political opinions Clindacin ETZ Generic Name: clindamycin phosphate Dosage Form: single-use pledget applicator Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings Breastfeeding Warnings User Reviews Support Group Q & A Pricing & Coupons R x Only For External Use Clindacin ETZ Description Clindacin ETZ contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Each Clindacin ETZ pledget applicator contains approximately 1 mL of topical solution. 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, purified water, and sodium hydroxide (to adjust the pH to between 4.0 - 7.0). 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). Slideshow Acne Advice: Skin Care Solutions For Both Teens and Adults Alike Clindacin ETZ - Clinical Pharmacology Although clindamycin phosphate is inactive in vitro , rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin. Cross resistance has been demonstrated between clindamycin and lincomycin. Antagonism has been demonstrated between clindamycin and erythromycin. Following multiple topical applications of clindamycin phosphate at a concentration equivalent to 10 mg clindamycin per mL in an isopropyl alcohol and water solution, very low levels of clindamycin are present in the serum (0-3 ng/mL) and less than 0.2% of the dose is recovered in urine as clindamycin. Clindamycin activity has been demonstrated in comedones from acne patients. The mean concentration of antibiotic activity in extracted comedones after application of clindamycin phosphate topical solution for 4 weeks was 597 mcg/g of comedonal material (range 0-1490). Clindamycin in vitro inhibits all Propionibacterium acnes cultures tested (MICs 0.4 mcg/mL). Free fatty acids on the skin surface have been decreased from approximately 14% to 2% following application of clindamycin. Indications and Usage for Clindacin ETZ Clindacin ETZ 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 ). Contraindications Clindacin ETZ 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. Precautions General Clindacin ETZ contains an alcohol base which will cause burning and irritation of the eye. In the event of accidental contact with sensitive surfaces (eye, abraded skin, mucous membranes), bathe with copious amounts of cool tap water. The solution has an unpleasant taste and caution should be exercised when applying medication around the mouth. Clindamycin phosphate topical products should be prescribed with caution in atopic individuals. 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. Pregnancy Teratogenic Effects Pregnancy Category B In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters has not been associated with an increased frequency of congenital abnormalities. There are no adequate studies in pregnant women during the first trimester of pregnancy. Clindamycin should be used during the first trimester of pregnancy only if clearly needed. Nursing Mothers It is not known whether clindamycin is excreted in human milk following use of Clindacin ETZ . 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 pediatric patients under the age of 12 have not been established. Geriatric Use Clinical studies for clindamycin phosphate topical solution USP, 1% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. 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 (%) * not recorded of 126 subjects 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) 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. Overdosage Topically applied Clindacin ETZ can be absorbed in sufficient amounts to produce systemic effects (see WARNINGS ). Clindacin ETZ Dosage and Administration Do not use if the unit-dose pouch seal is broken. Remove pledget just before use. Use 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. How is Clindacin ETZ Supplied Clindacin ETZ (Clindamycin Phosphate Topical Solution USP, 1% (Pledgets)) is available as follows: A carton containing 60 individually wrapped single-use pledget applicators (NDC 43538-172-60) STORAGE Store at 20-25 C (68-77 F) [see USP Controlled Room Temperature]. Protect from freezing. Manufactured for Medimetriks Pharmaceuticals, Inc. 383 Route 46 West, Fairfield, NJ 07004-2402 www.medimetriks.com Manufactured by PERRIGO Bronx, NY 10457 Rev 10-16 IP032-R3 0T972 EK J4 PRINCIPAL DISPLAY PANEL - 10 mg Pledget Carton NDC 43538-172-60 For Topical Use Only R x Only Clindacin ETZ Clindamycin Phosphate Topical Solution USP, 1%* (Pledgets) *equivalent to 1% (10 mg/mL) clindamycin 60 Individual Pledgets MEDIMETRIKS PHARMACEUTICALS, INC. PRINCIPAL DISPLAY PANEL - Kit Carton NDC 43538-173-60 R x Only Clindacin ETZ KIT Clindamycin Phosphate Topical Solution USP, 1%* (Pledgets) *equivalent to 1% (10 mg/mL) clindamycin CONTENTS: Clindacin ETZ Clindamycin Phosphate Topical Solution USP, 1% (Pledgets) 1 - Carton (60 Pledgets) AcuWash Moisturizing Daily Cleanser 1 - Bottle (16 fl. oz.) MEDIMETRIKS PHARMACEUTICALS, INC. Established Pharmacological Class Substance Pharmacological Class AcuWash CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, AND PADS) Clindacin ETZ clindamycin phosphate swab Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:43538-172 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength clindamycin phosphate (clindamycin) clindamycin 10 mg Inactive Ingredients Ingredient Name Strength isopropyl alcohol propylene glycol water sodium hydroxide Packaging # Item Code Package Description 1 NDC:43538-172-60 60 PACKET in 1 CARTON 1 1 SWAB in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065049 06/15/2013 Clindacin ETZ clindamycin phosphate kit Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:43538-173 Packaging # Item Code Package Description 1 NDC:43538-173-60 1 KIT in 1 CARTON Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 CARTON 60 Part 2 1 BOTTLE 473 mL Part 1 of 2 Clindacin ETZ clindamycin phosphate swab Product Information Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength clindamycin phosphate (clindamycin) clindamycin 10 mg Inactive Ingredients Ingredient Name Strength isopropyl alcohol propylene glycol water sodium hydroxide Packaging # Item Code Package Description 1 60 SWAB in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065049 06/15/2013 Part 2 of 2 ACUWASH inert cream Product Information Route of Administration TOPICAL DEA Schedule Ingredients Ingredient Name Quantity water cetyl alcohol laureth-12 sodium coco-sulfate sodium lauroamphoacetate propylene glycol aloe vera leaf glycerin magnesium aluminum silicate edetate disodium xanthan gum Packaging # Item Code Package Description 1 473 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 06/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065049 06/15/2013 Labeler - Medimetriks Pharmaceuticals, Inc. (019903816) Establishment Name Address ID/FEI Operations Perrigo Inc. 078846912 MANUFACTURE(43538-172, 43538-173) Revised: 11/2017 Medimetriks Pharmaceuticals, Inc. Next Interactions Print this page Add to My Med List More about Clindacin ETZ (clindamycin topical) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: topical acne agents Consumer resources Clindacin ETZ Clindacin ETZ Topical (Advanced Reading) Professional resources Clindamycin Phosphate topical (AHFS Monograph) Clindamycin Vaginal Cream (FDA) Other brands: Clindamax , Clindagel , Clindesse , Evoclin , ... +4 more Related treatment guides Acne} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Drug Class Topical acne agents Related Drugs topical acne agents clindamycin topical , erythromycin topical , tretinoin topical , tetracycline topical , dapsone topical , Finacea Acne doxycycline , clindamycin topical , erythromycin topical , minocycline , tretinoin topical , tetracycline , dapsone topical , Accutane , Vibramycin , Retin-A , isotretinoin , Minocin , Ortho Tri-Cyclen , Yasmin , Monodox , adapalene topical , Yaz , TriNessa , Epiduo , Claravis , Benzaclin , Tazorac , Differin , Adoxa , More... 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