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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  • DESCRIPTION
    Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir Tablets are formulations for oral administration. Each 800-mg tablet of acyclovir contains 800mg of ...
  • VIROLOGY
    Mechanism 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 ...
  • CLINICAL PHARMACOLOGY
    Pharmacokinetics: The pharmacokinetics of acyclovir after oral administration have been evaluated in healthy volunteers and in immunocompromised patients with herpes simplex or ...
  • SPL UNCLASSIFIED SECTION
    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 ...
  • SPL UNCLASSIFIED SECTION
    There 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 ...
  • INDICATIONS AND USAGE
    Herpes 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
  • SPL UNCLASSIFIED SECTION
    Acyclovir is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.
  • WARNINGS
  • SPL UNCLASSIFIED SECTION
    Acyclovir 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
  • SPL UNCLASSIFIED SECTION
    Dosage adjustment is recommended when administering acyclovir to patients with renal impairment (see DOSAGE AND ADMINISTRATION). Caution should also be exercised when administering acyclovir to ...
  • ADVERSE REACTIONS
    Herpes 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
  • SPL UNCLASSIFIED SECTION
    Overdoses 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 ...
  • DOSAGE AND ADMINISTRATION
    Acute 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 ...
  • HOW SUPPLIED
    Acyclovir 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 ...
  • PRINCIPAL DISPLAY PANEL
    Acyclovir 800mg Tablet
  • INGREDIENTS AND APPEARANCE
    Product Information