Mimvey

Generic name: Estradiol and Norethindrone Acetate

Drug class: Estrogens and Progestins

Dosage form: Tablet, Film Coated

Route of administration: Oral

Dose: 1 mg estradiol and 0.5 mg norethindrone acetate, taken once daily

Mechanism of action: Estradiol, a form of estrogen, and norethindrone acetate, a progestin, work together to alleviate menopausal symptoms and prevent bone loss by compensating for decreased hormone levels during menopause.

Drug usage cases:

• Treatment of moderate to severe vasomotor symptoms due to menopause
• Management of moderate to severe vulvar and vaginal atrophy due to menopause
• Prevention of postmenopausal osteoporosis

Drug contraindications:

• Known or suspected pregnancy
• Active or history of deep vein thrombosis, pulmonary embolism, or other known or suspected thromboembolic disorders
• Active or history of arterial thromboembolic disease (e.g., stroke, myocardial infarction)
• Known or suspected estrogen-dependent neoplasia, including breast cancer
• Undiagnosed abnormal genital bleeding
• Known or suspected liver dysfunction or disease
• Hypersensitivity to estradiol, norethindrone acetate, or any component of the formulation

Side effects:

• Headache
• Breast tenderness or enlargement
• Abdominal pain or bloating
• Nausea
• Weight changes
• Depression or mood changes
• Vaginal bleeding or spotting
• Edema
• Skin rash
• Changes in libido

Warnings:

• Regular monitoring is recommended to assess the need for continued therapy and to detect any adverse effects
• Discontinue use and consult a healthcare provider if unusual vaginal bleeding occurs
• Use with caution in patients with a history of cardiovascular disease, liver disease, or gallbladder disease
• Smoking may increase the risk of serious cardiovascular events; patients should be advised to avoid smoking during therapy
• Not recommended for use during pregnancy; if pregnancy occurs, therapy should be discontinued immediately
• May pass into breast milk; caution is advised when administered to breastfeeding women

Use during pregnancy or breastfeeding:

Estradiol and norethindrone acetate are contraindicated during pregnancy due to potential risks to the fetus. If pregnancy is suspected or confirmed, therapy should be discontinued immediately. The hormones in this medication can pass into breast milk; therefore, caution is advised when administering to breastfeeding women, and the decision to continue therapy should be made after evaluating the potential benefits and risks.