United States - English - NLM (National Library of Medicine)

renaissance pharma, inc. - penciclovir (unii: 359hue8fjc) (penciclovir - unii:359hue8fjc) - penciclovir 10 mg in 1 g - penciclovir cream is a nucleoside 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. category   b there are no adequate and well-controlled studies in pregnant women. animal data   no adverse effects on the course and outcome of pregnancy or on fetal development were noted in rats and rabbits following the intravenous administration of penciclovir at doses of 80 and 60 mg/kg/day, respectively (estimated human equivalent doses of 13 and 18 mg/kg/day for the rat and rabbit, respectively, based on body surface area conversion; the body surface area doses being 260 and 355x the maximum recommended dose following topical application of the penciclovir cream). because animal reproduction studies are not always predictive of human response, penciclovir should be used during pregnancy only if clear

United States - English - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - penciclovir (unii: 359hue8fjc) (penciclovir - unii:359hue8fjc) - 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 is contraindicated in patients with known hypersensitivity to the product or any of its components. risk summary penciclovir is not absorbed systemically following topical administration and maternal use is not expected to result in fetal exposure to the drug. risk summary 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 to 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 subject

United States - English - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - penciclovir (unii: 359hue8fjc) (penciclovir - unii:359hue8fjc) - 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

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - penciclovir (unii: 359hue8fjc) (penciclovir - unii:359hue8fjc) - penciclovir 10 mg in 1 g - denavir (penciclovir cream) is indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age and older. denavir is contraindicated in patients with known hypersensitivity to the product or any of its components.

United States - English - NLM (National Library of Medicine)

prestium pharma, inc. - penciclovir (unii: 359hue8fjc) (penciclovir - unii:359hue8fjc) - penciclovir 10 mg in 1 g - denavir is a nucleoside 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. denavir is contraindicated in patients with known hypersensitivity to the product or any of its components. category b there are no adequate and well-controlled studies in pregnant women.  animal data no adverse effects on the course and outcome of pregnancy or on fetal development were noted in rats and rabbits following the intravenous administration of penciclovir at doses of 80 and 60 mg/kg/day, respectively (estimated human equivalent doses of 13 and 18 mg/kg/day for the rat and rabbit, respectively, based on body surface area conversion; the body surface area doses being 260 and 355x the maximum recommended dose following topical application of the penciclovir cream).  because animal reproduction studies are not always predictive of human response, penciclovir should be used during pregnancy only if clearly needed. there

United States - English - NLM (National Library of Medicine)

torrent pharmaceuticals limited - penciclovir (unii: 359hue8fjc) (penciclovir - unii:359hue8fjc) - 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 cream is not absorbed systemically following topical administration and maternal use is not expected to result in fetal exposure to the drug. penciclovir cream is not absorbed systemically by the mother following topical administration and breastfeeding is not expected to result in exposure of the child to penciclovir cream. an open-label, uncontrolled trial with penciclovir cream 1% was conducted in 102 subjects, ages 12 to 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 ≥ 6

United States - English - NLM (National Library of Medicine)

new american therapeutics, inc - penciclovir (unii: 359hue8fjc) (penciclovir - unii:359hue8fjc) - penciclovir 10 mg in 1 g

Israel - English - Ministry of Health

perrigo israel agencies ltd, israel - penciclovir - cream - penciclovir 10 mg/g - penciclovir - penciclovir - for the topical treatment for cold sores (oral herpes).

United States - English - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - penciclovir (unii: 359hue8fjc) (penciclovir - unii:359hue8fjc) - denavir 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. denavir is contraindicated in patients with known hypersensitivity to the product or any of its components. denavir is not absorbed systemically following topical administration and maternal use is not expected to result in fetal exposure to the drug. denavir is not absorbed systemically by the mother following topical administration and breastfeeding is not expected to result in exposure of the child to denavir. 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 adverse events profile was compar

Israel - English - Ministry of Health

padagis israel agencies ltd, israel - penciclovir - cream - penciclovir 10 mg/g - penciclovir - for the topical treatment for cold sores (oral herpes).