Label: CLINDAMYCIN PHOAPHATE TOPICAL SOLUTION USP, 1%- clindamycin phosphate topical solution usp, 1% solution

  • NDC Code(s): 21922-002-01, 21922-002-21
  • Packager: Encube Ethicals Private Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated November 30, 2020

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  • DESCRIPTION


    Clindamycin phosphate topical solution USP, 1% contain 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 solution contains isopropyl alcohol 50% v/v, propylene glycol, sodium hydroxide and purified water.

    The structural formula is represented below:


    Strucutre Clinda




    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


    Mechanism of Action:

     

    The Mechanism of action of clindamycin in treating acne vulgaris is unknown.

     

    Pharmacokinetics

     

    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.


    Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin.

     

    Microbiology


    Clindamycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the ribosome. Clindamycin is bacteriostatic.


    Antimicrobial Activity


    Clindamycin is active in vitro against most isolates of Propionibacterium acnes; however, the clinical significance is unknown.

     

    Resistance


    Resistance to clindamycin is most often caused by modification of specific bases of the 23S ribosomal RNA. Cross-resistance between clindamycin and lincomycin is complete. Because the binding sites for these antibacterial drugs overlap, cross resistance is sometimes observed among lincosamides, macrolides and streptogramin B. Macrolide-inducible resistance to clindamycin occurs in some isolates of macrolide-resistant bacteria.

  • 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 CONTRAINDICATIONSWARNINGS and ADVERSE REACTIONS).

  • 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.

  • 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.

  • 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 topical solution 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


    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 breast milk following use of clindamycin phosphate topical solution USP, 1%. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Clindamycin has the potential to cause adverse effects on the breast-fed infant's gastrointestinal flora. Monitor the breast-fed 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 breast-fed child from clindamycin or from the underlying maternal condition.

    Clinical Considerations

    If used during lactation and clindamycin phosphate topical solution USP, 1% is applied to the chest, care should be taken to avoid accidental ingestion by the infant.

    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.

  • 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 (%)

    Lotion
    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)

    # 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.


  • OVERDOSAGE


    Topically applied clindamycin phosphate topical solution USP, 1% can be absorbed in sufficient amounts to produce systemic effects ( see WARNINGS).

  • DOSAGE AND ADMINISTRATION


    Apply a thin film of Clindamycin phosphate topical solution USP, 1% twice daily to affected area.

    Keep container tightly closed.

  • HOW SUPPLIED


    Clindamycin phosphate topical solution USP, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per millilitre is available in the following size:
    60 mL Bottle – NDC – 21922-002-01
    30 mL Bottle – NDC – 21922-002-21
    Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
    Protect from freezing.
    To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 


    Rx only

    Manufactured By:
    Encube Ethicals Private Limited
    Plot No. C1, Madkaim Ind. Estate,
    Madkaim, Post Mardol, Ponda, Goa-403 404, India.

    Distributed By:
    Encube Ethicals, Inc.
    200 Meredith Avenue,
    Suite 101A,
    Durham, NC 27713
    USA



    Rev: 08
    August 2020






  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL - 60ML BOTTLE CARTON



    NDC - 21922-002-01



    Clindamycin Phosphate Topical Solution USP, 1%*

    Solution for topical use only

    60 mL

    Rx only

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



    Store in an upright fashion.

    Keep container tightly closed.

    For external use only.

    Avoid contact with eyes.

    Usual Dosage: See accompanying prescribing information.

    To use enclosed applicator:

    1. Remove cap and discard.

    2. Firmly press applicator into bottle.

    3. Seal firmly by tightening domed-cap.

    Patient information

    1. Clean and dry the skin area to be treated.

    2. Apply a thin film of medication to the affected area. Use sparingly, avoiding eyes and mouth. If medication accidentally enters eyes, rinse thoroughly with tap water.

    3. If using the applicator top, use dabbing motion of the tip rather than a rolling action. If tip becomes dry, invert the bottle and depress tip several times until it becomes moist.

    *Each mL contains clindamycin phosphate equivalent to 10mg/mL (1%) of clindamycin. Also contains isopropyl alcohol 50%v/v, propylene glycol, sodium hydroxide and purified water.

    Mfg. Lic. No.:

    Manufactured by:

    Encube Ethicals Pvt. Ltd.

