Label: CLINDAMAX LOTION- clindamycin phosphate suspension

  • NDC Code(s): 0462-0391-60
  • Packager: PharmaDerm, A division of Nycomed US Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 08/09

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  • SPL UNCLASSIFIED SECTION

    Rx Only

    FOR EXTERNAL USE ONLY

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  • DESCRIPTION

    ClindaMax® Lotion (clindamycin phosphate topical suspension USP 1%) contains 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 topical lotion contains cetostearyl alcohol (2.5%), glycerin, glyceryl stearate SE (with potassium monostearate), isostearyl alcohol (2.5%), methylparaben (0.3%), sodium lauroyl sarcosinate, stearic acid and purified water.

    The structural formula is represented below:

    Structural Formula

    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).

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  • 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.

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  • INDICATIONS AND USAGE

    ClindaMax® Lotion (clindamycin phosphate topical suspension 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.)

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  • CONTRAINDICATIONS

    ClindaMax® Lotion (clindamycin phosphate topical suspension 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.

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  • 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 difficileand stool assay forC. difficiletoxin 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 byClostridium 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 vancomycinin 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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  • PRECAUTIONS

    General - ClindaMax® Lotion (clindamycin phosphate topical suspension USP 1%) 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 have not been established.

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  • ADVERSE REACTIONS

    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].

    Number of Patients Reporting Events

    # not recorded

    * of 126 subjects

    Treatment Emergent Solution Gel Lotion
    Adverse Event

    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.

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  • OVERDOSAGE

    Topically applied ClindaMax® Lotion (clindamycin phosphate topical suspension USP 1%) can be absorbed in sufficient amounts to produce systemic effects. (See WARNINGS.)

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  • DOSAGE AND ADMINISTRATION

    Apply a thin film of ClindaMax® Lotion (clindamycin phosphate topical suspension USP 1%) twice daily to affected area.

    Shake well immediately before using.

    Keep in container and keep tightly closed.

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  • HOW SUPPLIED

    ClindaMax® Lotion (clindamycin phosphate topical suspension USP 1%) containing clindamycin phosphate equivalent to 10 mg clindamycin per mL, is supplied as follows:

     
    NDC 0462-0391-60  60 mL bottle

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

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

    I8391C/IF8391C
    #43
    R10/08

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  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 mL BOTTLE LABEL

    PharmaDerm®

    NDC 0462-0391-60

    ClindaMax® Lotion

    (clindamycin phosphate

    topical suspension

    USP 1%)

    equivalent to 1%

    (10 mg/mL) clindamycin

    FOR TOPICAL

    USE ONLY

    Rx only

    60 mL

    Bottle Label
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  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 mL CARTON

    PharmaDerm®

    NDC 0462-0391-60

    ClindaMax® Lotion

    (clindamycin phosphate

    topical suspension

    USP 1%)

    equivalent to 1%

    (10 mg/mL) clindamycin

    FOR TOPICAL

    USE ONLY

    Rx only

    60 mL

    Carton Label
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  • INGREDIENTS AND APPEARANCE
    CLINDAMAX LOTION 
    clindamycin phosphate suspension
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0462-0391
    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 mL
    Inactive Ingredients
    Ingredient Name Strength
    cetostearyl alcohol  
    glyceryl monostearate  
    stearic acid  
    glycerin  
    water  
    methylparaben  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0462-0391-60 60 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA065067 01/31/2002
    Labeler - PharmaDerm, A division of Nycomed US Inc. (043838424)
    Registrant - Nycomed US Inc. (043838424)
    Establishment
    Name Address ID/FEI Business Operations
    Nycomed US Inc. 043838424 ANALYSIS
    Establishment
    Name Address ID/FEI Business Operations
    Nycomed US Inc. 174491316 MANUFACTURE
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