acyclovir

Generic: ACYCLOVIR

Prescription DrugTOPICAL

Drug Information

Brand Name
acyclovir
Generic Name
ACYCLOVIR
Manufacturer
Viona Pharmaceuticals Inc
Product Type
Prescription Drug
Route
TOPICAL
Application Number
12df1991-fb1c-45df-acf3-706b1e8ecfc3

Pharmacological Class

Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]

Indications & Usage

INDICATIONS AND USAGE Acyclovir Ointment 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients.

Warnings

WARNINGS Acyclovir Ointment 5% is intended for cutaneous use only and should not be used in the eye.

Adverse Reactions

ADVERSE REACTIONS In the controlled clinical trials, mild pain (including transient burning and stinging) was reported by about 30% of patients in both the active and placebo arms; treatment was discontinued in 2 of these patients. Local pruritus occurred in 4% of these patients. In all studies, there was no significant difference between the drug and placebo group in the rate or type of reported adverse reactions nor were there any differences in abnormal clinical laboratory findings. Observed ...

Read full adverse reactions

ADVERSE REACTIONS In the controlled clinical trials, mild pain (including transient burning and stinging) was reported by about 30% of patients in both the active and placebo arms; treatment was discontinued in 2 of these patients. Local pruritus occurred in 4% of these patients. In all studies, there was no significant difference between the drug and placebo group in the rate or type of reported adverse reactions nor were there any differences in abnormal clinical laboratory findings. Observed During Clinical Practice Based on clinical practice experience in patients treated with Acyclovir Ointment in the US, spontaneously reported adverse events are uncommon. Data are insufficient to support an estimate of their incidence or to establish causation. These events may also occur as part of the underlying disease process. Voluntary reports of adverse events that have been received since market introduction include: General Edema and/or pain at the application site. Skin Pruritus, rash.

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare provider before making any decisions about your medications. Data sourced from openFDA.

acyclovir - Side Effects, Warnings, Uses | FDA Drug Database