Drug Guide
Drospirenone; Ethinyl Estradiol
Classification
Therapeutic: Contraceptive, Estrogen and Progestin Combination
Pharmacological: Hormonal contraceptive
FDA Approved Indications
- Prevention of pregnancy
- Treatment of moderate acne in women in certain age groups
Mechanism of Action
Combined estrogen and progestin suppresses ovulation, alters uterine lining, and thickens cervical mucus to prevent sperm penetration.
Dosage and Administration
Adult: Taken orally once daily, at the same time each day, with or without food.
Pediatric: Not indicated for use in pediatric populations.
Geriatric: Not specified, use exclusively as hormonal contraception or under medical supervision.
Renal Impairment: Use with caution; dose adjustments may be necessary.
Hepatic Impairment: Contraindicated in severe hepatic disease.
Pharmacokinetics
Absorption: Well absorbed orally, peak levels in 1-2 hours.
Distribution: Extensively bound to plasma proteins, mainly albumin.
Metabolism: Metabolized in the liver via multiple pathways including CYP enzymes.
Excretion: Excreted primarily via urine and feces.
Half Life: Drospirenone: approximately 26 hours; Ethinyl Estradiol: approximately 13 hours.
Contraindications
- History of thrombotic disorders
- Breast cancer or hormone-sensitive tumors
- Pregnancy
- Severe liver disease
Precautions
- Smokers over age 35
- Migraine with aura
- Hypertension
- Diabetes with vascular disease
Adverse Reactions - Common
- Nausea (Common)
- Breast tenderness (Common)
- Headache (Common)
- Weight changes (Common)
Adverse Reactions - Serious
- Venous thromboembolism (Serious)
- Arterial thromboembolism (Serious)
- Hypertension (Serious)
- Liver tumors (Serious)
Drug-Drug Interactions
- Certain antibiotics (may decrease contraceptive efficacy)
- Anticonvulsants (decrease effectiveness)
- Warfarin (may affect INR)
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing Implications
Assessment: Monitor blood pressure, weight, and for signs of thromboembolism.
Diagnoses:
- Risk for thromboembolic events
- Ineffective tissue perfusion
Implementation: Ensure patient understands the importance of adherence, timing, and not smoking.
Evaluation: Assess effectiveness in pregnancy prevention and side effects.
Patient/Family Teaching
- Take medication at the same time daily.
- Do not smoke while on this medication.
- Report severe headache, visual changes, or leg pain.
- Use additional contraception if advised.
Special Considerations
Black Box Warnings:
- Venoembolic disease risk
Genetic Factors: Genetic predisposition may affect thrombotic risk.
Lab Test Interference: May affect thyroid and other lab tests.
Overdose Management
Signs/Symptoms: Nausea, vomiting, dizziness, and withdrawal bleeding.
Treatment: Supportive care, symptomatic treatment, and gastrointestinal decontamination if recent ingestion.
Storage and Handling
Storage: Store at room temperature, away from moisture and light.
Stability: Stable until expiry date when stored properly.