Indications
Osmina Tablet is used for:
Dyspareunia, Vaginal Dryness
Adult Dose
Dyspareunia
Estrogen agonist/antagonist indicated for treatment of moderate-to-severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause
60 mg PO once daily
Use for the shortest duration consistent with treatment goals and risks for the individual woman
Vaginal Dryness
Indicated for treatment of moderate-to-severe vaginal dryness, a symptom of vulvar and vaginal atrophy, due to menopause
60 mg PO once daily
Hepatic impairment
Mild-to-moderate hepatic impairment: No dosage adjustment required
Severe hepatic impairment: Not studied; do not use
Child Dose
Renal Dose
Renal impairment: No dosage adjustment required
Administration
Take with food; food increases bioavailability by ~2-3 fold
Contra Indications
Undiagnosed abnormal genital bleeding
Known or suspected estrogen-dependent neoplasia
History of, or active DVT or PE
History of, or active arterial thromboembolic disease (eg, stroke, MI)
Known or suspected pregnancy or women who may become pregnant
Documented hypersensitivity to drug or ingredients
Precautions
Manage risk factors for cardiovascular disorders, arterial vascular disease (eg, hypertension, DM, smoking, hypercholesterolemia, obesity), and/or venous thromboembolism to reduce risk for progression to serious disease
Increased risk for endometrial hyperplasia
Has not been studied in women with breast cancer; do not use with known or suspected breast cancer or history of breast cancer
Do not use with severe hepatic impairment (not studied)
Ospemifene is primarily metabolized by CYP3A4 and CYP2C9; CYP2C19 also contributes to its metabolism; avoid moderate-to-strong inhibitors of these isoenzymes as they may increase risk of adverse effects
May initiate or increase occurrence of hot flashes in some women
Pregnancy-Lactation
Pregnancy
Contraindicated in women who are or may become pregnant; if a woman becomes pregnant while taking this drug, she should be apprised of the potential hazard to a fetus
Based on animal data, ospemifene is likely to increase risk for adverse outcomes during pregnancy and labor
Adverse findings at maternally toxic doses included embryofetal lethality in rats and rabbits, and neonatal mortality and difficult labor in rats
Reproductive effects observed are consistent with, and are considered to be related to ospemifene’s estrogen receptor activity
Lactation
Unknown if excreted in human breast milk
Do not breastfeed
Animal studies
Excreted in rat milk and detected at concentrations higher than that in maternal plasma
Interactions
Ospemifene should not be used concomitantly with estrogen or estrogen agonist/antagonist.
Do not use fluconazole and ketoconazole concomitantly with Ospemifene as they increase serum concentrations of Ospemifene.
Side Effects
Side effects of Ospemifene :
1-10%
Hot flush (7.5%)
Vaginal discharge (3.8%)
Muscle spasms (3.2%)
Hyperhidrosis (1.6%)
Genital discharge (1.3%)
Mode of Action
Estrogen agonist/antagonist with tissue selective effects; its biological actions are mediated through binding to estrogen receptors resulting in activation of estrogenic pathways in some tissues and blockade in others
Note
Osmina 60mg Tablet generic name is Ospemifene. Osmina 60mg Tablet is manufactured by Navana Pharmaceuticals Ltd.Osmina is availble in all over Bangladesh.
Mes BD drug index information on Osmina Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.