Drug Guide

Generic Name

Ethinyl Estradiol; Levonorgestrel

Brand Names Nordette-21, Nordette-28, Triphasil-28, Triphasil-21, Alesse, Levlite, Preven Emergency Contraceptive Kit, Seasonale, Seasonique, Lybrel, Loseasonique, Levora 0.15/30-21, Levora 0.15/30-28, Trivora-21, Trivora-28, Aviane-28, Aviane-21, Lessina-21, Lessina-28, Enpresse-21, Enpresse-28, Levonorgestrel And Ethinyl Estradiol, Portia-21, Portia-28, Orsythia, Quasense, Myzilra, Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol, Introvale, Altavera, Setlakin, Levonest, Falmina, Kurvelo, Marlissa, Daysee, Ethinyl Estradiol And Levonorgestrel, Dolishale, Vienva, Elifemme, Cerinta, Sylevia, Ashlyna, Jaimiess, Twirla, Quartette, Fayosim, Iclevia, Simpesse, Lo Simpesse, Ayuna, Afirmelle, Balcoltra, Tyblume, Levonorgestrel And Ethinyl Estradiol And Ferrous Fumarate, Minzoya

Classification

Therapeutic: Contraceptive, Hormonal

Pharmacological: Estrogen and Progestin Combination

FDA Approved Indications

  • Prevention of pregnancy

Mechanism of Action

Combined estrogen and progestin inhibit ovulation, alter cervical mucus to prevent sperm penetration, and modify the endometrial lining to prevent implantation.

Dosage and Administration

Adult: As directed by healthcare provider, typically one tablet daily for 21, 28, or 84 days depending on the formulation.

Pediatric: Not approved for use in individuals under 18 for contraception; consult specific product labeling.

Geriatric: Not applicable; primarily used in reproductive age women.

Renal Impairment: Use with caution; see specific product labeling.

Hepatic Impairment: Use caution or avoid in women with significant hepatic disease.

Pharmacokinetics

Absorption: Rapid absorption after oral administration.

Distribution: Widely distributed, highly protein bound.

Metabolism: Primarily hepatic via conjugation and hydroxylation.

Excretion: Excreted mainly in urine and feces.

Half Life: Approximately 13 hours for levonorgestrel; ethinyl estradiol half-life approximately 17 hours.

Contraindications

  • History of thrombotic disorders
  • Horses with breast cancer or estrogen-dependent neoplasia
  • Active or recent vascular disease

Precautions

  • Monitor for signs of thromboembolic events, especially in women over 35 or smokers

Adverse Reactions - Common

  • Nausea (Common)
  • Breast tenderness (Common)
  • Bloating (Common)
  • Headache (Common)

Adverse Reactions - Serious

  • Venous thromboembolism (Rare)
  • Stroke (Rare)
  • Myocardial infarction (Rare)
  • Liver tumors (Rare)

Drug-Drug Interactions

  • Anticonvulsants (e.g., phenytoin, carbamazepine) reduce effectiveness
  • Rifampin
  • St. John's Wort

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor blood pressure, assess for signs of thromboembolism, evaluate for contraindications.

Diagnoses:

  • Ineffective tissue perfusion related to thromboembolic risk
  • Risk for impaired skin integrity related to estrogen effects

Implementation: Administer orally at the same time each day, provide counseling on use and side effects, and assess for adverse effects.

Evaluation: Ensure patient understands the correct method of use, monitor for adverse reactions, and confirm effectiveness of contraception.

Patient/Family Teaching

  • Take medication at the same time daily.
  • Do not skip doses.
  • Report signs of thromboembolism, such as sudden severe headache, chest pain, leg swelling.
  • Use additional contraception if taking other interacting medications.
  • Discuss smoking risks, especially if over 35.

Special Considerations

Black Box Warnings:

  • Routes of estrogen increase the risk of thromboembolism and ischemic stroke.
  • Absolute contraindication in women with thrombotic disorders or known hormone-sensitive cancers.

Genetic Factors: Variations in clotting factors (e.g., Factor V Leiden) may increase thrombotic risk.

Lab Test Interference: Oral contraceptives may slightly affect liver function tests and lipid profiles.

Overdose Management

Signs/Symptoms: Nausea, vomiting, withdrawal bleeding, dizziness.

Treatment: Supportive; focus on symptomatic treatment. No specific antidote. Remove the medication if overdose suspected.

Storage and Handling

Storage: Store at room temperature, 20°C to 25°C (68°F to 77°F).

Stability: Stable until expiration date on the packaging.

This guide is for educational purposes only and is not intended for clinical use.