% of maximum at 24 hours and the duration of inhibition lasts up to 72 hours. The antisecretory effect thus lasts far longer than would be expected from the very short (less than one hour) plasma half-life, apparently due to prolonged binding to the parietal H+/K+ ATPase enzyme. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days. The inhibitory effect of omeprazole on acid secretion increases with repeated once-daily dosing, reaching a plateau after four days.
Results from numerous studies of the antisecretory effect of multiple doses of 20 mg and 40 mg of omeprazole in normal volunteers and patients are shown below. The “max” value represents determinations at a time of maximum effect (2 to 6 hours after dosing), while “min” values are those 24 hours after the last dose of omeprazole.
*Single Studies
Single daily oral doses of omeprazole ranging from a dose of 10 mg to 40 mg have produced 100% inhibition of 24-hour intragastric acidity in some patients.
Serum Gastrin Effects
In studies involving more than 200 patients, serum gastrin levels increased during the first 1 to 2 weeks of once-daily administration of therapeutic doses of omeprazole in parallel with inhibition of acid secretion. No further increase in serum gastrin occurred with continued treatment. In comparison with histamine H2-receptor antagonists, the median increases produced by 20 mg doses of omeprazole were higher (1.3 to 3.6 fold vs. 1.1 to 1.8 fold increase). Gastrin values returned to pretreatment levels, usually within 1 to 2 weeks after discontinuation of therapy.
Increased gastrin causes enterochromaffin-like cell hyperplasia and increased serum Chromogranin A (CgA) levels. The increased CgA levels may cause false positive results in diagnostic investigations for neuroendocrine tumors.
Enterochromaffin-like (ECL) Cell Effects
Human gastric biopsy specimens have been obtained from more than 3000 patients treated with omeprazole in long-term clinical trials. The incidence of ECL cell hyperplasia in these studies increased with time; however, no case of ECL cell carcinoids, dysplasia, or neoplasia has been found in these patients. [See Clinical Pharmacology (12)] However, these studies are of insufficient duration and size to rule out the possible influence of long-term administration of omeprazole on the development of any premalignant or malignant conditions.
Other Effects
Systemic effects of omeprazole in the CNS, cardiovascular and respiratory systems have not been found to date. Omeprazole, given in oral doses of 30 or 40 mg for 2 to 4 weeks, had no effect on thyroid function, carbohydrate metabolism, or circulating levels of parathyroid hormone, cortisol, estradiol, testosterone, prolactin, cholecystokinin or secretin.
No effect on gastric emptying of the solid and liquid components of a test meal was demonstrated after a single dose of omeprazole 90 mg. In healthy subjects, a single I.V. dose of omeprazole (0.35 mg/kg) had no effect on intrinsic factor secretion. No systematic dose-dependent effect has been observed on basal or stimulated pepsin output in humans.
However, when intragastric pH is maintained at 4.0 or above, basal pepsin output is low, and pepsin activity is decreased.
As do other agents that elevate intragastric pH, omeprazole administered for 14 days in healthy subjects produced a significant increase in the intragastric concentrations of viable bacteria. The pattern of the bacterial species was unchanged from that commonly found in saliva. All changes resolved within three days of stopping treatment.
The course of Barrett’s esophagus in 106 patients was evaluated in a U.S. double-blind controlled study of omeprazole 40 mg twice daily for 12 months followed by 20 mg twice daily for 12 months or ranitidine 300 mg twice daily for 24 months. No clinically significant impact on Barrett’s mucosa by antisecretory therapy was observed. Although neosquamous epithelium developed during antisecretory therapy, complete elimination of Barrett’s mucosa was not achieved. No significant difference was observed between treatment groups in development of dysplasia in Barrett’s mucosa and no patient developed esophageal carcinoma during treatment. No significant differences between treatment groups were observed in development of ECL cell hyperplasia, corpus atrophic gastritis, corpus intestinal metaplasia, or colon polyps exceeding 3 mm in diameter [See Clinical Pharmacology (12)].
12.3 Pharmacokinetics
Absorption
Omeprazole delayed-release capsules contain an enteric-coated granule formulation of omeprazole (because omeprazole is acid-labile), so that absorption of omeprazole begins only after the granules leave the stomach. Absorption is rapid, with peak plasma levels of omeprazole occurring within 0.5 to 3.5 hours. Peak plasma concentrations of omeprazole and AUC are approximately proportional to doses up to 40 mg, but because of a saturable first-pass effect, a greater than linear response in peak plasma concentration and AUC occurs with doses greater than 40 mg. Absolute bioavailability (compared with intravenous administration) is about 30 to 40% at doses of 20 to 40 mg, due in large part to presystemic metabolism. In healthy subjects the plasma half-life is 0.5 to 1 hour, and the total body clearance is 500 to 600 mL/min.
