DAPSONE gel

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

dapsone (UNII: 8W5C518302) (dapsone - UNII:8W5C518302)

Доступна с:

Pacific Pharma, Inc.

ИНН (Международная Имя):

dapsone

состав:

dapsone 50 mg in 1 g

Администрация маршрут:

TOPICAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Dapsone gel, 5%, is indicated for the topical treatment of acne vulgaris. None. Risk Summary There are no available data on dapsone gel, 5% 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%

Обзор продуктов:

Dapsone gel, 5%, is supplied in the following size tubes: NDC 60758-670-30 30 gram laminate tube NDC 60758-670-60 60 gram laminate tube NDC 60758-670-90 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.

Статус Авторизация:

New Drug Application Authorized Generic

Характеристики продукта

DAPSONE- DAPSONE GEL
PACIFIC PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DAPSONE GEL, 5% SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR DAPSONE GEL, 5%.
DAPSONE GEL, 5%, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1955
INDICATIONS AND USAGE
Dapsone gel is indicated for the topical treatment of acne vulgaris
(1).
DOSAGE AND ADMINISTRATION
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. Not for oral, ophthalmic, or intravaginal use
(2).
DOSAGE FORMS AND STRENGTHS
Gel, 5% (3).
CONTRAINDICATIONS
None (4).
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).
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥ 10%) are
oiliness/peeling, dryness and erythema at the application site (6).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ALLERGAN AT
1-800-678-1605 OR FDA AT 1-800-FDA-1088
OR WWW.FDA.GOV/MEDWATCH.
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).
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 9/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 METHEMOGLOBINEMIA
5.2 HEMATOLOGIC EFFECTS
5.3 PERIPHERAL NEUROPATHY
5.4 SKIN
6 ADVERSE REACTIONS
6.1 CLINICAL STUDIES EXPERIENCE
6.2 EXPERIENCE WITH ORAL USE OF DAPSONE