Norgestrel + Ethinyloestradiol Tablets

Description

Product Description: Norgestrel + Ethinyl Estradiol Tablets are a combination oral contraceptive containing two active ingredients, norgestrel and ethinyl estradiol. This combination provides effective birth control by inhibiting ovulation, altering cervical mucus viscosity, and disrupting the endometrial lining.

Indications and Usage: Norgestrel + Ethinyl Estradiol Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives.

Dosage and Administration: The dosage regimen typically involves taking one tablet daily at the same time each day for 21 consecutive days, followed by a 7-day hormone-free interval. The tablets should be taken orally, with or without food.

Dosage Forms and Strengths: Norgestrel + Ethinyl Estradiol Tablets are available in oral tablet form, with each tablet containing a specific dose of norgestrel and ethinyl estradiol. Common strengths include 0.5 mg norgestrel combined with 0.035 mg ethinyl estradiol or similar combinations.

Contraindications: Norgestrel + Ethinyl Estradiol Tablets are contraindicated in women with a known hypersensitivity to norgestrel, ethinyl estradiol, or any other components of the formulation. They should not be used by women with a history of thrombosis or thromboembolic disorders, liver disease, or undiagnosed vaginal bleeding.

Warnings and Precautions: Patients should be informed about the potential risks associated with Norgestrel + Ethinyl Estradiol Tablets, including an increased risk of thromboembolic events, cardiovascular events, and liver dysfunction. These tablets should be used with caution in women with a history of depression, migraine, or hypertension.

Adverse Reactions/Side Effects: Common adverse reactions associated with Norgestrel + Ethinyl Estradiol Tablets may include breakthrough bleeding, breast tenderness, headache, nausea, and mood changes. Less common but serious side effects may include thromboembolic events, hepatic dysfunction, and allergic reactions.

Drug Interactions: Norgestrel + Ethinyl Estradiol Tablets may interact with certain medications, including anticonvulsants, anticoagulants, and drugs that induce or inhibit cytochrome P450 enzymes, potentially altering their efficacy or increasing the risk of adverse effects.

Use In Specific Populations Description: Norgestrel + Ethinyl Estradiol Tablets should be used with caution in pregnant women and should not be used during breastfeeding. They are not recommended for use in children or adolescents.

How Supplied/Storage and Handling: Norgestrel + Ethinyl Estradiol Tablets are typically supplied in blister packs or bottles, with specific packaging details varying depending on the manufacturer. 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.