Generic Name

Ethinyl Estradiol and Norgestrel

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Classification

FDA Approved Indications

• Prevention of pregnancy

Mechanism of Action

Suppression of ovulation, alteration of cervical mucus, and endometrial changes to prevent fertilization and implantation.

Dosage and Administration

Adult: Take one tablet daily at the same time every day, starting on the first day of the menstrual cycle or as directed; adjust based on formulation.

Pediatric: Not indicated for pediatric use.

Geriatric: Not indicated for postmenopausal women.

Renal Impairment: Use with caution; no specific adjustments established.

Hepatic Impairment: Contraindicated in women with liver disease due to risk of hepatic adenomas and cholestatic jaundice.

Pharmacokinetics

Absorption: Rapidly absorbed from the gastrointestinal tract.

Distribution: Widely distributed; crosses the placenta and enters breast milk.

Metabolism: Extensively metabolized in the liver via first-pass effect.

Excretion: Excreted primarily in feces and urine.

Half Life: Ethinyl estradiol: approximately 13 hours; Norgestrel: approximately 22 hours.

Contraindications

• History of thromboembolic disorders
• Hepatic disease or tumors
• Breast cancer or estrogen-dependent tumors
• Undiagnosed abnormal vaginal bleeding

Precautions

• Use cautiously in women with migraine, hypertension, or risk factors for cardiovascular disease. Monitor blood pressure regularly.

Adverse Reactions - Common

• Nausea (Common)
• Breast tenderness (Common)
• Weight gain (Common)

Adverse Reactions - Serious

• Blood clots (DVT, PE) (Rare)
• Stroke or myocardial infarction (Rare)
• Liver tumors (Rare)
• Hypertension (Rare)

Drug-Drug Interactions

• Antibiotics (may reduce efficacy)
• Anticonvulsants (enzyme inducers)
• Rifampin, carbamazepine, phenytoin

Drug-Food Interactions

• Grapefruit juice (may affect metabolism)

Drug-Herb Interactions

N/A

Nursing Implications

Patient/Family Teaching

• Use consistent daily timing.
• Report symptoms of blood clots, severe headache, chest pain, or abdominal pain.
• Use additional contraception methods if advised during antibiotic or other interacting drug use.

Special Considerations

Black Box Warnings:

• Smoking increases risk of serious cardiovascular events in women over 35.

Genetic Factors: Presence of thrombophilia increases risk.

Lab Test Interference: May affect thyroid and glucose testing.

Overdose Management

Signs/Symptoms: Nausea, vomiting, and vaginal bleeding.

Treatment: Supportive care; gastrointestinal decontamination if ingestion is recent; no specific antidote.

Storage and Handling

Storage: Store at room temperature away from moisture and heat.

Stability: Stable until expiration date on package.