Myfene 60 mg (Tablet)

Title

• Myfene 60 mg Tablet

Categories

• Medicine
• Women's Health
• Vaginal and Vulval Conditions
• Menopause

Description

• Myfene is an estrogen agonist/antagonist indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.

Dosage and Administration

• 60 mg tablet with food once daily for the treatment of moderate to severe dyspareunia
• 60 mg tablet with food once daily for the treatment of moderate to severe vaginal dryness

Mode of Action

• Ospemifene is a next-generation SERM (selective estrogen receptor modulator) that selectively binds to estrogen receptors and either stimulates or blocks estrogen’s activity in different tissue types. It has an agonistic effect on the endometrium.

Interaction

• Metabolized by CYP3A4 and CYP2C9
• Do not use with estrogens and estrogen agonists/antagonists
• Avoid concomitant use with fluconazole, rifampin, ketoconazole, and highly protein-bound drugs
• Co-administration with drugs known to inhibit CYP3A4 and CYP2C9 isoenzymes may increase the risk of adverse reactions

Contraindications

• Undiagnosed abnormal genital bleeding
• Known or suspected estrogen-dependent neoplasia
• Active DVT, pulmonary embolism, or a history of these conditions
• Active arterial thromboembolic disease
• Hypersensitivity to any ingredients
• Pregnancy and potential fetal harm

Side Effects

• Cardiovascular Disorders
• Malignant Neoplasms
• Hot flush
• Vaginal discharge
• Muscle spasms
• Hyperhidrosis

Pregnancy and Lactation

• Contraindicated in pregnancy
• No data on excretion in human breast milk
• Do not breastfeed while taking Ospemifene

Precautions and Warnings

• Manage risk factors for cardiovascular disorders and venous thromboembolism
• Discontinue if thromboembolic event occurs
• Surveillance for endometrial and breast cancer
• Avoid use in severe hepatic impairment
• Inform healthcare provider of unusual vaginal bleeding
• Potential to induce or increase occurrence of hot flashes

Special Populations

• Not indicated in children
• No clinically meaningful differences in safety or effectiveness observed in women over 65 years
• No dose adjustment needed in women with severe renal impairment
• Do not use in women with severe hepatic impairment

Therapeutic Class

• Drugs used in Vaginal and Vulval conditions

Storage Conditions

• Keep below 30°C temperature
• Away from light and moisture
• Keep out of reach of children

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