Dapsone Gel, 5%
Generic Name: dapsone gel, 5%
Brand Names:
Dapsone
11 DESCRIPTION Dapsone gel, 5% contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 5% is a gritty translucent material with visible drug substance particles. Chemically, dapsone has an empirical formula of C 12 H 12 N 2 O 2 S. It is a white, odorless crystalline powder that has a molecular weight of 248.
Overview
11 DESCRIPTION Dapsone gel, 5% contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 5% is a gritty translucent material with visible drug substance particles. Chemically, dapsone has an empirical formula of C 12 H 12 N 2 O 2 S. It is a white, odorless crystalline powder that has a molecular weight of 248.
Uses
1 INDICATIONS AND USAGE Dapsone gel, 5%, is indicated for the topical treatment of acne vulgaris. Dapsone gel is indicated for the topical treatment of acne vulgaris.
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, 5%, in a thin layer to the acne affected areas twice daily. Rub in dapsone gel, 5%, gently and completely. Dapsone gel, 5%, is gritty with visible drug substance particles. Wash hands after application of dapsone gel, 5%. If there is no improvement after 12 weeks, treatment with dapsone gel, 5% should be reassessed. Apply twice daily ( 2 ). Apply approximately a pea-sized amount of dapsone gel, 5%, in a thin layer to the acne affected area ( 2 ). If there is no improvement after 12 weeks, treatment with dapsone gel, 5%, should be reassessed ( 2 ). For topical use only.
Side Effects
6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥ 10%) are oiliness/ peeling, dryness and erythema at the application site. To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals at 1-833-285-4151 or FDA at 1-800-FDA-1088or 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. Serious adverse reactions reported in subjects treated with dapsone gel, 5%, during clinical trials included but were not limited to the following: Nervous system/ Psychiatric – Suicide attempt, tonic clonic movements.
Interactions
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. ( 7.2 ). 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. Systemic exposure (AUC 0-12 ) of dapsone and N-acetyl-dapsone (NAD) were increased by about 40% and 20% respectively 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 ). Hematologic Effects: Some subjects with G6PD deficiency using dapsone gel developed laboratory changes suggestive of hemolysis. ( 5.2 )( 8.6 ). 5.1 Methemoglobinemia Cases of methemoglobinemia, with resultant hospitalization, have been reported postmarketing in association with 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 dapsonegel, 5% in those patients with congenital or idiopathic methemoglobinemia. 4 CONTRAINDICATIONS None. None.
Pregnancy
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.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Dapsone gel, 5%, is supplied in the following size tubes: NDC 21922-018-07 60 gram laminate tube NDC 21922-018-08 90 gram laminate tube Store Dapsone gel at controlled room temperature, 20°-25°C (68°-77°F), excursions permitted to 15°-30ºC (59°-86ºF). Protect from freezing.
Frequently Asked Questions
What is Dapsone Gel, 5% used for?▼
1 INDICATIONS AND USAGE Dapsone gel, 5%, is indicated for the topical treatment of acne vulgaris. Dapsone gel is indicated for the topical treatment of acne vulgaris.
What are the side effects of Dapsone Gel, 5%?▼
6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥ 10%) are oiliness/ peeling, dryness and erythema at the application site. To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals at 1-833-285-4151 or FDA at 1-800-FDA-1088or 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. Serious adverse reactions reported in subjects treated with dapsone gel, 5%, during clinical trials included but were not limited to the following: Nervous system/ Psychiatric – Suicide attempt, tonic clonic movements.
Can I take Dapsone Gel, 5% during pregnancy?▼
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.
What are the important warnings for Dapsone Gel, 5%?▼
5 WARNINGS AND PRECAUTIONS Methemoglobinemia: Cases of methemoglobinemia have been reported. Discontinue dapsone gel if signs of methemoglobinemia occur ( 5.1 ). Hematologic Effects: Some subjects with G6PD deficiency using dapsone gel developed laboratory changes suggestive of hemolysis. ( 5.2 )( 8.6 ). 5.1 Methemoglobinemia Cases of methemoglobinemia, with resultant hospitalization, have been reported postmarketing in association with 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 dapsonegel, 5% in those patients with congenital or idiopathic methemoglobinemia. 4 CONTRAINDICATIONS None. None.
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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.