Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/931
| Predicate | Object |
|---|---|
| rdf:type | |
| rdfs:label |
Cleocin (Suppository)
|
| dailymed-instance:dosage |
The recommended dose is one CLEOCIN Vaginal Ovule (containing clindamycin phosphate equivalent to 100 mg clindamycin per 2.5 g suppository) intravaginally per day, preferably at bedtime, for 3 consecutive days.
|
| dailymed-instance:descripti... |
Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. 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-��-D-galacto-octopyranoside 2-(dihydrogen phosphate). The monohydrate form has a molecular weight of 522.98, and the molecular formula is CHClNOPS���HO. The structural formula is represented below: CLEOCIN Vaginal Ovules are semisolid, white to off-white suppositories for intravaginal administration. Each 2.5 g suppository contains clindamycin phosphate equivalent to 100 mg clindamycin in a base consisting of a mixture of glycerides of saturated fatty acids.
|
| dailymed-instance:clinicalP... |
Systemic absorption of clindamycin was estimated following a once-a-day intravaginal dose of one clindamycin phosphate vaginal suppository (equivalent to 100 mg clindamycin) administered to 11 healthy female volunteers for 3 days. Approximately 30% (range 6% to 70%) of the administered dose was absorbed systemically on day 3 of dosing based on area under the concentration-time curve (AUC). Systemic absorption was estimated using a subtherapeutic 100 mg intravenous dose of clindamycin phosphate as a comparator in the same volunteers. The mean AUC following day 3 of dosing with the suppository was 3.2��g���hr/mL (range 0.42 to 11��g���hr/mL). The Cobserved on day 3 of dosing with the suppository averaged 0.27��g/mL (range 0.03 to 0.67��g/mL) and was observed about 5 hours after dosing (range 1 to 10 hours). In contrast, the AUC and Cafter the single intravenous dose averaged 11��g���hr/mL (range 5.1 to 26��g���hr/mL) and 3.7��g/mL (range 2.4 to 5.0��g/mL), respectively. The mean apparent elimination half-life after dosing with the suppository was 11 hours (range 4 to 35 hours) and is considered to be limited by the absorption rate. The results from this study showed that systemic exposure to clindamycin (based on AUC) from the suppository was, on average, three fold lower than that from a single subtherapeutic 100 mg intravenous dose of clindamycin. In addition, the recommended daily and total doses of intravaginal clindamycin suppository are far lower than those typically administered in oral or parenteral clindamycin therapy (100 mg of clindamycin per day for 3 days equivalent to about 30 mg absorbed per day from the ovule relative to 600 to 2700 mg/day for up to 10days or more, orally or parenterally). The overall systemic exposure to clindamycin from Cleocin Vaginal Ovules is substantially lower than the systemic exposure from therapeutic doses of oral clindamycin hydrochloride (two-fold to 20-fold lower) or parenteral clindamycin phosphate (40-fold to 50-fold lower).
|
| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
CLEOCIN Vaginal Ovules are contraindicated in individuals with a history of hypersensitivity to clindamycin, lincomycin, or any of the components of this vaginal suppository. CLEOCIN Vaginal Ovules are also contraindicated in individuals with a history of regional enteritis, ulcerative colitis, or a history of "antibiotic-associated" colitis.
