Skin: pruritus (topical application site) and erythema. This leaflet summarizes the most important information about Clindesse. The determination of clinical cure was based on the absence of Relabeling of "Additional Barcode Label" by. [/Pattern /DeviceRGB] (See Clinical Studies.). Safety and effectiveness in pediatric patients have not been established. Table 2. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells. It is not known if clindamycin is excreted in human breast milk following the use of vaginally administered clindamycin phosphate. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin. /SM 0.02 absent or few white blood cells. In the event of accidental contact with the eye, rinse the eye with copious amounts of cool tap water. It is unknown if topical Clindamax Vaginal Cream passes into breast milk. Our Clindamax Vaginal Cream (clindamycin phosphate vaginal cream, 2%) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. the antibacterially active clindamycin. from the vagina. Save 2.20. 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. The following in vitro data are available but their clinical significance is unknown. Its major disadvantage is its propensity to cause antibiotic-associated diarrhea, including Clostridioides difficile colitis. rubber products such as condoms or vaginal contraceptive diaphragms. less likely to produce the common reactions seen with oral clindamycin, the possibility of these and Adverse Reactions Occurring in 2% of Clindesse-Treated Patients and at a Higher Rate than Placebo-Treated Patients, The use of clindamycin may result in the overgrowth of non-susceptible fungal organisms in the vagina and may require antifungal treatment. Cure rates were consistently higher for Clindesse compared to placebo for the following demographic subsets: age, race, height, weight, sexual behavior, and recalcitrant infection status. Pharmacokinetics Following a once a day intravaginal dose of 100 mg of clindamycin phosphate vaginal cream 2%, administered to 6 healthy female volunteers for 7 days, approximately 5% (range 0.6% to 11%) of the administered dose was absorbed systemically. In 7.2% of the patients, vaginitis was recorded. Liver: Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy. Standard methodology for the susceptibility testing of the potential bacterial vaginosis pathogens has not been defined. hypersensitivity reaction occurs, the drug should be discontinued. treatment. event of accidental contact with the eye, rinse the eye with copious amounts of cool tap water. Do not administer Clindesse to patients with regional enteritis, ulcerative colitis, or a history of Clostridium difficile-associated diarrhea. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. (See WARNINGS.). Clindesse is indication for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerellavaginitis, nonspecific vaginitis, Corynebacteriumvaginitis, or anaerobic vaginosis) in non-pregnant women. events judged to be related, probably related, possibly related, or of unknown relationship to vaginally Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. The cream also contains benzyl alcohol, cetostearyl alcohol, cetyl palmitate, mineral oil, polysorbate 60, propylene glycol, sorbitan . 12/3/2021 Established/proper name Clindamycin phosphate vaginal gel (Proposed) proprietary name Xaciato Pharmacologic class Lincosamide Code name DARE-BV1 Applicant Dar Biosciences, Inc.. cream having a slight odor and is supplied as follows: 40 g tube (with 7 disposable applicators) NDC 0462-0277-40. A few cases of anaphylactoid reactions have been reported. See INDICATIONS AND USAGE; PRECAUTIONS, General; and ADVERSE REACTIONS. Unscrew the applicator from the tube and replace the cap. CLEOCIN Vaginal Cream 2%, can be used to treat non-pregnant women and pregnant women during the second and third trimester. Medical Call your doctor for medical advice about side effects. These peak concentrations were attained approximately 10 hours post-dosing (range 424 hours). Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly Store Clindesse at 68 to 77F (20 to 25). Diarrhea, Following a single intravaginal application of Clindesse cream to 20 healthy women, the mean (range) AUC0-inf and Cmax estimates were 175 (38.6 to 541) ng/mLhr and 6.6 (0.8 to 39) ng/mL, respectively . ], Manufactured By: Perrigo, Yeruham 80500, Israel. ng/mL). have been associated with clindamycin. Table 1. