Femipil Tablet

Introduction

Ethinyl estradiol, levonorgestrel, and ferrous fumarate are combined in some oral contraceptive formulations and multi-nutrient supplements. Ethinyl estradiol is an estrogen hormone used in birth control pills, levonorgestrel is a progestin hormone also used in contraceptives, and ferrous fumarate is a form of iron used to prevent or treat iron deficiency anemia. This combination is designed to provide contraceptive benefits while also addressing potential iron deficiency.

Uses

The combination of ethynyl estradiol, levonorgestrel, and ferrous fumarate is used for:

Contraception: Ethinyl estradiol and levonorgestrel work together to prevent pregnancy by inhibiting ovulation, altering cervical mucus, and changing the uterine lining to reduce the likelihood of implantation.
Iron Supplementation: Ferrous fumarate provides iron to prevent or treat iron deficiency anemia, which is important for maintaining healthy red blood cell levels and overall health.

Brand Name	Femipil
Type	Tablet
Weight	0.03 mg+0.15 mg+75 mg
Generic	Ethinyl Estradiol + Levonorgestrel + Ferrous Fumarate
Manufacturer	Beximco Pharmaceuticals Ltd.
Available in	English বাংলা

Mechanism of Action

Ethinyl estradiol and levonorgestrel act primarily on the hypothalamic-pituitary-ovarian axis to prevent ovulation. Ethinyl estradiol inhibits the release of follicle-stimulating hormone (FSH) and luteinizing hormone (LH), while levonorgestrel thickens cervical mucus and alters the endometrium. Ferrous fumarate provides iron, which is essential for the production of hemoglobin in red blood cells, helping to alleviate iron deficiency.

How Long Does It Take to Work?

The contraceptive effects of ethynyl estradiol and levonorgestrel are typically effective within 7 days if taken as directed. Full contraceptive protection is usually achieved after 7 consecutive days of use. The iron supplementation effects of ferrous fumarate may take several weeks to months to improve iron levels and symptoms of anemia.

Absorption

Ethinyl estradiol and levonorgestrel are absorbed in the gastrointestinal tract and undergo first-pass metabolism in the liver before entering systemic circulation. Ferrous fumarate is absorbed in the upper gastrointestinal tract, with absorption enhanced by vitamin C and reduced by calcium and certain medications.

Route of Elimination

Ethinyl estradiol and levonorgestrel are metabolized primarily in the liver and excreted in the urine and feces. Ferrous fumarate is absorbed into the bloodstream and excess iron is primarily excreted through feces, with minimal loss through urine and sweat.

Dosage

One should start taking this tablet from the first day of menstruation. It can be starts any day in first 5 days of menstruation. One tablet should be taken same time of each day with food, but best time is after dinner or before sleeping at night. Start your dose with one white tablet each day for 3 (three) weeks. After that, take one brown color tablet each day for 7(seven) days. If menstruation starts while taking brown color tablet, don’t stop the medicine. If not pregnant is confirmed then dose can be start from any day of menstruation, but after menstruation must have to use condom during sexual intercourse for next 7 (seven) days. When 7(seven) brown tablet finished, either menstruation starts or not, start the dose from beginning with white Tablet.

If forget to take tablet for a day, one should take the tablet as soon as patient noticed it, and take another tablet as the dose of present day. If forget to take the tablet for consecutive two days, then this contraceptive will not work. However, to maintain the date of menstruation cycle one should take two tablets at a time as soon as patient noticed it.

The dosage varies based on the specific formulation and intended use:

Contraceptive Use: Typically involves a daily oral dose of 1 tablet containing 0.02 mg of ethynyl estradiol and 0.1 mg of levonorgestrel. The regimen usually follows a 21-day on, 7-day off schedule, or continuous use as prescribed.
Iron Supplementation: The dose of ferrous fumarate commonly used is 325 mg (equivalent to 100 mg of elemental iron) once or twice daily, depending on the level of deficiency and clinical needs.

