ACANYA

ACANYA- clindamycin phosphate and benzoyl peroxide gel
Coria Laboratories

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

Apply a pea-sized amount of ACANYA Gel to the face once daily.

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.

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, 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)].

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 with the use of topical and systemic clindamycin. When significant diarrhea occurs, ACANYA Gel should be discontinued.

Severe colitis has occurred following oral and parenteral administration of clindamycin with an onset of up to several weeks following cessation of therapy. Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen severe colitis. Severe colitis may result in death.

Studies indicate toxin(s) produced by Clostridia is one primary cause of antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.

5.2 Ultraviolet Light and Environmental Exposure

Minimize sun exposure including use of tanning beds or sun lamps following drug application [see Nonclinical Toxicology (13.1) ].

6 ADVERSE REACTIONS

6.1 Clinical Studies Experience

Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trial may not reflect the rates observed in practice. Because clinical trials are also 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 patients 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 treatment, the maximum value recorded during treatment, and the percent with symptoms present at week 12 are shown in Table 1.

Table 1: Local Skin Reactions — Percent of Subjects with Symptoms Present. Combined Results from the Two Phase 3 Trials (N = 773)
Before Treatment (Baseline) Maximum During Treatment End of Treatment (Week 12)
Mild Mod.* Severe Mild Mod.* Severe Mild Mod.* Severe
*
Mod. = Moderate
Erythema 22 4 0 25 5 < 1 15 2 0
Scaling 8 < 1 0 18 3 0 8 1 0
Itching 10 2 0 15 2 0 6 < 1 0
Burning 3 < 1 0 8 2 0 2 < 1 0
Stinging 2 < 1 0 6 1 0 1 < 1 0

6.2 Postmarketing Experience

Anaphylaxis, as well as allergic reactions leading to hospitalizations, has been reported in postmarketing use of products containing clindamycin/benzoyl peroxide.

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 and clindamycin. The clinical significance of this in vitro antagonism is not known.

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