PENCICLOVIR cream

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

PENCICLOVIR (UNII: 359HUE8FJC) (PENCICLOVIR - UNII:359HUE8FJC)

Pieejams no:

Mylan Pharmaceuticals Inc.

Ievadīšanas:

TOPICAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Penciclovir cream is a deoxynucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age or older. Penciclovir cream is contraindicated in patients with known hypersensitivity to the product or any of its components. Penciclovir is not absorbed systemically following topical administration and maternal use is not expected to result in fetal exposure to the drug. Penciclovir is not absorbed systemically by the mother following topical administration and breastfeeding is not expected to result in exposure of the child to penciclovir. An open-label, uncontrolled trial with penciclovir cream 1% was conducted in 102 subjects, ages 12-17 years, with recurrent herpes labialis. The frequency of adverse events was generally similar to the frequency previously reported for adult patients. Safety and effectiveness in pediatric patients less than 12 years of age have not been established. In 74 subjects ≥ 65 years of age, the a

Produktu pārskats:

Penciclovir cream is supplied in a 5 gram tube containing 10 mg of penciclovir per gram in a cream base, which is equivalent to 1% (w/w). The white cream is available as follows: NDC 0378-0896-55 carton containing one 5 gram tube Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]

Autorizācija statuss:

New Drug Application Authorized Generic

Produkta apraksts

PENCICLOVIR- PENCICLOVIR CREAM
MYLAN PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PENCICLOVIR CREAM
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PENCICLOVIR CREAM.
PENCICLOVIR CREAM, FOR TOPICAL ADMINISTRATION
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Penciclovir cream is a deoxynucleoside analog HSV DNA polymerase
inhibitor indicated for the treatment
of recurrent herpes labialis (cold sores) in adults and pediatric
patients 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 MYLAN AT 1-877-446-3679
(1-877-4-INFO-
RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 9/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 General
6 ADVERSE REACTIONS
6.1 Clinical Studies
Apply penciclovir cream every 2 hours during waking hours for a period
of 4 days (2).
Start treatment as early as possible (i.e., during the prodrome or
when lesions appear). (2)
Topical cream containing 1% penciclovir (3).
Contraindicated in patients with known hypersensitivity to the product
or any of its components. (4)
Only for topical use of herpes labialis on the lips and face. (5)
One or more local skin reactions were reported by 3% of the subjects
treated with penciclovir cream
and 4% of placebo-treated patients. (6.1)
6.2 Post-Marketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
12.4 Microbiology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUD