Home Drug Guide Ethinyl Estradiol; Norethindrone

Drug Guide

Generic Name

Ethinyl Estradiol; Norethindrone

Brand Names Modicon 21, Ortho-novum 1/35-21, Norinyl 1+35 21-day, Norinyl 1+35 28-day, Brevicon 21-day, Ovcon-50, Ovcon-35, Modicon 28, Brevicon 28-day, Ortho-novum 1/35-28, Ortho-novum 10/11-21, Ortho-novum 10/11-28, Tri-norinyl 21-day, Tri-norinyl 28-day, Ortho-novum 7/7/7-21, Ortho-novum 7/7/7-28, Ortho-novum 7/14-21, Ortho-novum 7/14-28, Femcon Fe, Norethindrone And Ethinyl Estradiol And Ferrous Fumarate, Norethindrone And Ethinyl Estradiol, Norethindrone And Ethinyl Estradiol (7/14), Norethindrone And Ethinyl Estradiol (10/11), Norethin 1/35e-21, Norethin 1/35e-28, N.e.e. 1/35 21, N.e.e. 1/35 28, Norcept-e 1/35 21, Norcept-e 1/35 28, Nortrel 0.5/35-21, Nortrel 1/35-21, Gencept 10/11-21, Nortrel 0.5/35-28, Nortrel 1/35-28, Gencept 10/11-28, Nortrel 7/7/7, Balziva-21, Balziva-28, Cyclafem 1/35, Cyclafem 7/7/7, Aranelle, Gildagia, Briellyn, Dasetta 7/7/7, Philith, Dasetta 1/35, Wera, Alyacen 1/35, Alyacen 7/7/7, Pirmella 7/7/7, Pirmella 1/35, Vyfemla, Cyclafem 0.5/35, Kaitlib Fe, Nylia 7/7/7, Cyonanz, Nylia 1/35, Nexesta Fe, Rhuzdah

Classification

Therapeutic: Contraceptive, hormonal replacement therapy

Pharmacological: Combined estrogen-progestin

FDA Approved Indications

Prevention of pregnancy
Treatment of acne vulgaris (certain formulations)
Hormonal replacement therapy for deficiency or imbalance

Mechanism of Action

Suppresses ovulation by inhibiting the mid-cycle surge of luteinizing hormone (LH) and follicle-stimulating hormone (FSH). It also alters the cervical mucus, making it less permeable to sperm, and changes the endometrial lining to prevent implantation.

Dosage and Administration

Adult: Typically one tablet daily at the same time every day for 21, 28, or 84 days depending on the regimen.

Pediatric: Not approved for use in pediatric patients.

Geriatric: Not specifically indicated but should be used cautiously in women over 35 with cigarette smoking or other risk factors.

Renal Impairment: Use with caution; no specific dosage adjustment necessary but monitor closely.

Hepatic Impairment: Contraindicated in significant hepatic disease; risk of serious adverse effects.

Pharmacokinetics

Absorption: Well absorbed orally.

Distribution: Widely distributed, highly protein-bound (binding mostly to albumin and SHBG).

Metabolism: Extensively metabolized in the liver via conjugation and first-pass metabolism.

Excretion: Metabolites excreted mainly in urine and feces.

Half Life: Approximately 13 hours for ethyinyl estradiol and 18-25 hours for norethindrone.

Contraindications

History of thrombosis or thromboembolic disorders
Breast cancer or other estrogen-dependent tumors
Liver tumors or active liver disease
Pregnancy

Precautions

Use with caution in smokers over 35 years, women with hypertension, migraines with aura, or those at risk for cardiovascular disease.

Adverse Reactions - Common

Nausea (Common)
Breast tenderness (Common)
Weight change (Common)

Adverse Reactions - Serious

Venous thromboembolism (DVT, PE) (Serious; rare but significant)
Stroke or myocardial infarction (Serious; rare)

Drug-Drug Interactions

Antibiotics that reduce enterohepatic recirculation of estrogens
Anticonvulsants (e.g., phenytoin, carbamazepine)
Rifampin

Drug-Food Interactions

N/A

Drug-Herb Interactions

St. John's Wort

Nursing Implications

Assessment: Monitor blood pressure, weight, and for signs of thromboembolism.

Diagnoses:

Risk for thromboembolism
Imbalanced nutrition: less than body requirements

Implementation: Instruct patient on daily intake, importance of adherence, and recognizing adverse effects.

Evaluation: Effectiveness in preventing pregnancy, absence of adverse effects or complications.

Patient/Family Teaching

Take medication at the same time daily.
Discuss potential side effects and when to seek medical attention.
Use additional contraceptive methods if advised during initial months.

Special Considerations

Black Box Warnings:

Smoking increases risk of serious cardiovascular events, especially in women over 35.
Increased risk of venous thromboembolism

Genetic Factors: Women with factor V Leiden mutation may have increased risk for thromboembolism.

Lab Test Interference: May alter results of some endocrine and bleeding tests.

Overdose Management

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

Treatment: Supportive care; no specific antidote. Consider gastric lavage and activated charcoal if ingestion was recent.

Storage and Handling

Storage: Store at room temperature 20–25°C (68–77°F), protected from light and moisture.

Stability: Stable under recommended storage conditions.