Ethinyl Estradiol + Cyproterone Acetate Tablets

Description

Product Description: Ethinyl Estradiol + Cyproterone Acetate Tablets combine two active ingredients, ethinyl estradiol, and cyproterone acetate, in a single formulation. Ethinyl estradiol is a synthetic estrogen, while cyproterone acetate is an antiandrogen. This combination medication is primarily used in the treatment of conditions related to androgen excess, such as hirsutism, acne, and polycystic ovary syndrome (PCOS), and as an oral contraceptive.

Indications and Usage: Ethinyl Estradiol + Cyproterone Acetate Tablets are indicated for the treatment of androgen-dependent conditions such as hirsutism, acne, and seborrhea, as well as for the management of symptoms associated with PCOS. Additionally, they are widely used as an oral contraceptive for the prevention of pregnancy.

Dosage and Administration: The dosage of Ethinyl Estradiol + Cyproterone Acetate Tablets varies depending on the indication and the specific formulation. Typically, one tablet is taken orally once daily, preferably at the same time each day. For contraception, the tablets are usually started on the first day of the menstrual cycle or on the first Sunday after the onset of menstruation.

Dosage Forms and Strengths: Ethinyl Estradiol + Cyproterone Acetate Tablets are available in various strengths, typically containing ethinyl estradiol in doses ranging from 0.02 mg to 0.035 mg and cyproterone acetate in doses ranging from 1 mg to 2 mg per tablet. They are supplied in blister packs or bottles containing a specified number of tablets.

Contraindications: Ethinyl Estradiol + Cyproterone Acetate Tablets are contraindicated in patients with a history of estrogen-dependent tumors, thromboembolic disorders, liver dysfunction, and undiagnosed abnormal genital bleeding. They should also not be used during pregnancy or lactation.

Warnings and Precautions: Patients taking Ethinyl Estradiol + Cyproterone Acetate Tablets should be monitored closely for potential adverse effects, including an increased risk of cardiovascular events, venous thromboembolism, stroke, and breast cancer. Regular medical check-ups and mammograms may be recommended. Caution should be exercised in patients with a history of hormone-sensitive cancers, liver dysfunction, or gallbladder disease.

Adverse Reactions/Side Effects: Common adverse reactions associated with Ethinyl Estradiol + Cyproterone Acetate Tablets may include nausea, breast tenderness, headache, and irregular menstrual bleeding. Serious adverse effects such as cardiovascular events, thromboembolism, and liver dysfunction are rare but require prompt medical attention.

Drug Interactions: Ethinyl Estradiol + Cyproterone Acetate Tablets may interact with certain medications, including rifampicin, barbiturates, phenytoin, and St. John's Wort, potentially reducing their efficacy or increasing the risk of adverse effects. Patients should inform their healthcare provider of all medications they are taking before starting Ethinyl Estradiol + Cyproterone Acetate therapy.

Use In Specific Populations Description: Ethinyl Estradiol + Cyproterone Acetate Tablets are intended for use in women experiencing androgen-dependent conditions or seeking contraception. They should be used with caution in patients with a history of estrogen-dependent tumors, cardiovascular disease, or liver dysfunction.

How Supplied/Storage and Handling: Ethinyl Estradiol + Cyproterone Acetate Tablets are supplied in blister packs or bottles containing a specified number of tablets. They should be stored at room temperature (20°C to 25°C) away from moisture and heat. Unused tablets should be properly disposed of according to local regulations.