DENAVIR

Measurable penciclovir concentrations were not detected in plasma or urine of healthy male volunteers (n=12) following single or repeat application of the 1% cream at a dose of 180 mg penciclovir daily (approximately 67 times the estimated usual clinical dose). Pediatric Patients The systemic absorption of penciclovir following topical administration has not been evaluated in patients < 18 years of age.

DENAVIR was studied in two double-blind, placebo (vehicle)-controlled trials for the treatment of recurrent herpes labialis in which otherwise healthy adults were randomized to either DENAVIR or placebo. Therapy was to be initiated by the subjects within 1 hour of noticing signs or symptoms and continued for 4 days, with application of study medication every 2 hours while awake. In both studies, the mean duration of lesions was approximately one-half-day shorter in the subjects treated with DENAVIR (N=1,516) as compared to subjects treated with placebo (N=1,541) (approximately 4.5 days versus ...

• One or more local skin reactions were reported by 3% of the subjects treated with DENAVIR and 4% of placebo-treated patients. ( 6.1 ) 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. 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 anoth...

DENAVIR 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 )

• Only for topical use of herpes labialis on the lips and face. ( 5 ) 5.1 General DENAVIR should only be used on herpes labialis on the lips and face. Because no data are available, application to human mucous membranes is not recommended. Particular care should be taken to avoid application in or near the eyes since it may cause irritation. Lesions that do not improve or that worsen on therapy should be evaluated for secondary bacterial infection. The effect of DENAVIR has not been established ...

7 DRUG INTERACTIONS No drug interaction studies have been performed with DENAVIR. Due to minimal systemic absorption of DENAVIR, systemic drug interactions are unlikely.