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Levonorgestrel and Ethinyl Estradiol

LEVONORGESTREL AND ETHINYL ESTRADIOL

Manufacturer: Glenmark Pharmaceuticals Inc., USA

Score: 141.0

Quick Summary

Levonorgestrel and Ethinyl Estradiol is a combination oral contraceptive used for the prevention of pregnancy in women. It works by suppressing gonadotropins, inhibiting ovulation, and altering the cervical mucus and endometrium. The drug has several benefits, including a low daily dose of estrogen and progestin, but it also carries risks such as thromboembolic disorders, myocardial infarction, and stroke. Women who smoke, are over 35, or have certain medical conditions should not use this drug. The typical dosage is one tablet daily, taken at the same time each day, with no tablet-free interval. The drug is not recommended for use in pregnant or nursing women, and its use in pediatric and geriatric populations requires special consideration.

Key Clinical Findings and Indications

  • Prevention of pregnancy in women
  • Suppression of gonadotropins
  • Inhibition of ovulation
  • Alteration of cervical mucus and endometrium

Important Safety Information

Warning

Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from oral contraceptive use.

Contraindications

  • Thrombophlebitis or thromboembolic disorders
  • Cerebrovascular or coronary artery disease
  • Valvular heart disease with thrombogenic complications
  • Breast cancer
  • Undiagnosed abnormal genital bleeding
  • Cholestatic jaundice of pregnancy or jaundice with prior pill use
  • Hepatic adenomas or carcinomas, or active liver disease

Adverse Reactions

  • Thromboembolic and thrombotic disorders
  • Myocardial infarction
  • Stroke
  • Breast changes
  • Cervical erosion and secretion
  • Cholestatic jaundice
  • Headache
  • Nausea
  • Vomiting

Dosing Recommendations

General Guidance

None

Prevention of pregnancy

Adult Dose

One tablet daily, taken at the same time each day, with no tablet-free interval

Pediatric Dose

Special Population Considerations

Pregnancy

  • The drug is contraindicated in pregnant women

Nursing Mothers

  • Small amounts of oral contraceptive steroids and/or metabolites have been identified in the milk of nursing mothers

Pediatric Use

  • Safety and efficacy have been established in women of reproductive age, but not in postpubertal adolescents under the age of 16

Geriatric Use

  • This product has not been studied in women over 65 years of age and is not indicated in this population