Levonorgestrel + Ethinyloestradiol Tablets

Description

Product Description: Levonorgestrel + Ethinyl Estradiol Tablets are a combined hormonal contraceptive medication containing two active ingredients: levonorgestrel, a synthetic progestin, and ethinyl estradiol, a synthetic estrogen. These tablets are designed to prevent pregnancy by inhibiting ovulation, thickening cervical mucus to impede sperm penetration, and altering the endometrium to prevent implantation.

Indications and Usage: Levonorgestrel + Ethinyl Estradiol Tablets are indicated for use as a contraceptive to prevent pregnancy in women of reproductive age. They are also used to regulate menstrual cycles and alleviate symptoms of premenstrual dysphoric disorder (PMDD) and moderate acne vulgaris.

Dosage and Administration: The dosage regimen of Levonorgestrel + Ethinyl Estradiol Tablets typically involves taking one tablet daily for 21 consecutive days, followed by a 7-day interval without tablets. During the tablet-free interval, withdrawal bleeding usually occurs. The next pack is started on the eighth day, regardless of whether bleeding has ceased.

Dosage Forms and Strengths: Levonorgestrel + Ethinyl Estradiol Tablets are available as oral tablets containing varying doses of levonorgestrel and ethinyl estradiol. The specific strengths may vary depending on the product formulation.

Contraindications: Levonorgestrel + Ethinyl Estradiol Tablets are contraindicated in women with a history of thromboembolic disorders, liver disease, hormone-sensitive cancers, or undiagnosed abnormal vaginal bleeding. They are also contraindicated in pregnant women and smokers over the age of 35.

Warnings and Precautions: Patients should be advised that Levonorgestrel + Ethinyl Estradiol Tablets do not protect against sexually transmitted infections (STIs) and should not be used as a sole method of contraception in high-risk populations. The risk of cardiovascular events, including stroke and myocardial infarction, increases with age and smoking status.

Adverse Reactions/Side Effects: Common adverse reactions associated with Levonorgestrel + Ethinyl Estradiol Tablets may include nausea, breast tenderness, headache, breakthrough bleeding, and mood changes. Serious adverse effects such as thromboembolism and cardiovascular events are rare but can occur.

Drug Interactions: Levonorgestrel + Ethinyl Estradiol Tablets may interact with certain medications, including anticonvulsants, antibiotics, and herbal supplements, 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 this contraceptive.

Use In Specific Populations Description: Levonorgestrel + Ethinyl Estradiol Tablets are intended for use in women of reproductive age who require contraception. They are not recommended during pregnancy or breastfeeding. Special caution should be exercised in women with certain medical conditions, such as hypertension or diabetes.

How Supplied/Storage and Handling: Levonorgestrel + Ethinyl Estradiol Tablets are typically supplied in blister packs or unit-dose packaging containing a 28-day supply. 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.