Aciclovir

Acyclovir

200MG, 400MG, 800MG tabletEstados UnidosComercializadoAutorizado el 27 mar 1997

Contenido en inglés

Indicaciones

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).

Contraindicaciones

Acyclovir tablets are contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.

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.

Interacciones

Drug Interactions See CLINICAL PHARMACOLOGY: Pharmacokinetics .

Embarazo y lactancia

Pregnancy 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. 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.

Indicaciones

Advertencias y precauciones

Embarazo y lactancia

Reacciones adversas

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. Long-Term Administration: The most frequent adverse events reported in a clinical trial for the prevention of recurrences with continuous administration of 400 mg (two 200-mg capsules) 2 times daily for 1 year in 586 patients treated with acyclovir tablets were nausea (4.8%) and diarrhea (2.4%).

The 589 control patients receiving intermittent treatment of recurrences with acyclovir tablets for 1 year reported diarrhea (2.7%), nausea (2.4%), and headache (2.2%). Herpes Zoster The most frequent adverse event reported during 3 clinical trials of treatment of herpes zoster (shingles) with 800 mg of oral acyclovir tablets 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 acyclovir tablets 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 acyclovir tablets.

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 acyclovir tablets or a combination of these factors. General: Anaphylaxis, angioedema, fever, headache, pain, peripheral edema. Nervous: Aggressive behavior, agitation, ataxia, coma, confusion, decreased consciousness, delirium, dizziness, dysarthria, encephalopathy, hallucinations, paresthesia, psychosis, seizure, somnolence, tremors.

These symptoms may be marked, particularly in older adults or in patients with renal impairment (see PRECAUTIONS ). Digestive: Diarrhea, gastrointestinal distress, nausea. Hematologic and Lymphatic: Anemia, leukocytoclastic vasculitis, leukopenia, lymphadenopathy, thrombocytopenia. Hepatobiliary Tract and Pancreas: Elevated liver function tests, hepatitis, hyperbilirubinemia, jaundice. Musculoskeletal: Myalgia. Skin: Alopecia, erythema multiforme, photosensitive rash, pruritus, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria.

Special Senses: Visual abnormalities. Urogenital: Renal failure, renal pain (may be associated with renal failure), elevated blood urea nitrogen, elevated creatinine, hematuria (see WARNINGS ).

Presentación	Código	Estado
ACYCLOVIR 800MG	ANDA204314-002	Prescription
ACYCLOVIR 400MG	ANDA204314-001	Prescription
ACYCLOVIR 800MG	ANDA210401-002	Prescription
ACYCLOVIR 400MG	ANDA210401-001	Prescription
ACYCLOVIR 400MG	ANDA074836-001	Discontinued
ACYCLOVIR 800MG	ANDA074836-002	Discontinued
ACYCLOVIR 400MG	ANDA074891-001	Prescription
ACYCLOVIR 800MG	ANDA074891-002	Prescription
ACYCLOVIR 800MG	ANDA074980-002	Discontinued
ACYCLOVIR 400MG	ANDA074980-001	Discontinued
ACYCLOVIR 400MG	ANDA074946-001	Discontinued
ACYCLOVIR 800MG	ANDA074946-002	Discontinued
ACYCLOVIR 400MG	ANDA074976-001	Discontinued
ACYCLOVIR 800MG	ANDA074976-002	Discontinued
ACYCLOVIR 800MG	ANDA075211-002	Prescription
ACYCLOVIR 400MG	ANDA075211-001	Prescription
ACYCLOVIR 800MG	ANDA202168-002	Prescription
ACYCLOVIR 400MG	ANDA202168-001	Prescription
ACYCLOVIR 400MG	ANDA074658-001	Discontinued
ACYCLOVIR 800MG	ANDA074658-002	Discontinued
ACYCLOVIR 800MG	ANDA075021-002	Discontinued
ACYCLOVIR 400MG	ANDA075021-001	Discontinued
ACYCLOVIR 800MG	ANDA074870-002	Discontinued
ACYCLOVIR 400MG	ANDA074870-001	Discontinued
ACYCLOVIR 800MG	ANDA074834-002	Discontinued
ACYCLOVIR 400MG	ANDA074834-001	Discontinued
ACYCLOVIR 400MG	ANDA209366-001	Prescription
ACYCLOVIR 800MG	ANDA209366-002	Prescription
ACYCLOVIR 800MG	ANDA074556-003	Prescription
ACYCLOVIR 200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ANDA074556-001	Discontinued

Acyclovir

Indicaciones

Contraindicaciones

Advertencias y precauciones

Interacciones

Embarazo y lactancia

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Acyclovir

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