Acanya Information
Acanya (Clindamycin) Indications And Usage
Acanya (Clindamycin) Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.
Acanya (Clindamycin) Dosage And Administration
Apply a pea-sized amount of Acanya (Clindamycin) Gel to the face once daily.
Use of Acanya (Clindamycin) Gel beyond 12 weeks has not been evaluated. Acanya (Clindamycin) Gel is not for oral, ophthalmic, or intravaginal use.
Acanya (Clindamycin) Dosage Forms And Strengths
Each gram of Acanya (Clindamycin) Gel contains, as dispensed, 10 mg (1%) clindamycin as phosphate, and 25 mg (2.5%) benzoyl peroxide in a white to off-white, opaque, smooth gel.
Acanya (Clindamycin) Contraindications
Acanya (Clindamycin) Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.
Acanya (Clindamycin) Warnings And Precautions
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 (Clindamycin) 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 and stool assay for toxin may be helpful diagnostically.
Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against colitis.
Acanya (Clindamycin) Adverse Reactions
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. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse reactions that appear to be related to drug use and for approximating rates.
The following selected adverse reactions occurred in less than 0.2% of patients treated with Acanya (Clindamycin) Gel: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%).
During clinical trials, patients 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 patients 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.
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.
Acanya (Clindamycin) Use In Specific Populations
Safety and effectiveness of Acanya (Clindamycin) Gel in pediatric patients under the age of 12 have not been evaluated.
Clinical trials of Acanya (Clindamycin) Gel included patients 12-17 years of age. []
Acanya (Clindamycin) Description
Acanya (Clindamycin) (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/2.5% is a combination product with two active ingredients in an aqueous gel formulation. Clindamycin phosphate is a water-soluble ester of the semi-synthetic 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 -(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below:
Clindamycin phosphate:
Molecular Formula: CHClNOPS Molecular Weight: 504.97
Benzoyl peroxide is an antibacterial and keratolytic agent. The structural formula for benzoyl peroxide is represented below:
Benzoyl peroxide:
Molecular Formula: CHO Molecular Weight: 242.23
Acanya (Clindamycin) Gel contains the following inactive ingredients: purified water, carbomer 980, propylene glycol, and potassium hydroxide. Each gram of Acanya (Clindamycin) Gel contains 1.2% of clindamycin phosphate which is equivalent to 1% clindamycin.
Acanya (Clindamycin) Clinical Pharmacology
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.
Clindamycin and benzoyl peroxide individually have been shown to have activity against , an organism which has been associated with acne vulgaris; however, the clinical significance of this activity against is not known and was not examined in clinical trials with Acanya (Clindamycin) Gel.
P. acnes
Acanya (Clindamycin) Clinical Studies
The safety and efficacy of once daily use of Acanya (Clindamycin) Gel were assessed in two 12-week multi-center, randomized, blinded studies in patients 12 years and older with moderate to severe acne vulgaris. The two studies were identical in design and compared Acanya (Clindamycin) Gel to clindamycin in the vehicle gel, benzoyl peroxide in the vehicle gel, and the vehicle gel alone. The co-primary efficacy variables were:
The EGS scoring scale used in all of the clinical trials for Acanya (Clindamycin) Gel is as follows:
The results of Study 1 at week 12 are presented in the table below:
The results of Study 2 at week 12 are presented in the table below:
Acanya (Clindamycin) Patient Counseling Information
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Acanya (Clindamycin) Gel may cause irritation such as erythema, scaling, itching, burning, or stinging.
Patients should report any signs or symptoms of local skin irritation to their physician.
Acanya (Clindamycin)
Acanya (Clindamycin)
