Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3731
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Clindesse (Cream)
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The recommended dose is a single applicatorful of Clindesse���(approximately 5 g of vaginal cream containing approximately 100 mg of clindamycin phosphate) administered once intravaginally at anytime of the day.
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Pharmacokinetics: Following a single intravaginal application of Clindessecream to twenty healthy women, the mean (range) AUCand Cestimates were 175 (38.6 to 541) ng/mL���hr and 6.6 (0.8 to 39) ng/mL, respectively. The mean Cof clindamycin for Clindessewas approximately 0.3%, 0.1%, and 7.6% of that observed after the administration of a 150 mg Cleocin oral capsule (2.5��g/mL), a 600 mg Cleocin intravenous injection (10.9��g/mL), and a single dose of 100 mg of Cleocin Vaginal Cream (86.5 ng/mL), respectively. The peak serum concentration of clindamycin was attained approximately 20 hours post dosing for Clindesse���.
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Clindesse���(clindamycin phosphate) Vaginal Cream, 2%, is available in cartons containing one single-dose pre-filled disposable applicator (NDC 64011-124-08). Each applicator delivers approximately 5 g of vaginal cream containing approximately 100 mg of clindamycin phosphate. Store at controlled room temperature 25��C (77��F); excursions permitted to 15��-30��C (59��-86��F). [See USP Controlled Room Temperature.] Avoid heat above 30��C (86��F). U.S. Patent No. 5,266,329; Other patents pending. Marketed by Ther-Rx CorporationSt. Louis, MO 63044 P4250-1 02/05<br/>Patient Instructions:: Clindesse���(clindamycin phosphate) Vaginal Cream, 2%<br/>Step 1: Preparing the Applicator: Peel back the protective foil and remove the prefilled applicator.
Applicator is designed to be used with tip in place. Do not remove tip; do not use applicator if tip has been removed. Do not warm applicator before using.While holding the applicator firmly, pull the ring back to fully extend the plunger (See Figure 2).<br/>Step 2: Inserting the Applicator: Gently insert the applicator into the vagina as far as it will comfortably go (See Figure 3).<br/>Step 3: Applying the Cream: Push the plunger to release the cream (See Figure 4). Remove the empty applicator from the vagina and throw it away. Important Instructions:
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| dailymed-instance:inactiveI... |
dailymed-ingredient:edetate_disodium,
dailymed-ingredient:glycerol_monisostearate,
dailymed-ingredient:lecithin,
dailymed-ingredient:methylparaben,
dailymed-ingredient:microcrystalline_wax,
dailymed-ingredient:mineral_oil,
dailymed-ingredient:polyglyceryl-3-oleate,
dailymed-ingredient:propylparaben,
dailymed-ingredient:silicon_dioxide,
dailymed-ingredient:sorbitol_solution,
dailymed-ingredient:water
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| dailymed-instance:genericMe... |
clindamycin phosphate
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| dailymed-instance:fullName |
Clindesse (Cream)
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| dailymed-instance:adverseRe... |
Clinical Trials: In clinical trials totaling 368 women treated with a single dose of Clindesse���, 1.6% of the patients discontinued therapy due to adverse events. Medical events judged to be definitely related, probably related, or possibly drug-related were reported for 10.6% of the patients after receiving a single dose of Clindesse���and in 17.6% of patients treated with placebo. Adverse events occurred in 126 of 368 patients (34.2%) treated with Clindesse���and in 32 of 85 patients (37.6%) treated with placebo. Events occurring in���1% of patients receiving Clindesse���in 3 clinical studies are shown in Table 1. Other events not necessarily related to Clindesse���but reported by<1% of those women treated with Clindesse���:Dermatologic: dermatitis, dry skin, pruritic rashGastrointestinal: diarrhea, dyspepsia, flatulence, hemorrhoids, vomitingGeneral: fatigue, pain, pyrexia, increased tendency to bruise, palpable lymph nodeImmune System: hypersensitivity, food allergyInfections: bladder infection, fungal infection, Herpes simplex, influenza, papilloma virus infection, sinusitis, tooth abscess, upper respiratory tract infection, vaginal infection, vulvovaginal trichomoniasisMusculoskeletal: arthralgia, myalgia, neck pain, sciaticaNervous System: dizziness, hypoesthesiaPsychiatric: anxiety disorderRenal and Urinary Tract: bladder spasmReproductive System: pregnancy, cervical dysplasia, dysfunctional uterine bleeding,dysmennorrhea, intermenstrual bleeding, pelvic pain, uterine cervical disorder, uterine spasm, vaginal burning, vaginal irritation, atrophic vaginitis, vulvar erythema, vulvar laceration, vulvitis, vulvovaginal discomfort, vulvovaginal dryness, vulvovaginitisRespiratory Tract: cough, epistaxis, pharyngitis, rhinorrhea, sinusitis, wheezing<br/>Other Clindamycin Formulations: Clindesse���Vaginal Cream affords minimal peak serum levels and systemic exposure (AUCs) of clindamycin compared to an oral or intravenous dose of clindamycin . 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, pseudomembranous colitisHematopoietic: 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, vesiculobullous 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.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.
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Clindesse���is indicated for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in non-pregnant women. There are no adequate and well-controlled studies of Clindesse���in pregnant women. Note: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually 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. Gram's stain results consistent witha 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. Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans, and Herpes simplex virus should be ruled out.
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Clindesse
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