    Plot No. C-1, 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


    Carton-Label-30ml.jpg

    PRINCIPAL DISPLAY PANEL - 60ML BOTTLE LABEL



    Clindamycin Phosphate Topical Solution USP, 1%*

    NDC 21922-002-01

    Solution for topical use only

    60 mL



    Rx only

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

    Protect from freezing.

    Store in an upright fashion.

    Keep container tightly closed.

    For external use only.

    Avoid contact with eyes.

    Usual Dosage: See accompanying prescribing information.

    Patient information

    1. Clean and dry the skin area to be treated.

    2. Apply a thin film of medication to the affected area. Use sparingly, avoiding eyes and mouth. If medication accidentally enters eyes, rinse thoroughly with tap water.

    3. If using the applicator top, use dabbing motion of the tip rather than a rolling action. If tip becomes dry, invert the bottle and depress tip several times until it becomes moist.

    *Each mL contains clindamycin phosphate equivalent to 10mg/mL (1%) of clindamycin. Also contains isopropyl alcohol 50%v/v, propylene glycol, sodium hydroxide and purified water.

    Mfg. Lic. No.:

    Manufactured by:

    Encube Ethicals Pvt. Ltd.

    Plot No. C-1, 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



    bottle-label-60ml.jpg



    PRINCIPAL DISPLAY PANEL - 30ML BOTTLE CARTON

    Clindamycin Phosphate Topical Solution USP, 1%*

    NDC 21922- 002-21

    Solution for topical use only

    30 mL

    Rx only

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

    Keep container tightly closed.

    For external use only.

    Avoid contact with eyes.

    Usual Dosage: See accompanying prescribing information.

    To use enclosed applicator:

    1. Remove cap and discard.

    2. Firmly press applicator into bottle.

    3. Seal firmly by tightening domed-cap.

    Patient information

    1. Clean and dry the skin area to be treated.

    2. Apply a thin film of medication to the affected area. Use sparingly, avoiding eyes and mouth. If medication accidentally enters eyes, rinse thoroughly with tap water.

    3. If using the applicator top, use dabbing motion of the tip rather than a rolling action. If tip becomes dry, invert the bottle and depress tip several times until it becomes moist.

    *Each mL contains clindamycin phosphate equivalent to 10mg/mL (1%) of clindamycin. Also contains isopropyl alcohol 50%v/v, propylene glycol, sodium hydroxide and purified water.

    Mfg. Lic. No.: 362

    Manufactured by:

    Encube Ethicals Pvt. Ltd.

    Plot No. C-1, 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


    Carton-Label-30ml.jpg

    PRINCIPAL DISPLAY PANEL - 30ML BOTTLE LABEL



    Clindamycin Phosphate Topical Solution USP, 1%*

    NDC 21922- 002-21

    Solution for topical use only

    30 mL



    Rx only

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

    Protect from freezing.

    Store in an upright fashion.

    Keep container tightly closed.

    For external use only.

    Avoid contact with eyes.

    Usual Dosage: See accompanying prescribing information.

    Patient information

    1. Clean and dry the skin area to be treated.

    2. Apply a thin film of medication to the affected area. Use sparingly, avoiding eyes and mouth. If medication accidentally enters eyes, rinse thoroughly with tap water.

    3. If using the applicator top, use dabbing motion of the tip rather than a rolling action. If tip becomes dry, invert the bottle and depress tip several times until it becomes moist.

    *Each mL contains clindamycin phosphate equivalent to 10mg/mL (1%) of clindamycin. Also contains isopropyl alcohol 50%v/v, propylene glycol, sodium hydroxide and purified water.

    Mfg. Lic. No.: 362

    Manufactured by:

    Encube Ethicals Pvt. Ltd.

    Plot No. C-1, 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


    Bottle label 30 ml

  • INGREDIENTS AND APPEARANCE
    CLINDAMYCIN PHOAPHATE TOPICAL SOLUTION USP, 1%  
    clindamycin phosphate topical solution usp, 1% solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:21922-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN PHOSPHATE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21922-002-011 in 1 CARTON03/04/2019
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:21922-002-211 in 1 CARTON07/13/2020
    230 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20991403/04/2019
    Labeler - Encube Ethicals Private Limited (915834105)
    Registrant - Encube Ethicals Private Limited (915834105)
    Establishment
    NameAddressID/FEIBusiness Operations
    Encube Ethicals Private Limited725076298analysis(21922-002) , label(21922-002) , manufacture(21922-002) , pack(21922-002) , particle size reduction(21922-002)