Ethinyl Estradiol + Levonorgestrel + Ferrous Fumarate

Composition

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

Indications

This pill is indicated in-
  • Inhibit Ovulation
  • Inhibit sperm to enter into the uterus by condensing uterine mucus
  • Inhibit fertilized egg to accept by uterus by protecting the growth of membrane inside the uterus
  • It reduces the movement of sperm by minimizing normal movement of fallopian tube. So sperms die as it takes long time to come into contact of Ova
This pill is Suitable for:
  • Women aged between 15-69 years (except smoker and who use tobacco regularly)
  • Women who want an effective, temporary contraceptive method
  • Women who is suffering from anemia due to excessive blood loss during menstruation
  • Women having irregular menstruation cycle
  • Breastfeeding mother (if child age is more than 6 months).

Pharmacology

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 oral contraceptives lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanism may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

Dosage & Administration

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.

Interaction

With medicine: Drugs or herbal products that induce certain enzymes, including CYP3A4 may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with COCs.

With food and other: It is recommended to avoid caffeine, dairy foods, phytic acid containing food while taking the drug.

Contraindications

Contraindicated in case of known hypersensitivity to any of the components of this product.

Side Effects

Common: Headache, nausea, mood changes including depression, vaginal infections, irregular vaginal bleeding, pain and discomfort. Rare: liver tumors, jaundice, high blood pressure & gallbladder problem.

Pregnancy & Lactation

This pill is contraindicated in pregnancy. Discontinue this pill if pregnancy occurs. Combined hormonal contraceptives (CHCs) and/or metabolites are present in human milk and in breast-fed infants. CHCs including this pill can reduce milk production in breastfeeding females.

Precautions & Warnings

  • Thrombotic disorder and other vascular problems: Stops this pill if a thrombotic disorder occurs. Stop at least 4 weeks before through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery in women who are not breastfeeding
  • Liver disease: Discontinue this pill if jaundice occurs
  • High blood pressure: If used in women with well-controlled hypertension, monitor blood pressure and stop this pill if blood pressure rises significantly
  • Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking this pill. Consider an alternative contraceptive method for women with uncontrolled dyslipidemia
  • Headache: Evaluate significant change in headaches and discontinue this pill if indicated
  • Bleeding irregularities and amenorrhea: Evaluate irregular bleeding or amenorrhea

Use in Special Populations

Safety and efficacy of this pill have been established in women of reproductive age. Efficacy is expected to be the same in post-pubertal adolescents under the age of 18 years as for users 18 years and older. Use of this product before menarche is not indicated.

Overdose Effects

There have been no reports of serious illness effects from overdose of oral contraceptives including ingestion by children. Over dosage may cause withdrawal bleeding in females and nausea.

Therapeutic Class

Oral Contraceptive preparations

Storage Conditions

Store below 30°C, protected from light & moisture. Keep all medicines out of reach of children.