ACZONE- dapsone gel

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

DAPSONE (UNII: 8W5C518302) (DAPSONE - UNII:8W5C518302)

Disponível em:

Almirall, LLC

Via de administração:

TOPICAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

ACZONE® (dapsone) Gel, 7.5%, is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. None. Risk Summary There are no available data on ACZONE Gel, 7.5%, use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. The systemic absorption of ACZONE in humans following topical application is low relative to oral dapsone administration [see Clinical Pharmacology (12.3)] . In animal reproduction studies, oral doses of dapsone administered to pregnant rats and rabbits during organogenesis that resulted in systemic exposures more than 400 times the systemic exposure at the maximum recommended human dose (MRHD) of ACZONE Gel, 7.5%, resulted in embryocidal effects. When orally administered to rats from the onset of organogenesis through the end of lactation at systemic exposures approximately 500 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% and 15-20%, respectively. Data Animal Data Dapsone has been shown to have an embryocidal effect in rats and rabbits when administered orally daily to females during organogenesis at dosages of 75 mg/kg/day and 150 mg/kg/day, respectively. These dosages resulted in systemic exposures that represented approximately 1407 times [rats] and 425 times [rabbits] the systemic exposure observed in human females as a result of use of the MRHD of ACZONE Gel, 7.5%, based on AUC comparisons. These effects were probably secondary to maternal toxicity. Dapsone was assessed for effects on perinatal/postnatal pup development and postnatal maternal behavior and function in a study in which dapsone was orally administered to female rats daily beginning on the seventh day of gestation and continuing until the twenty-seventh day postpartum. Maternal toxicity (decreased body weight and food consumption) and developmental effects (increase in stillborn pups and decreased pup weight) were seen at a dapsone dose of 30 mg/kg/day (approximately 563 times the systemic exposure that is associated with the MRHD of ACZONE Gel, 7.5%, based on AUC comparisons). No effects were observed on the viability, physical development, behavior, learning ability, or reproductive function of surviving pups. Risk Summary There is no information regarding the presence of topical dapsone in breastmilk, the effects on the breastfed infant or the effects 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 low relative to oral dapsone administration. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ACZONE Gel, 7.5% and any potential adverse effects on the breastfed child from ACZONE Gel, 7.5% or from the underlying maternal condition. The safety and effectiveness of ACZONE Gel, 7.5% for the topical treatment of acne vulgaris have been established in patients 9 years of age and older. Use of ACZONE Gel, 7.5% in patients 9 to 11 years of age for this indication is supported by evidence from adequate and well-controlled clinical trials in 1066 subjects 12 years of age and older and with additional pharmacokinetic and safety data in pediatric subjects 9 to 11 years of age from an open label study of 100 subjects with acne [see Adverse Reactions (6.1), and Clinical Pharmacology (12.3)] . The safety profile for ACZONE Gel, 7.5% in clinical trials was similar to the vehicle control group. Safety and effectiveness of ACZONE Gel, 7.5%, have not been established in pediatric patients below the age of 9 years. Clinical trials of ACZONE Gel, 7.5% did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency may be more prone to methemoglobinemia and hemolysis [see Warnings and Precautions (5.1)] . ACZONE Gel, 5% and vehicle were evaluated in a randomized, double-blind, cross-over design clinical study of 64 subjects with G6PD deficiency and acne vulgaris. Subjects were Black (88%), Asian (6%), Hispanic (2%) or of other racial origin (5%). Blood samples were taken at Baseline, Week 2, and Week 12 during both vehicle and ACZONE Gel, 5% treatment periods. Some of these subjects developed laboratory changes suggestive of hemolysis, but there was no evidence of clinically significant hemolytic anemia in this study [see Warnings and Precautions (5.1)] .

Resumo do produto:

ACZONE Gel 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. ACZONE (dapsone) Gel, 7.5%, is supplied in the following sizes:           NDC 16110-526-30                    30 gram pump           NDC 16110-526-60                    60 gram pump           NDC 16110-526-90                    90 gram pump Storage : Store at 20°C-25°C (68°F-77°F), excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Protect from freezing.

Status de autorização:

New Drug Application

Características técnicas

ACZONE- DAPSONE GEL
ALMIRALL, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ACZONE GEL, 7.5%
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ACZONE
GEL, 7.5%.
ACZONE (DAPSONE) GEL, 7.5%, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1955
RECENT MAJOR CHANGES
Indications and Usage (1)
09/2019
INDICATIONS AND USAGE
ACZONE Gel, 7.5%, is a sulfone indicated for the topical treatment of
acne vulgaris in patients 9 years of
age and older (1).
DOSAGE AND ADMINISTRATION
Apply once daily (2).
Apply approximately a pea-sized amount of ACZONE 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 ACZONE Gel,
7.5% should be reassessed (2).
For topical use only. Not for oral, ophthalmic, or intravaginal use
(2).
DOSAGE FORMS AND STRENGTHS
Gel, 7.5% (3).
CONTRAINDICATIONS
None (4).
WARNINGS AND PRECAUTIONS
Methemoglobinemia: Cases of methemoglobinemia have been reported.
Discontinue ACZONE 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).
ADVERSE REACTIONS
Most common (incidence ≥ 0.9%) adverse reactions are application
site dryness and pruritus (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ALMIRALL AT
1-866-665-2782 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Trimethoprim/sulfamethoxazole (TMP/SMX) increases the systemic level
of dapsone and its metabolites
(7.1).
Topical benzoyl peroxide used at the same time as ACZONE Gel, 7.5% may
result in temporary local
yellow or orange skin discoloration (7.2).
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 12/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
®
®
®
®
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIO