ACZONE Gel (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Almirall, LLC

Λέξεις κλειδιά

16110-526

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1. Indications and Usage

ACZONE (dapsone) Gel, 7.5%, is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

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 ACZONE Gel, 7.5%, in a thin layer to the entire ...

3. Dosage Forms and Strengths

Gel, 7.5%. Each gram of ACZONE Gel, 7.5% contains 75 mg of dapsone in an off-white to yellow gel with suspended particles.

4. Contraindications

None.

5. Warnings and Precautions

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 ...

6. Adverse Reactions

6.2 Experience with Oral Use of Dapsone Although not observed in the clinical trials with topical dapsone, serious adverse reactions have been reported with oral use of dapsone, including agranulocytosis, ...

6.1. Clinical Trials 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 ...

6.3. Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. ...

7. Drug Interactions

No formal drug-drug interaction studies were conducted with ACZONE Gel, 7.5%. 7.1 Trimethoprim-Sulfamethoxazole A drug-drug interaction study evaluated the effect of the use of dapsone gel, 5% in combination ...

8. Use in Specific Populations

8.6 Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency Individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency may be more prone to methemoglobinemia and hemolysis [see Warnings and Precautions ...

8.1. Pregnancy

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 ...

8.2. Lactation

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 ...

8.4. Pediatric Use

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 ...

8.5. Geriatric Use

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.

11. Description

ACZONE (dapsone) Gel, 7.5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. ACZONE Gel, 7.5% is an off-white to yellow gel with suspended particles. Chemically, dapsone ...

12.1. Mechanism of Action

The mechanism of action of dapsone gel in treating acne vulgaris is not known.

12.3. Pharmacokinetics

In a pharmacokinetic study, male and female subjects 16 years of age or older with acne vulgaris (N=19) applied 2 grams of ACZONE Gel, 7.5% to the face, upper chest, upper back and shoulders once daily ...

12.4. Microbiology

In Vivo Activity No microbiology or immunology studies were conducted during ACZONE Gel, 7.5% clinical studies. Drug Resistance No dapsone resistance studies were conducted during dapsone gel ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Dapsone was not carcinogenic to rats when orally administered to females for 92 weeks or males for 100 weeks at dose levels up to 15 mg/kg/day (approximately 340 times the systemic exposure observed in ...

14. Clinical Studies

The safety and efficacy of once daily use of ACZONE Gel, 7.5%, was assessed in two 12-week multicenter, randomized, double-blind, vehicle-controlled trials. Efficacy was assessed in a total of 4340 subjects ...

16.1. How Supplied

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%, ...

16.2. Storage and Handling

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.

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information). Hematological Effects: Inform patients that methemoglobinemia can occur with topical dapsone treatment. Advise ...