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ZOVIRAX
Overview
What is ZOVIRAX?
ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analogue active against herpesviruses. ZOVIRAX Capsules, Tablets, and Suspension are formulations for oral administration. Each capsule of ZOVIRAX contains 200 mg of acyclovir and the inactive ingredients corn starch, lactose, magnesium stearate, and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C Blue No. 2, and titanium dioxide. May contain one or more parabens. Printed with edible black ink.
Each 800-mg tablet of ZOVIRAX contains 800 mg of acyclovir and the inactive ingredients FD&C Blue No. 2, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.
Each 400-mg tablet of ZOVIRAX contains 400 mg of acyclovir and the inactive ingredients magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.
Each teaspoonful (5 mL) of ZOVIRAX Suspension contains 200 mg of acyclovir and the inactive ingredients methylparaben 0.1% and propylparaben 0.02% (added as preservatives), carboxymethylcellulose sodium, flavor, glycerin, microcrystalline cellulose, and sorbitol.
Acyclovir is a white, crystalline powder with the molecular formula CHNO and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir are 2.27 and 9.25.
The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6-purin-6-one; it has the following structural formula:
What does ZOVIRAX look like?
What are the available doses of ZOVIRAX?
Sorry No records found.
What should I talk to my health care provider before I take ZOVIRAX?
Sorry No records found
How should I use ZOVIRAX?
ZOVIRAX is indicated for the acute treatment of herpes zoster (shingles).
800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
What interacts with ZOVIRAX?
ZOVIRAX is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.
What are the warnings of ZOVIRAX?
In late pregnancy, as with other NSAIDs, ibuprofen tablets should be avoided because it may cause premature closure of the ductus arteriosus.
What are the precautions of ZOVIRAX?
Dosage adjustment is recommended when administering ZOVIRAX to patients with renal impairment (see DOSAGE AND ADMINISTRATION). Caution should also be exercised when administering ZOVIRAX to patients receiving potentially nephrotoxic agents since this may increase the risk of renal dysfunction and/or the risk of reversible central nervous system symptoms such as those that have been reported in patients treated with intravenous acyclovir. Adequate hydration should be maintained.
Information for Patients:
Patients are instructed to consult with their physician if they experience severe or troublesome adverse reactions, they become pregnant or intend to become pregnant, they intend to breastfeed while taking orally administered ZOVIRAX, or they have any other questions.
Patients should be advised to maintain adequate hydration.
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Drug Interactions:
See CLINICAL PHARMACOLOGY: Pharmacokinetics.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
The data presented below include references to peak steady-state plasma acyclovir concentrations observed in humans treated with 800 mg given orally 5 times a day (dosing appropriate for treatment of herpes zoster) or 200 mg given orally 5 times a day (dosing appropriate for treatment of genital herpes). Plasma drug concentrations in animal studies are expressed as multiples of human exposure to acyclovir at the higher and lower dosing schedules (see CLINICAL PHARMACOLOGY: Pharmacokinetics).
Acyclovir was tested in lifetime bioassays in rats and mice at single daily doses of up to 450 mg/kg administered by gavage. There was no statistically significant difference in the incidence of tumors between treated and control animals, nor did acyclovir shorten the latency of tumors. Maximum plasma concentrations were 3 to 6 times human levels in the mouse bioassay and 1 to 2 times human levels in the rat bioassay.
Acyclovir was tested in 16 in vitro and in vivo genetic toxicity assays. Acyclovir was positive in 5 of the assays.
Acyclovir did not impair fertility or reproduction in mice (450 mg/kg/day, p.o.) or in rats (25 mg/kg/day, s.c.). In the mouse study, plasma levels were 9 to 18 times human levels, while in the rat study, they were 8 to 15 times human levels. At higher doses (50 mg/kg/day, s.c.) in rats and rabbits (11 to 22 and 16 to 31 times human levels, respectively) implantation efficacy, but not litter size, was decreased. In a rat peri- and post-natal study at 50 mg/kg/day, s.c., there was a statistically significant decrease in group mean numbers of corpora lutea, total implantation sites, and live fetuses.
No testicular abnormalities were seen in dogs given 50 mg/kg/day, IV for 1 month (21 to 41 times human levels) or in dogs given 60 mg/kg/day orally for 1 year (6 to 12 times human levels). Testicular atrophy and aspermatogenesis were observed in rats and dogs at higher dose levels.
Pregnancy:
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There are no adequate and well-controlled studies in pregnant women. A prospective epidemiologic registry of acyclovir use during pregnancy was established in 1984 and completed in April 1999. There were 749 pregnancies followed in women exposed to systemic acyclovir during the first trimester of pregnancy resulting in 756 outcomes. The occurrence rate of birth defects approximates that found in the general population. However, the small size of the registry is insufficient to evaluate the risk for less common defects or to permit reliable or definitive conclusions regarding the safety of acyclovir in pregnant women and their developing fetuses. Acyclovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers:
Acyclovir concentrations have been documented in breast milk in 2 women following oral administration of ZOVIRAX and ranged from 0.6 to 4.1 times corresponding plasma levels. These concentrations would potentially expose the nursing infant to a dose of acyclovir up to 0.3 mg/kg/day. ZOVIRAX should be administered to a nursing mother with caution and only when indicated.
Pediatric Use:
Safety and effectiveness of oral formulations of acyclovir in pediatric patients younger than 2 years of age have not been established.
Geriatric Use:
Of 376 subjects who received ZOVIRAX in a clinical study of herpes zoster treatment in immunocompetent subjects ≥50 years of age, 244 were 65 and over while 111 were 75 and over. No overall differences in effectiveness for time to cessation of new lesion formation or time to healing were reported between geriatric subjects and younger adult subjects. The duration of pain after healing was longer in patients 65 and over. Nausea, vomiting, and dizziness were reported more frequently in elderly subjects. Elderly patients are more likely to have reduced renal function and require dose reduction. Elderly patients are also more likely to have renal or CNS adverse events. With respect to CNS adverse events observed during clinical practice, somnolence, hallucinations, confusion, and coma were reported more frequently in elderly patients (see CLINICAL PHARMACOLOGY, ADVERSE REACTIONS: Observed During Clinical Practice, and DOSAGE AND ADMINISTRATION).
What are the side effects of ZOVIRAX?
Herpes Simplex:
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Herpes Zoster:
The most frequent adverse event reported during 3 clinical trials of treatment of herpes zoster (shingles) with 800 mg of oral ZOVIRAX 5 times daily for 7 to 10 days in 323 patients was malaise (11.5%). The 323 placebo recipients reported malaise (11.1%).
Chickenpox:
The most frequent adverse event reported during 3 clinical trials of treatment of chickenpox with oral ZOVIRAX at doses of 10 to 20 mg/kg 4 times daily for 5 to 7 days or 800 mg 4 times daily for 5 days in 495 patients was diarrhea (3.2%). The 498 patients receiving placebo reported diarrhea (2.2%).
Observed During Clinical Practice:
In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of ZOVIRAX. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, potential causal connection to ZOVIRAX, or a combination of these factors.
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What should I look out for while using ZOVIRAX?
ZOVIRAX is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.
ZOVIRAX Capsules, Tablets, and Suspension are intended for oral ingestion only. Renal failure, in some cases resulting in death, has been observed with acyclovir therapy (see ADVERSE REACTIONS: Observed During Clinical Practice and OVERDOSAGE). Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), which has resulted in death, has occurred in immunocompromised patients receiving acyclovir therapy.
What might happen if I take too much ZOVIRAX?
Overdoses involving ingestion of up to 100 capsules (20 g) have been reported. Adverse events that have been reported in association with overdosage include agitation, coma, seizures, and lethargy. Precipitation of acyclovir in renal tubules may occur when the solubility (2.5 mg/mL) is exceeded in the intratubular fluid. Overdosage has been reported following bolus injections or inappropriately high doses and in patients whose fluid and electrolyte balance were not properly monitored. This has resulted in elevated BUN and serum creatinine and subsequent renal failure. In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored (see DOSAGE AND ADMINISTRATION).
How should I store and handle ZOVIRAX?
