Generic Name

Drospirenone; Estetrol

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Classification

FDA Approved Indications

• Prevention of pregnancy in women of reproductive age
• Hormone replacement therapy for menopausal symptoms in certain cases

Mechanism of Action

Estetrol is a natural estrogen that binds to estrogen receptors, exerting estrogenic effects. Drospirenone is a progestin with antimineralocorticoid and antiandrogenic properties, providing progestogenic activity and counteracting estrogen effects on the endometrium.

Dosage and Administration

Adult: One tablet daily, taken orally with or without food

Pediatric: Not indicated for pediatric use

Geriatric: Appropriate adjustments depend on clinical context; no specific dosing for postmenopausal women as a contraceptive

Renal Impairment: No specific adjustment recommended; use with caution

Hepatic Impairment: Use caution; hormone therapy is generally avoided or used with caution in hepatic impairment

Pharmacokinetics

Absorption: Well absorbed orally

Distribution: Extensively bound to plasma proteins

Metabolism: Primarily hepatic metabolism

Excretion: Metabolites excreted in urine and feces

Half Life: Estetrol: approximately 8-12 hours; Drospirenone: approximately 24 hours

Contraindications

• History of thromboembolic disorders
• Hormone-sensitive cancers (e.g., breast, endometrial)
• Vascular disease
• Liver dysfunction or disease

Precautions

• Smoking in women over 35
• Migraine with aura
• Hypertension
• Diabetes with vascular involvement
• Use with caution in women with renal or hepatic impairment

Adverse Reactions - Common

• Nausea (Common)
• Headache (Common)
• Breast tenderness (Common)
• Irregular bleeding (Common)

Adverse Reactions - Serious

• Deep vein thrombosis (DVT) (Rare)
• Pulmonary embolism (PE) (Rare)
• Stroke (Rare)
• Liver tumors (Rare)

Drug-Drug Interactions

• Other estrogen-containing medications
• Anticoagulants (may alter INR)
• Anticonvulsants (may reduce efficacy)

Drug-Food Interactions

• St. John's Wort (may reduce hormone efficacy)

Drug-Herb Interactions

N/A

Nursing Implications

Patient/Family Teaching

• Take medication at the same time daily
• Report any signs of blood clots (e.g., leg pain, chest pain, sudden severe headache)
• Use additional contraception if doses are missed
• Discuss smoking cessation if applicable
• Attend regular follow-up appointments

Special Considerations

Black Box Warnings:

• Increased risk of thrombotic events associated with combined hormonal contraceptives

Genetic Factors: Genetic predispositions to clotting disorders can increase risks

Lab Test Interference: Hormonal contraceptives may alter results of lipid profiles and coagulation tests

Overdose Management

Signs/Symptoms: Nausea, vomiting, breast tenderness, withdrawal bleeding

Treatment: Supportive care; no specific antidote; symptomatic treatment as needed

Storage and Handling

Storage: Store at room temperature between 20-25°C (68-77°F), away from moisture, heat, and light

Stability: Stable for the duration of the expiration date on the packaging