clindamycin and benzoyl peroxide
clindamycin and benzoyl peroxide · KIT · Padagis Israel Pharmaceuticals Ltd
clindamycin and benzoyl peroxide is a kit containing clindamycin and benzoyl peroxide. Manufactured by Padagis Israel Pharmaceuticals Ltd.
Key Facts
- Brand Name
- clindamycin and benzoyl peroxide
- Generic Name
- clindamycin and benzoyl peroxide
- NDC Code (Product)
45802-510- Manufacturer
- Padagis Israel Pharmaceuticals Ltd
- Dosage Form
- KIT
- Marketing Status
- Application #
- ANDA202440
- Marketing Start
- 03/08/2021
Recall History
TOLMAR, Inc.
Superpotent Drug
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Clindamycin and benzoyl peroxide topical gel, 1%/5% is indicated for the topical treatment of acne vulgaris.
Dosage & Administration
DOSAGE AND ADMINISTRATION Clindamycin and benzoyl peroxide topical gel, 1%/5% should be applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is gently washed, rinsed with warm water and patted dry.
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 WEEKS …
Contraindications
CONTRAINDICATIONS Clindamycin and benzoyl peroxide topical gel, 1%/5% is contraindicated in those individuals who have shown hypersensitivity to any of its components or to lincomycin. It is also contraindicated in those having a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.
Adverse Reactions
ADVERSE REACTIONS During clinical trials, the most frequently reported adverse event in the clindamycin and benzoyl peroxide topical gel, 1%/5% treatment group was dry skin (12%). The Table below lists local adverse events reported by at least 1% of patients in the clindamycin and benzoyl peroxide topical gel, 1%/5% and vehicle groups. Local Adverse Events – all causalities in >/= 1% of patients Clindamycin and benzoyl peroxide topical gel, 1%/5% n=420 Vehicle n=168 Application site reaction 13 (3%) 1 (<1%) Dry skin 50 (12%) 10 (6%) Pruritus 8 (2%) 1 (<1%) Peeling 9 (2%) - Erythema 6 (1%) 1 (<1%) Sunburn 5 (1%) - The actual incidence of dry skin might have been greater were it not for the use of a moisturizer in these studies. Anaphylaxis, as well as allergic reactions leading to hospitalization, have been reported during post-marketing use of clindamycin/benzoyl peroxide products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Frequently Asked Questions
What is clindamycin and benzoyl peroxide used for?
clindamycin and benzoyl peroxide contains clindamycin and benzoyl peroxide. It is a kit taken as directed. Consult your doctor for specific uses.
Is clindamycin and benzoyl peroxide a controlled substance?
clindamycin and benzoyl peroxide is not classified as a controlled substance by the DEA.
What is the generic name for clindamycin and benzoyl peroxide?
The generic name for clindamycin and benzoyl peroxide is clindamycin and benzoyl peroxide. There are 4 other brand versions of clindamycin and benzoyl peroxide.
What is the NDC code for clindamycin and benzoyl peroxide ?
The NDC (National Drug Code) for clindamycin and benzoyl peroxide is 45802-510, listed by Padagis Israel Pharmaceuticals Ltd.