Acanya 25 mg/g

Clindamycin Phosphate and Benzoyl Peroxide · GEL · Bausch Health US, LLC

1 Recall on RecordCurrently in Shortage

Plain English

Acanya is a gel containing clindamycin phosphate and benzoyl peroxide at 25 mg/g, taken topical. Manufactured by Bausch Health US, LLC.

Key Facts

Brand Name: Acanya
Generic Name: Clindamycin Phosphate and Benzoyl Peroxide
NDC Code (Product): 13548-132
Manufacturer: Bausch Health US, LLC
Strength: 25 mg/g
Dosage Form: GEL
Route: TOPICAL
Marketing Status
Application #: NDA050819
Marketing Start: 07/26/2010

Recall History

1 Recall on Record

Class III09/20/2013

Valeant Pharmaceuticals North Am

Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being carried out due to an incorrect expiration date assigned to a lot of physicians samples.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective16 reports

pruritus13 reports

acne8 reports

pain8 reports

application site pain7 reports

blood pressure increased7 reports

dry skin7 reports

nausea7 reports

skin discolouration7 reports

condition aggravated6 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE 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 (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of acne vulgaris in patients 12 years or older. ( 1 )

Dosage & Administration

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 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. • Apply a pea-sized amount of ACANYA Gel to the face once daily. ( 2 ) • Not for oral, ophthalmic, or intravaginal use. ( 2 )

Contraindications

4 CONTRAINDICATIONS ACANYA Gel is contraindicated in: • Patients who have demonstrated hypersensitivity (e.g., anaphylaxis) to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. ( 4.1 ) • Patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. ( 4.2 ) 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, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with ACANYA Gel [see Postmarketing Experience (6.2) ] . 4.2 Colitis/Enteritis ACANYA Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis [see Warnings and Precautions (5.1) ] .

Drug Interactions

7 DRUG INTERACTIONS • Avoid using ACANYA Gel in combination with topical or oral erythromycin-containing products because of its clindamycin component. ( 7.1 ) 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 and clindamycin. The clinical significance of this in vitro antagonism is not known. 7.2 Neuromuscular Blocking Agents Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, ACANYA Gel should be used with caution in patients receiving such agents.

Adverse Reactions

6 ADVERSE REACTIONS The following selected adverse reactions occurred in less than 0.2% of patients: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 another drug and may not reflect the rates observed in practice. The following selected adverse reactions occurred in less than 0.2% of subjects treated with ACANYA Gel: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%). During clinical trials, subjects were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging. Most local skin reactions increased and peaked around Week 4 and continually decreased over time reaching near baseline levels by Week 12. The percentage of subjects that had symptoms present before …

Frequently Asked Questions

What is Acanya used for?

Acanya contains Clindamycin Phosphate and Benzoyl Peroxide. It is a gel taken topical. Consult your doctor for specific uses.

Is Acanya a controlled substance?

Acanya is not classified as a controlled substance by the DEA.

What is the generic name for Acanya?

The generic name for Acanya is Clindamycin Phosphate and Benzoyl Peroxide. There are 11 other brand versions of Clindamycin Phosphate and Benzoyl Peroxide.

What is the NDC code for Acanya 25 mg/g?

The NDC (National Drug Code) for Acanya 25 mg/g is 13548-132, listed by Bausch Health US, LLC.

Product NDC

13548-132

Package NDC

13548-132-50

Other Clindamycin Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)