Aciclovir

Aciclovir tablets

Usos autorizados

• 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 treatment of initial episodes and the management of recurrent episodes of genital herpes.
• Chickenpox: Acyclovir tablets, USP are indicated for the treatment of chickenpox (varicella).

Formas y dosis

• Acyclovir tablets USP, 800 mg containing 800 mg of acyclovir USP are blue, oval, biconvex tablets debossed with 'J' on one side and '50' on the other side.

Cómo se toma

• 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 hours, 5 times daily for 10 days.
• Chronic Suppressive Therapy for Recurrent Disease: 400 mg 2 times daily for up to 12 months, followed by re-evaluation.
• Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.

No debe usarse en caso de

• Acyclovir tablets are contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction [e.g., anaphylaxis, severe cutaneous adverse reactions (SCARs)] to acyclovir, valacyclovir, or any component of the formulation (see WARNINGS and ADVERSE REACTIONS).

Interacciones

• See CLINICAL PHARMACOLOGY: Pharmacokinetics.

Advertencias y precauciones

• 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 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.
• Severe cutaneous adverse reactions (SCARs), including acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and erythema multiforme (EM) have been reported with acyclovir (see CONTRAINDICATIONS and ADVERSE REACTIONS).

Efectos adversos frecuentes

• 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 times daily every 4 hours for 10 days were nausea and/or vomiting in 8 of 298 patient treatments (2.7%). Nausea and/or vomiting occurred in 2 of 287 (0.7%) patients who received placebo.

Embarazo

Teratogenic Effects: Pregnancy Category B. Acyclovir administered during organogenesis was not teratogenic in the mouse (450 mg/kg/day, p.o.), rabbit (50 mg/kg/day, s.c. and IV), or rat (50 mg/kg/day, s.c.). These exposures resulted in plasma levels 9 and 18, 16 and 106, and 11 and 22 times, respectively, human levels.

Titular de la autorización:

Camber Pharmaceuticals, Inc.

Versión de la ficha:

2 de febrero de 2026

Las secciones anteriores están citadas de la ficha en inglés, porque es ese documento el que porta la autorización. Cuando una autoridad europea publica la misma información en español, el enlace figura en las fuentes. No traducimos por nuestra cuenta los textos reguladores: un error de traducción en una contraindicación sería más peligroso que una línea en otro idioma.

Esta sección recoge la ficha técnica autorizada. El texto está condensado a partir del resumen de la propia autoridad, y el documento completo figura en las fuentes.