and many others [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. Post-marketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In the post-marketing period, there have been case reports of pseudomembranous colitis with the use of clindamycin phosphate vaginal cream. 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, diarrhea and pseudomembranous colitis. (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 clindamycin phosphate vaginal cream 2% could be absorbed in sufficient amounts to produce systemic effects. (See WARNINGS .) Cleocin Vaginal Cream Dosage and Administration The recommended dose is one applicatorful of clindamycin phosphate vaginal cream 2%, (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 Cleocin Vaginal Cream Supplied Cleocin Vaginal Cream 2%, (clindamycin phosphate vaginal cream) is supplied as follows: 40 g tube (with 7 disposable applicators) NDC 0009-3448-01 Store at controlled room temperature 20 to 25 C (68 to 77 F) [see USP]. Protect from freezing. Clinical Studies In two clinical studies involving 674 evaluable non-pregnant women with bacterial vaginosis comparing Cleocin 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. CLEOCIN 3 Day CLEOCIN 7 Day US 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. Rx only This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com. LAB-0043-7.0 June 2017 Cleocin (clindamycin phosphate vaginal cream, USP) FOR INTRAVAGINAL USE ONLY NOT FOR OPHTHALMIC, DERMAL, OR ORAL USE DIRECTIONS FOR USE 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 aplicadores de plástico desechables. Los aplicadores están diseñados para la administración 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 espalda y agarrando firmemente 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 ACUERDO CON LAS INDICACIONES DE SU MEDICO. LAB-1058-1.0 PRINCIPAL DISPLAY PANEL - 40 g Tube Label NDC 0009-3448-01 40 Gram Rx only Cleocin clindamycin phosphate vaginal cream, USP For Intravaginal Use Only 2%* PRINCIPAL DISPLAY PANEL - 40 g Tube Carton NDC 0009-3448-01 40 Gram With 7 Applicators Rx only Cleocin clindamycin phosphate vaginal cream, USP For Intravaginal Use Only 2%* Pfizer Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, NY, NY 10017 CLEOCIN clindamycin phosphate cream Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0009-3448 Route of Administration VAGINAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLINDAMYCIN PHOSPHATE (CLINDAMYCIN) CLINDAMYCIN 20 mg in 1 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL CETOSTEARYL ALCOHOL MINERAL OIL POLYSORBATE 60 PROPYLENE GLYCOL WATER SORBITAN MONOSTEARATE STEARIC ACID Packaging # Item Code Package Description 1 NDC:0009-3448-01 1 TUBE, WITH APPLICATOR in 1 CARTON 1 40 g in 1 TUBE, WITH APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA050680 08/11/1992 Labeler - Pharmacia and Upjohn Company LLC (618054084) Establishment Name Address ID/FEI Operations Pharmacia and Upjohn Company LLC 618054084 ANALYSIS(0009-3448), API MANUFACTURE(0009-3448), LABEL(0009-3448), MANUFACTURE(0009-3448), PACK(0009-3448) Revised: 06/2017 Pharmacia and Upjohn Company LLC Next Interactions Print this page Add to My Med List More about Cleocin Vaginal (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 Generic Availability Drug class: vaginal anti-infectives Consumer resources Cleocin Vaginal ... +3 more Professional resources Clindamycin Phosphate topical (AHFS Monograph) Clindamycin Vaginal Cream (FDA) Other brands: Clindamax , Clindagel , Clindesse , Evoclin , ... +4 more Other Formulations Cleocin ... +5 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 Approval History Drug history at FDA 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 , Clindamax , acetic acid topical , secnidazole , Tindamax , Solosec , Clindesse , Cleocin Pediatric , Vandazole , Flagyl ER , Nuvessa , Relagard , More... 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