PrBIACNA® Topical Gel Clindamycin phosphate and tretinoin 1.2% w/w and 0.025% w/w Acne Therapy Bausch Health, Canada Inc. 2150 St-Elzear Blvd. Clindamycin Phosphate Topical Gel, 1%, a topical antibiotic, contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram in a gel vehicle consisting of carbomer 941, methylparaben, polyethylene glycol 400, propylene glycol, purified water, and sodium hydroxide. Endoscopic examination may reveal pseudomembranous colitis.
This drug should be used during pregnancy only if clearly needed AU TGA pregnancy category: A US FDA pregnancy category: Not assigned Risk Summary: There are no available data to inform a drug-associated risk …
This information should not take the place of medical care and advice from your healthcare provider.Clindamycin is an antibiotic used to treat or prevent bacterial infections.
Clindamycin might cause some gastrointestinal (GI) effects in a breastfeeding baby similar to those seen in adults (e.g.
Reproduction studies in rats using oral doses of clindamycin hydrochloride and clindamycin palmitate hydrochloride have revealed no evidence of impaired fertility.Reproduction studies have been performed in rats and mice using subcutaneous and oral doses of clindamycin phosphate, clindamycin hydrochloride, and clindamycin palmitate hydrochloride. Tretinoin is different from other topical treatments that will be discussed here. Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.
Chambers is the Program Director of MotherToBaby California and directs MotherToBaby Pregnancy Studies. Select one or more newsletters to continue. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Since systemic absorption can follow topical application, the possibility of interactions should be borne in mind. Use of the topical formulation of clindamycin results in absorption of theantibiotic from the skin surface. Studies have not been done to see if using clindamycin could increase the chance for miscarriage.In every pregnancy, a woman starts out with a 3-5% chance of having a baby with a birth defect.
It is not . In clinical trials with pregnant women, systemic administration of clindamycin during second and third trimesters has not been associated with increased frequency of congenital abnormalities; there are no adequate studies in pregnant women during first trimester of pregnancy; clindamycin should be used during first trimester of pregnancy only if clearly needed Use enough to cover the entire affected area lightly.Clindamycin Phosphate Topical Gel containing clindamycin phosphate equivalent to 10 mg clindamycin per gram, is available in the following size:The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records.
2002 This website also contains material copyrighted by 3rd parties. The mean percent reductions in lesion counts at the end of treatment in this study are shown in the following table:There was a trend in the investigator's global assessment of the results, which favored Clindamycin Phosphate Topical Gel QD over the vehicle QD. I J Rosenstein, D J Morgan, ... Hill GB, Livengood CH., 3rd Bacterial vaginosis-associated microflora and effects of topical intravaginal clindamycin. Diseases & Conditions Diseases & Conditions Her interests are in the areas of birth defects and other pregnancy outcomes, with a special focus on exposures that can cause birth defects. Before Using.
If you become pregnant while using topical clindamycin, call your doctor.
Combination therapy with other acne medications is recommended. If you notice any symptoms in your child, contact their healthcare provider.
Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.Safety and effectiveness in children under the age of 12 have not been established.The clinical study with Clindamycin Phosphate Topical Gel did not include sufficient numbers of patients aged 65 and over to determine if they respond differently than younger patients.In the one well-controlled clinical study comparing Clindamycin Phosphate Topical Gel and its vehicle, the incidence of skin and appendages adverse events occurring in ≥1% of the patients in either group is presented below: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 To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Topically applied Clindamycin Phosphate Topical Gel may be absorbed in sufficient amounts to produce systemic effects (see WARNINGS).Apply a thin film of Clindamycin Phosphate Topical Gel once daily to the skin where acne lesions appear.
Sections. When clindamycin is used on the skin (topical use), only small amounts pass through skin and get into the bloodstream. Product Monograph – BIACNA Topical Gel Page 2 of 31 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION .....3 SUMMARY PRODUCT …
This information should not take the place of medical care and advice from your healthcare provider.Clindamycin is an antibiotic used to treat or prevent bacterial infections.
Clindamycin might cause some gastrointestinal (GI) effects in a breastfeeding baby similar to those seen in adults (e.g.
Reproduction studies in rats using oral doses of clindamycin hydrochloride and clindamycin palmitate hydrochloride have revealed no evidence of impaired fertility.Reproduction studies have been performed in rats and mice using subcutaneous and oral doses of clindamycin phosphate, clindamycin hydrochloride, and clindamycin palmitate hydrochloride. Tretinoin is different from other topical treatments that will be discussed here. Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.
Chambers is the Program Director of MotherToBaby California and directs MotherToBaby Pregnancy Studies. Select one or more newsletters to continue. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Since systemic absorption can follow topical application, the possibility of interactions should be borne in mind. Use of the topical formulation of clindamycin results in absorption of theantibiotic from the skin surface. Studies have not been done to see if using clindamycin could increase the chance for miscarriage.In every pregnancy, a woman starts out with a 3-5% chance of having a baby with a birth defect.
It is not . In clinical trials with pregnant women, systemic administration of clindamycin during second and third trimesters has not been associated with increased frequency of congenital abnormalities; there are no adequate studies in pregnant women during first trimester of pregnancy; clindamycin should be used during first trimester of pregnancy only if clearly needed Use enough to cover the entire affected area lightly.Clindamycin Phosphate Topical Gel containing clindamycin phosphate equivalent to 10 mg clindamycin per gram, is available in the following size:The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records.
2002 This website also contains material copyrighted by 3rd parties. The mean percent reductions in lesion counts at the end of treatment in this study are shown in the following table:There was a trend in the investigator's global assessment of the results, which favored Clindamycin Phosphate Topical Gel QD over the vehicle QD. I J Rosenstein, D J Morgan, ... Hill GB, Livengood CH., 3rd Bacterial vaginosis-associated microflora and effects of topical intravaginal clindamycin. Diseases & Conditions Diseases & Conditions Her interests are in the areas of birth defects and other pregnancy outcomes, with a special focus on exposures that can cause birth defects. Before Using.
If you become pregnant while using topical clindamycin, call your doctor.
Combination therapy with other acne medications is recommended. If you notice any symptoms in your child, contact their healthcare provider.
Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.Safety and effectiveness in children under the age of 12 have not been established.The clinical study with Clindamycin Phosphate Topical Gel did not include sufficient numbers of patients aged 65 and over to determine if they respond differently than younger patients.In the one well-controlled clinical study comparing Clindamycin Phosphate Topical Gel and its vehicle, the incidence of skin and appendages adverse events occurring in ≥1% of the patients in either group is presented below: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 To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Topically applied Clindamycin Phosphate Topical Gel may be absorbed in sufficient amounts to produce systemic effects (see WARNINGS).Apply a thin film of Clindamycin Phosphate Topical Gel once daily to the skin where acne lesions appear.
Sections. When clindamycin is used on the skin (topical use), only small amounts pass through skin and get into the bloodstream. Product Monograph – BIACNA Topical Gel Page 2 of 31 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION .....3 SUMMARY PRODUCT …