Clindamycin Phosphate Topical Solution Usp, 1% (Clindamycin Phoaphate Topical Solution Usp, 1%)

Trade Name	Clindamycin Phoaphate Topical Solution USP, 1%
Active Ingredient
Power	10 mg/mL
Type / form	Tablets
Status
Manufacturer	Encube Ethicals Private Limited

Storage and handling for Clindamycin Phoaphate Topical Solution USP, 1%

CLINDAMYCIN PHOSPHATE Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]

Disclaimer

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Clindamycin Phosphate Topical Solution Usp, 1% (Clindamycin Phoaphate Topical Solution Usp, 1%) which is also known as Clindamycin Phoaphate Topical Solution USP, 1% and Manufactured by Encube Ethicals Private Limited. It is available in strength of 10 mg/mL per ml. Read more

Clindamycin Phosphate Topical Solution Usp, 1% (Clindamycin Phoaphate Topical Solution Usp, 1%) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Clindamycin phosphate topical solution USP, 1% contain clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter.n Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)u2013chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin.n The solution contains isopropyl alcohol 50% v/v, propylene glycol, sodium hydroxide and purified water.n The structural formula is represented below:
The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl--4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L--u03b1-D--octopyranoside 2-(dihydrogen phosphate).u00a0

Mechanism of Action:
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The Mechanism of action of clindamycin in treating acne vulgaris is unknown.
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Pharmacokinetics
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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 (0u20133 ng/mL) and less than 0.2% of the dose is recovered in urine as clindamycin.
Although clindamycin phosphate is inactive , rapid hydrolysis converts this compound to the antibacterially active clindamycin.
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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 however, the clinical significance is unknown.
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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.

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 ,u00a0 and ).

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.

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. .n 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.n n

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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].
# not recorded * of 126 subjectsn n Orally and parenterally administered clindamycin has been associated with severe colitis which may end fatally.n 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 ().u00a0u00a0n 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.

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

Apply a thin film of Clindamycin phosphate topical solution USP, 1% twice daily to affected area.n Keep container tightly closed.

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 u2013 NDC u2013 21922-002-01 Store at controlled room temperature 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP]. Protect from freezing. To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited atu00a01-833-285-4151or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.u00a0
Rx onlyn- Manufactured By:n- Distributed By:
Rev: 07 January 2020

PRINCIPAL DISPLAY PANEL - 60ML BOTTLE CARTON NDC - 21922-002-01 CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION USP, 1%* Solution n- 60ML Rx onlyn
PRINCIPAL DISPLAY PANEL - 60ML BOTTLE LABEL NDC - 21922-002-01 CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION USP, 1%* Solutionn- 60ML Rx onlyn n n n