Penciclovir 10 mg/g
Penciclovir · CREAM · Teva Pharmaceuticals USA, Inc.
Penciclovir is a cream containing penciclovir at 10 mg/g, taken topical. Manufactured by Teva Pharmaceuticals USA, Inc..
Key Facts
- Brand Name
- Penciclovir
- Generic Name
- Penciclovir
- NDC Code (Product)
0093-3186- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Strength
- 10 mg/g
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA212710
- Drug Class
- Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
- Marketing Start
- 11/14/2022
Recall History
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Penciclovir cream 1% 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 1% 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 & Administration
2 DOSAGE AND ADMINISTRATION Apply penciclovir cream 1% every 2 hours during waking hours for a period of 4 days. Start treatment as early as possible (i.e., during the prodrome or when lesions appear). Apply penciclovir cream 1% 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 )
Contraindications
4 CONTRAINDICATIONS Penciclovir is contraindicated in patients with known hypersensitivity to the product or any of its components. Contraindicated in patients with known hypersensitivity to the product or any of its components. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS No drug interaction studies have been performed with penciclovir. Due to minimal systemic absorption of penciclovir, systemic drug interactions are unlikely.
Adverse Reactions
6 ADVERSE REACTIONS One or more local skin reactions were reported by 3% of the subjects treated with penciclovir and 4% of placebo-treated patients. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In two double-blind, placebo-controlled trials, 1,516 patients were treated with penciclovir cream and 1,541 with placebo. One or more local adverse reactions were reported by 3% of the patients treated with penciclovir cream and 4% of placebo-treated patients. The rates of reported local adverse reactions are shown in Table 1. TABLE 1: Local Adverse Reactions Reported in Phase III Trials Penciclovir N=1,516 % Placebo N=1,541 % Application site reaction Hypesthesia/Local anesthesia Taste perversion Rash (erythematous) 1 <1 <1 <1 2 <1 <1 <1 Two studies, enrolling 108 healthy subjects, were conduc…
Frequently Asked Questions
What is Penciclovir used for?
Penciclovir contains Penciclovir. It is a cream taken topical. Consult your doctor for specific uses.
Is Penciclovir a controlled substance?
Penciclovir is not classified as a controlled substance by the DEA.
What is the generic name for Penciclovir?
The generic name for Penciclovir is Penciclovir. There are 2 other brand versions of Penciclovir.
What is the NDC code for Penciclovir 10 mg/g?
The NDC (National Drug Code) for Penciclovir 10 mg/g is 0093-3186, listed by Teva Pharmaceuticals USA, Inc..