Generic Name

Dienogest, Estradiol Valerate

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Classification

FDA Approved Indications

• Prevention of pregnancy
• Treatment of abnormal uterine bleeding associated with menopausal or peri-menopausal transition

Mechanism of Action

Dienogest is a progestin that inhibits ovulation and causes cervical mucus thickening, while estradiol valerate provides estrogen to stabilize the endometrial lining. Together, they prevent ovulation and regulate menstrual cycles.

Dosage and Administration

Adult: Take one tablet orally once daily for 24 days, followed by a 4-day pill-free interval or placebo. Repeat for each cycle.

Pediatric: Not established for use in individuals under 18 years old.

Geriatric: Not applicable; not indicated for menopausal hormone therapy, specific to contraceptive use.

Renal Impairment: No specific dosage adjustment required; use with caution.

Hepatic Impairment: Use with caution; avoid in severe hepatic impairment.

Pharmacokinetics

Absorption: Well absorbed orally.

Distribution: Extensively bound to plasma proteins, mainly albumin and sex hormone-binding globulin.

Metabolism: Primarily hepatic via conjugation and aromatization.

Excretion: Metabolites excreted in urine and feces.

Half Life: Dienogest approximately 9-12 hours; estradiol valerate approx. 13-20 hours.

Contraindications

• History of thromboembolic disorders
• Estrogen-dependent neoplasms
• Severe hepatic disease or liver tumors
• Pregnancy

Precautions

• Use with caution in women with a history of migraines, hypertension, smoking, or diabetes with vascular complications.

Adverse Reactions - Common

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

Adverse Reactions - Serious

• Venous thromboembolism (Less common)
• Arterial thromboembolism (Rare)
• Hypertension (Less common)
• Liver tumors (Very rare)

Drug-Drug Interactions

• Enzyme inducers (e.g., rifampin, anticonvulsants) may decrease efficacy.
• Other hormonal contraceptives may additive effects.

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Patient/Family Teaching

• Take medication exactly as prescribed at the same time each day.
• Report signs of blood clots (leg pain, chest pain, sudden headache).
• Use additional contraception if pills are missed.
• Discuss potential side effects and when to seek medical advice.

Special Considerations

Black Box Warnings:

• Increased risk of cardiovascular events, especially in women over 35 who smoke.

Genetic Factors: Consider genetic predisposition to clotting disorders.

Lab Test Interference: May alter liver function tests, lipid profile, and glucose tolerance tests.

Overdose Management

Signs/Symptoms: Nausea, vomiting, withdrawal bleeding, or no symptoms.

Treatment: Supportive care; there is no specific antidote. Remove missed pills and provide symptomatic treatment.

Storage and Handling

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

Stability: Stable until the expiration date printed on the packaging.