Drosperinone + Ethinyl Estradiol Tablets

Description

Product Description: Drospirenone + Ethinyl Estradiol Tablets are an oral contraceptive medication combining two active ingredients: drospirenone, a progestin, and ethinyl estradiol, an estrogen. These tablets are formulated to prevent pregnancy by inhibiting ovulation, thickening cervical mucus, and altering the endometrium.

Indications and Usage: Drospirenone + Ethinyl Estradiol Tablets are indicated for the prevention of pregnancy in women of reproductive age. They offer a reliable and reversible method of contraception when taken consistently and correctly.

Dosage and Administration: The typical dosage regimen involves taking one tablet daily at the same time each day, without interruption, for 28 days. The tablets should be swallowed whole with water, with or without food. Adherence to the prescribed dosing schedule is crucial to maintain contraceptive efficacy.

Dosage Forms and Strengths: Drospirenone + Ethinyl Estradiol Tablets are available as oral tablets for daily administration. Each tablet contains a specific dose of drospirenone and ethinyl estradiol, typically in combinations such as 3 mg drospirenone and 0.02 mg ethinyl estradiol.

Contraindications: Drospirenone + Ethinyl Estradiol Tablets are contraindicated in women with a history of thrombosis or thromboembolic disorders, liver disease or tumors, undiagnosed abnormal vaginal bleeding, known or suspected pregnancy, hypersensitivity to drospirenone, ethinyl estradiol, or any component of the formulation, and certain cardiovascular conditions.

Warnings and Precautions: Women taking Drospirenone + Ethinyl Estradiol Tablets should be informed of the potential risks associated with hormonal contraceptives, including an increased risk of thrombotic disorders, cardiovascular events, liver tumors, and certain cancers. Patients should also be educated on the importance of regular medical check-ups and monitoring for adverse effects.

Adverse Reactions/Side Effects: Common adverse reactions associated with Drospirenone + Ethinyl Estradiol Tablets may include headache, nausea, breast tenderness, breakthrough bleeding, mood changes, and weight fluctuations. Serious adverse effects such as blood clots, stroke, heart attack, and liver problems are rare but require immediate medical attention.

Drug Interactions: Drospirenone + Ethinyl Estradiol Tablets may interact with certain medications, including anticonvulsants, antibiotics, antiretrovirals, and herbal supplements, potentially reducing contraceptive efficacy or increasing the risk of adverse effects. Patients should be advised to consult their healthcare provider before starting or stopping any medications.

Use In Specific Populations Description: Drospirenone + Ethinyl Estradiol Tablets are intended for use in women of reproductive age seeking contraception. They are not recommended for use in pregnant women or women with certain medical conditions, such as severe liver disease, uncontrolled hypertension, or a history of thromboembolic events.

How Supplied/Storage and Handling: Drospirenone + Ethinyl Estradiol 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.