Clindacin ETZ

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Although the risk of serious side effects is low when clindamycin is applied to the skin, side effects can occur if the medication is absorbed into your bloodstream.

Stop using clindamycin topical and call your doctor at once if you have:

• severe redness, itching, or dryness of treated skin areas; or
• severe stomach pain, diarrhea that is watery or bloody.

Common side effects may include:

• mild burning or itching;
• oily skin;
• mild dryness of treated skin; or
• redness or other irritation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Do not smoke while using clindamycin topical foam, or immediately after applying it. The contents of the foam canister are flammable.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Do not use other medicated skin products unless your doctor has told you to. Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime.

Rinse with water if this medicine gets in your eyes.

It is not likely that other drugs you take orally or inject will have an effect on topically applied clindamycin. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Clindamycin is an antibiotic that fights bacteria.

Clindamycin topical (for the skin) is used to treat severe acne in adults and children who are at least 12 years old.

Clindamycin topical may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to clindamycin or lincomycin, or if you have:

• inflammation of your intestines (also called enteritis);

• ulcerative colitis; or

• if you have ever had severe diarrhea caused by antibiotic medicine.

Clindamycin topical is not expected to harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether clindamycin topical passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not use this medication on a child younger than 12 years old without the advice of a doctor.

Rx Only

For External Use

Clindacin® ETZ contains clindamycin phosphate USP at a concentration equivalent to 10 mg clindamycin per milliliter.

Each Clindacin® ETZ pledget applicator contains approximately 1 mL of topical solution.

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 solution contains isopropyl alcohol 50% v/v, propylene glycol, purified water, and sodium hydroxide (to adjust the pH to between 4.0 - 7.0).

The structural formula is represented below:

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).

Orally and parenterally administered clindamycin has been associated with severe colitis which may result in patient death. Use of the topical formulation of clindamycin results in absorption of the antibiotic from the skin surface. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin.

Studies indicate a 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. Endoscopic examination may reveal pseudomembranous colitis. Stool culture for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.

When significant diarrhea occurs, the drug should be discontinued. Large bowel endoscopy should be considered to establish a definitive diagnosis in cases of severe diarrhea.

Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen the condition. Vancomycin has been found to be effective in the treatment of antibiotic-associated pseudomembranous colitis produced by Clostridium difficile. The usual adult dosage is 500 milligrams to 2 grams of vancomycin orally per day in three to four divided doses administered for 7 to 10 days. Cholestyramine or colestipol resins bind vancomycin in vitro. If both a resin and vancomycin are to be administered concurrently, it may be advisable to separate the time of administration of each drug.

Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parenteral therapy with clindamycin.

General

Clindacin® ETZ contains an alcohol base which will cause burning and irritation of the eye. In the event of accidental contact with sensitive surfaces (eye, abraded skin, mucous membranes), bathe with copious amounts of cool tap water. The solution has an unpleasant taste and caution should be exercised when applying medication around the mouth. Clindamycin phosphate topical products should be prescribed with caution in atopic individuals.

Drug Interactions

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore it should be used with caution in patients receiving such agents.

Pregnancy

Pregnancy Category B

Reproduction studies have been performed in rats and mice using subcutaneous and oral doses of clindamycin ranging from 100 to 600 mg/kg/day and have revealed no evidence of impaired fertility or harm to the fetus due to clindamycin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether clindamycin is excreted in human milk following use of Clindacin® ETZ. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients under the age of 12 have not been established.

Geriatric Use

Clinical studies for clindamycin phosphate topical solution USP, 1% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Topically applied Clindacin® ETZ can be absorbed in sufficient amounts to produce systemic effects (see WARNINGS).

Clindacin® ETZ (Clindamycin Phosphate Topical Solution USP, 1% (Pledgets)) is available as follows:

A carton containing 60 individually wrapped single-use pledget applicators (NDC 43538-172-60)

STORAGE

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Protect from freezing.

Manufactured for Medimetriks Pharmaceuticals, Inc.
363 Route 46 West, Fairfield, NJ 07004-2402 • www.medimetriks.com

Manufactured by PERRIGO
Bronx, NY 10457

Rev. Date: 10/12
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