|
| dailymed-instance:supply |
CLEOCIN Vaginal Ovules are supplied as follows: Important Information: Store at 25��C (77��F); excursions permitted to 15���30��C (59���86��F) [see USP Controlled Room Temperature]. Caution: Avoid heat over 30��C (86��F). Avoid high humidity. See end of carton for the lot number and expiration date. Rx only LAB-0047-2.0 November 2005
|
| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... | |
| dailymed-instance:precautio... |
General: The use of CLEOCIN Vaginal Ovules may result in the overgrowth of nonsusceptible organisms in the vagina. In clinical studies using CLEOCIN Vaginal Ovules, treatment-related moniliasis was reported in 2.7% and vaginitis in 3.6% of 589 nonpregnant women. Moniliasis, as reported here, includes the terms: vaginal or nonvaginal moniliasis and fungal infection. Vaginitis includes the terms: vulvovaginal disorder, vaginal discharge, and vaginitis/vaginal infection.<br/>Information for the Patient: The patient should be instructed not to engage in vaginal intercourse or use other vaginal products (such as tampons or douches) during treatment with this product. The patient should also be advised that these suppositories use an oleaginous base that may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms. Therefore, the use of such products within 72 hours following treatment with CLEOCIN Vaginal Ovules is not recommended.<br/>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.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals have not been performed with clindamycin to evaluate carcinogenic potential. Genotoxicity tests performed included a rat micronucleus test and an Ames test. Both tests were negative. Fertility studies in rats treated orally with up to 300 mg/kg/day (31 times the human exposure based on mg/m) revealed no effects on fertility or mating ability.<br/>Pregnancy:<br/>Teratogenic effects:<br/>Nursing Mothers: Clindamycin has been detected in human milk after oral or parenteral administration. It is not known if clindamycin is excreted in human milk following the use of vaginally administered clindamycin phosphate. Because of the potential for serious adverse reactions in nursing infants from clindamycin phosphate, 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.<br/>Pediatric Use: The safety and efficacy of CLEOCIN Vaginal Ovules in the treatment of bacterial vaginosis in post-menarchal females have been established on the extrapolation of clinical trial data from adult women. When a post-menarchal adolescent presents to a health professional with bacterial vaginosis symptoms, a careful evaluation for sexually transmitted diseases and other risk factors for bacterialvaginosis should be considered. The safety and efficacy of CLEOCIN Vaginal Ovules in pre-menarchal females have not been established.<br/>Geriatric Use: Clinical studies of CLEOCIN Vaginal Ovules did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
|
| dailymed-instance:overdosag... |
Vaginally applied clindamycin phosphate contained in CLEOCIN Vaginal Ovules could be absorbed in sufficient amounts to produce systemic effects .
|
| dailymed-instance:genericMe... |
clindamycin phosphate
|
| dailymed-instance:fullName |
Cleocin (Suppository)
|
| dailymed-instance:adverseRe... |
Clinical Trials: In clinical trials, 3 (0.5%) of 589 nonpregnant women who received treatment with CLEOCIN Vaginal Ovules discontinued therapy due to drug-related adverse events. Adverse events judged to have a reasonable possibility of having been caused by clindamycin phosphate vaginal suppositories were reported for 10.5% of patients. Events reported by 1% or more of patients receiving CLEOCIN Vaginal Ovules were as follows: Urogenital system: Vulvovaginal disorder (3.4%), vaginal pain (1.9%), and vaginal moniliasis (1.5%). Body as a whole: Fungal infection (1.0%). Other events reported by<1% of patients included: Urogenital system: Menstrual disorder, dysuria, pyelonephritis, vaginal discharge, and vaginitis/vaginal infection. Body as a whole: Abdominal cramps, localized abdominal pain, fever, flank pain, generalized pain, headache, localized edema, and moniliasis. Digestive system: Diarrhea, nausea, and vomiting. Skin: Nonapplication-site pruritis, rash, application-site pain, and application-site pruritis.<br/>Other clindamycin formulations: The overall systemic exposure to clindamycin from CLEOCIN Vaginal Ovules is substantially lower than the systemic exposure from therapeutic doses of oral clindamycin hydrochloride (two-fold to 20-fold lower) or parenteral clindamycin phosphate (40-fold to 50-fold lower) . Although these lower levels of exposure are less likely to produce the common reactions seen with oral or parenteral clindamycin, the possibility of these and other reactions cannot be excluded. The following adverse reactions and altered laboratory tests have been reported with the oral or parenteral use of clindamycin and may also occur following administration of CLEOCIN Vaginal Ovules: Gastrointestinal: Abdominal pain, esophagitis, nausea, vomiting, and diarrhea. 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.
|
| dailymed-instance:indicatio... |
CLEOCIN Vaginal Ovules are indicated for 3-day treatment of bacterial vaginosis in non-pregnant women. There are no adequate and well-controlled studies of CLEOCIN Vaginal Ovules 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 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. Other pathogens commonly associated with vulvovaginitis, eg, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans, and herpes simplex virus, should be ruled out.
|
| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Cleocin
|