Clindamycin Phosphate - Clindamycin Phosphate Gel Usp, 1% gel prescribing information
INDICATIONS AND USAGE
Clindamycin phosphate gel, 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 ).
DOSAGE AND ADMINISTRATION
Apply a thin film of clindamycin phosphate gel USP 1% twice daily to affected area.
Keep container tightly closed.
CONTRAINDICATIONS
Clindamycin phosphate gel 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) | # ( – ) | # ( – ) |
| 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.
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 gel USP, 1% contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram.
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 gel contains allantoin, carbomer 934P, methylparaben, polyethylene glycol 400, propylene glycol, purified water and sodium hydroxide.
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 to 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 i n 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 gel USP, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per gram is available in the following sizes:
60 gram tube - NDC 21922-027-07
30 gram tube- NDC 21922-027-05
To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
Protect from freezing.
Rx only
Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C1, 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
Revised: 03/2021
