kind of [1%:<1% of the clindamycin vaginal cream 2% group include: Urogenital system: dysuria, metrorrhagia, vaginal pain, and trichomonal vaginitis. Body as a whole: upper respiratory infection. Skin: pruritus (topical application site) and erythema. Other clindamycin formulations: Clindamycin vaginal cream affords minimal peak serum levels and systemic exposure (AUCs) of clindamycin compared to 100 mg oral clindamycin dosing. Although these lower levels of exposure are less likely to produce the common reactions seen with oral clindamycin, the possibility of these and other reactions cannot be excluded presently. Data from well-controlled trials directly comparing clindamycin administered orally to clindamycin administered vaginally are not available. The following adverse reactions and altered laboratory tests have been reported with the oral or parenteral use of clindamycin: Gastrointestinal: Abdominal pain, esophagitis, nausea, vomiting, and diarrhea. (See WARNINGS. ) Hematopoietic: Transient neutropenia (leukopenia), eosinophilia, agranulocytosis, and thrombocytopenia have been reported. No direct etiologic relationship to concurrent clindamycin therapy could be made in any of these reports. Hypersensitivity Reactions : Maculopapular rash and urticaria have been observed during drug therapy. Generalized mild to moderate morbilliform-like skin rashes are the most frequently reported of all adverse reactions. Rare instances of erythema multiforme, some resembling Stevens-Johnson syndrome, have been associated with clindamycin. A few cases of anaphylactoid reactions have been reported. If a hypersensitivity reaction occurs, the drug should be discontinued. Liver: Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy. Musculoskeletal : Rare instances of polyarthritis have been reported. Renal: Although no direct relationship of clindamycin to renal damage has been established, renal dysfunction as evidenced by azotemia, oliguria, and/or proteinuria has been observed in rare instances. Overdosage Vaginally applied Clindamax Vaginal Cream could be absorbed in sufficient amounts to produce systemic effects. (See WARNINGS .) Clindamax Dosage and Administration The recommended dose is one applicatorful of Clindamax Vaginal Cream, (5 grams containing approximately 100 mg of clindamycin phosphate) intravaginally, preferably at bedtime, for 3 or 7 consecutive days in non-pregnant patients and for 7 consecutive days in pregnant patients. (See CLINICAL STUDIES .) How is Clindamax Supplied Clindamax Vaginal Cream (clindamycin phosphate vaginal cream USP, 2%) is a white to off-white cream having a slight odor and is supplied as follows: 40 g tube (with 7 disposable applicators) NDC 0462-0277-40 Store at 20 to 25 C (68 to 77 F)[see USP Controlled Room Temperature]. Clinical Studies In two clinical studies involving 674 evaluable non-pregnant women with bacterial vaginosis comparing clindamycin phosphate vaginal cream 2% for 3 or 7 days, the clinical cure rates, determined at 1 month posttherapy, ranged from 72% to 81% for the 3-day treatment and 84% to 86% for the 7-day treatment. Clindamycin Phosphate 3 Day Clindamycin Phosphate 7 Day U.S. Study 94/131 72% 110/128 86% European Study 161/199 81% 181/216 84% In a clinical study involving 249 evaluable pregnant patients in the second and third trimester treated for 7 days, the clinical cure rate, determined at 1 month posttherapy, was 60% (77/129) in the clindamycin arm and 9% (11/120) for the vehicle arm. The determination of clinical cure was based on the absence of a "fishy" amine odor when the vaginal discharge was mixed with a 10% KOH solution and the absence of clue cells on microscopic examination. PharmaDerm A division of Nycomed US Inc. Melville, NY 11747 USA www.pharmaderm.com I8277B R3/08 #305 DIRECTIONS FOR USE 7 Disposable plastic applicators are provided with this package. They are designed to allow proper vaginal administration of the cream. Remove cap from cream tube. Screw a plastic applicator on the threaded end of the tube. Rolling tube from the