The bioavailability of omeprazole increases slightly upon repeated administration of omeprazole delayed-release capsules.
Omeprazole delayed-release capsule 40 mg was bioequivalent when administered with and without applesauce. However, omeprazole delayed-release capsule 20 mg was not bioequivalent when administered with and without applesauce. When administered with applesauce, a mean 25% reduction in Cmax was observed without a significant change in AUC for omeprazole delayed-release capsule 20 mg. The clinical relevance of this finding is unknown.
Distribution
Protein binding is approximately 95%.
Metabolism
Omeprazole is extensively metabolized by the cytochrome P450 (CYP) enzyme system.
Excretion
Following single dose oral administration of a buffered solution of omeprazole, little if any unchanged drug was excreted in urine. The majority of the dose (about 77%) was eliminated in urine as at least six metabolites. Two were identified as hydroxyomeprazole and the corresponding carboxylic acid. The remainder of the dose was recoverable in feces. This implies a significant biliary excretion of the metabolites of omeprazole. Three metabolites have been identified in plasma — the sulfide and sulfone derivatives of omeprazole, and hydroxyomeprazole. These metabolites have very little or no antisecretory activity.
Combination Therapy with Antimicrobials
Omeprazole 40 mg daily was given in combination with clarithromycin 500 mg every 8 hours to healthy adult male subjects. The steady state plasma concentrations of omeprazole were increased (Cmax, AUC0-24, and T1/2 increases of 30%, 89% and 34% respectively) by the concomitant administration of clarithromycin. The observed increases in omeprazole plasma concentration were associated with the following pharmacological effects. The mean 24-hour gastric pH value was 5.2 when omeprazole was administered alone and 5.7 when co-administered with clarithromycin.
The plasma levels of clarithromycin and 14-hydroxy-clarithromycin were increased by the concomitant administration of omeprazole. For clarithromycin, the mean Cmax was 10% greater, the mean Cmin was 27% greater, and the mean AUC0-8 was 15% greater when clarithromycin was administered with omeprazole than when clarithromycin was administered alone. Similar results were seen for 14-hydroxy-clarithromycin, the mean Cmax was 45% greater, the mean Cmin was 57% greater, and the mean AUC0-8 was 45% greater. Clarithromycin concentrations in the gastric tissue and mucus were also increased by concomitant administration of omeprazole.
1Mean ± SD (mcg/g)
Concomitant Use with Clopidogrel
In a crossover clinical study, 72 healthy subjects were administered clopidogrel (300 mg loading dose followed by 75 mg per day) alone and with omeprazole (80 mg at the same time as clopidogrel) for 5 days. The exposure to the active metabolite of clopidogrel was decreased by 46% (Day 1) and 42% (Day 5) when clopidogrel and omeprazole were administered together.
Results from another crossover study in healthy subjects showed a similar pharmacokinetic interaction between clopidogrel (300 mg loading dose/75 mg daily maintenance dose) and omeprazole 80 mg daily when co-administered for 30 days. Exposure to the active metabolite of clopidogrel was reduced by 41% to 46% over this time period.
In another study, 72 healthy subjects were given the same doses of clopidogrel and 80 mg omeprazole but the drugs were administered 12 hours apart; the results were similar, indicating that administering clopidogrel and omeprazole at different times does not prevent their interaction.
Special Populations
Geriatric Population
The elimination rate of omeprazole was somewhat decreased in the elderly, and bioavailability was increased. Omeprazole was 76% bioavailable when a single 40 mg oral dose of omeprazole (buffered solution) was administered to healthy elderly volunteers, versus 58% in young volunteers given the same dose. Nearly 70% of the dose was recovered in urine as metabolites of omeprazole and no unchanged drug was detected. The plasma clearance of omeprazole was 250 mL/min (about half that of young volunteers) and its plasma half-life averaged one hour, about twice that of young healthy volunteers.
Pediatric Use
The pharmacokinetics of omeprazole have been investigated in pediatric patients 2 to 16 years of age:
Doses of 10, 20 and 40 mg omeprazole as enteric-coated granules
Following comparable mg/kg doses of omeprazole, younger children (2 to 5 years of age) have lower AUCs than children 6 to 16 years of age or adults; AUCs of the latter two groups did not differ. [See Dosage and Administration (2)]
Hepatic Impairment
In patients with chronic hepatic disease, the bioavailability increased to approximately 100% compared with an I.V. dose, reflecting decreased first-pass effect, and the plasma half-life of the drug increased to nearly 3 hours compared with the half-life in normals of 0.5 to 1 hour. Plasma clearance averaged 70 mL/min, compared with a value of 500 to 600 mL/min in normal subjects. Dose reduction, particularly where maintenance of healing of erosive esophagitis is indicated, for the hepatically impaired should be considered.
