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CLINDAMYCIN
Overview
What is Clindagel?
CLINDAGEL
The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L--a-D--octopyranoside 2-(dihydrogen phosphate).
What does Clindagel look like?
What are the available doses of Clindagel?
Sorry No records found.
What should I talk to my health care provider before I take Clindagel?
Sorry No records found
How should I use Clindagel?
In one 12-week multicenter, randomized, evaluator-blind, vehicle-controlled, parallel comparison clinical trial in which patients used (clindamycin phosphate topical gel, 1%) once daily or the vehicle gel once daily, in the treatment of acne vulgaris of mild to moderate severity, applied once daily was more effective than the vehicle applied once daily. 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 QD over the vehicle QD.
In a contact sensitization study, four of the 200 subjects appeared to develop suggestive evidence of allergic contact sensitization to There was no signal for contact sensitization in the clinical trials under normal use conditions.
Apply a thin film of once daily to the skin where acne lesions appear. Use enough to cover the entire affected area lightly.
Keep container tightly closed.
What interacts with Clindagel?
CLINDAGEL
What are the warnings of Clindagel?
Array
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 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 and stool assay for . 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 following cessation of oral and parenteral therapy with clindamycin.
What are the precautions of Clindagel?
General: CLINDAGEL
Drug Interactions:
Carcinogenesis, Mutagenesis, Impairment of Fertility:
The carcinogenicity of a 1% clindamycin phosphate gel similar to was evaluated by daily application to mice for 2 years. The daily doses used in this study were approximately 3 and 15 times higher than the human dose of clindamycin phosphate from 5 mL of , assuming complete absorption and based on a body surface area comparison. No significant increase in tumors was noted in the treated animals.
A 1% clindamycin phosphate gel similar to caused a statistically significant shortening of the median time to tumor onset in a study in hairless mice in which tumors were induced by exposure to simulated sunlight.
Genotoxicity tests performed included a rat micronucleus test and an Ames Salmonella reversion test. Both tests were negative. Reproduction studies in rats using oral doses of clindamycin hydrochloride and clindamycin palmitate hydrochloride have revealed no evidence of impaired fertility.
Pregnancy:
Array
Reproduction studies have been performed in rats and mice using subcutaneous and oral doses of clindamycin phosphate, clindamycin hydrochloride, and clindamycin palmitate hydrochloride. These studies revealed no evidence of fetal harm. The highest dose used in the rat and mouse teratogenicity studies was equivalent to a clindamycin phosphate dose of 432 mg/kg. For a rat, this dose is 84- fold higher and for a mouse, 42-fold higher than the anticipated human dose of clindamycin phosphate from based on a mg/m comparison. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers:
It is not known whether clindamycin is excreted in human milk following use of . However, orally and parenterally administered clindamycin has been reported to appear in breast milk. 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.
Pediatric Use:
Safety and effectiveness in children under the age of 12 have not been established.
Geriatric Use:
The clinical study with did not include sufficient numbers of patients aged 65 and over to determine if they respond differently than younger patients.
What are the side effects of Clindagel?
Sorry No records found
What should I look out for while using Clindagel?
CLINDAGEL
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 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 and stool assay for . 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 following cessation of oral and parenteral therapy with clindamycin.
What might happen if I take too much Clindagel?
Topically applied may be absorbed in sufficient amounts to produce systemic effects (see WARNINGS).
How should I store and handle Clindagel?
Contains no preservatives. Store in original carton at 20°C to 25°C (68° F to 77° F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Syringe StabilityIntravenous Admixture Stability:Do not dilute to concentrations below 1 mg/mL. Do not mix Venofer with other medications or add to parenteral nutrition solutions for intravenous infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to infusion. Contains no preservatives. Store in original carton at 20°C to 25°C (68° F to 77° F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Syringe StabilityIntravenous Admixture Stability:Do not dilute to concentrations below 1 mg/mL. Do not mix Venofer with other medications or add to parenteral nutrition solutions for intravenous infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to infusion. Contains no preservatives. Store in original carton at 20°C to 25°C (68° F to 77° F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Syringe StabilityIntravenous Admixture Stability:Do not dilute to concentrations below 1 mg/mL. Do not mix Venofer with other medications or add to parenteral nutrition solutions for intravenous infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to infusion. Contains no preservatives. Store in original carton at 20°C to 25°C (68° F to 77° F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Syringe StabilityIntravenous Admixture Stability:Do not dilute to concentrations below 1 mg/mL. Do not mix Venofer with other medications or add to parenteral nutrition solutions for intravenous infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to infusion. Contains no preservatives. Store in original carton at 20°C to 25°C (68° F to 77° F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Syringe StabilityIntravenous Admixture Stability:Do not dilute to concentrations below 1 mg/mL. Do not mix Venofer with other medications or add to parenteral nutrition solutions for intravenous infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to infusion. Contains no preservatives. Store in original carton at 20°C to 25°C (68° F to 77° F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Syringe StabilityIntravenous Admixture Stability:Do not dilute to concentrations below 1 mg/mL. Do not mix Venofer with other medications or add to parenteral nutrition solutions for intravenous infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to infusion. CLINDAGEL75 mL bottle - 16781-462-75Store at controlled room temperature 20to 25C (68 to 77F); excursions permitted between 15 to 30C (59 to 86F). Do not store in direct sunlight.Manufactured for: Bridgewater, NJ 08807 USABy:San Antonio, Texas 78215 USAUS Patent Number: 6,387,383Clindagel is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.© Valeant Pharmaceuticals North America LLC9496601-1115Rev. 11/17 Ortho Dermatologics CLINDAGEL75 mL bottle - 16781-462-75Store at controlled room temperature 20to 25C (68 to 77F); excursions permitted between 15 to 30C (59 to 86F). Do not store in direct sunlight.Manufactured for: Bridgewater, NJ 08807 USABy:San Antonio, Texas 78215 USAUS Patent Number: 6,387,383Clindagel is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.© Valeant Pharmaceuticals North America LLC9496601-1115Rev. 11/17 Ortho Dermatologics CLINDAGEL75 mL bottle - 16781-462-75Store at controlled room temperature 20to 25C (68 to 77F); excursions permitted between 15 to 30C (59 to 86F). Do not store in direct sunlight.Manufactured for: Bridgewater, NJ 08807 USABy:San Antonio, Texas 78215 USAUS Patent Number: 6,387,383Clindagel is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.© Valeant Pharmaceuticals North America LLC9496601-1115Rev. 11/17 Ortho Dermatologics CLINDAGEL75 mL bottle - 16781-462-75Store at controlled room temperature 20to 25C (68 to 77F); excursions permitted between 15 to 30C (59 to 86F). Do not store in direct sunlight.Manufactured for: Bridgewater, NJ 08807 USABy:San Antonio, Texas 78215 USAUS Patent Number: 6,387,383Clindagel is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.© Valeant Pharmaceuticals North America LLC9496601-1115Rev. 11/17 Ortho Dermatologics CLINDAGEL75 mL bottle - 16781-462-75Store at controlled room temperature 20to 25C (68 to 77F); excursions permitted between 15 to 30C (59 to 86F). Do not store in direct sunlight.Manufactured for: Bridgewater, NJ 08807 USABy:San Antonio, Texas 78215 USAUS Patent Number: 6,387,383Clindagel is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.© Valeant Pharmaceuticals North America LLC9496601-1115Rev. 11/17 Ortho Dermatologics CLINDAGEL75 mL bottle - 16781-462-75Store at controlled room temperature 20to 25C (68 to 77F); excursions permitted between 15 to 30C (59 to 86F). Do not store in direct sunlight.Manufactured for: Bridgewater, NJ 08807 USABy:San Antonio, Texas 78215 USAUS Patent Number: 6,387,383Clindagel is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.© Valeant Pharmaceuticals North America LLC9496601-1115Rev. 11/17 Ortho Dermatologics CLINDAGEL75 mL bottle - 16781-462-75Store at controlled room temperature 20to 25C (68 to 77F); excursions permitted between 15 to 30C (59 to 86F). Do not store in direct sunlight.Manufactured for: Bridgewater, NJ 08807 USABy:San Antonio, Texas 78215 USAUS Patent Number: 6,387,383Clindagel is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.© Valeant Pharmaceuticals North America LLC9496601-1115Rev. 11/17 Ortho Dermatologics CLINDAGEL75 mL bottle - 16781-462-75Store at controlled room temperature 20to 25C (68 to 77F); excursions permitted between 15 to 30C (59 to 86F). Do not store in direct sunlight.Manufactured for: Bridgewater, NJ 08807 USABy:San Antonio, Texas 78215 USAUS Patent Number: 6,387,383Clindagel is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.© Valeant Pharmaceuticals North America LLC9496601-1115Rev. 11/17 Ortho Dermatologics CLINDAGEL75 mL bottle - 16781-462-75Store at controlled room temperature 20to 25C (68 to 77F); excursions permitted between 15 to 30C (59 to 86F). Do not store in direct sunlight.Manufactured for: Bridgewater, NJ 08807 USABy:San Antonio, Texas 78215 USAUS Patent Number: 6,387,383Clindagel is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.© Valeant Pharmaceuticals North America LLC9496601-1115Rev. 11/17 Ortho Dermatologics CLINDAGEL75 mL bottle - 16781-462-75Store at controlled room temperature 20to 25C (68 to 77F); excursions permitted between 15 to 30C (59 to 86F). Do not store in direct sunlight.Manufactured for: Bridgewater, NJ 08807 USABy:San Antonio, Texas 78215 USAUS Patent Number: 6,387,383Clindagel is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.© Valeant Pharmaceuticals North America LLC9496601-1115Rev. 11/17 Ortho Dermatologics CLINDAGEL75 mL bottle - 16781-462-75Store at controlled room temperature 20to 25C (68 to 77F); excursions permitted between 15 to 30C (59 to 86F). Do not store in direct sunlight.Manufactured for: Bridgewater, NJ 08807 USABy:San Antonio, Texas 78215 USAUS Patent Number: 6,387,383Clindagel is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.© Valeant Pharmaceuticals North America LLC9496601-1115Rev. 11/17 Ortho Dermatologics CLINDAGEL75 mL bottle - 16781-462-75Store at controlled room temperature 20to 25C (68 to 77F); excursions permitted between 15 to 30C (59 to 86F). Do not store in direct sunlight.Manufactured for: Bridgewater, NJ 08807 USABy:San Antonio, Texas 78215 USAUS Patent Number: 6,387,383Clindagel is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.© Valeant Pharmaceuticals North America LLC9496601-1115Rev. 11/17 Ortho Dermatologics CLINDAGEL75 mL bottle - 16781-462-75Store at controlled room temperature 20to 25C (68 to 77F); excursions permitted between 15 to 30C (59 to 86F). Do not store in direct sunlight.Manufactured for: Bridgewater, NJ 08807 USABy:San Antonio, Texas 78215 USAUS Patent Number: 6,387,383Clindagel is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.© Valeant Pharmaceuticals North America LLC9496601-1115Rev. 11/17 Ortho Dermatologics CLINDAGEL75 mL bottle - 16781-462-75Store at controlled room temperature 20to 25C (68 to 77F); excursions permitted between 15 to 30C (59 to 86F). Do not store in direct sunlight.Manufactured for: Bridgewater, NJ 08807 USABy:San Antonio, Texas 78215 USAUS Patent Number: 6,387,383Clindagel is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.© Valeant Pharmaceuticals North America LLC9496601-1115Rev. 11/17 Ortho Dermatologics
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Following multiple applications of less than 0.04% of the total dose was excreted in the urine.
Non-Clinical Toxicology
CLINDAGELOrally 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 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 and stool assay for . 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 following cessation of oral and parenteral therapy with clindamycin.
The hypoglycemic action of sulfonylureas may be potentiated by certain drugs including nonsteroidal anti-inflammatory agents, some azoles, and other drugs that are highly protein bound, salicylates, sulfonamides, chloramphenicol, probenecid, coumarins, monoamine oxidase inhibitors, quinolones and beta adrenergic blocking agents. When such drugs are administered to a patient receiving glipizide, the patient should be observed closely for hypoglycemia. When such drugs are withdrawn from a patient receiving glipizide, the patient should be observed closely for loss of control. binding studies with human serum proteins indicate that glipizide binds differently than tolbutamide and does not interact with salicylate or dicumarol. However, caution must be exercised in extrapolating these findings to the clinical situation and in the use of glipizide with these drugs.
Certain drugs tend to produce hyperglycemia and may lead to loss of control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are administered to a patient receiving glipizide, the patient should be closely observed for loss of control. When such drugs are withdrawn from a patient receiving glipizide, the patient should be observed closely for hypoglycemia.
A potential interaction between oral miconazole and oral hypoglycemic agents leading to severe hypoglycemia has been reported. Whether this interaction also occurs with the intravenous, topical, or vaginal preparations of miconazole is not known. The effect of concomitant administration of fluconazole and glipizide has been demonstrated in a placebo-controlled crossover study in normal volunteers. All subjects received glipizide alone and following treatment with 100 mg of fluconazole as a single daily oral dose for 7 days. The mean percentage increase in the glipizide AUC after fluconazole administration was 56.9% (range: 35 to 81).
In studies assessing the effect of colesevelam on the pharmacokinetics of glipizide ER in healthy volunteers, reductions in glipizide AUC and C of 12% and 13%, respectively were observed when colesevelam was coadministered with glipizide ER. When glipizide ER was administered 4 hours prior to colesevelam, there was no significant change in glipizide AUC or C , -4% and 0%, respectively. Therefore, glipizide should be administered at least 4 hours prior to colesevelam to ensure that colesevelam does not reduce the absorption of glipizide.
General: CLINDAGEL
Drug Interactions:
In the one well-controlled clinical study comparing 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 ). Abdominal pain and gastrointestinal disturbances, as well as gram-negative folliculitis, have also been reported in association with the use of topical formulations of clindamycin.
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
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