Label: CLINDAMYCIN PHOSPHATE- clindamycin phosphate gel

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 30, 2017

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  • SPL UNCLASSIFIED SECTION

    Rx only

    For External Use.

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  • DESCRIPTION

    Clindamycin Phosphate Topical Solution and Clindamycin Phosphate Lotion (Clindamycin Phosphate Topical Suspension USP, 1%) contain clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Clindamycin Phosphate Gel 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 solution contains isopropyl alcohol 50% v/v, propylene glycol, and purified water.

    The gel contains allantoin, carbomer 974P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water.

    The 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 to 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 to 1,490). 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

    Clindamycin Phosphate Topical Solution, Clindamycin Phosphate Gel, and Clindamycin Phosphate Lotion are 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

    Clindamycin Phosphate Topical Solution, Clindamycin Phosphate Gel, and Clindamycin Phosphate Lotion are 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 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.

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  • PRECAUTIONS

    General: Clindamycin Phosphate Topical Solution contains an alcohol base which will cause burning and irritation of the eye. In the event of accidental contact with sensitive surfaces (eye, abraded skin, mucous membranes), bathe with copious amounts of cool tap water. The solution has an unpleasant taste and caution should be exercised when applying medication around the mouth.

    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. In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters has not been associated with an increased frequency of congenital abnormalities. There are no adequate studies in pregnant women during the first trimester of pregnancy. Clindamycin should be used during the first trimester of 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.

    Geriatric Use: Clinical studies for topical Clindamycin products did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

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

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  • OVERDOSAGE

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

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  • DOSAGE AND ADMINISTRATION

    Apply a thin film of Clindamycin Phosphate Topical Solution, Clindamycin Phosphate Lotion, or Clindamycin Phosphate Gel twice daily to affected area.

    Lotion: Shake well immediately before using.

    Keep all liquid dosage forms in containers tightly closed.

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  • HOW SUPPLIED

    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 68788-9780-3

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

    Fougera
    PHARMACEUTICALS INC.

    E. FOUGERA & CO.
    A division of Fougera Pharmaceuticals Inc.
    MELVILLE, NEW YORK 11747

    I201D/IF201D
    R10/16
    #90

    Relabeled By: Preferred Pharmaceuticals Inc.

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  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 G CARTON

    NDC 68788-9780-3

    Rx only

    Fougera ®

    CLINDAMYCIN
    PHOSPHATE GEL USP, 1%
    equivalent to 1% clindamycin
    For Topical Use Only.

    FOR EXTERNAL USE ONLY.
    AVOID CONTACT WITH EYES.
    WARNING: Keep out of
    reach of children.

    NET WT 30 grams

    Relabeled By: Preferred Pharmaceuticals Inc.

    Clindamycin Phosphate Gel 1%
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  • INGREDIENTS AND APPEARANCE
    CLINDAMYCIN PHOSPHATE 
    clindamycin phosphate gel
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-9780(NDC:0168-0202)
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALLANTOIN (UNII: 344S277G0Z)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68788-9780-3 1 in 1 CARTON 07/27/2012
    1 30 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA064160 07/27/2012
    Labeler - Preferred Pharmaceuticals, Inc. (791119022)
    Registrant - Preferred Pharmaceuticals, Inc. (791119022)
    Establishment
    Name Address ID/FEI Business Operations
    Preferred Pharmaceuticals, Inc. 791119022 RELABEL(68788-9780)
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