Ethinyl Estradiol/Norethindrone/Ferrous fumarate

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[edit] BRAND NAMES

[edit] MECHANISM OF ACTION

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

[edit] INDICATIONS

Ethinyl Estradiol/Norethindrone/Ferrous fumarate is an estrogen/progestin COC indicated for use by women to prevent pregnancy.

The efficacy in women with a body mass index (BMI) of > 35 kg/m2 has not been evaluated.

[edit] DOSAGE

One tablet without water at the same time every day.

Take tablets in the order directed on the blister pack.

[edit] CONTRAINDICATIONS

  • A high risk of arterial or venous thrombotic diseases.
  • Undiagnosed abnormal uterine bleeding.
  • Breast cancer or other estrogen- or progestin-sensitive cancer.
  • Liver tumors or liver disease.
  • Pregnancy.

[edit] WARNINGS AND PRECAUTIONS

  • Vascular risks: Stop GENERESS Fe if a thrombotic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery in women who are not breastfeeding.
  • Liver disease: Discontinue if jaundice occurs.
  • High blood pressure: Do not prescribe for women with uncontrolled hypertension or hypertension with vascular disease.
  • Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking GENERESS Fe. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia.
  • Headache: Evaluate significant change in headaches and discontinue if indicated.
  • Uterine bleeding: Evaluate irregular bleeding or amenorrhea.

[edit] INTERACTIONS

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.

[edit] PREGNANCY AND LACTATION

Pregnancy

There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy. The administration of COCs to induce withdrawal bleeding should not be used as a test for pregnancy. COCs should not be used during pregnancy to treat threatened or habitual abortion. Women who do not breastfeed may start COCs no earlier than four weeks postpartum.

Nursing mothers: Not recommended, can decrease milk production.

[edit] SIDE EFFECTS

The most common adverse reactions (≥ 2%) are nausea/vomiting (8.8%), headaches/migraine (7.5%), depression/mood complaints (4.1%), dysmenorrhea (3.9%), acne (3.2%), anxiety symptoms (2.4%), breast pain/tenderness (2.4%), and increased weight (2.3%).

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[edit] BIBLIOGRAPHY

[edit] REFERENCES