Label: ACYCLOVIR tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 28, 2025

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  • DESCRIPTION
    Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets, USP is a formulation for oral administration. Each Acyclovir Tablet contains 400 mg or ...
  • 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 ...
  • CLINICAL PHARMACOLOGY
    Pharmacokinetics - The pharmacokinetics of acyclovir after oral administration have been evaluated in healthy volunteers and in immunocompromised patients with herpes simplex or varicella-zoster ...
  • INDICATIONS & USAGE
    Herpes Zoster Infections: Acyclovir tablets, USP are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets, USP are indicated for the ...
  • CONTRAINDICATIONS
    Acyclovir tablets are contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.
  • WARNINGS
    Acyclovir tablets are intended for oral ingestion only. Renal failure, in some cases resulting in death, has been observed with acyclovir therapy (see ADVERSE REACTIONS: Observed ...
  • PRECAUTIONS
    Dosage adjustment is recommended when administering acyclovir tablets to patients with renal impairment (see DOSAGE AND ADMINISTRATION). Caution should also be exercised when ...
  • ADVERSE REACTIONS
    Herpes Simplex - Short-Term Administration: The most frequent adverse events reported during clinical trials of treatment of genital herpes with acyclovir tablets 200 mg administered orally 5 ...
  • OVERDOSAGE
    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 ...
  • DOSAGE & ADMINISTRATION
    Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days. Genital Herpes: Treatment of Initial Genital Herpes: 200 mg every 4 ...
  • HOW SUPPLIED
    Acyclovir tablets USP, 400 mg containing 400 mg of acyclovir USP are pink, shield shaped, flat tablets debossed with 'J' on one side and '49' in triangle on the other. They are supplied as ...
  • Package/Label Display Panel
    MAJOR® NDC 0904-7507-61 - Unit Dose - Acyclovir - Tablets, USP - 400 mg - 100 TABLETS (10 x 10) Rx only
  • INGREDIENTS AND APPEARANCE
    Product Information