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Generic Name
Clindamycin
Brand Names
Acanya, Altreno, Atralin, Cleocin, ClindaCare, Clindacin, Clindacin ETZ, Clindagel, Clindamycin Phoaphate, Clindesse, Neuac, Onexton, Renova, Retin-A, Tretinoin, Tri-Luma, Twyneo, Xaciato, ZIANA
FDA approval date: May 22, 1970
Classification: Retinoid
Form: Solution, Lotion, Injection, Suppository, Cream, Aerosol, Kit, Granule, Powder, Swab, Capsule, Gel
What is Acanya (Clindamycin)?
ACANYA ® Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. ACANYA Gel is a combination of clindamycin phosphate and benzoyl peroxide indicated for the topical treatment of acne vulgaris in patients 12 years or older.
Approved To Treat
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Brand Information
Acanya (Clindamycin Phosphate and Benzoyl Peroxide)
1INDICATIONS AND USAGE
ACANYA
2DOSAGE 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 membranes, or areas of broken skin.
Use of ACANYA Gel beyond 12 weeks has not been evaluated.
Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents.
ACANYA Gel is not for oral, ophthalmic, or intravaginal use.
3DOSAGE 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.
4DESCRIPTION
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 use. Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)‑hydroxyl group of the parent antibiotic lincomycin.
The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below:
Clindamycin phosphate:
- Molecular Formula: C
Benzoyl peroxide is an antibacterial and keratolytic agent. The structural formula for benzoyl peroxide is represented below:
Benzoyl peroxide:
- Molecular Formula: C
ACANYA Gel contains the following inactive ingredients: carbomer 980, potassium hydroxide, propylene glycol, and purified water. Each gram of ACANYA Gel contains 1.2% of clindamycin phosphate which is equivalent to 1% clindamycin.
5CLINICAL 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 trials were identical in design and compared ACANYA Gel to clindamycin in the vehicle gel, benzoyl peroxide in the vehicle gel, and the vehicle gel alone.
The co-primary efficacy variables were:
- Mean absolute change from baseline at Week 12 in:
- Inflammatory lesion counts
- Non-inflammatory lesion counts
- Percent of subjects who had a 2-grade improvement from baseline on an Evaluator’s Global Severity (EGS) score.
The EGS scoring scale used in all of the clinical trials for ACANYA Gel is as follows:
The results of Trial 1 at Week 12 are presented in Table 2:
The results of Trial 2 at Week 12 are presented in Table 3:
6PATIENT 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 their physician immediately.
- ACANYA Gel may cause irritation such as erythema, scaling, itching, or burning, especially when used in combination with other topical acne therapies.
- Excessive or prolonged exposure to sunlight should be limited. To minimize exposure to sunlight, a hat or other clothing should be worn. Sunscreen may also be used.
- ACANYA Gel may bleach hair or colored fabric.
Distributed by:Bausch Health US, LLC
Bridgewater, NJ 08807 USA
Bridgewater, NJ 08807 USA
Manufactured by:Bausch Health Companies Inc.
Laval, Quebec H7L 4A8, Canada
Laval, Quebec H7L 4A8, Canada
U.S. Patent Numbers: 8,288,434; 8,663,699; 8,895,070; 9,078,870; 10,220,049 and 10,624,918
ACANYA is a trademark of Bausch Health Companies Inc. or its affiliates.
© 2020 Bausch Health Companies Inc. or its affiliates
9387203
7Patient Package Insert
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: 09/2020
- 9387203
8Instructions for Use
INSTRUCTIONS FOR USE
ACANYA
(clindamycin phosphate and benzoyl peroxide) gel, 1.2%/2.5%
(clindamycin phosphate and benzoyl peroxide) gel, 1.2%/2.5%
Important Information: ACANYA Gel is for use on skin only (topical use). ACANYA Gel is not for use in your mouth, eyes or vagina.
Read this Instructions for Use before you start using ACANYA Gel and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.
- Apply ACANYA Gel to your face 1 time each day as prescribed.
- Before you apply ACANYA Gel, wash your face gently with a mild soap, rinse with warm water, and pat your skin dry.
- To apply ACANYA Gel to your face, use the pump to dispense one pea-sized amount of ACANYA Gel onto your fingertip.
- One pea-sized amount of ACANYA Gel should be enough to cover your entire face.
- Figure 1
- Dot the one pea-sized amount of ACANYA Gel onto six areas of your face (chin, left cheek, right cheek, nose, left forehead, right forehead).
Figure 2
- Spread the gel over your face and gently rub it in.
- Wash your hands with soap and water after applying ACANYA Gel.
How should I store ACANYA Gel?
- Store ACANYA Gel at room temperature at or below 77°F (25°C).
- Do not freeze ACANYA Gel.
- Throw away (discard) ACANYA Gel that has passed the expiration date.
- Store pump upright.
- Keep the container tightly closed.
Keep ACANYA Gel and all medicines out of the reach of children.
Distributed by: Bausch Health US, LLC, Bridgewater, NJ 08807 USA
Manufactured by: Bausch Health Companies Inc., Laval, Quebec H7L 4A8, Canada
U.S. Patent Numbers: 8,288,434; 8,663,699; 8,895,070; 9,078,870; 10,220,049 and 10,624,918
ACANYA is a trademark of Bausch Health Companies Inc. or its affiliates.
© 2020 Bausch Health Companies Inc. or its affiliates
The Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.
Issued: 09/2020
9387203
9PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 13548-132-50
Rx only
Acanya®
(Clindamycin Phosphate and
Benzoyl Peroxide) Gel, 1.2% /2.5%
(Clindamycin Phosphate and
Benzoyl Peroxide) Gel, 1.2% /2.5%
FOR TOPICAL USE ONLY
One premixed 50-gram pump dispenser
Ortho Dermatologics
