Clindacin P Description

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

Each Clindacin•P® 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-pyrrolidine-carboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate).

Clindacin P - Clinical Pharmacology

Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin.

Cross resistance has been demonstrated between clindamycin and lincomycin. Antagonism has been demonstrated between clindamycin and erythromycin.

Following multiple topical applications of clindamycin phosphate at a concentration equivalent to 10 mg clindamycin per mL in an isopropyl alcohol and water solution, very low levels of clindamycin are present in the serum (0–3 ng/mL) and less than 0.2% of the dose is recovered in urine as clindamycin.

Clindamycin activity has been demonstrated in comedones from acne patients. The mean concentration of antibiotic activity in extracted comedones after application of clindamycin phosphate topical solution for 4 weeks was 597 mcg/g of comedonal material (range 0–1490). Clindamycin in vitro inhibits all Propionibacterium acnes cultures tested (MICs 0.4 mcg/mL). Free fatty acids on the skin surface have been decreased from approximately 14% to 2% following application of clindamycin.

Indications and Usage for Clindacin P

Clindacin•P® is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudo-membranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS).

Contraindications

Clindacin•P® is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.

Warnings

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.

Precautions

Adverse Reactions/Side Effects

In 18 clinical studies of various formulations of topical clindamycin phosphate using placebo vehicle and/or active comparator drugs as controls, patients experienced a number of treatment emergent adverse dermatologic events [see table below].

Orally and parenterally administered clindamycin has been associated with severe colitis which may end fatally. Cases of diarrhea, bloody diarrhea and colitis (including pseudomembranous colitis) have been reported as adverse reactions in patients treated with oral and parenteral formulations of clindamycin and rarely with topical clindamycin (see WARNINGS).

Abdominal pain, gastrointestinal disturbances, gram-negative folliculitis, eye pain and contact dermatitis have also been reported in association with the use of topical formulations of clindamycin.

To report SUSPECTED ADVERSE REACTIONS, contact Medimetriks Pharmaceuticals, Inc., at 1-973-882-7512 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Overdosage

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

Clindacin P Dosage and Administration

Do not use if the seal on jar is broken. Remove pledget from jar just before use. Use a pledget to apply a thin film of Clindamycin Phosphate Topical Solution to the affected area twice daily. More than one pledget may be used. Each pledget should be used only once and then discarded. Keep jar tightly closed when not in use.

How is Clindacin P supplied

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

A jar containing 69 single-use pledget applicators (NDC 43538-170-69)

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

Manufactured by Padagis, Yeruham, Israel

IL015-R7
Rev. Date: 10/22

PRINCIPAL DISPLAY PANEL - 69 Pledget Jar Label

Rx Only

NDC 43538-170-69

For Topical Use Only

Clindacin•P®

Clindamycin Phosphate
Topical Solution USP, 1%* (Pledgets)

*equivalent to 1% (10 mg/mL) clindamycin

MEDIMETRIKS
PHARMACEUTICALS, INC.

69 Pledgets

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC 43538-171-69
MEDIMETRIKS
PHARMACEUTICALS, INC.

Rx Only

Clindacin® pac

Clindamycin Phosphate
Topical Solution USP, 1%*
(Pledget) *equivalent to 1% (10 mg/mL) clindamycin

CONTENTS:
1-Clindacin•P® (Clindamycin Phosphate Topical Solution USP, 1% (Pledgets) Jar (69 Pledgets)
1-AcuWash® Moisturizing Daily Cleanser Bottle (16 fl. oz.)