Clindamycin Phosphate
Clindamycin Phosphate Prescribing Information
Clindamycin phosphate topical lotion 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
Clindamycin phosphate topical lotion 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.
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 tablebelow].
| Number of Patients Reporting Events | |||
|---|---|---|---|
| Treatment Emergent Adverse Event | Solution n=553 (%) | Gel n=148 (%) | Lotion n=160 (%) |
| # not recorded | |||
| 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) | 12of 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.
Apply a thin film of clindamycin phosphate topical lotion, 1% twice daily to affected area.
Shake well immediately before using.
Keep all liquid dosage forms in containers tightly closed.
Clindamycin phosphate topical lotion 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.
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
| Number of Patients Reporting Events | |||
|---|---|---|---|
| Treatment Emergent Adverse Event | Solution n=553 (%) | Gel n=148 (%) | Lotion n=160 (%) |
| # not recorded | |||
| 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) | 12of 126 subjects(10) |
| Peeling | 61 (11) | # ( – ) | 11 ( 7) |
| Number of Patients Reporting Events | |||
|---|---|---|---|
| Treatment Emergent Adverse Event | Solution n=553 (%) | Gel n=148 (%) | Lotion n=160 (%) |
| # not recorded | |||
| 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 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
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.
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.
Clindamycin Phosphate Topical Lotion, 1% contains 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 lotion contains cetostearyl alcohol (2.5%); glycerin; glyceryl stearate SE (with potassium monostearate);isostearyl alcohol (2.5%); methylparaben (0.3%); purified water; sodium lauroyl sarcosinate and stearic acid.
The structural formula is represented below:
The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-