Label: ACYCLOVIR tablet
- NDC Code(s): 71335-2555-0, 71335-2555-1, 71335-2555-2, 71335-2555-3, view more
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 69452-291
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 23, 2025
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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DESCRIPTIONAcyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir Tablets are formulations for oral administration. Each 800-mg tablet of acyclovir contains 800mg of ...
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VIROLOGYMechanism of Antiviral Action: Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and ...
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CLINICAL PHARMACOLOGYPharmacokinetics: The pharmacokinetics of acyclovir after oral administration have been evaluated in healthy volunteers and in immunocompromised patients with herpes simplex or ...
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SPL UNCLASSIFIED SECTIONIn 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 ...
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SPL UNCLASSIFIED SECTIONThere was no effect of food on the absorption of acyclovir (n = 6); therefore, acyclovir tablets, may be administered with or without food. The only known urinary metabolite is 9 ...
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INDICATIONS AND USAGEHerpes Zoster Infections: Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir is indicated for the treatment of initial episodes and the ...
- CONTRAINDICATIONS
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SPL UNCLASSIFIED SECTIONAcyclovir is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.
- WARNINGS
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SPL UNCLASSIFIED SECTIONAcyclovir Tablets is 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 ...
- PRECAUTIONS
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SPL UNCLASSIFIED SECTIONDosage adjustment is recommended when administering acyclovir to patients with renal impairment (see DOSAGE AND ADMINISTRATION). Caution should also be exercised when administering acyclovir to ...
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ADVERSE REACTIONSHerpes Simplex: Short-Term Administration: The most frequent adverse events reported during clinical trials of treatment of genital herpes with acyclovir 200mg administered orally 5 times ...
- OVERDOSAGE
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SPL UNCLASSIFIED SECTIONOverdoses involving ingestion of up to 100 capsules (20g) have been reported. Adverse events that have been reported in association with overdosage include agitation, coma, seizures, and lethargy ...
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DOSAGE AND ADMINISTRATIONAcute Treatment of Herpes Zoster: 800mg every 4 hours orally, 5 times daily for 7 to 10 days. Genital Herpes: Treatment of Initial Genital Herpes: 200mg every 4 hours, 5 times daily ...
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HOW SUPPLIEDAcyclovir tablets, USP (light blue, caplet) containing 800mg acyclovir, USP and engraved "S042" on one side and plain on the other side. Bottle of 100 (69452-291-20) Bottle of 500 ...
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PRINCIPAL DISPLAY PANELAcyclovir 800mg Tablet
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INGREDIENTS AND APPEARANCEProduct Information