Clindamycin Phosphate 10 mg/mL
Clindamycin Phosphate · SOLUTION · Viona Pharmaceuticals Inc
Clindamycin Phosphate is a solution containing clindamycin phosphate at 10 mg/mL, taken topical. Manufactured by Viona Pharmaceuticals Inc.
Key Facts
- Brand Name
- Clindamycin Phosphate
- Generic Name
- Clindamycin Phosphate
- NDC Code (Product)
72578-084- Manufacturer
- Viona Pharmaceuticals Inc
- Strength
- 10 mg/mL
- Dosage Form
- SOLUTION
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA208767
- Marketing Start
- 06/15/2020
Recall History
MCKESSON CORPORATION
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
G & W Laboratories, Inc.
CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
Contract Pharmaceuticals Limited Canada
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Valeant Pharmaceuticals North Am
Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being carried out due to an incorrect expiration date assigned to a lot of physicians samples.
Contract Pharmaceuticals Limited Canada
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
American Pharmaceutical Ingredients LLC
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Akorn, Inc.
Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities
L. Perrigo Company
Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Contract Pharmaceuticals Limited Canada
Defective Container: slow leakage under the cap
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 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 CONTRAINDICATIONS , WARNINGS and ADVERSE REACTIONS ).
Dosage & Administration
DOSAGE AND ADMINISTRATION Apply a thin film of clindamycin phosphate topical lotion twice daily to affected area. Lotion: Shake well immediately before using. Keep all liquid dosage forms in containers 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 pseudomembra…
Contraindications
CONTRAINDICATIONS 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.
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 cli…
Frequently Asked Questions
What is Clindamycin Phosphate used for?
Clindamycin Phosphate contains Clindamycin Phosphate. It is a solution taken topical. Consult your doctor for specific uses.
Is Clindamycin Phosphate a controlled substance?
Clindamycin Phosphate is not classified as a controlled substance by the DEA.
What is the generic name for Clindamycin Phosphate?
The generic name for Clindamycin Phosphate is Clindamycin Phosphate. There are 10 other brand versions of Clindamycin Phosphate.
What is the NDC code for Clindamycin Phosphate 10 mg/mL?
The NDC (National Drug Code) for Clindamycin Phosphate 10 mg/mL is 72578-084, listed by Viona Pharmaceuticals Inc.
Other Clindamycin Phosphate Dosages
Other Clindamycin Brands
See all →- Clindamycin Phosphate and Benzoyl Peroxide25 mg/g72162-2077
- Clindamycin Phoaphate Topical Solution USP, 1%10 mg/mL21922-002
- CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE50 mg/g21922-022
- CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE25 mg/g21922-074
- Clindamycin phosphate600 mg/50mL43066-993
- Clindamycin Phosphate and Benzoyl Peroxide37.5 mg/g45802-383
- Cleocin Phosphate150 mg/mL0009-0870
- Cleocin Phosphate150 mg/mL0009-5095
- Cleocin100 mg/10009-7667
- clindamycin phosphate10 mg/g59762-3743
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)