ACANYA Gel (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Bausch Health US, LLC

Λέξεις κλειδιά

13548-132

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1. Indications and Usage

ACANYA Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.

2. Dosage and Administration

Before applying ACANYA Gel, wash your face gently with a mild soap, rinse with warm water, and pat your skin dry. Apply a pea-sized amount of ACANYA Gel to the face once daily. Avoid the eyes, mouth, mucous ...

3. Dosage Forms and Strengths

Gel, 1.2%/2.5%. Each gram of ACANYA Gel contains 10 mg (1%) clindamycin as phosphate, and 25 mg (2.5%) benzoyl peroxide in a white to off-white, opaque, smooth gel.

4. Contraindications

4.1 Hypersensitivity ACANYA Gel is contraindicated in those individuals who have shown hypersensitivity to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. Anaphylaxis, ...

5. Warnings and Precautions

5.1 Colitis Systemic absorption of clindamycin has been demonstrated following topical use of clindamycin. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reactions observed in the clinical trials of a drug cannot always be directly compared to rates in the clinical trials of ...

6.2. 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

7.1 Erythromycin ACANYA Gel should not be used in combination with topical or oral erythromycin-containing products due to its clindamycin component. In vitro studies have shown antagonism between erythromycin ...

8.1. Pregnancy

Risk Summary There are no available data on ACANYA Gel use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. The limited published ...

8.2. Lactation

Risk Summary There are no data on the presence of clindamycin or benzoyl peroxide in human milk, the effects on the breastfed child, or the effects on milk production following topical administration. ...

8.4. Pediatric Use

Safety and effectiveness of ACANYA Gel in pediatric patients under the age of 12 have not been evaluated.

8.5. Geriatric Use

Clinical trials of ACANYA Gel did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects.

11. Description

ACANYA (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/2.5% is a combination product with two active ingredients in a white to off-white, opaque, smooth, aqueous gel formulation intended for topical ...

12.1. Mechanism of Action

Clindamycin: Clindamycin is a lincosamide antibacterial [see Microbiology (12.4)]. Benzoyl Peroxide: Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects ...

12.3. Pharmacokinetics

The systemic absorption of clindamycin was investigated in an open-label, multiple-dose trial in 16 adult subjects with moderate to severe acne vulgaris treated with 1 gram of ACANYA Gel applied to the ...

12.4. Microbiology

Clindamycin binds to the 50S ribosomal subunits of susceptible bacteria and prevents elongation of peptide chains by interfering with peptidyl transfer, thereby suppressing bacterial protein synthesis. ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and impairment of fertility testing of ACANYA Gel have not been performed. Benzoyl peroxide has been shown to be a tumor promoter and progression agent in a number of animal ...

14. Clinical Studies

The safety and efficacy of once daily use of ACANYA Gel were assessed in two 12-week multi-center, randomized, blinded trials in subjects 12 years and older with moderate to severe acne vulgaris. The two ...

16.1. How Supplied

ACANYA Gel, 1.2%/2.5%, a white to off-white smooth gel is supplied as: NDC 13548-132-50 50 g pump. Dispensing Instructions for the Pharmacist Dispense ACANYA Gel with a 10-week expiration date. Specify ...

16.2. Storage and Handling

PHARMACIST: Prior to Dispensing: Store in a refrigerator, 2° to 8°C (36° to 46°F). PATIENT: Store at room temperature at or below 25°C (77°F). Protect from freezing. Store pump upright. Keep out of the ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information). Patients who develop allergic reactions such as severe swelling or shortness of breath should discontinue use and contact ...