Label: CLINDAMYCIN PHOSPHATE - clindamycin phosphate solution

  • NDC Code(s): 52565-018-29, 52565-018-59
  • Packager: Teligent Pharma, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 2, 2018

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  • SPL UNCLASSIFIED SECTION

    For External Use

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  • DESCRIPTION

    Clindamycin Phosphate Topical Solution USP, 1% contains clindamycin phosphate 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 water.

    The structural formula is represented below:

    molecular formula
    Molecular Formula:  C18H34ClN2O8PS Molecular Weight: 504.97

    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

    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.)

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  • 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.

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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 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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  • PRECAUTIONS

    General

    Clindamycin Phosphate Topical Solution USP, 1% 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

    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. Clindamycin has the potential to cause adverse effects on the breastfed infant's gastrointestinal flora. If oral or intravenous clindamycin is required by a nursing mother, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred. Monitor the infant for possible adverse effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash) or rarely, blood in the stool indicating possible antibiotic-associated colitis.

    The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clindamycin and any potential adverse effects on the breastfed child from clindamycin or from the underlying maternal conditions.

    Pediatric Use

    Safety and effectiveness in pediatric patients under the age of 12 have not been established.

    Geriatric Use

    Clinical studies for clindamycin phosphate 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
    Treatment Emergent Adverse Event Solution
    n=553(%)
    Gel
    N=148(%)
    Suspension
    N=160(%)
    *
    not recorded
    of 126 subjects
    Burning 62(11) 15(10) 17(11)
    Itching 36(7) 15(10) 17(11)
    Burning/Stinging 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.

    To report SUSPECTED ADVERSE REACTIONS, contact Teligent Pharma, Inc. at 1-856-697-1441, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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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 twice daily to affected area

    Keep container tightly closed.

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  • HOW SUPPLIED

    Clindamycin Phosphate Topical Solution USP, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following sizes:

    30 mL applicator bottle — NDC 52565-018-29
    60 mL applicator bottle — NDC 52565-018-59

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

    Protect from freezing.

    Manufactured by:

    Teligent Pharma, Inc.
    Buena, New Jersey 08310

    Rev. 12/2017

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 30mL Bottle

    NDC 52565-018-29

    Clindamycin
    Phosphate
    Topical Solution USP, 1%

    30 mL
    Solution for topical use only

    Teligent

    30 mL PDP
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  • INGREDIENTS AND APPEARANCE
    CLINDAMYCIN PHOSPHATE  
    clindamycin phosphate solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52565-018
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Clindamycin Phosphate (UNII: EH6D7113I8) (Clindamycin - UNII:3U02EL437C) Clindamycin Phosphate 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Isopropyl Alcohol (UNII: ND2M416302)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52565-018-29 1 in 1 CARTON 12/30/2016
    1 30 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    2 NDC:52565-018-59 1 in 1 CARTON 12/30/2016
    2 60 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA206945 12/30/2016
    Labeler - Teligent Pharma, Inc. (011036910)
    Registrant - Teligent Pharma, Inc. (011036910)
    Establishment
    Name Address ID/FEI Business Operations
    Teligent Pharma, Inc. 011036910 manufacture(52565-018)
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