Australia - English - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia -

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

almirall, llc - dapsone (unii: 8w5c518302) (dapsone - unii:8w5c518302) - aczone® (dapsone) gel, 7.5%, is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. none. risk summary there are no available data on aczone gel, 7.5%, use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. the systemic absorption of aczone in humans following topical application is low relative to oral dapsone administration [see clinical pharmacology (12.3)] . in animal reproduction studies, oral doses of dapsone administered to pregnant rats and rabbits during organogenesis that resulted in systemic exposures more than 400 times the systemic exposure at the maximum recommended human dose (mrhd) of aczone gel, 7.5%, resulted in embryocidal effects. when orally administered to rats from the onset of organogenesis through the end of lactation at systemic exposures approximately 500 times the exposure at the mrhd, dapsone resulted in increased stillbirths and decreased pup weight [see data] . the estimated background risks of major birth defects and miscarriage for the indicated population are unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data dapsone has been shown to have an embryocidal effect in rats and rabbits when administered orally daily to females during organogenesis at dosages of 75 mg/kg/day and 150 mg/kg/day, respectively. these dosages resulted in systemic exposures that represented approximately 1407 times [rats] and 425 times [rabbits] the systemic exposure observed in human females as a result of use of the mrhd of aczone gel, 7.5%, based on auc comparisons. these effects were probably secondary to maternal toxicity. dapsone was assessed for effects on perinatal/postnatal pup development and postnatal maternal behavior and function in a study in which dapsone was orally administered to female rats daily beginning on the seventh day of gestation and continuing until the twenty-seventh day postpartum. maternal toxicity (decreased body weight and food consumption) and developmental effects (increase in stillborn pups and decreased pup weight) were seen at a dapsone dose of 30 mg/kg/day (approximately 563 times the systemic exposure that is associated with the mrhd of aczone gel, 7.5%, based on auc comparisons). no effects were observed on the viability, physical development, behavior, learning ability, or reproductive function of surviving pups. risk summary there is no information regarding the presence of topical dapsone in breastmilk, the effects on the breastfed infant or the effects on milk production. orally administered dapsone appears in human milk and could result in hemolytic anemia and hyperbilirubinemia especially in infants with g6pd deficiency. systemic absorption of dapsone following topical application is low relative to oral dapsone administration. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for aczone gel, 7.5% and any potential adverse effects on the breastfed child from aczone gel, 7.5% or from the underlying maternal condition. the safety and effectiveness of aczone gel, 7.5% for the topical treatment of acne vulgaris have been established in patients 9 years of age and older. use of aczone gel, 7.5% in patients 9 to 11 years of age for this indication is supported by evidence from adequate and well-controlled clinical trials in 1066 subjects 12 years of age and older and with additional pharmacokinetic and safety data in pediatric subjects 9 to 11 years of age from an open label study of 100 subjects with acne [see adverse reactions (6.1), and clinical pharmacology (12.3)] . the safety profile for aczone gel, 7.5% in clinical trials was similar to the vehicle control group. safety and effectiveness of aczone gel, 7.5%, have not been established in pediatric patients below the age of 9 years. clinical trials of aczone gel, 7.5% did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. individuals with glucose-6-phosphate dehydrogenase (g6pd) deficiency may be more prone to methemoglobinemia and hemolysis [see warnings and precautions (5.1)] . aczone gel, 5% and vehicle were evaluated in a randomized, double-blind, cross-over design clinical study of 64 subjects with g6pd deficiency and acne vulgaris. subjects were black (88%), asian (6%), hispanic (2%) or of other racial origin (5%). blood samples were taken at baseline, week 2, and week 12 during both vehicle and aczone gel, 5% treatment periods. some of these subjects developed laboratory changes suggestive of hemolysis, but there was no evidence of clinically significant hemolytic anemia in this study [see warnings and precautions (5.1)] .

Canada - English - Health Canada

apotex inc - colesevelam hydrochloride - tablet - 625mg - colesevelam hydrochloride 625mg - bile acid sequestrants

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

unicorn media partners llc - benzalkonium chloride (unii: f5um2km3w7) (benzalkonium - unii:7n6jud5x6y) - antiseptic hand sanitizer foam. for hand sanitizing to decrease bacteria on skin. safe for repeated use. for use when soap and water not available.

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

unicorn media partners llc - benzalkonium chloride (unii: f5um2km3w7) (benzalkonium - unii:7n6jud5x6y) - antiseptic sanitizing hand wash for hand washing to decrease bacteria on skin. for repeated use.

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

unicorn media partners llc - benzalkonium chloride (unii: f5um2km3w7) (benzalkonium - unii:7n6jud5x6y) - antiseptic hand sanitizer mist. for hand sanitizing to decrease bacteria on skin. safe for repeated use. for use when soap and water not available.

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

unicorn media partners llc - benzalkonium chloride (unii: f5um2km3w7) (benzalkonium - unii:7n6jud5x6y) - antiseptic hand sanitizer gel. for hand sanitizing to decrease bacteria on skin. safe for repeated use. for use when soap and water not available.

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

unicorn media partners llc - benzalkonium chloride (unii: f5um2km3w7) (benzalkonium - unii:7n6jud5x6y) - antiseptic antibacterial hand wipes for rapid kill of bacteria on skin. for use when soap and water not available.

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

heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc. - pentamidine isethionate (unii: v2p3k60da2) (pentamidine - unii:673lc5j4lq) - pentamidine isethionate for injection is indicated for the treatment of pneumonia due to pneumocystis carinii . contraindicated in patients with a history of hypersensitivity to pentamidine isethionate.

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

xgen pharmaceuticals djb, inc. - pentamidine isethionate (unii: v2p3k60da2) (pentamidine - unii:673lc5j4lq) - pentamidine isethionate for injection is indicated for the treatment of pneumonia due to pneumocystis carinii . contraindicated in patients with a history of hypersensitivity to pentamidine isethionate.