In two food effect studies in healthy males using different ospemifene tablet formulations Cmax and AUC0-inf increased by 2. This binding results in activation of estrogenic pathways in some tissues agonism and blockade of estrogenic pathways in others antagonism. Our information is based on the results of good-quality studies. No study was conducted with multiple doses of warfarin. The apparent volume of distribution is L.
Ospemifene exhibits less than dose-proportional pharmacokinetics from 25 to mg with ospemifene capsule formulation. Introduction The new drug ospemifene trade names EU: Fluconazole mg was taken for three additional days under fasted condition. In two food effect studies in healthy males using different ospemifene tablet formulations Cmax and AUC0-inf increased by 2. August 1, ; Next update: We do not offer individual consultations. The treatment involves a combination of estrogen and gestagen if the uterus is still intact. Multiple doses of fluconazole in fourteen postmenopausal women increased the Cmax and AUC0-inf of ospemifene by 1. Drug-induced malformations were not observed in either rats or rabbits. Ospemifene is not a significant P- glycoprotein substrate in vitro; no in vivo transporter study was conducted. Steady-state was reached after nine days of ospemifene administration. Race Race did not have clinically relevant effect on ospemifene pharmacokinetics. No study was conducted with multiple doses of warfarin. No clinically meaningful differences in safety or effectiveness were observed between these women and younger women less than 65 years of age. The major metabolite was 4-hydroxyospemifene. The apparent volume of distribution is L. Geriatric No differences in ospemifene pharmacokinetics were detected with regard to age range 40 to 80 years [see Use In Specific Populations ]. It becomes thinner and drier. Its biological actions are mediated through binding to estrogen receptors. Ketoconazole administration once daily continued for an additional 3 days Days 6 to 8. Vaginal dryness and painful intercourse, or dyspareunia, are two common symptoms of postmenopausal vulvovaginal atrophy -- thinning of the tissue and lining of the vulva and vagina. CYP2C19 and other pathways contribute to the metabolism of ospemifene. The drug aims to increase the production of estrogen in order to restore the vaginal lining and reduce symptoms. The study involved postmenopausal women at 80 different medical centers across the U. Assessment In the Institute for Quality and Efficiency in Health Care IQWiG, Germany looked into whether ospemifene has any advantages or disadvantages compared with the standard treatments for women with moderate and severe symptoms due to vaginal atrophy. Clinical Stuides The effectiveness and safety of OSPHENA on moderate to severe symptoms of vulvar and vaginal atrophy in postmenopausal women were examined in three placebo-controlled clinical trials two week efficacy trials and one week long-term safety trial.
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