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. (clindamycin phosphate) Vaginal Cream, 2%. Data from well-controlled trials directly comparing clindamycin administered orally to clindamycin administered vaginally are not available. Visit the FDA MedWatch website or call 1-800-FDA-1088. (clin-DESS) A single dose of Clindesse was shown to be similar to 7 daily doses of the clindamycin vaginal cream for treatment of bacterial vaginosis as measured by therapeutic cure, clinical cure of Nugent score cure assessed at 21-30 days after administration of the drug in the modified intent-to-treat population (Table 3) and for the per protocol population (Table 4). Reported reactions to other formulations of clindamycin include rashes, urticaria, erythema multiforme, and anaphylactoid reactions [see ADVERSE REACTIONS]. Rolling tube from the bottom, squeeze gently and force the medication into the applicator. Consult your doctor before breastfeeding. Check with your physician for additional information about side effects. patients. They are designed to allow proper adverse reactions. (See CLINICAL STUDIES.). absence of clue cells on microscopic examination. Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans, and Herpes simplex virus should be ruled out. The peak serum clindamycin concentration observed on the first day averaged 18 ng/mL (range 4 to 47 ng/mL) and on day 7 it averaged 25 ng/mL (range 6 to 61 ng/mL). Protect from freezing. The following adverse reactions and altered laboratory tests have been reported with the oral or parenteral use of clindamycin: Infections and Infestations: Clostridioides difficile colitis, Gastrointestinal: Abdominal pain, esophagitis, nausea, vomiting, diarrhea, and pseudomembranous colitis. Store at 20 to 25C (68 to 77 F)[see USP Controlled Room Temperature]. Musculoskeletal: Cases of polyarthritis have been reported. Other events occurring in <1% of the clindamycin vaginal cream 2% group include: Urogenital system: dysuria, metrorrhagia, vaginal pain, and trichomonal vaginitis. vitro against most strains of the following organisms that have been reported to be associated with Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated [see ADVERSE REACTIONS]. Therefore, do not use barrier contraceptives concurrently or for 5 days following treatment with Clindesse. Clindesse comes in a single-dose, pre-filled, disposable applicator that gives you a certain amount of clindamycin cream to be inserted into your vagina. Other events occurring in <1% of the clindamycin vaginal cream 2% group include: Urogenital system: dysuria, metrorrhagia, vaginal pain, and trichomonal vaginitis. Orally and parenterally Mechanism of Action Clindamycin is an antibacterial drug (See MICROBIOLOGY ). posttherapy, ranged from 72% to 81% for the 3-day treatment and 84% to 86% for the 7-day treatment. Reproduction studies have been performed in rats and mice using oral and parenteral doses of clindamycin up to 600 mg/kg/day (62 and 25 times, respectively, the maximum human exposure based on mg/m2 ) and have revealed no evidence of harm to the fetus due to clindamycin. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. Following a once a day intravaginal dose of 100 mg of clindamycin phosphate vaginal cream 2%, administered to 6 healthy female volunteers for 7 days, approximately 5% (range 0.6% to 11%) of the administered dose was absorbed systemically. The systemic half-life was 1.5 to 2.6 hours. The alcohol in it may irritate freshly washed or shaved skin. Efficacy of Clindesse in Treatment of Bacterial Vaginosis in a Randomized, Investigator-Blind, Active-Controlled Comparative Study Per Protocol, Clindesse Clindamycin phosphate vaginal cream 2% has been studied in pregnant women during the second Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of Clindamycin is an antibiotic which works by stopping the growth of bacteria. in any of these reports. /Height 221 The applicator is filled when the plunger reaches its predetermined stopping point. Remueva la tapa del tubo de crema y enrosque el aplicador de plstico al tubo. 4 UNI | 4.95 per 1UNI. How to use Clindamycin. Instruct the patient not to engage in vaginal intercourse, or use other vaginal products (such as tampons or douches) during treatment with this product. Store at 20 to 25C (68 to 77 F) [see USP Controlled Room Temperature]. the vagina. Topical clindamycin is used to help control acne. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. the first day averaged 18 ng/mL (range 4 to 47 ng/mL) and on day 7 it averaged 25 ng/mL (range 6 to 61 Other events occurring in <1% of the clindamycin vaginal cream 2% group include: Urogenital system: dysuria, metrorrhagia, vaginal pain, and trichomonal vaginitis. Clindesse (clindamycin phosphate) Vaginal Cream, 2%, is available in cartons containing one single-dose, pre-filled disposable appliicator (NDC 45802-042-01). Activate the plunger before you use it. Set id: f9be442d-0782-4b93-828f-9ebbf67dbced, Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans, TABLE 1 Events Occurring in 1% of Non-pregnant Patients Receiving Clindamycin Phosphate Vaginal Cream 2%, TABLE 2 - Events Occurring in 1% of Pregnant Patients Receiving Clindamycin Phosphate Vaginal Cream 2% or Placebo, Infections and Infestations: Clostridioides difficile. Peptostreptococcusspp. Pill Identifier Tool Quick, Easy, Pill Identification, Drug Interaction Tool Check Potential Drug Interactions, Pharmacy Locator Tool Including 24 Hour, Pharmacies. Efficacy of Clindesse in Treatment of Bacterial Vaginosis in a Randomized, Investigator-Blind, Active-Controlled Comparative Study Modified-Intent-to-Treat, Table 4. Write a review. Genotoxicity tests performed included a rat micronucleus test and an Ames test. Grams stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerellamorphotype, and (c) absent or few white blood cells. Helps you get and maintain an erection when you need it. Non-pregnant Women: In clinical trials involving non-pregnant women, 1.8% of 600 patients who received treatment with clindamycin phosphate vaginal cream 2% for 3 days and 2.7% of 1325 patients who received treatment for 7 days discontinued therapy due to drug-related adverse events. Each applicatorful of 5 grams of vaginal cream contains approximately 100 mg of clindamycin phosphate. Generalized mild to moderate morbilliform-like skin rashes are the most frequently reported of all adverse reactions. CLINDAMYCIN PHOSPHATE- clindamycin phosphatecream These peak concentrations were attained approximately 10 hours post-dosing (range 4-24 hours). Clindamycin phosphate vaginal cream 2%, is contraindicated in individuals with a history of hypersensitivity to clindamycin, lincomycin, or any of the components of this vaginal cream. No direct etiologic relationship to concurrent clindamycin therapy could be made in any of these reports. Clindamycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the ribosome. The UK is the first country to allow OTC access to Sanofi's tadalafil-based erectile dysfunction drug Cialis following a successful switch. Clindamycin is an antibacterial drug [see CLINICAL PHARMACOLOGY, Microbiology]. Included as part of the "PRECAUTIONS" Section. bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the trimester. Clindamax Vaginal Cream (clindamycin phosphate vaginal cream, 2%) is an antibiotic indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). 7 Disposable plastic applicators are provided with this package. Reproduction studies have been performed in rats and mice using oral and parenteral doses of The systemic half-life was 1.5 to 2.6 hours. Safety and effectiveness in pediatric patients have not been established. Clindamycin is predominantly bacteriostatic. If a In the event of accidental contact with the eye, rinse the eye with copious amounts of cool tap water and consult a physician. patients. Talk to your healthcare provider before using this medicine if you have any of these conditions. or placebo are shown in Table 2. Because of the potential for serious adverse reactions in nursing infants from clindamycin phosphate, a Therefore, use of such 2% (See WARNINGS. Caution should be exercised when Clindesse is administered to a nursing woman. Clindamycin inhibits bacterial protein synthesis at the level of the bacterial ribosome. Breastfeeding while using Clindamax Vaginal Cream is not recommended. Onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment. /CA 1.0 There was little or no systemic accumulation of clindamycin after repeated vaginal dosing of clindamycin phosphate vaginal cream 2%. The following adverse reactions have been identified during postapproval use of Clindesse. Topical clindamycin may also be used for other problems as determined by your doctor. Nonetheless, clindamycin is an antimicrobial agent active in vitro against most strains of the following organisms that have been reported to be associated with bacterial vaginosis: Clindamycin phosphate vaginal cream 2%, is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). Of the 368 women treated with a single dose of Clindesse, 1.6% of the patients discontinued therapy due to adverse reactions. (See WARNINGS.). If a hypersensitivity reaction occurs, the drug should be discontinued. endobj This cream contains mineral oil that may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms. Following a once a day intravaginal dose of 100 mg of clindamycin phosphate vaginal cream 2%, administered to 6 healthy female volunteers for 7 days, approximately 5% (range 0.6% to 11%) of the administered dose was absorbed systemically. This medicine contains alcohol and is flammable. 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. (See WARNINGS.). Hematopoietic: Transient neutropenia (leukopenia), eosinophilia, agranulocytosis, and thrombocytopenia have been reported. equivalent to 2% clindamycin. Medical events judged to be related, probably related, possibly related, or of unknown relationship to vaginally administered clindamycin phosphate vaginal cream 2%, were reported for 20.7% of the patients receiving treatment for 3 days and 21.3% of the patients receiving treatment for 7 days. less variable than that observed in healthy females. bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the Pharmacokinetics Following a once a day intravaginal dose of 100 mg of clindamycin phosphate vaginalcream 2%, administered to 6 healthy female volunteers for 7 days, approximately 5%(range 0.6% to 11%) of the administered dose was absorbed systemically. Onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment. have been reported. Body as a whole: upper respiratory infection. ClindaMax Vaginal Cream, contains ingredients that will cause burning and irritation of the eye. The patient should also be advised that this cream contains mineral oil that may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms. CLEOCIN Vaginal Cream 2%, contains ingredients that will cause burning and irritation of the eye. 180 patients who received treatment for 7 days discontinued therapy due to drug-related adverse events. Since this effect was not observed in other mouse strains or in other species, the effect may be strain specific. Therefore, it is important to consider this diagnosis in patients who PACKAGE LABEL PRINCIPAL DISPLAY PANEL 40 Remueva la tapa del tubo de crema y enrosque el aplicador de plstico al tubo. In 180 pregnant women who received treatment for 7 days, Candida albicans was detected, either symptomatically or by culture, in 13.3% of patients. It has a molecular weight of 504.96, and the molecular formula is C 18 H 34 ClN 2 O 8 PS. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Other reported exposure based on mg/m2 ) revealed no effects on fertility or mating ability. Because of the potential for serious adverse reactions in nursing infants, a decision to continue or diiscontinue nursing should take into account the importance of the drug to the mother. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of "antibioticassociated" Before you use Clindesse, tell your healthcare provider if you: Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. administered clindamycin phosphate vaginal cream 2%, were reported for 20.7% of the patients Reproduction studies have been performed in rats and mice using oral and parenteral doses of clindamycin up to 600/mg/kg/day (58 and 29 times, respectively, the recommended human dose based on body surface area comparisons) and have revealed no evidence of harm to the fetus due to clindamycin. In one mouse strain, It not known if Clindesse is safe and effective in females who have not yet reached puberty. patients, vaginitis was recorded. Digestive system: nausea, vomiting, constipation, dyspepsia, flatulence, diarrhea, and gastrointestinal disorder. Clindamycin phosphate vaginal cream 2%, is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). Onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment. Mycoplasma hominis, has not been defined. Events occurring in 1% of patients receiving either clindamycin phosphate vaginal cream 2% or placebo are shown in Table 2. %PDF-1.4 Other events occurring in <1% of the clindamycin vaginal cream 2% groups include: Urogenital system: vaginal discharge, metrorrhagia, urinary tract infection, endometriosis, menstrual disorder, vaginitis/vaginal infection, and vaginal pain. It helps to decrease the number of acne lesions. Clindesse may cause serious side effects, including diarrhea. averaged 13 ng/mL (range 6 to 34 ng/mL) and on day 7 it averaged 16 ng/mL (range 7 to 26 ng/mL). It is not known if Clindesse passes into your breast milk. 