ZOVIRAX- acyclovir cream

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

acyclovir (UNII: X4HES1O11F) (acyclovir - UNII:X4HES1O11F)

Saatavilla:

Bausch Health US, LLC

INN (Kansainvälinen yleisnimi):

acyclovir

Koostumus:

acyclovir 50 mg in 1 g

Antoreitti:

TOPICAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

ZOVIRAX Cream 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. ZOVIRAX Cream is contraindicated in patients with known hypersensitivity to acyclovir, 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 ZOVIRAX 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 estimated backgr

Tuoteyhteenveto:

Each gram of ZOVIRAX Cream contains 50 mg (equivalent to 5% w/w) of acyclovir in an aqueous cream base. ZOVIRAX Cream is supplied as follows: NDC 0187-0994-45: 5 g tubes Store at or below 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Valtuutuksen tilan:

New Drug Application

Valmisteyhteenveto

ZOVIRAX- ACYCLOVIR CREAM
BAUSCH HEALTH US, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOVIRAX CREAM SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZOVIRAX CREAM.
ZOVIRAX (ACYCLOVIR) CREAM, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 2002
INDICATIONS AND USAGE
ZOVIRAX Cream 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
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
•
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BAUSCH HEALTH US, LLC
AT 1-800-321-
4576 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 2/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
®
Apply 5 times a day for 4 days. (2)
Administer immediately following the onset of cold sore lesions. (2)
Cream, 50 mg (equivalent to 5% w/w) acyclovir. (3)
ZOVIRAX Cream is contraindicated in patients with known
hypersensitivity to acyclovir, valacyclovir or
any component of the formulation. (4)
Only for topical use of recurrent HSV lesions on the external aspect
of lips and the face. ZOVIRAX
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)
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)
Clinical experience has identified no interactions resulting from
topical or systemic administration of
other drugs concomitantly with ZOVIRAX Cream. Due to minimal systemic
absorption of ZOV