Unopened vials of gemcitabine for injection, USP are stable until the expiration date indicated on the package when stored at controlled room temperature 20° to 25°C (68° to 77°F) and that allows for excursions between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature] [].ZOVIRAX Capsules (blue, opaque cap and body) containing 200 mg acyclovir and printed with “Prestium ZOVIRAX 200”Bottle of 100 (NDC 40076-991-55) ZOVIRAX Tablets (light blue, oval) containing 800 mg acyclovir and “ZOVIRAX 800”Bottle of 100 (NDC 40076-945-55) ZOVIRAX Tablets (white, shield-shaped) containing 400 mg acyclovir and engraved with “ZOVIRAX” on one side and a triangle on the other side.Bottle of 100 (NDC 40076-949-55) ZOVIRAX Suspension (off-white, banana-flavored) containing 200 mg acyclovir in each teaspoonful (5 mL).Bottle of 1 pint (473 mL) (NDC 40076-953-96) ZOVIRAX is a registered trademark of GlaxoSmithKline.Manufactured for:Prestium Pharma, Inc.Newtown, PA 18940ByGlaxoSmithKlineMississauga, ON, CANADAManufactured for:Prestium Pharma, Inc.Newtown, PA 18940ByGlaxoSmithKlineResearch Triangle Park, NC 277092013 Delcor Asset Corporation, an affiliate of Prestium Pharma, Inc.ZOVIRAX Capsules (blue, opaque cap and body) containing 200 mg acyclovir and printed with “Prestium ZOVIRAX 200”Bottle of 100 (NDC 40076-991-55) ZOVIRAX Tablets (light blue, oval) containing 800 mg acyclovir and “ZOVIRAX 800”Bottle of 100 (NDC 40076-945-55) ZOVIRAX Tablets (white, shield-shaped) containing 400 mg acyclovir and engraved with “ZOVIRAX” on one side and a triangle on the other side.Bottle of 100 (NDC 40076-949-55) ZOVIRAX Suspension (off-white, banana-flavored) containing 200 mg acyclovir in each teaspoonful (5 mL).Bottle of 1 pint (473 mL) (NDC 40076-953-96) ZOVIRAX is a registered trademark of GlaxoSmithKline.Manufactured for:Prestium Pharma, Inc.Newtown, PA 18940ByGlaxoSmithKlineMississauga, ON, CANADAManufactured for:Prestium Pharma, Inc.Newtown, PA 18940ByGlaxoSmithKlineResearch Triangle Park, NC 277092013 Delcor Asset Corporation, an affiliate of Prestium Pharma, Inc.ZOVIRAX Capsules (blue, opaque cap and body) containing 200 mg acyclovir and printed with “Prestium ZOVIRAX 200”Bottle of 100 (NDC 40076-991-55) ZOVIRAX Tablets (light blue, oval) containing 800 mg acyclovir and “ZOVIRAX 800”Bottle of 100 (NDC 40076-945-55) ZOVIRAX Tablets (white, shield-shaped) containing 400 mg acyclovir and engraved with “ZOVIRAX” on one side and a triangle on the other side.Bottle of 100 (NDC 40076-949-55) ZOVIRAX Suspension (off-white, banana-flavored) containing 200 mg acyclovir in each teaspoonful (5 mL).Bottle of 1 pint (473 mL) (NDC 40076-953-96) ZOVIRAX is a registered trademark of GlaxoSmithKline.Manufactured for:Prestium Pharma, Inc.Newtown, PA 18940ByGlaxoSmithKlineMississauga, ON, CANADAManufactured for:Prestium Pharma, Inc.Newtown, PA 18940ByGlaxoSmithKlineResearch Triangle Park, NC 277092013 Delcor Asset Corporation, an affiliate of Prestium Pharma, Inc.ZOVIRAX Capsules (blue, opaque cap and body) containing 200 mg acyclovir and printed with “Prestium ZOVIRAX 200”Bottle of 100 (NDC 40076-991-55) ZOVIRAX Tablets (light blue, oval) containing 800 mg acyclovir and “ZOVIRAX 800”Bottle of 100 (NDC 40076-945-55) ZOVIRAX Tablets (white, shield-shaped) containing 400 mg acyclovir and engraved with “ZOVIRAX” on one side and a triangle on the other side.Bottle of 100 (NDC 40076-949-55) ZOVIRAX Suspension (off-white, banana-flavored) containing 200 mg acyclovir in each teaspoonful (5 mL).Bottle of 1 pint (473 mL) (NDC 40076-953-96) ZOVIRAX is a registered trademark of GlaxoSmithKline.Manufactured for:Prestium Pharma, Inc.Newtown, PA 18940ByGlaxoSmithKlineMississauga, ON, CANADAManufactured for:Prestium Pharma, Inc.Newtown, PA 18940ByGlaxoSmithKlineResearch