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. You are encouraged to report negative side effects of prescription drugs to the FDA. In women treated for seven days, abnormal labor was reported in 1.1% of patients who trachomatis, N. gonorrhoeae, Candida albicans, and Herpes simplex virus should be ruled out. Body as a whole: localized abdominal pain, generalized abdominal pain, abdominal cramps, halitosis, /SMask /None>> Cleft palates were observed in fetuses from one mouse strain treated intraperitoneally with clindamycin at 200 mg/kg/day (about 10 times the recommended dose based on body surface area conversions). Slowly push the plunger until it stops. It is not known whether this medicine will harm an unborn baby. In a clinical trial involving pregnant women during the second trimester, 1.7% of 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. Both tests were negative. Screw a plastic applicator on the threaded end of the tube. 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. Remove cap from cream tube. They are designed to allow proper vaginal administration of the cream. Pill Identifier Tool Quick, Easy, Pill Identification, Drug Interaction Tool Check Potential Drug Interactions, Pharmacy Locator Tool Including 24 Hour, Pharmacies. clindamycin phosphate vaginal cream 2%. The population was female, aged 18 to 78, who were diagnosed with bacterial vaginosis. administered for 7 consecutive days to 5 women with bacterial vaginosis, absorption was slower and It is not known if Clindesse will harm your unborn baby. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. placebo. terms: vaginal moniliasis and moniliasis (body as a whole). examination. Saque el aplicador cuidadosamente de la vagina y descrtelo. GRAM CARTON, CLINDAMYCINPHOSPHATEVAGINAL CREAMUSP, The antibiotic Clindesse was studied in three clinical studies: placebo-controlled (n=85), active-controlled (n=263), and single-arm (n=20). After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be It has a molecular weight of 504.96, and the molecular formula is C18H34ClN2O8PS. ClindaMax Vaginal Cream, is A few cases of anaphylactoid reactions have been reported. It belongs to the class of medicines known as macrolide antibiotics. Adverse reactions occurring in 2% of patients receiving Clindesse in the placebo-controlled clinical trial are shown in Table 1. Events occurring in 1% of patients receiving clindamycin phosphate vaginal cream 2% are shown in Table 1. Central nervous system: dizziness and vertigo. The mean Cmax of clindamycin for Clindesse was approximately 0.3%, 0.1%, and 7.6% of that observed after the administration of a 150 mg Cleocin oral capsule (2.5 mcg/mL), a 600 mg Cleocin intravenous injection (10.9 mcg/mL), and a single dose of 100 mg of Cleocin Vaginal Cream (86.5 ng/mL), respectively. << initiated. Active Ingredient: clindamycin phosphate Company: Pfizer Limited See contact details ATC code: G01AA10 About Medicine Prescription only medicine Healthcare Professionals (SmPC) Patient Leaflet (PIL) Chat Online This information is for use by healthcare professionals Last updated on emc: 11 Oct 2022 Quick Links Exprima el tubo suavemente desde el extremo inferior y fuerce el medicamento al aplicador. Exprima el tubo suavemente desde el extremo inferior y fuerce el medicamento al aplicador. Gardnerellavaginalis Cross resistance has been demonstrated between clindamycin and lincomycin. (such as tampons or douches) during treatment with this product. 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. Generalized mild to moderate morbilliform-like skin rashes are the most frequently reported of all adverse reactions. A clinical diagnosis of bacterial vaginosis was defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a fishy amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Cream 2%. The patient should also be advised that this cream contains mineral oil that may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms. Terms: vaginal moniliasis and moniliasis ( body as a whole ) liver: Jaundice and in. Leaflet summarizes the most frequently reported of all adverse reactions ] skin rashes are the important. Doses of the `` PRECAUTIONS '' Section phosphate is inactive in vitro rapid! For 5 days following treatment with this product clindamycin phosphate cream female cialis hypersensitivity reaction occurs, the may! 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