Clindagel 10 mg/mL
CLINDAMYCIN · GEL · Bausch Health US, LLC
Clindagel is a gel containing clindamycin at 10 mg/mL, taken topical. Manufactured by Bausch Health US, LLC.
Key Facts
- Brand Name
- Clindagel
- Generic Name
- CLINDAMYCIN
- NDC Code (Product)
16781-462- Manufacturer
- Bausch Health US, LLC
- Strength
- 10 mg/mL
- Dosage Form
- GEL
- Route
- TOPICAL
- Marketing Status
- Application #
- NDA050782
- Marketing Start
- 11/25/2013
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
CLINICAL STUDIES In one 12-week multicenter, randomized, evaluator-blind, vehicle-controlled, parallel comparison clinical trial in which patients used CLINDAGEL (clindamycin phosphate topical gel, 1%) once daily or the vehicle gel once daily, in the treatment of acne vulgaris of mild to moderate severity, CLINDAGEL applied once daily was more effective than the vehicle applied once daily. The mean percent reductions in lesion counts at the end of treatment in this study are shown in the following table: Lesions CLINDAGEL QD N=162 Vehicle Gel QD N=82 Inflammatory 51% 40% P<0.05 Noninflammatory 25% 12% Total 38% 27% There was a trend in the investigator’s global assessment of the results, which favored CLINDAGEL QD over the vehicle QD. In a contact sensitization study, four of the 200 subjects appeared to develop suggestive evidence of allergic contact sensitization to CLINDAGEL. There was no signal for contact sensitization in the clinical trials under normal use conditions.
Dosage & Administration
DOSAGE AND ADMINISTRATION Apply a thin film of CLINDAGEL once daily to the skin where acne lesions appear. Use enough to cover the entire affected area lightly. Keep container tightly closed.
Warnings
WARNINGS 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. Stool culture for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically. 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. Antiperistaltic agents, such as opiates and diphenoxylate with atropine, may prolong and/or worsen the condition. Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several wee…
Contraindications
CONTRAINDICATIONS CLINDAGEL 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
ADVERSE REACTIONS In the one well-controlled clinical study comparing CLINDAGEL and its vehicle, the incidence of skin and appendages adverse events occurring in ≥1% of the patients in either group is presented in the following table: Number (%) of Patients Body System/Adverse Event CLINDAGEL QD N=168 Vehicle Gel QD N=84 Skin and Appendages Disorders Dermatitis 0 (0.0) 1 (1.2) Dermatitis contact 0 (0.0) 1 (1.2) Dermatitis fungal 0 (0.0) 1 (1.2) Folliculitis 0 (0.0) 1 (1.2) Photosensitivity reaction 0 (0.0) 1 (1.2) Pruritus 1 (0.6) 1 (1.2) Rash erythematous 0 (0.0) 0 (0.0) Skin dry 0 (0.0) 0 (0.0) Peeling 1 (0.6) 0 (0.0) 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 and gastrointestinal disturbances, as well as gram-negative folliculitis, have also been reported in association with the use of topical formulations of clindamycin. To report SUSPECTED ADVERSE…
Frequently Asked Questions
What is Clindagel used for?
Clindagel contains CLINDAMYCIN. It is a gel taken topical. Consult your doctor for specific uses.
Is Clindagel a controlled substance?
Clindagel is not classified as a controlled substance by the DEA.
What is the generic name for Clindagel?
The generic name for Clindagel is CLINDAMYCIN. There are 12 other brand versions of CLINDAMYCIN.
What is the NDC code for Clindagel 10 mg/mL?
The NDC (National Drug Code) for Clindagel 10 mg/mL is 16781-462, listed by Bausch Health US, LLC.
Other Clindamycin Brands
See all →- Clindamycin Phosphate and Benzoyl Peroxide25 mg/g72162-2077
- CLINDAMYCIN HYDROCHLORIDE300 mg/172789-167
- Clindamycin hydrochloride300 mg/172789-207
- Clindamycin in 5 Percent Dextrose18 mg/mL0781-3290
- Clindamycin Phoaphate Topical Solution USP, 1%10 mg/mL21922-002
- CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE50 mg/g21922-022
- Clindamycin Phosphate10 mg/g21922-027
- Clindamycin and Benzoyl Peroxide21922-068
- CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE25 mg/g21922-074
- clindamycin palmitate hydrochloride75 mg/5mL23155-603
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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