Dapgel


Dapsone USP 7.5% w/w Gel


Composition


Each gram gel contains Dapsone USP 75 mg.


Pharmacology


Dapsone has both anti-inflammatory and antimicrobial properties. A combination of these activities account for its efficacy in acne. Anti-inflammatory effects include inhibition of neutrophil myeloperoxidase and eosinophil peroxidase activity, suppression of hypochlorous acid production, scavenging oxygen species, suppression of neutrophil activity, and inhibition of reactive chemoattractant-induced signal transduction. Antimicrobial activity, similar to that of sulfones and sulfonamides, is by inhibition of bacterial dihydropteroate synthase in the folic acid metabolic pathway. This mechanism is effective against microorganisms synthesizing their own folic acid, In vitro susceptibility testing has demonstrated some activity for Dapsone against Propionibacterium species, including Propionibacterium acnes (P. acnes).


Indication Dapgel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older,


Dosage & Administration


fter the layer skin is gently washed and patted dry, apply approximately a pea-sized amount to the entire face once daily. In addition, a thin layer may be tof Dapgel in a thin e applied Ito other affected areas once daily. Rub in Dapgel, gently and completely. If there is no improvement after 12 weeks, treatment with Dapgel should be reassessed. Not for oral, ophthalmic or intravaginal use.


Contraindications


Those who are hypersensitive to Dapsone.


Side effects


Most common (incidence ≥ 0.9%) effects are application site dryness and pruritus.


Precautions & Warnings


Methemoglobinemia: Cases of methemoglobinemia have been reported. Discontinue Dapsone if signs of methemoglobinemia occur. Hemolysis: Some patients with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency using topical Dapsone developed laboratory changes suggestive of hemolysis.


Drug Interactions


Trimethoprim/sulfamethoxazole (TMP/SMX) increases the systemic level of Dapsone and its metabolites. Topical benzoyl peroxide used at the same time as Dapsone may result in temporary local yellow or orange skin discoloration.


Use in Special Population


Pregnancy


Pregnancy Category C. There are no adequate and well controlled studies in pregnant women. Dapsone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.


Nursing Mothers


Although systemic absorption of Dapsone following topical application of Dapsone is minimal relative to oral Dapsone administration, it is known that Dapsone is excreted in human milk. Because of the potential for oral Dapsone to cause adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue Dapsone, taking into account the importance of the drug to the mother.


Pediatric Use


Safety and effectiveness of Dapsone have not been established in pediatric patients below the age of 12 years.


Genatric Use Clinical trials of Dapsone did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects.


Storage


Store in a cool & dry place. Keep out of reach of children. Do not freeze.


Packaging


Each carton contains a tube of 30 g gel, an insert and a usage guideline leaflet.


Manufactured by


ZISKA PHARMA

+8801731202131


Ziska Pharmaceuticals Ltd. Kaliakoir, Gazipur, Bangladesh