ClindaMax Gel

Generic Name: clindamycin phosphate
Dosage Form: gel

ClindaMax® Gel
(Clindamycin Phosphate Gel USP, 1%)

Rx only

FOR EXTERNAL USE ONLY
AVOID CONTACT WITH EYES

DESCRIPTION

ClindaMax® Gel (Clindamycin Phosphate Gel), for topical use, 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.

Slideshow: View Frightful (But Dead Serious) Drug Side Effects

The gel contains allantoin, carbomer 934P, methylparaben, polyethylene glycol 400, 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

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

ClindaMax® (Clindamycin Phosphate Gel) 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.)

CONTRAINDICATIONS

ClindaMax® (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.

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 cultures 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 mg 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

General: Clindamycin phosphate 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:Teratogenic Effects–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 clindamycin phosphate. 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 has not been established.

Adverse Reactions

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].

Number of patients reporting events

# not recorded

* of 126 subjects

Treatment Emergent Adverse Event Solution Gel Lotion
n=553 (%) n=148 (%) n=160 (%)

Burning

62 (11)

15 (10)

17 (11)
Itching 36 (7) 15 (10) 17 (11)
Burning/Itching 60 (11) # (–) # (–)
Dryness 105 (19) 34 (23) 29 (18)
Erythema 86 (16) 10 (7) 22 (14)
Oiliness/Oily Skin 8 (1) 26 (18) 12* (10)
Peeling 61 (11) # (–) 11 (7)

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 and gastrointestinal disturbances as well as gram-negative folliculitis have also been reported in association with the use of topical formulations of clindamycin.

OVERDOSAGE

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

DOSAGE AND ADMINISTRATION

Apply a thin film of ClindaMax® (Clindamycin Phosphate Gel) twice daily to affected area.

Keep container tightly closed.

HOW SUPPLIED

ClindaMax® Gel (Clindamycin Phosphate Gel USP, 1%) containing clindamycin phosphate equivalent to 10 mg clindamycin per gram is available in the following sizes:

30 gram tube NDC 0462 - 0390 - 30                     60 gram tube NDC 0462-0390-60

Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing.

January 2008

PharmaDerm®
A division of Nycomed US Inc.
Melville, NY 11747 USA
www.pharmaderm.com

I8390C
R1/08

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 G LABEL

NDC 0462-0390-30

PharmaDerm ®

ClindaMax ® Gel
(clindamycin phosphate gel USP 1%)
equivalent to 1% clindamycin

For Topical Use Only FOR EXTERNAL USE ONLY AVOID CONTACT WITH EYES

Rx only
30 g

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 G CARTON

NDC 0462-0390-30

PharmaDerm ®

ClindaMax ® Gel
(clindamycin phosphate gel USP 1%) equivalent to 1% clindamycin

For Topical Use Only FOR EXTERNAL USE ONLY AVOID CONTACT WITH EYES

Rx only

30 g

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 G LABEL

NDC 0462-0390-60

PharmaDerm ®

ClindaMax ® Gel
(clindamycin phosphate gel USP 1%)
equivalent to 1% clindamycin

For Topical Use Only FOR EXTERNAL USE ONLY AVOID CONTACT WITH EYES

Rx only
60 g

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 G CARTON

NDC 0462-0390-60

PharmaDerm ®

ClindaMax ® Gel
(clindamycin phosphate gel USP 1%) equivalent to 1% clindamycin

For Topical Use Only FOR EXTERNAL USE ONLY AVOID CONTACT WITH EYES

Rx only
60 g

CLINDAMAX 
clindamycin phosphate gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0462-0390
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
clindamycin phosphate (clindamycin) clindamycin phosphate 10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Water  
Allantoin  
Polyethylene Glycol 400  
Propylene Glycol  
Methylparaben  
Sodium Hydroxide  
Packaging
# Item Code Package Description
1 NDC:0462-0390-30 1 TUBE (1 TUBE) in 1 CARTON
1 30 g in 1 TUBE
2 NDC:0462-0390-60 1 TUBE (1 TUBE) in 1 CARTON
2 60 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064160 10/01/2009
Labeler -  PharmaDerm, A division of Nycomed US Inc. (043838424)
Registrant - Nycomed US Inc. (043838424)
Establishment
Name Address ID/FEI Operations
Nycomed US Inc. 043838424 ANALYSIS
Establishment
Name Address ID/FEI Operations
Nycomed US Inc. 174491316 MANUFACTURE
Revised: 10/2009
 
PharmaDerm, A division of Nycomed US Inc.
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