Daspone
Generic Name: daspone
Brand Names:
Dapsone
11 DESCRIPTION Dapsone gel, 7.5%, contains dapsone USP, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 7.5% is an off-white to yellow gel with suspended particles. Chemically, dapsone, USP has an empirical formula of C 12 H 12 N 2 O 2 S. It is a white or slightly yellow-white, crystalline powder that has a molecular weight of 248.30.
Overview
11 DESCRIPTION Dapsone gel, 7.5%, contains dapsone USP, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 7.5% is an off-white to yellow gel with suspended particles. Chemically, dapsone, USP has an empirical formula of C 12 H 12 N 2 O 2 S. It is a white or slightly yellow-white, crystalline powder that has a molecular weight of 248.30.
Uses
1 INDICATIONS AND USAGE Dapsone gel, 7.5%, is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Dapsone gel, 7.5%, is a sulfone indicated for the topical treatment of acne vulgaris in patients 9 years of age and older (1) .
Dosage
2 DOSAGE AND ADMINISTRATION For topical use only. Not for oral, ophthalmic, or intravaginal use. After the skin is gently washed and patted dry, apply approximately a pea-sized amount of dapsone gel, 7.5%, in a thin layer to the entire face once daily. In addition, a thin layer may be applied to other affected areas once daily. Rub in dapsone gel, 7.5%, gently and completely. If there is no improvement after 12 weeks, treatment with dapsone gel, 7.5% should be reassessed. Apply once daily (2) . Apply approximately a pea-sized amount of dapsone gel, 7.5%, in a thin layer to the entire face. A thin layer can also be applied to other affected areas (2) . If there is no improvement after 12 weeks, treatment with dapsone gel, 7.5% should be reassessed (2) . For topical use only.
Side Effects
6 ADVERSE REACTIONS Most common (incidence ≥ 0.9%) adverse reactions are application site dryness and pruritus (6.1) . To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 2,161 subjects were treated with dapsone gel, 7.5%, for 12 weeks in 2 controlled clinical trials. The population ranged in age from 12 to 63 years, was 56% female, and 58% Caucasian.
Interactions
7 DRUG INTERACTIONS No formal drug-drug interaction studies were conducted with dapsone gel, 7.5%. Trimethoprim/sulfamethoxazole (TMP/SMX) increases the systemic level of dapsone and its metabolites (7.1) . Topical benzoyl peroxide used at the same time as dapsone gel, 7.5% may result in temporary local yellow or orange skin discoloration (7.2) . 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). During co-administration, systemic levels of TMP and SMX were essentially unchanged, however, levels of dapsone and its metabolites increased in the presence of TMP/SMX.
Warnings
5 WARNINGS AND PRECAUTIONS Methemoglobinemia: Cases of methemoglobinemia have been reported. Discontinue dapsone gel if signs of methemoglobinemia occur (5.1) . Hemolysis: Some patients with Glucose-6-phosphate Dehydrogenase (G6PD) deficiency using topical dapsone developed laboratory changes suggestive of hemolysis (5.1) (8.6) . 5.1 Hematological Effects Methemoglobinemia Cases of methemoglobinemia, with resultant hospitalization, have been reported postmarketing in association with twice daily dapsone gel, 5%, treatment. Patients with glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methemoglobinemia are more susceptible to drug-induced methemoglobinemia. Avoid use of dapsone gel, 7.5% in those patients with congenital or idiopathic methemoglobinemia. 4 CONTRAINDICATIONS None. None (4) .
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on dapsone gel, 7.5%, use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. The systemic absorption of dapsone in humans following topical application is low relative to oral dapsone administration [see Clinical Pharmacology (12.3) ] .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Dapsone gel, 7.5% is an off-white to yellow gel with suspended particles. It is supplied in an airless pump containing a polypropylene bottle with a high density polyethylene piston.
Frequently Asked Questions
What is Daspone used for?▼
1 INDICATIONS AND USAGE Dapsone gel, 7.5%, is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Dapsone gel, 7.5%, is a sulfone indicated for the topical treatment of acne vulgaris in patients 9 years of age and older (1) .
What are the side effects of Daspone?▼
6 ADVERSE REACTIONS Most common (incidence ≥ 0.9%) adverse reactions are application site dryness and pruritus (6.1) . To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 2,161 subjects were treated with dapsone gel, 7.5%, for 12 weeks in 2 controlled clinical trials. The population ranged in age from 12 to 63 years, was 56% female, and 58% Caucasian.
Can I take Daspone during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available data on dapsone gel, 7.5%, use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. The systemic absorption of dapsone in humans following topical application is low relative to oral dapsone administration [see Clinical Pharmacology (12.3) ] .
What are the important warnings for Daspone?▼
5 WARNINGS AND PRECAUTIONS Methemoglobinemia: Cases of methemoglobinemia have been reported. Discontinue dapsone gel if signs of methemoglobinemia occur (5.1) . Hemolysis: Some patients with Glucose-6-phosphate Dehydrogenase (G6PD) deficiency using topical dapsone developed laboratory changes suggestive of hemolysis (5.1) (8.6) . 5.1 Hematological Effects Methemoglobinemia Cases of methemoglobinemia, with resultant hospitalization, have been reported postmarketing in association with twice daily dapsone gel, 5%, treatment. Patients with glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methemoglobinemia are more susceptible to drug-induced methemoglobinemia. Avoid use of dapsone gel, 7.5% in those patients with congenital or idiopathic methemoglobinemia. 4 CONTRAINDICATIONS None. None (4) .
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.