Evoclin

• Prestium Pharma, Inc.

• Quality Care Products, LLC

• Stiefel Laboratories, Inc.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of clindamycin, there are no specific foods that you must exclude from your diet when receiving this medication.

Take clindamycin exactly as prescribed.

Oral:

This medication is available as an oral capsule, an oral liquid, and granules for oral solution.

Take oral forms of clindamycin with a full glass of water so that the medicine will not irritate your throat.

Topical:

This medication is available as a topical cream, topical gel, topical solution, topical foam, topical swab (pledget), vaginal cream, and vaginal suppository. The topical products are used for treating acne and are applied 1 to 2 times a day. The vaginal products are usually used once a day.

Injectable:

This medication is also available in an injectable form to be given directly into a vein (IV) or a muscle (IM) by a healthcare professional.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of clindamycin at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age

Oral:

The recommended dose of oral clindamycin for the treatment of bacterial infections is 150 to 450 mg every 6 hours.

Topical:

The recommended dose of topical clindamycin for the treatment of acne is application to the affected skin 1 to 2 times daily. The recommended dose of clindamycin vaginal preparations is application once daily at bedtime.

Injectable:

The recommended dose of clindamycin injection for the treatment of bacterial infections is 600 to 2700 mg per day in 2, 3, or 4 doses.

• Store at room temperature. Do not freeze.
• Keep lid tightly closed.
• Protect from heat and sunlight. Do not puncture or burn even if it seems empty.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

White to off-white thermolabile foam. Each gram of Evoclin Foam contains, as dispensed, 12 mg (1.2%) of clindamycin phosphate, equivalent to 10 mg (1%) of clindamycin.

Mechanism of Action

Mechanism of action in acne vulgaris is unknown. [See Microbiology (12.4)]

Pharmacodynamics

Pharmacodynamics of Evoclin Foam is unknown.

Pharmacokinetics

In an open label, parallel group study in 24 subjects with acne vulgaris, 12 subjects (3 male and 9 female) applied 4 grams of Evoclin Foam once-daily for five days, and 12 subjects (7 male and 5 female) applied 4 grams of a clindamycin gel, 1%, once daily for five days. On Day 5, the mean Cmax and AUC(0-12) were 23% and 9% lower, respectively, for Evoclin Foam than for the clindamycin gel, 1%.

Following multiple applications of Evoclin Foam, less than 0.024% of the total dose was excreted unchanged in the urine over 12 hours on Day 5.

Microbiology

No microbiology studies were conducted in the clinical trials with this product.

Clindamycin binds to the 50S ribosomal subunits of susceptible bacteria and prevents elongation of peptide chains by interfering with peptidyl transfer, thereby suppressing protein synthesis. Clindamycin has been shown to have in vitro activity against Propionibacterium acnes (P. acnes), an organism that has been associated with acne vulgaris; however, the clinical significance of this activity against P. acnes was not examined in clinical studies with Evoclin Foam. P. acnes resistance to clindamycin has been documented.

Inducible Clindamycin Resistance

The treatment of acne with antimicrobials is associated with the development of antimicrobial resistance in P. acnes as well as other bacteria (e.g. Staphylococcus aureus, Streptococcus pyogenes). The use of clindamycin may result in developing inducible resistance in these organisms. This resistance is not detected by routine susceptibility testing.

Cross Resistance

Resistance to clindamycin is often associated with resistance to erythromycin.

Carcinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenicity of a 1.2% clindamycin phosphate gel similar to Evoclin Foam was evaluated by daily application to mice for two years. The daily doses used in this study were approximately 3 and 15 times higher than the human dose of clindamycin phosphate from 5 milliliters of Evoclin Foam, assuming complete absorption and based on a body surface area comparison. No significant increase in tumors was noted in the treated animals.

A 1.2% clindamycin phosphate gel similar to Evoclin Foam caused a statistically significant shortening of the median time to tumor onset in a study in hairless mice in which tumors were induced by exposure to simulated sunlight.

Genotoxicity tests performed included a rat micronucleus test and an Ames Salmonella reversion test. Both tests were negative.

Reproduction studies in rats using oral doses of clindamycin hydrochloride and clindamycin palmitate hydrochloride have revealed no evidence of impaired fertility.

In one multicenter, randomized, double-blind, vehicle-controlled clinical trial, subjects with mild to moderate acne vulgaris used Evoclin Foam or the vehicle Foam once daily for twelve weeks. Treatment response, defined as the proportion of subjects clear or almost clear, based on the Investigator Static Global Assessment (ISGA), and the mean percent reductions in lesion counts at the end of treatment in this study are shown in Table 2.

How Supplied

Evoclin Foam containing clindamycin phosphate equivalent to 10 mg clindamycin per gram, is white to off-white in color and thermolabile. It is available in the following sizes:

Storage and Handling

Store at controlled room temperature between 68°F to 77°F (20°C to 25°C).

Flammable. Avoid fire, flame or smoking during and immediately following application.

Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperature above 120°F (49°C).

Keep out of reach of children.