Label: CLINDAMYCIN PHOSPHATE- clindamycin phosphate gel usp, 1% gel

Clindamycin phosphate gel USP, 1% contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram.

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 gel contains allantoin, carbomer 934P, methylparaben, polyethylene glycol 400, propylene glycol, purified water and sodium hydroxide.

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).

Clindamycin phosphate gel, 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).

Clindamycin phosphate gel 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.

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.

In 18 clinical studies of various formulations of 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].

# not recorded
* of 126 subjects

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.

Topically applied clindamycin phosphate can be absorbed in sufficient amounts to produce systemic effects (see WARNINGS).

Apply a thin film of clindamycin phosphate gel USP 1% twice daily to affected area.

Keep container tightly closed.

Clindamycin phosphate gel USP, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per gram is available in the following sizes:

60 gram tube - NDC 21922-027-07

30 gram tube- NDC 21922-027-05

To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Protect from freezing.

Rx only

Manufactured by:
Encube Ethicals Pvt. Ltd.
Plot No. C1, 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

Revised: 03/2021

Clindamycin Phosphate Gel USP, 1% - 30 GM Tube Pack

Container Label ( 30 GM):

NDC 21922- 027-05

Clindamycin Phosphate Gel USP, 1%

For topical use only

30 gram

Rx only

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

[see USP]. Protect from freezing.

For external use only. Avoid contact with eyes See crimp of tube for Expiration Date and Lot Number.

Carton Label ( 30 GM):

NDC 21922- 027-05

Clindamycin Phosphate Gel USP, 1%

For topical use only

30 gram

Rx only

Clindamycin Phosphate Gel USP, 1% - 60 GM Tube Pack

Container Label ( 60 GM):

NDC 21922- 027-07

Clindamycin Phosphate Gel USP, 1%

For topical use only

60 gram

Rx only

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

[see USP]. Protect from freezing.

For external use only. Avoid contact with eyes

See crimp of tube for Expiration Date and Lot Number.

Carton Label ( 60 GM):

NDC 21922- 027-07

Clindamycin Phosphate Gel USP, 1%

For topical use only

60 gram

Rx only