Triangle Park, NC 277092013 Delcor Asset Corporation, an affiliate of Prestium Pharma, Inc.ZOVIRAX Capsules (blue, opaque cap and body) containing 200 mg acyclovir and printed with “Prestium ZOVIRAX 200”Bottle of 100 (NDC 40076-991-55) ZOVIRAX Tablets (light blue, oval) containing 800 mg acyclovir and “ZOVIRAX 800”Bottle of 100 (NDC 40076-945-55) ZOVIRAX Tablets (white, shield-shaped) containing 400 mg acyclovir and engraved with “ZOVIRAX” on one side and a triangle on the other side.Bottle of 100 (NDC 40076-949-55) ZOVIRAX Suspension (off-white, banana-flavored) containing 200 mg acyclovir in each teaspoonful (5 mL).Bottle of 1 pint (473 mL) (NDC 40076-953-96) ZOVIRAX is a registered trademark of GlaxoSmithKline.Manufactured for:Prestium Pharma, Inc.Newtown, PA 18940ByGlaxoSmithKlineMississauga, ON, CANADAManufactured for:Prestium Pharma, Inc.Newtown, PA 18940ByGlaxoSmithKlineResearch Triangle Park, NC 277092013 Delcor Asset Corporation, an affiliate of Prestium Pharma, Inc.ZOVIRAX Capsules (blue, opaque cap and body) containing 200 mg acyclovir and printed with “Prestium ZOVIRAX 200”Bottle of 100 (NDC 40076-991-55) ZOVIRAX Tablets (light blue, oval) containing 800 mg acyclovir and “ZOVIRAX 800”Bottle of 100 (NDC 40076-945-55) ZOVIRAX Tablets (white, shield-shaped) containing 400 mg acyclovir and engraved with “ZOVIRAX” on one side and a triangle on the other side.Bottle of 100 (NDC 40076-949-55) ZOVIRAX Suspension (off-white, banana-flavored) containing 200 mg acyclovir in each teaspoonful (5 mL).Bottle of 1 pint (473 mL) (NDC 40076-953-96) ZOVIRAX is a registered trademark of GlaxoSmithKline.Manufactured for:Prestium Pharma, Inc.Newtown, PA 18940ByGlaxoSmithKlineMississauga, ON, CANADAManufactured for:Prestium Pharma, Inc.Newtown, PA 18940ByGlaxoSmithKlineResearch Triangle Park, NC 277092013 Delcor Asset Corporation, an affiliate of Prestium Pharma, Inc.ZOVIRAX Capsules (blue, opaque cap and body) containing 200 mg acyclovir and printed with “Prestium ZOVIRAX 200”Bottle of 100 (NDC 40076-991-55) ZOVIRAX Tablets (light blue, oval) containing 800 mg acyclovir and “ZOVIRAX 800”Bottle of 100 (NDC 40076-945-55) ZOVIRAX Tablets (white, shield-shaped) containing 400 mg acyclovir and engraved with “ZOVIRAX” on one side and a triangle on the other side.Bottle of 100 (NDC 40076-949-55) ZOVIRAX Suspension (off-white, banana-flavored) containing 200 mg acyclovir in each teaspoonful (5 mL).Bottle of 1 pint (473 mL) (NDC 40076-953-96) ZOVIRAX is a registered trademark of GlaxoSmithKline.Manufactured for:Prestium Pharma, Inc.Newtown, PA 18940ByGlaxoSmithKlineMississauga, ON, CANADAManufactured for:Prestium Pharma, Inc.Newtown, PA 18940ByGlaxoSmithKlineResearch Triangle Park, NC 277092013 Delcor Asset Corporation, an affiliate of Prestium Pharma, Inc.ZOVIRAX Capsules (blue, opaque cap and body) containing 200 mg acyclovir and printed with “Prestium ZOVIRAX 200”Bottle of 100 (NDC 40076-991-55) ZOVIRAX Tablets (light blue, oval) containing 800 mg acyclovir and “ZOVIRAX 800”Bottle of 100 (NDC 40076-945-55) ZOVIRAX Tablets (white, shield-shaped) containing 400 mg acyclovir and engraved with “ZOVIRAX” on one side and a triangle on the other side.Bottle of 100 (NDC 40076-949-55) ZOVIRAX Suspension (off-white, banana-flavored) containing 200 mg acyclovir in each teaspoonful (5 mL).Bottle of 1 pint (473 mL) (NDC 40076-953-96) ZOVIRAX is a registered trademark of GlaxoSmithKline.Manufactured for:Prestium Pharma, Inc.Newtown, PA 18940ByGlaxoSmithKlineMississauga, ON, CANADAManufactured for:Prestium Pharma, Inc.Newtown, PA 18940ByGlaxoSmithKlineResearch Triangle Park, NC 277092013 Delcor Asset Corporation, an affiliate of Prestium Pharma, Inc.ZOVIRAX Capsules (blue, opaque cap and body) containing 200 mg acyclovir and printed with “Prestium ZOVIRAX 200”Bottle of 100 (NDC 40076-991-55) ZOVIRAX Tablets (light blue, oval) containing 800 mg acyclovir and “ZOVIRAX 800”Bottle of 100 (NDC 40076-945-55) ZOVIRAX Tablets (white, shield-shaped) containing 400 mg acyclovir and engraved with “ZOVIRAX” on one side and a triangle on the other side.Bottle of 100 (NDC 40076-949-55) ZOVIRAX Suspension (off-white, banana-flavored) containing 200 mg acyclovir in each teaspoonful (5 mL).Bottle of 1 pint (473 mL) (NDC 40076-953-96) ZOVIRAX is a registered trademark of GlaxoSmithKline.Manufactured for:Prestium Pharma, Inc.Newtown, PA 18940ByGlaxoSmithKlineMississauga, ON, CANADAManufactured for:Prestium Pharma, Inc.Newtown, PA 18940ByGlaxoSmithKlineResearch Triangle Park, NC 277092013 Delcor Asset Corporation, an affiliate of Prestium Pharma, Inc.ZOVIRAX Capsules (blue, opaque cap and body) containing 200 mg acyclovir and printed with “Prestium ZOVIRAX 200”Bottle of 100 (NDC 40076-991-55) ZOVIRAX Tablets (light blue, oval) containing 800 mg acyclovir and “ZOVIRAX 800”Bottle of 100 (NDC 40076-945-55) ZOVIRAX Tablets (white, shield-shaped) containing 400 mg acyclovir and engraved with “ZOVIRAX” on one side and a triangle on the other side.Bottle of 100 (NDC 40076-949-55) ZOVIRAX Suspension (off-white, banana-flavored) containing 200 mg acyclovir in each teaspoonful (5 mL).Bottle of 1 pint (473 mL) (NDC 40076-953-96) ZOVIRAX is a registered trademark of GlaxoSmithKline.Manufactured for:Prestium Pharma, Inc.Newtown, PA 18940ByGlaxoSmithKlineMississauga, ON, CANADAManufactured for:Prestium Pharma, Inc.Newtown, PA 18940ByGlaxoSmithKlineResearch Triangle Park, NC 277092013 Delcor Asset Corporation, an affiliate of Prestium Pharma, Inc.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The pharmacokinetics of acyclovir after oral administration have been evaluated in healthy volunteers and in immunocompromised patients with herpes simplex or varicella-zoster virus infection. Acyclovir pharmacokinetic parameters are summarized in Table 1.
In one multiple-dose, crossover study in healthy subjects (n = 23), it was shown that increases in plasma acyclovir concentrations were less than dose proportional with increasing dose, as shown in Table 2. The decrease in bioavailability is a function of the dose and not the dosage form.
There was no effect of food on the absorption of acyclovir (n = 6); therefore, ZOVIRAX Capsules, Tablets, and Suspension may be administered with or without food.
The only known urinary metabolite is 9-[(carboxymethoxy)methyl]guanine.
Non-Clinical Toxicology
ZOVIRAX is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.ZOVIRAX Capsules, Tablets, and Suspension are intended for oral ingestion only. Renal failure, in some cases resulting in death, has been observed with acyclovir therapy (see ADVERSE REACTIONS: Observed During Clinical Practice and OVERDOSAGE). Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), which has resulted in death, has occurred in immunocompromised patients receiving acyclovir therapy.
See CLINICAL PHARMACOLOGY: Pharmacokinetics.
Dosage adjustment is recommended when administering ZOVIRAX to patients with renal impairment (see DOSAGE AND ADMINISTRATION). Caution should also be exercised when administering ZOVIRAX to patients receiving potentially nephrotoxic agents since this may increase the risk of renal dysfunction and/or the risk of reversible central nervous system symptoms such as those that have been reported in patients treated with intravenous acyclovir. Adequate hydration should be maintained.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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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. 315.72Tips
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