PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 60ML BOTTLE CARTON

NDC – 68788-7810-6

Clindamycin Phosphate Topical Solution USP, 1%*

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Solutionfor topical use only

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60 mL

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Rx only

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Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Protect from freezing.

** Store in an upright fashion.**

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Keep container tightly closed.

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For external use only.

Avoid contact with eyes.

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**Usual Dosage:**See accompanying prescribing information.

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To use enclosed applicator:

1. Remove cap and discard.

2. Firmly press applicator into bottle.

3. Seal firmly by tightening domed-cap.

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Patient information

1. Clean and dry the skin area to be treated.

2. Apply a thin film of medication to the affected area. Use sparingly, avoiding eyes and mouth. If medication accidentally enters eyes, rinse thoroughly with tap water.

3. If using the applicator top, use dabbing motion of the tip rather than a rolling action. If tip becomes dry, invert the bottle and depress tip several times until it becomes moist.

*Each mL contains clindamycin phosphate equivalent to 10mg/mL (1%) of clindamycin. Also contains isopropyl alcohol 50%v/v, propylene glycol, sodium hydroxide and purified water.

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Mfg. Lic. No.:

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Manufactured by:

Encube Ethicals Pvt. Ltd.

Plot No. C-1, Madkaim Industrial Estate,

Madkaim, Post: Mardol, Ponda,

Goa - 403 404, India.

Distributed by:

Encube Ethicals, Inc.

200 Meredith Avenue, Suite 101A

Durham, NC 27713 USA

Relabeled By: Preferred Pharmaceuticals Inc.


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DESCRIPTION SECTION

DESCRIPTION

Clindamycin phosphate topical solution USP, 1% contain clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter.

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, sodium hydroxide and purified water.

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).

CLINICAL PHARMACOLOGY SECTION

CLINICAL PHARMACOLOGY

Mechanism of Action:

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The Mechanism of action of clindamycin in treating acne vulgaris is unknown.

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Pharmacokinetics

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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.

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

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Microbiology

Clindamycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the ribosome. Clindamycin is bacteriostatic.

Antimicrobial Activity

Clindamycin is active in vitro against most isolates of Propionibacterium acnes; however, the clinical significance is unknown.

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Resistance

Resistance to clindamycin is most often caused by modification of specific bases of the 23S ribosomal RNA. Cross-resistance between clindamycin and lincomycin is complete. Because the binding sites for these antibacterial drugs overlap, cross resistance is sometimes observed among lincosamides, macrolides and streptogramin B. Macrolide-inducible resistance to clindamycin occurs in some isolates of macrolide-resistant bacteria.

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INDICATIONS & USAGE SECTION

INDICATIONS AND USAGE

Clindamycin phosphate topical solution USP, 1% is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS).

DOSAGE & ADMINISTRATION SECTION

DOSAGE AND ADMINISTRATION

Apply a thin film of Clindamycin phosphate topical solution USP, 1% twice daily to affected area.

Keep container tightly closed.

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CONTRAINDICATIONS SECTION

CONTRAINDICATIONS

Clindamycin phosphate topical solution USP, 1% 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 SECTION

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 forClostridium difficile**** and stool assay forC. 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.**

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OVERDOSAGE SECTION

OVERDOSAGE

Topically applied clindamycin phosphate topical solution USP, 1% can be absorbed in sufficient amounts to produce systemic effects (see WARNINGS).

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HOW SUPPLIED SECTION

HOW SUPPLIED

Clindamycin phosphate topical solution USP, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per millilitre is available in the following size:
60 mL Bottle – NDC – 68788-7810-6

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
Protect from freezing.
To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Rx only

Manufactured By:
Encube Ethicals Private Limited
Plot No. C1, Madkaim Ind. Estate,
Madkaim, Post Mardol, Ponda, Goa-403 404, India.

Distributed By:
Encube Ethicals, Inc.
200 Meredith Avenue,
Suite 101A,
Durham, NC 27713
USA

Rev: 08
August 2020

Relabeled By: Preferred Pharmaceuticals Inc.

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