Betametasona clotrimazol gentamicina tablets (N=8): -mean±SD number of days with at least moderate-to-severe drowsiness after first dose, n=28.3±15.5 days -mean±SD number of days with at least mild drowsiness, n=22.5±14.4 days -mean±SD number of days with at least moderate intensity or duration of sleepiness, n=14.0±10.5 days -mean±SD duration of sleepiness, n=13.4±10.4 days -mean±SD number of doses taken (median), n=8 (-/-2) -mean±SD number of double-dosing sessions, n=3 (-/-1) -mean±SD number of doses missed due to nausea and vomiting, n=4 (-/-1) For each patient, at least the following data for 1 dose were reported: - mean dosage (mg) per day - proportion of patients reporting insomnia - proportion receiving additional doses (males only) - mean±SD number of double-dosing days due to nausea and vomiting - mean±SD number of double-dosing days due to loss of appetite, n=1 The most commonly observed adverse events following IM administration were sedation. Drug Interactions: The study was not designed to evaluate the pharmacodynamic interaction between IM metyrapone and SSRIs or citalopram. As a result, no drug interactions are considered likely or possible. Carcinogenesis, Mutagenesis, Impairment of Fertility: A 907-day mouse carcinogenicity study in Sprague-Dawley rats revealed no evidence of an increased risk carcinogenic effects associated with IM metyrapone (0-100 mg/kg) treatment. No effect on spontaneous and neoplastic tumor development has been found in a two-generation mouse carcinogenicity study in Xanax for sale in mexico rats, and no significant abnormalities have been found in a 10-generation mouse mammary tumor model or in a test mouse embryo development study or in a developmental mammary tumor study in pregnant Wistar rats at any dose (≥40 mg/kg IM bromocriptine) (Lippert 2003). In animal studies for the evaluation of carcinogenicity, metyrapone, with maximum recommended human therapeutic doses of 40-50 mg/day, did not produce any evidence of mutagenic or teratogenic effects in rat, mouse, dog, and hamster embryotoxicity studies, in the carcinogenicity studies of nonhuman primates and mice female rats, in the reproductive toxicity studies of female rats, and to a lesser extent in male rats and female mice (Lippert 2003). Biological Metabolism: Metyrapone was well absorbed from a rat gastric capsule containing formulation 6.6% of the total dose and was bioequivalent (98% as administered) to the racemate (Lippert 2003). rate of elimination metyrapone from the digestive tract was approximately half the rate of metyrapone administered orally to mice (Lippert 2003). In the rat, oral administration of 10 and 40 mg/kg metyrapone was similarly effective as the racemate; bioequivalent metyrapone dose to humans would be approximately 2 mg/day, 100 times less and 400 than the dose administered by oral gavage to the mice. Absorption was also enhanced by increased gastrointestinal transit time of metyrapone. A study using the mouse micronucleus test to assess cellular proliferation and gene transfer, demonstrated that metyrapone was well absorbed and that the activity of metyrapone was bioequivalent (98% as administered) and greater than that of oral gavage treatment (Bergheim et al. 1985). In addition, an vitro study employing cell lines derived from human brain indicated that no DNA was transferred from metyrapone-treated animals. Metyrapone has been shown to be bioequivalent sertraline in the mouse micronucleus test vivo, and in vitro, no effects were observed on human neurons or glial cells (D'Angelo & Schulkind 2004), but an increase in plasma levels were observed some studies. Further studies in different models of cell proliferation in vitro and vivo are needed before the use of IM bromocriptine in the mouse micronucleus test as an experimental tool for determining a potential cell proliferation. In vitro studies rats have demonstrated that the metabolism of metyrapone in humans differs qualitatively and quantitatively compared to that in the rat (Sato et al. 1992). Studies using the mouse micronucleus test have also identified differences in metabolism, including absorption rates.
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