Clindamycin Phoaphate Topical Solution USP, 1% 10 mg/mL
Clindamycin Phosphate Topical Solution USP, 1% · SOLUTION · Encube Ethicals, Inc.
Clindamycin Phoaphate Topical Solution USP, 1% is a solution containing clindamycin phosphate topical solution usp, 1% at 10 mg/mL, taken topical. Manufactured by Encube Ethicals, Inc..
Key Facts
- Brand Name
- Clindamycin Phoaphate Topical Solution USP, 1%
- Generic Name
- Clindamycin Phosphate Topical Solution USP, 1%
- NDC Code (Product)
21922-002- Manufacturer
- Encube Ethicals, Inc.
- Strength
- 10 mg/mL
- Dosage Form
- SOLUTION
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA209914
- Marketing Start
- 03/04/2019
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Clindamycin phosphate topical solution USP, 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 & Administration
DOSAGE AND ADMINISTRATION Apply a thin film of Clindamycin phosphate topical solution USP, 1% twice daily to affected area. 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. Vancomycin has been found to be effective in the treatment of antibiotic-associated pseudomembr…
Contraindications
CONTRAINDICATIONS Clindamycin phosphate topical solution USP, 1% 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.
Drug Interactions
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.
Adverse Reactions
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]. Number of Patients Reporting Events 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 clindamyci…
Frequently Asked Questions
What is Clindamycin Phoaphate Topical Solution USP, 1% used for?
Clindamycin Phoaphate Topical Solution USP, 1% contains Clindamycin Phosphate Topical Solution USP, 1%. It is a solution taken topical. Consult your doctor for specific uses.
Is Clindamycin Phoaphate Topical Solution USP, 1% a controlled substance?
Clindamycin Phoaphate Topical Solution USP, 1% is not classified as a controlled substance by the DEA.
What is the generic name for Clindamycin Phoaphate Topical Solution USP, 1%?
The generic name for Clindamycin Phoaphate Topical Solution USP, 1% is Clindamycin Phosphate Topical Solution USP, 1%. There are no other listed brand versions of Clindamycin Phosphate Topical Solution USP, 1%.
What is the NDC code for Clindamycin Phoaphate Topical Solution USP, 1% 10 mg/mL?
The NDC (National Drug Code) for Clindamycin Phoaphate Topical Solution USP, 1% 10 mg/mL is 21922-002, listed by Encube Ethicals, Inc..
Other Clindamycin Phoaphate Topical Solution USP, 1% Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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