Renal Impairment
In patients with chronic renal impairment, whose creatinine clearance ranged between 10 and 62 mL/min/1.73 m2, the disposition of omeprazole was very similar to that in healthy volunteers, although there was a slight increase in bioavailability. Because urinary excretion is a primary route of excretion of omeprazole metabolites, their elimination slowed in proportion to the decreased creatinine clearance. No dose reduction is necessary in patients with renal impairment.
Asian Population
In pharmacokinetic studies of single 20 mg omeprazole doses, an increase in AUC of approximately four-fold was noted in Asian subjects compared with Caucasians. Dose reduction, particularly where maintenance of healing of erosive esophagitis is indicated, for Asian subjects should be considered.
12.4 Microbiology
Omeprazole and clarithromycin dual therapy and omeprazole, clarithromycin and amoxicillin triple therapy have been shown to be active against most strains of Helicobacter pylori in vitro and in clinical infections as described in the Indications and Usage section (1.1).
Helicobacter
Helicobacter pylori-Pretreatment Resistance
Clarithromycin pretreatment resistance rates were 3.5% (4/113) in the omeprazole/clarithromycin dual therapy studies (4 and 5) and 9.3% (41/439) in omeprazole/clarithromycin/amoxicillin triple therapy studies (1, 2, and 3).
Amoxicillin pretreatment susceptible isolates (≤ 0.25 mcg/mL) were found in 99.3% (436/439) of the patients in the omeprazole/clarithromycin/amoxicillin triple therapy studies (1, 2, and 3). Amoxicillin pretreatment minimum inhibitory concentrations (MICs) > 0.25 mcg/mL occurred in 0.7% (3/439) of the patients, all of whom were in the clarithromycin and amoxicillin study arm. One patient had an unconfirmed pretreatment amoxicillin minimum inhibitory concentration (MIC) of > 256 mcg/mL by Etest®.
Patients not eradicated of H. pylori following omeprazole/clarithromycin/amoxicillin triple therapy or omeprazole/clarithromycin dual therapy will likely have clarithromycin resistant H. pylori isolates. Therefore, clarithromycin susceptibility testing should be done, if possible. Patients with clarithromycin resistant H. pylori should not be treated with any of the following: omeprazole/clarithromycin dual therapy, omeprazole/clarithromycin/amoxicillin triple therapy, or other regimens which include clarithromycin as the sole antimicrobial agent.
Amoxicillin Susceptibility Test Results and Clinical/Bacteriological Outcomes
In the triple therapy clinical trials, 84.9% (157/185) of the patients in the omeprazole/clarithromycin/amoxicillin treatment group who had pretreatment amoxicillin susceptible MICs (≤ 0.25 mcg/mL) were eradicated of H. pylori and 15.1% (28/185) failed therapy. Of the 28 patients who failed triple therapy, 11 had no post-treatment susceptibility test results and 17 had post-treatment H. pylori isolates with amoxicillin susceptible MICs. Eleven of the patients who failed triple therapy also had post-treatment H. pylori isolates with clarithromycin resistant MICs.
Susceptibility Test for Helicobacter pylori
For susceptibility testing information about Helicobacter pylori, see Microbiology section in prescribing information for clarithromycin and amoxicillin.
Effects on Gastrointestinal Microbial Ecology
Decreased gastric acidity due to any means including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and, in hospitalized patients, possibly also
Non-Clinical Toxicology
Omeprazole delayed-release capsules are contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, and urticaria [See Adverse Reactions (6)].For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with omeprazole, refer to the section of their package inserts.
5.1 Concomitant Gastric Malignancy
Symptomatic response to therapy with omeprazole does not preclude the presence of gastric malignancy.
5.2 Atrophic Gastritis
Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole.
5.3 Clostridium difficile associated diarrhea
Published observational studies suggest that PPI therapy like omeprazole may be associated with an increased risk of Clostridium difficile associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve [see Adverse Reactions (6.2)].
Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents. For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with omeprazole, refer to WARNINGS and PRECAUTIONS sections of those package inserts.
