ACYCLOVIR cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACYCLOVIR (UNII: X4HES1O11F) (ACYCLOVIR - UNII:X4HES1O11F)

Available from:

Amneal Pharmaceuticals LLC

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Acyclovir cream, 5% is a herpes simplex virus (HSV) deoxynucleoside analogue DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older. Acyclovir cream is contraindicated in patients with known hypersensitivity to acyclovir USP, valacyclovir, or any component of the formulation. Risk Summary Acyclovir is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the acyclovir cream [see Clinical Pharmacology (12.3)]. Experience with topical acyclovir use in pregnant women over several decades, based on published literature including observational studies, has not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies with systemic exposure of acyclovir have been conducted. Refer to acyclovir prescribing information for additional details. The es

Product summary:

Each gram of acyclovir cream, contains 50 mg (equivalent to 5% w/w) of acyclovir, USP in a smooth homogeneous white to off-white cream. Acyclovir cream, 5% is supplied as follows: Store at or below 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACYCLOVIR- ACYCLOVIR CREAM
AMNEAL PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ACYCLOVIR CREAM SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ACYCLOVIR CREAM.
ACYCLOVIR CREAM, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 2002
INDICATIONS AND USAGE
Acyclovir cream, 5% is a herpes simplex virus (HSV) deoxynucleoside
analogue DNA polymerase inhibitor
indicated for the treatment of recurrent herpes labialis (cold sores)
in immunocompetent adults and
adolescents 12 years of age and older. (1)
DOSAGE AND ADMINISTRATION
Apply 5 times a day for 4 days. (2)
Administer immediately following the onset of cold sore lesions. (2)
DOSAGE FORMS AND STRENGTHS
Cream, 50 mg (equivalent to 5% w/w) acyclovir, USP. (3)
CONTRAINDICATIONS
Acyclovir cream is contraindicated in patients with known
hypersensitivity to acyclovir USP, valacyclovir
or any component of the formulation. (4)
WARNINGS AND PRECAUTIONS
Only for topical use of recurrent HSV lesions on the external aspect
of lips and the face. Acyclovir
cream should not be applied on mucous membranes including in the eye
or inside the mouth or nose.
(5.1)
There is a potential for irritation and contact sensitization. (5.2)
ADVERSE REACTIONS
The most common adverse reactions reported were local skin reactions
at the application site. (6.1)
Angioedema, anaphylaxis, contact dermatitis and eczema have been
reported. (6.2)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AMNEAL PHARMACEUTICALS
AT 1-877-835-
5472 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Clinical experience has identified no interactions resulting from
topical or systemic administration of
other drugs concomitantly with acyclovir cream. Due to minimal
systemic absorption of acyclovir
cream, systemic drug interactions are unlikely. (7)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 7/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND A