Drug Facts
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Identifiers & Packaging
HOW SUPPLIED Clindamycin phosphate topical solution USP, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per millilitre is available in the following size: 60 mL Bottle – NDC – 72603-321-02 30 mL Bottle – NDC – 72603-321-01 Store at controlled room temperature 20° to 25°C (68° to 77°F). Protect from freezing. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Northstar Healthcare Rx LLC at (1-800-206-7821) . Rx only Manufactured By: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Ind. Estate, Madkaim, Post Mardol, Ponda, Goa-403 404, India. Manufactured for: Northstar Rx LLC. Memphis, TN 38141. Toll-free: 1-800-206-7821 Rev: 07/24; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL PRINCIPAL DISPLAY PANEL - 60ML BOTTLE CARTON NDC - 72603- 321 -02 Clindamycin Phosphate Topical Solution USP, 1%* Solution for topical use only 60 mL Rx only Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Protect from freezing. Store in an upright fashion. Keep container tightly closed. For external use only. Avoid contact with eyes. Usual Dosage: See accompanying prescribing information. To use enclosed applicator: 1. Remove cap and discard. 2. Firmly press applicator into bottle. 3. Seal firmly by tightening domed-cap. Patient information 1. Clean and dry the skin area to be treated. 2. Apply a thin film of medication to the affected area. Use sparingly, avoiding eyes and mouth. If medication accidentally enters eyes, rinse thoroughly with tap water. 3. If using the applicator top, use dabbing motion of the tip rather than a rolling action. If tip becomes dry, invert the bottle and depress tip several times until it becomes moist. 4. Do not squeeze the bottle. *Each mL contains clindamycin phosphate equivalent to 10mg/mL (1%) of clindamycin. Also contains isopropyl alcohol 50%v/v, propylene glycol, sodium hydroxide and purified water. Mfg. Lic. No.: 362 Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India. Manufactured for: Northstar Rx LLC. Memphis, TN 38141. Product of China. PRINCIPAL DISPLAY PANEL - 30ML BOTTLE CARTON NDC 72603- 321 -01 Clindamycin Phosphate Topical Solution USP, 1%* Solution for topical use only 30 mL Rx only Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Protect from freezing. Store in an upright fashion. Keep container tightly closed. For external use only. Avoid contact with eyes. Usual Dosage: See accompanying prescribing information. To use enclosed applicator: 1. Remove cap and discard. 2. Firmly press applicator into bottle. 3. Seal firmly by tightening domed-cap. Patient information 1. Clean and dry the skin area to be treated. 2. Apply a thin film of medication to the affected area. Use sparingly, avoiding eyes and mouth. If medication accidentally enters eyes, rinse thoroughly with tap water. 3. If using the applicator top, use dabbing motion of the tip rather than a rolling action. If tip becomes dry, invert the bottle and depress tip several times until it becomes moist. 4. Do not squeeze the bottle. *Each mL contains clindamycin phosphate equivalent to 10mg/mL (1%) of clindamycin. Also contains isopropyl alcohol 50%v/v, propylene glycol, sodium hydroxide and purified water. Mfg. Lic. No.: 362 Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India. Manufactured for: Northstar Rx LLC. Memphis, TN 38141. Product of China. carton-label-60ml carton-label-30ml
- HOW SUPPLIED Clindamycin phosphate topical solution USP, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per millilitre is available in the following size: 60 mL Bottle – NDC – 72603-321-02 30 mL Bottle – NDC – 72603-321-01 Store at controlled room temperature 20° to 25°C (68° to 77°F). Protect from freezing. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Northstar Healthcare Rx LLC at (1-800-206-7821) . Rx only Manufactured By: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Ind. Estate, Madkaim, Post Mardol, Ponda, Goa-403 404, India. Manufactured for: Northstar Rx LLC. Memphis, TN 38141. Toll-free: 1-800-206-7821 Rev: 07/24
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL PRINCIPAL DISPLAY PANEL - 60ML BOTTLE CARTON NDC - 72603- 321 -02 Clindamycin Phosphate Topical Solution USP, 1%* Solution for topical use only 60 mL Rx only Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Protect from freezing. Store in an upright fashion. Keep container tightly closed. For external use only. Avoid contact with eyes. Usual Dosage: See accompanying prescribing information. To use enclosed applicator: 1. Remove cap and discard. 2. Firmly press applicator into bottle. 3. Seal firmly by tightening domed-cap. Patient information 1. Clean and dry the skin area to be treated. 2. Apply a thin film of medication to the affected area. Use sparingly, avoiding eyes and mouth. If medication accidentally enters eyes, rinse thoroughly with tap water. 3. If using the applicator top, use dabbing motion of the tip rather than a rolling action. If tip becomes dry, invert the bottle and depress tip several times until it becomes moist. 4. Do not squeeze the bottle. *Each mL contains clindamycin phosphate equivalent to 10mg/mL (1%) of clindamycin. Also contains isopropyl alcohol 50%v/v, propylene glycol, sodium hydroxide and purified water. Mfg. Lic. No.: 362 Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India. Manufactured for: Northstar Rx LLC. Memphis, TN 38141. Product of China. PRINCIPAL DISPLAY PANEL - 30ML BOTTLE CARTON NDC 72603- 321 -01 Clindamycin Phosphate Topical Solution USP, 1%* Solution for topical use only 30 mL Rx only Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Protect from freezing. Store in an upright fashion. Keep container tightly closed. For external use only. Avoid contact with eyes. Usual Dosage: See accompanying prescribing information. To use enclosed applicator: 1. Remove cap and discard. 2. Firmly press applicator into bottle. 3. Seal firmly by tightening domed-cap. Patient information 1. Clean and dry the skin area to be treated. 2. Apply a thin film of medication to the affected area. Use sparingly, avoiding eyes and mouth. If medication accidentally enters eyes, rinse thoroughly with tap water. 3. If using the applicator top, use dabbing motion of the tip rather than a rolling action. If tip becomes dry, invert the bottle and depress tip several times until it becomes moist. 4. Do not squeeze the bottle. *Each mL contains clindamycin phosphate equivalent to 10mg/mL (1%) of clindamycin. Also contains isopropyl alcohol 50%v/v, propylene glycol, sodium hydroxide and purified water. Mfg. Lic. No.: 362 Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India. Manufactured for: Northstar Rx LLC. Memphis, TN 38141. Product of China. carton-label-60ml carton-label-30ml
Overview
Clindamycin phosphate topical solution USP, 1% contain clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)–chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The solution contains isopropyl alcohol 50% v/v, propylene glycol, sodium hydroxide and purified water. The structural formula is represented below: 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- threo -α-D- galacto -octopyranoside 2-(dihydrogen phosphate). Strucutre Clinda
Indications & Usage
Clindamycin phosphate topical solution USP, 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 & Administration
Apply a thin film of Clindamycin phosphate topical solution USP, 1% twice daily to affected area. Keep container tightly closed.
Warnings & Precautions
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.
Contraindications
Clindamycin phosphate topical solution USP, 1% 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.
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 clindamycin.
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.
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