bottom, squeeze gently and force the medication into the applicator. The applicator is filled when the plunger reaches its predetermined stopping point. Unscrew the applicator from the tube and replace the cap. While lying on your back, firmly grasp the applicator barrel and insert into vagina as far as possible without causing discomfort. Slowly push the plunger until it stops. Carefully withdraw applicator from vagina, and discard applicator. REMEMBER TO APPLY ONE APPLICATORFUL EACH NIGHT BEFORE BEDTIME, OR AS PRESCRIBED BY YOUR DOCTOR. INSTRUCCIONES PARA LA PACIENTE Este envase contiene 7 aplicadores de plástico desechables. Los aplicadores están diseñados para la adminstración apropiada de la crema en la vagina. Remueva la tapa del tubo de crema y enrosque el aplicador de plástico al tubo. Exprima el tubo suavemente desde el extremo inferior y fuerce el medicamento al aplicador. El aplicador estará lleno cuando el émbolo llega a su máxima longitud. Desenrosque el aplicador del tubo y vuelva a poner la tapa. Acuéstese de espada y agarrando firemente el aplicador, introdúzcalo en la vagina tanto como sea posible sin causar molestias. Empuje lentamente el émbolo hasta que se detenga. Saque el aplicador cuidadosamente de la vagina y descártelo. RECUERDE APLICARSE UN APLICADOR LLENO TODAS LAS NOCHES AL ACOSTARSE, O DE ACUDERDO CON LAS INDICACIONES DE SU MEDICO. PACKAGE LABEL PRINCIPAL DISPLAY PANEL 40 GRAM TUBE NDC 0462-0277-40 Rx only Clindamax VAGINAL CREAM (clindamycin phosphate vaginal cream USP, 2%) equivalent to 2% clindamycin For Intravaginal Use Only. Not for Ophthalmic, Dermal, or Oral Use. NET WT 40 grams PharmaDerm PACKAGE LABEL PRINCIPAL DISPLAY PANEL 40 GRAM CARTON NDC 0462-0277-40 Rx only Clindamax VAGINAL CREAM (clindamycin phosphate vaginal cream USP, 2%) equivalent to 2% clindamycin For Intravaginal Use Only. Not for Ophthalmic, Dermal, or Oral Use. NET WT 40 grams with 7 applicators PharmaDerm Clindamax clindamycin phosphate cream Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0462-0277 Route of Administration VAGINAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Clindamycin Phosphate (Clindamycin) Clindamycin Phosphate 20 mg in 1 g Inactive Ingredients Ingredient Name Strength sorbitan monostearate polysorbate 60 propylene glycol stearic acid cetostearyl alcohol cetyl palmitate mineral oil benzyl alcohol Packaging # Item Code Package Description 1 NDC:0462-0277-40 40 g in 1 TUBE, WITH APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065139 10/29/2009 Labeler - PHARMADERM. A division of Nycomed US Inc. (043838424) Registrant - Nycomed US Inc. (043838424) Establishment Name Address ID/FEI Operations Nycomed US Inc. 174491316 MANUFACTURE Establishment Name Address ID/FEI Operations Nycomed US Inc. 043838424 ANALYSIS Revised: 10/2009 PHARMADERM. A division of Nycomed US Inc. Next Interactions Print this page Add to My Med List More about Clindamax (clindamycin topical) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group En Español 3 Reviews Add your own review/rating Drug class: vaginal anti-infectives Consumer resources ClindaMax ClindaMax Topical (Advanced Reading) ClindaMax Vaginal (Advanced Reading) Professional resources ClindaMax Gel (FDA) Clindamax Topical Suspension (FDA) Clindamycin Phosphate topical (AHFS Monograph) Other brands: Clindagel , Clindesse , Evoclin , Cleocin Vaginal , ... +4 more Related treatment guides Bacterial Vaginitis> ] 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 Vaginal anti-infectives Related Drugs vaginal anti-infectives metronidazole topical , clotrimazole topical , clindamycin topical , miconazole topical , Clotrimazole-3 , Betadine Bacterial Vaginitis metronidazole , clindamycin topical , Cleocin , tinidazole , MetroGel-Vaginal , acetic acid topical , secnidazole , Tindamax , Solosec , Clindesse , Cleocin Vaginal , Cleocin Pediatric , Vandazole , Flagyl ER , Nuvessa , Relagard , More... Clindamax Rating 3 User Reviews 6.7 /10 3 User Reviews 6.7 Rate it! work at home
engines like google Clindamax sizeable
EmoticonEmoticon