Acnesone Gel
Dapsone topical
7.50%
Incepta Pharmaceuticals Ltd.
| Pack size | 15gm tube |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 150.00 AED |
Indications
Acnesone Gel is used for:
Acne
Adult Dose
Topical/Cutaneous
Acne vulgaris
Adult:
As 5% gel: Apply a thin layer on the affected area bid.
As 7.5% gel: Apply a thin layer on the entire face or other affected areas once daily.
Reassess treatment if there is no improvement after 12 weeks.
Child Dose
Topical/Cutaneous
Acne Vulgaris
<9 years: Safety and efficacy not established
>9 years: Apply pea-sized amount in thin layer to the entire face once daily. (7.5% gel);
a thin layer can also be applied to other affected areas.
If no improvement after 12 weeks, reassess treatment
Renal Dose
Administration
Topical Administration
For topical use only; not for oral, ophthalmic, or intravaginal use
Gently cleanse skin and pat dry
Apply pea-size amount in thin layer to acne affected area
Rub gel in gently and completely
Wash hands after application
Contra Indications
Hypersensitivity to dapsone. Congenital or idiopathic methaemoglobinaemia.
Precautions
Methemoglobinemia: Cases of methemoglobinemia have been reported. Discontinue Dapsone Gel if signs of methemoglobinemia occur.
Hemolysis: Some patients with Glucose-6-phosphate Dehydrogenase (G6PD) deficiency using topical dapsone developed laboratory changes suggestive of hemolysis
Pregnancy-Lactation
Pregnancy
There are no available data on 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 maximum recommended human dose (MRHD) of 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; systemic absorption in humans following topical application is low relative to oral dapsone administration.
Lactation
There is no information regarding presence of topical dapsone in breastmilk, effects on breastfed infant, or 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 minimal relative to oral dapsone administration; however, it is known that dapsone is present in human milk following administration of oral dapsone; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition.
Interactions
Trimethoprim/sulfamethoxazole (TMP/SMX) increases the systemic level of dapsone and its metabolites.
Topical benzoyl peroxide used at the same time as Dapsone Gel, 7.5% may result in temporary local yellow or orange skin discoloration.
Contraindicated (0)
Serious (14)
artemether
artemether/lumefantrine
artesunate
atovaquone
chloroquine
dapsone
hydroxychloroquine sulfate
mefloquine
primaquine
proguanil
pyrimethamine
quinidine
quinine
tafenoquine
Adverse Effects
Side effects of Dapsone topical :
>10%
Dryness (16%)
Erythema (13%)
1-10%
Burning (1%)
Pruritus (1%)
Mechanism of Action
Mechanism of action of dapsone gel in treating acne vulgaris is not known. However, it may be a result from both of its anti-inflammatory and antimicrobial effects.
Dapsone is a sulfone that inhibits the synthesis of dihydrofolic acid by competing with para-aminobenzoic acid for the active site of dihydropteroate synthetase in susceptible organisms.
Note
Acnesone 7.50% Gel manufactured by Incepta Pharmaceuticals Ltd.. Its generic name is Dapsone topical. Acnesone is availble in Bangladesh.
Farmaco BD drug index information on Acnesone Gel is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.