Concomitant use may increase risk of developing methemoglobinemia. Monitor closely.
Source: NLP:dapsone gel, 5%
Brand names: Dapsone
Sulfone
Route: Topical
Contraindications
4 CONTRAINDICATIONS None. None.
Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary There are no available data on dapsone gel, 5%, use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. In animal reproduction studies, oral doses of dapsone administered to pregnant rats and rabbits during organogenesis that resulted in systemic exposures more than 250 times the systemic exposure at the maximum recommended human dose (MRHD) of dapsone gel, 5%, resulted in embryocidal effects. When orally administered to rats from the onset of organogenesis through the end of lactation at systemic exposures approximately 400 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 956 times [rats] and 289 times [rabbits] the systemic exposure observed in human females as a result of use of the MRHD of dapsone gel, 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 382 ti
22 interactions on record
Concomitant use may increase risk of developing methemoglobinemia. Monitor closely.
Source: NLP:dapsone gel, 5%
Concomitant use may increase risk of developing methemoglobinemia. Monitor closely.
Source: NLP:dapsone gel, 5%
Concomitant use may increase risk of developing methemoglobinemia. Monitor closely.
Source: NLP:dapsone gel, 5%
Concomitant use may increase risk of developing methemoglobinemia. Monitor closely.
Source: NLP:dapsone gel, 5%
Concomitant use may increase risk of developing methemoglobinemia. Monitor closely.
Source: NLP:dapsone gel, 5%
Concomitant use may increase risk of developing methemoglobinemia. Monitor closely.
Source: NLP:dapsone gel, 5%
Concomitant use may increase risk of developing methemoglobinemia. Monitor closely.
Source: NLP:dapsone gel, 5%
Concomitant use may increase risk of developing methemoglobinemia. Monitor closely.
Source: NLP:dapsone gel, 5%
Concomitant use may increase risk of developing methemoglobinemia. Monitor closely.
Source: NLP:dapsone gel, 5%
Concomitant use may increase risk of developing methemoglobinemia. Monitor closely.
Source: NLP:dapsone gel, 5%
Concomitant use may increase risk of developing methemoglobinemia. Monitor closely.
Source: NLP:dapsone gel, 5%
Concomitant use may increase risk of developing methemoglobinemia. Monitor closely.
Source: NLP:dapsone gel, 5%
Concomitant use may increase risk of developing methemoglobinemia. Monitor closely.
Source: NLP:dapsone gel, 5%
Concomitant use may increase risk of developing methemoglobinemia. Monitor closely.
Source: NLP:dapsone gel, 5%
May increase formation of dapsone hydroxylamine, a metabolite associated with hemolysis.
Source: NLP:dapsone gel, 5%
Folic acid antagonist that may increase the likelihood of hematologic reactions when used with dapsone.
Source: NLP:dapsone gel, 5%
May increase formation of dapsone hydroxylamine, a metabolite associated with hemolysis.
Source: NLP:dapsone gel, 5%
May increase formation of dapsone hydroxylamine, a metabolite associated with hemolysis.
Source: NLP:dapsone gel, 5%
TMP/SMX increases systemic levels of dapsone and its metabolites by approximately 40% for dapsone, 20% for N-acetyl-dapsone, and more than doubles dapsone hydroxylamine exposure.
Source: NLP:dapsone gel, 5%
Topical benzoyl peroxide used concurrently with dapsone gel may result in temporary local yellow or orange skin discoloration, with resolution in 4 to 57 days.
Source: NLP:dapsone gel, 5%
Topical application of benzoyl peroxide with dapsone gel may result in temporary local yellow or orange skin discoloration, typically resolving in 4-57 days.
Source: NLP:dapsone gel, 5%
7 DRUG INTERACTIONS Trimethoprim/sulfamethoxazole (TMP/ SMX) increases the level of dapsone and its metabolites ( 7.1 ) Topical benzoyl peroxide used at the same time as dapsone may result in temporary local yellow or orange skin discoloration. 7.1 Trimethoprim – Sulfamethoxazole A drug-drug interaction study evaluated the effect of the use of Dapsone Gel, 5%, in combination with double strength (160 mg/800 mg) trimethoprim-sulfamethoxazole (TMP/SMX).
Source: FDA drug label - dapsone gel, 5%