Generic Name

Norethindrone; Ethinyl Estradiol

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Classification

FDA Approved Indications

• Prevention of pregnancy
• Hormone replacement therapy in certain conditions like menstrual dysfunction

Mechanism of Action

Suppression of ovulation through inhibition of the hypothalamic-pituitary-ovarian axis; changes in cervical mucus and endometrial lining reduce the likelihood of fertilization and implantation.

Dosage and Administration

Adult: Typically 1 tablet daily for 21 days followed by a 7-day pill-free interval, or as prescribed by a physician.

Pediatric: Not typically used in pediatric patients.

Geriatric: Not applicable; use is limited to women of reproductive age.

Renal Impairment: Use with caution; no specific dose adjustment recommended but monitoring is advised.

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

Pharmacokinetics

Absorption: Rapid and complete absorption from the gastrointestinal tract.

Distribution: Widely distributed; extensively bound to plasma proteins.

Metabolism: Primarily hepatic via conjugation and oxidative metabolites.

Excretion: Metabolites excreted mainly in urine and feces.

Half Life: Norethindrone approx. 8 hours; Ethinyl Estradiol approx. 13 hours.

Contraindications

• History of thromboembolic disorders
• Estrogen or progestin-dependent neoplasms
• Vascular disease
• Liver disease or tumors
• Pregnancy

Precautions

• Use with caution in women with migraines, hypertension, or diabetes; monitor blood pressure and metabolic parameters regularly.

Adverse Reactions - Common

• Nausea, breast tenderness, headache (Common)
• Breakthrough bleeding or spotting (Common)

Adverse Reactions - Serious

• Blood clots (deep vein thrombosis, pulmonary embolism) (Rare but serious)
• Stroke, myocardial infarction (Rare)
• Liver tumors (Rare)

Drug-Drug Interactions

• Certain antibiotics (e.g., rifampin), anticonvulsants (e.g., phenytoin), and antiretrovirals may decrease effectiveness.
• Other medications that increase the risk of blood clots.

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Patient/Family Teaching

• Take the medication at the same time daily.
• Do not smoke while using hormonal contraceptives.
• Report any signs of blood clots or unusual symptoms immediately.

Special Considerations

Black Box Warnings:

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

Genetic Factors: Progestin and estrogen sensitivity vary among individuals.

Lab Test Interference: May alter results of thyroid and glucose tests.

Overdose Management

Signs/Symptoms: Nausea, vomiting, vaginal bleeding, or dizziness.

Treatment: Supportive care; no specific antidote, symptomatic treatment.

Storage and Handling

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

Stability: Stable under normal conditions, check expiration date.