Clindacin P

Clindacin P is an FDA-registered drug product whose active ingredient is CLINDAMYCIN PHOSPHATE. It is labelled by Eurofarma, Inc. taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 43538-170, application ANDA065049, label effective 20260610. It is one of 36 FDA drug label records sharing the active ingredient CLINDAMYCIN PHOSPHATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing CLINDAMYCIN PHOSPHATE are most often described in connection with: usage clindacin, treatment acne, vulgaris view, diarrhea bloody, pseudomembranous colitis, consider whether, appropriate see, contraindications warnings. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS AND USAGE Clindacin•P ® 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 Do not use if the seal on jar is broken. Remove pledget from jar just before use. Use a pledget to apply a thin film of Clindamycin Phosphate Topical Solution to the affected area twice daily. More than one pledget may be used. Each pledget should be used only once and then discarded. Keep jar tightly closed when not in use.

CONTRAINDICATIONS Clindacin•P ® 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.

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 pseudomembranous colitis produced by Clostridium difficile . The usual adult dosage is 500 milligrams to 2 grams of vancomycin orally per day in three to four divided doses administered for 7 to 10 days. Cholestyramine or colestipol resins bind vancomycin in vitro . If both a resin and vancomycin are to be administered concurrently, it may be advisable to separate the time of administration of each drug. Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parenteral therapy with clindamycin.

ADVERSE REACTIONS In 18 clinical studies of various formulations of topical 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) not recorded ( – ) ( – ) 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 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. To report SUSPECTED ADVERSE REACTIONS, contact Eurofarma, Inc., at 1-973-882-7512 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

FDA lists 36 drug label records with CLINDAMYCIN PHOSPHATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Clindacin P used for?
INDICATIONS AND USAGE Clindacin•P ® 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 ).

Who makes Clindacin P?
Eurofarma, Inc. is the labeler of record for Clindacin P. 36 FDA label records share the active ingredient CLINDAMYCIN PHOSPHATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Clindacin P come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Clindacin P prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing CLINDAMYCIN PHOSPHATE?
Yes. 36 FDA drug label records list CLINDAMYCIN PHOSPHATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Clindacin P been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.