Osmina 60 Tablet

Osmina is an estrogen receptor agonist/antagonist used to treat moderate to severe pain during sexual intercourse (dyspareunia) associated with vulvar and vaginal atrophy caused by menopause. It may also be used to relieve moderate to severe vaginal dryness related to menopause.

For moderate to severe dyspareunia or vaginal dryness associated with menopausal vulvovaginal atrophy, the recommended dose is 60 mg once daily with food, or as prescribed by the physician.

Drug Interactions

Osmina is mainly metabolized by CYP3A4 and CYP2C9, with CYP2C19 and other metabolic pathways also contributing.

• Estrogens and estrogen agonists/antagonists: Concomitant use is not recommended because safety has not been adequately established.
• Fluconazole: May substantially increase ospemifene exposure and potentially increase adverse effects; concurrent use should be avoided.
• Rifampin: May significantly reduce ospemifene levels and decrease its therapeutic effectiveness.
• Ketoconazole: Can increase ospemifene exposure and may raise the risk of adverse reactions.
• Warfarin: No significant effect on the pharmacokinetics of a single warfarin dose has been demonstrated, although the effect on clotting parameters has not been adequately studied.
• Highly protein-bound medicines: Because ospemifene is extensively protein-bound, it may alter the exposure of other highly protein-bound drugs.
• Multiple CYP inhibitors: Combining ospemifene with medicines that inhibit CYP3A4 and CYP2C9 may increase the risk of ospemifene-related adverse effects.

Contraindications

Osmina should not be used in women with:

• Unexplained or undiagnosed abnormal genital bleeding
• Known or suspected estrogen-dependent cancer
• Active or previous deep vein thrombosis (DVT) or pulmonary embolism (PE)
• Active or previous arterial thromboembolic conditions, such as stroke or myocardial infarction
• A known hypersensitivity to ospemifene or any of its ingredients
• Pregnancy or the possibility of becoming pregnant

Side Effects

Possible adverse effects may include:

• Hot flashes
• Vaginal discharge
• Muscle spasms
• Excessive sweating
• Cardiovascular or vascular events
• Malignant neoplasms

Pregnancy & Lactation

Pregnancy: Osmina is contraindicated during pregnancy and in women who may become pregnant because it may cause fetal harm. Animal studies have shown adverse effects on embryo-fetal development, neonatal survival, and labor.

Breastfeeding: It is not known whether ospemifene passes into human breast milk. Because its effects on breastfed infants and milk production are unknown, breastfeeding should be avoided during treatment.

Precautions & Warnings

• Women with cardiovascular risk factors such as hypertension, diabetes, smoking, high cholesterol, obesity, or a history of blood clots should be appropriately evaluated and monitored.
• Osmina may increase the risk of stroke and venous thromboembolism. Treatment should be stopped immediately if DVT or another thromboembolic event is suspected.
• Discontinuation at least 4–6 weeks before certain high-risk surgeries may be considered to reduce thromboembolic risk.
• Report any persistent or unusual vaginal bleeding promptly because endometrial abnormalities, including hyperplasia or malignancy, must be ruled out.
• Osmina should not be used in women with known or suspected breast cancer because adequate studies in these patients are lacking.
• It should not be used in women with severe liver impairment.
• Patients who develop hypersensitivity reactions such as angioedema, hives, rash, or itching should discontinue the medicine and seek medical advice.
• Osmina may cause or worsen hot flashes.
• Long-term treatment requires appropriate clinical monitoring for endometrial changes.

Use in Special Populations

Children: Osmina is not indicated for pediatric patients because clinical studies have not been conducted in children.

Elderly: Clinical studies did not show meaningful differences in safety or effectiveness between women aged 65 years and older and younger women.

Renal impairment: No dosage adjustment is generally required in women with renal impairment, including severe renal impairment, based on available pharmacokinetic data.

Hepatic impairment: Osmina should not be used in women with severe hepatic impairment because it has not been adequately studied in this population.

Therapeutic Class

Medicines used for vaginal and vulval conditions

Storage

Store below 30°C, protected from light and moisture. Keep out of reach of children.