Administration

Ethinyl estradiol and levonorgestrel are taken orally, typically as part of a daily regimen of oral contraceptive tablets. Ferrous fumarate is also taken orally, ideally with food to minimize gastrointestinal irritation. For optimal absorption, ferrous fumarate should be taken with vitamin C or as recommended by a healthcare provider.

Side Effects

Possible side effects include:

Nausea or vomiting
Headaches
Breast tenderness
Abdominal bloating
Iron supplements may cause constipation, dark stools, or gastrointestinal discomfort

Toxicity

Overdose of ethynyl estradiol and levonorgestrel is rare but may cause severe nausea, vomiting, and breakthrough bleeding. Excessive intake of iron supplements can lead to iron toxicity, characterized by symptoms such as abdominal pain, vomiting, diarrhea, and in severe cases, organ damage.

Precautions

Use with caution in individuals with a history of cardiovascular disease, liver dysfunction, or hormone-sensitive cancers. Monitor for signs of iron overload if taking high doses of iron. Regular medical follow-ups are recommended to monitor for potential side effects and ensure efficacy.

Interaction

Ethinyl estradiol and levonorgestrel may interact with other medications, including antibiotics and anticonvulsants, which may reduce their effectiveness. Ferrous fumarate may interact with medications that affect iron absorption or metabolism, such as antacids and calcium supplements.

Disease Interaction

Use cautiously in individuals with liver disease, blood clotting disorders, or gastrointestinal conditions that affect absorption. Regular monitoring is recommended to assess the impact of these conditions on the efficacy and safety of the combination therapy.

Drug Interaction

Drug interactions may occur with medications that induce hepatic enzymes (e.g., rifampin) or those affecting gastrointestinal pH (e.g., proton pump inhibitors). Consult a healthcare provider for guidance on managing potential interactions.

Food Interactions

Iron absorption is enhanced by vitamin C but may be reduced by calcium-rich foods or dairy products. Ethinyl estradiol and levonorgestrel do not have specific food interactions but should be taken consistently to maintain contraceptive effectiveness.

Pregnancy Use

This combination is contraindicated during pregnancy. If pregnancy occurs, discontinue use immediately and consult a healthcare provider. Iron supplementation during pregnancy should be managed under medical supervision to avoid excessive iron intake.

Lactation Use

Ethinyl estradiol and levonorgestrel can be passed into breast milk, potentially affecting the infant. Iron supplementation is generally considered safe during lactation, but dosing should be monitored to avoid adverse effects.

Acute Overdose

In case of acute overdose, seek medical attention immediately. Symptoms may include severe nausea, vomiting, and gastrointestinal distress. For iron overdose, treatment may involve chelation therapy or supportive care depending on the severity.

Contraindication

Contraindications include known hypersensitivity to any of the components, current or history of hormone-sensitive cancers, liver disease, and certain types of thrombosis. Consult a healthcare provider for individual assessment.

Use Direction

Follow the specific product instructions for dosage and administration. For contraceptive use, adhere to the prescribed regimen without interruption. For iron supplementation, take as directed, usually with meals to reduce gastrointestinal irritation.

Storage Conditions

Store at room temperature, away from moisture and heat. Keep in a tightly closed container and out of reach of children. Check specific product labels for detailed storage instructions.

Volume of Distribution

The volume of distribution for ethynyl estradiol and levonorgestrel is high due to their distribution into various tissues, including reproductive tissues. Ferrous fumarate has a more localized effect, with minimal systemic distribution.

Half Life

The half-life of ethynyl estradiol is approximately 13 to 27 hours, while levonorgestrel has a half-life of about 24 hours. Ferrous fumarate does not have a specific half-life due to its role as a supplement rather than a systemic drug.

Clearance

Ethynyl estradiol and levonorgestrel are cleared primarily through hepatic metabolism and urinary excretion. Ferrous fumarate is cleared from the body through fecal elimination and urinary excretion of excess iron.

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