5.4 Interaction with Clopidogrel
Avoid concomitant use of omeprazole with clopidogrel. Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is entirely due to an active metabolite. The metabolism of clopidogrel to its active metabolite can be impaired by use with concomitant medications, such as omeprazole, that inhibit CYP2C19 activity. Concomitant use of clopidogrel with 80 mg omeprazole reduces the pharmacological activity of clopidogrel, even when administered 12 hours apart. When using omeprazole, consider alternative anti-platelet therapy [see Drug Interactions (7.3) and Pharmacokinetics (12.3)].
5.5 Bone Fracture
Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines. [see Dosage and Administration (2) and Adverse Reactions (6.3)]
5.6 Hypomagnesemia
Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.
For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically. [See Adverse Reactions (6.3)]
5.7 Concomitant Use of Omeprazole with St John’s Wort or Rifampin
Drugs which induce CYP2C19 or CYP3A4 (such as St John’s Wort or rifampin) can substantially decrease omeprazole concentrations. [See Drug Interactions (7.3)]. Avoid concomitant use of omeprazole with St John’s Wort or rifampin.
5.8 Interactions with Diagnostic Investigations for Neuroendocrine Tumors
Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors. Providers should temporarily stop omeprazole treatment before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g. for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary.
5.9 Concomitant use of Omeprazole with Methotrexate
Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration a temporary withdrawal of the PPI may be considered in some patients. [See Drug Interactions (7.7) ]
6.1 Clinical Trials Experience with Omeprazole Monotherapy
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.
The safety data described below reflects exposure to omeprazole delayed-release capsules in 3096 patients from worldwide clinical trials (465 patients from US studies and 2,631 patients from international studies). Indications clinically studied in US trials included duodenal ulcer, resistant ulcer, and Zollinger-Ellison syndrome. The international clinical trials were double blind and open-label in design. The most common adverse reactions reported (i.e., with an incidence rate ≥ 2%) from omeprazole-treated patients enrolled in these studies included headache (6.9%), abdominal pain (5.2%), nausea (4.0%), diarrhea (3.7%), vomiting (3.2%), and flatulence (2.7%).
Additional adverse reactions that were reported with an incidence ≥1% included acid regurgitation (1.9%), upper respiratory infection (1.9%), constipation (1.5%), dizziness (1.5%), rash (1.5%), asthenia (1.3%), back pain (1.1%), and cough (1.1%).
The clinical trial safety profile in patients greater than 65 years of age was similar to that in patients 65 years of age or less. The clinical trial safety profile in pediatric patients who received omeprazole delayed-release capsules was similar to that in adult patients. Unique to the pediatric population, however, adverse reactions of the respiratory system were most frequently reported in the 2 to 16 year age group (18.5%). Similarly, accidental injuries were reported frequently in the 2 to 16 year age group (3.8%). [See Use in Specific Populations (8.4)]
6.2 Clinical Trials Experience with Omeprazole in Combination Therapy for H. pylori Eradication
In clinical trials using either dual therapy with omeprazole and clarithromycin, or triple therapy with omeprazole, clarithromycin, and amoxicillin, no adverse reactions unique to these drug combinations were observed. Adverse reactions observed were limited to those previously reported with omeprazole, clarithromycin, or amoxicillin alone.
Dual Therapy (omeprazole/clarithromycin)
Adverse reactions observed in controlled clinical trials using combination therapy with omeprazole and clarithromycin (n = 346) that differed from those previously described for omeprazole alone were taste perversion (15%), tongue discoloration (2%), rhinitis (2%), pharyngitis (1%) and flu-syndrome (1%). (For more information on clarithromycin, refer to the clarithromycin prescribing information, Adverse Reactions section).
Triple Therapy (omeprazole/clarithromycin/amoxicillin)
The most frequent adverse reactions observed in clinical trials using combination therapy with omeprazole, clarithromycin, and amoxicillin (n = 274) were diarrhea (14%), taste perversion (10%), and headache (7%). None of these occurred at a higher frequency than that reported by patients taking antimicrobial agents alone. (For more information on clarithromycin or amoxicillin, refer to the respective prescribing information, Adverse Reactions sections).
6.3 Post-marketing Experience
The following adverse reactions have been identified during post-approval use of omeprazole delayed-release capsules. Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their actual frequency or establish a causal relationship to drug exposure.
Body As a Whole:
Cardiovascular:
Endocrine
Gastrointestinal:
Hepatic:
Infections and Infestations:
Metabolism and Nutritional disorders:
Musculoskeletal:
Nervous System/Psychiatric:
Respiratory
Skin:
Special Senses:
Ocular
Urogenital:
Hematologic:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
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