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
Use a Clindamycin Phosphate Topical Solution pledget for the application 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.
Clindamycin Phosphate Topical Solution is flammable. Avoid fire, flame, and smoking during and immediately following application.
Pledget: Do not use if the seal is broken. Discard after single use.
Keep the jar tightly closed after each use.
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 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) | # ( – ) | # ( – ) |
| 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.
To report SUSPECTED ADVERSE REACTIONS, contact Carnegie Pharmaceuticals, LLC at 1-732-783-7010 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, USP contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Each Clindamycin Phosphate Topical Solution, USP pledget applicator contains approximately 1 mL of topical solution.
Clindamycin phosphate is a water soluble ester of the semi-synthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.
The solution contains isopropyl alcohol 50% v/v, propylene glycol, sodium hydroxide pellets, and 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 Topical Solution, USP containing clindamycin phosphate, USP equivalent to 10 mg clindamycin per milliliter is available in a jar containing 60 single-use pledget applicators (NDC 80005-131-09) and a jar containing 69 single-use pledget applicators (NDC 80005-131-38).
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Protect from freezing.
Clindamycin Phosphate Topical Solution, USP is flammable. Keep away from heat, sparks or open flames.
Mechanism of Action
The mechanism of action of clindamycin in treating acne vulgaris is unknown.
