ACZONE- dapsone gel

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Almirall, LLC

Administracija rute:

TOPICAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

ACZONE® Gel, 5%, is indicated for the topical treatment of acne vulgaris. None Risk Summary There are no available data on ACZONE 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 ACZONE 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% 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 956 times [rats] and 289 times [rabbits] the systemic exposure observed in human females as a result of use of the MRHD of ACZONE Gel, 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 382 times the systemic exposure that is associated with the MRHD of ACZONE Gel, 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 minimal relative to oral dapsone administration; however, it is known that dapsone is present in human milk following administration of oral dapsone. Safety and efficacy was evaluated in 1169 children aged 12-17 years old treated with ACZONE Gel, 5%, in the clinical trials. The adverse event rate for ACZONE Gel, 5%, was similar to the vehicle control group. Safety and efficacy was not studied in pediatric patients less than 12 years of age, therefore ACZONE Gel, 5%, is not recommended for use in this age group. Clinical trials of ACZONE Gel, 5%, did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. ACZONE Gel, 5% and vehicle were evaluated in a randomized, double-blind, cross-over design clinical trial 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. There were 56 out of 64 subjects who had a Week 2 blood draw and applied at least 50% of treatment applications. Table 3 contains results from testing of relevant hematology parameters for these two treatment periods. ACZONE Gel was associated with a 0.32 g/dL drop in hemoglobin after two weeks of treatment, but hemoglobin levels generally returned to baseline levels at Week 12. There were no changes from baseline in haptoglobin or lactate dehydrogenase during ACZONE or vehicle treatment at either the 2-week or 12-week time point. The proportion of subjects who experienced decreases in hemoglobin ≥1 g/dL was similar between ACZONE Gel, 5% and vehicle treatment (8 of 58 subjects had such decreases during ACZONE treatment compared to 7 of 56 subjects during vehicle treatment among subjects with at least one on-treatment hemoglobin assessment). Subgroups based on gender, race, or G6PD enzyme activity did not display any differences in laboratory results from the overall study group. There was no evidence of clinically significant hemolytic anemia in this study. Some of these subjects developed laboratory changes suggestive of hemolysis.

Proizvod sažetak:

ACZONE (dapsone) Gel, 5%, is supplied in the following size tubes: NDC 16110-367-60 60 gram laminate tube NDC 16110-367-90 90 gram laminate tube Store ACZONE gel at controlled room temperature, 20°-25℃ (68°-77℉), excursions permitted to 15°-30℃ (59°-86℉). Protect from freezing.

Status autorizacije:

New Drug Application

Svojstava lijeka

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, 5% SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR ACZONE GEL,
5%.
ACZONE GEL, 5% FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1955
INDICATIONS AND USAGE
ACZONE 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 ACZONE Gel, 5%, in a thin
layer to the acne affected area
(2).
If there is no improvement after 12 weeks, treatment with
ACZONE 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 ACZONE gel if
signs of methemoglobinemia occur (5.1).
Hematologic Effects: Some subjects with G6PD deficiency using ACZONE
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 ACZONE may result in
temporary local yellow or
orange skin discoloration (7.2).
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 12/2020
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
6.3