Ethinyl Estradiol + Levonorgestrel + Ferrous Fumarate

Ethinyl Estradiol + Levonorgestrel + Ferrous Fumarate is a medicine used for contraception (to prevent pregnancy) and in the treatment of irregular periods. It helps to prevent release of the egg and its fertilization by the sperm.

Each White (Hormone) Tablet contains Ethinylestradiol USP 0.03 mg and Levonorgestrel USP 0.15 mg. Each Brown (Iron) tablet contains Ferrous Fumarate BP 75 mg.

• Contraception: Used as a combined oral contraceptive pill for prevention of pregnancy.
• Irregular Periods: Used for the treatment of irregular menstrual cycles.

Oral Contraceptive preparations

Combined Oral Contraceptive + Iron Supplement

This pill is an effective, temporary and short term birth control management for women. This tablet contains two hormones: Levonorgestrel and Ethinyl Estradiol. Every single strip contains 28 tablets from which 21 tablets contains hormone and 7 tablets contains Iron.

Combination of hormonal contraceptives inhibits ovulation by modulating pituitary secretion of gonadotrophins through a negative feedback system. They also cause changes in the endometrium which reduce the risk of nidation.

Adult Dose:

• Contraception: 1 active tablet PO daily for 21 days, then 1 inert tablet PO daily for 7 days.
• Missed Dose: 1 missed: take as soon as remembered or take 2 tablets on following day; use other contraception for next 7 days.
• 2 missed consecutively: Take 2 tablets as soon as remembered; use other contraception for next 7 days.

Starting: Start from the first day of menstruation (can start any day within first 5 days).

Take 1 tablet at the same time every day. Start with white tablets (hormone) for 21 days from first day of menstruation, then brown tablets (iron) for 7 days. Swallow each pill whole with water if necessary. Do not chew.

If forget 1 day: take as soon as remembered and take present day's dose. If forget 2 consecutive days: contraception will not work; take 2 tablets as soon as remembered.

Common Side Effects:

• Headache
• Nausea
• Mood changes (including depression)
• Vaginal infections
• Irregular vaginal bleeding
• Pain and discomfort
• Breast pain

Rare Side Effects: Liver tumors, jaundice, high blood pressure, gallbladder problems.

Precautions:

• Thrombotic disorder: Stop if thrombosis occurs; stop 4 weeks before major surgery and start 2 weeks after.
• Liver disease: Discontinue if jaundice occurs.
• High blood pressure: Monitor if controlled; stop if significant rise.
• Do not use if pregnant or suspected pregnancy.
• Smoking increases risk, especially over 35 years of age.
• Do not use if obese, on prolonged bed rest, or have history of blood clots.

Contraindications:

• Pregnancy
• Undiagnosed vaginal bleeding
• Severe arterial disease
• Liver adenoma
• Porphyria
• History of breast cancer
• Hepatic impairment
• Thrombophlebitis or thromboembolic disorders
• Smoking >40 cigarettes daily
• BMI >39 kg/m²

Drug Interactions:

• CYP3A4 inducers (aminoglutethimide, carbamazepine, nafcillin, nevirapine, atazanavir, nelfinavir, phenobarbital, phenytoin, rifamycins, griseofulvin, ritonavir): May decrease levels/effects.
• Ampicillin, tetracycline and other antibiotics: May reduce efficacy.
• Estrogens: May antagonize anticoagulant effect of coumarins.

Food Interactions: Caution advised with alcohol. It is recommended to avoid caffeine, dairy foods, phytic acid containing foods.

Use in Pregnancy: Highly unsafe during pregnancy; animal and human studies have shown significant harmful effects.

Use in Lactation: Probably unsafe; limited data suggests drug may pass into breastmilk and harm the baby.

Pediatric Use: Safety and efficacy established in women of reproductive age; not indicated before menarche.

Geriatric Use: For women aged 15-69 years (except smokers and tobacco users).

Renal Impairment: Limited information available on use in patients with kidney disease.

Hepatic Impairment: Limited information available on use in patients with liver disease.

Overdose: No reports of serious illness from overdose; withdrawal bleeding in females and nausea may occur.

Storage: Store below 30 degree C, protected from light and moisture. Keep out of reach of children.

Ethinyl Estradiol + Levonorgestrel + Ferrous Fumarate