Get your patient on Clindamycin Phosphate - Clindamycin Phosphate Topical solution (Clindamycin Phosphate Topical)
Clindamycin Phosphate - Clindamycin Phosphate Topical solution prescribing information
INDICATIONS AND USAGE
Clindamycin Phosphate Topical Solution 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 .)
DOSAGE AND ADMINISTRATION
Apply a thin film of Clindamycin Phosphate Topical Solution twice daily to affected area. More than one pledget may be used. Each pledget should be used only once and then be discarded.
Pledget: Remove pledget from jar just before use. Do not use if the seal under the cap is broken. Discard after single use.
Keep all liquid dosage forms in containers tightly closed.
CONTRAINDICATIONS
Clindamycin Phosphate Topical Solution 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.
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 ].
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) | not recorded ( – ) | ( – ) |
Dryness | 105 (19) | 34 (23) | 29 (18) |
Erythema | 86 (16) | 10 ( 7) | 22 (14) |
Oiliness/Oily Skin | 8 (1) | 26 (18) | 12 of 126 subjects (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 i3 Pharmaceuticals, LLC at 1-844-874-7353 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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.
DESCRIPTION
Clindamycin Phosphate Topical Solution contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Each Clindamycin Phosphate Topical Solution pledget applicator contains approximately 1 mL of topical solution.
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 (to adjust the pH to between 4.0 – 7.0) and purified water.
The structural formula is represented below:
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.
HOW SUPPLIED
Clindamycin Phosphate Pledgets contain Clindamycin Phosphate Topical Solution. The solution contains clindamycin phosphate equivalent to 10 mg clindamycin per milliliter. Clindamycin Phosphate Pledgets are available in a jar of 60 single-use pledget applicators. (NDC 72319-696-60)
