Home Drug Guide Prasterone

Drug Guide

Generic Name

Prasterone

Brand Names Intrarosa

Classification

Therapeutic: Vaginal estrogen therapy, Hormone replacement therapy

Pharmacological: DHEA (Dehydroepiandrosterone)

FDA Approved Indications

Relief of discomfort associated with vulvar and vaginal atrophy due to menopause

Mechanism of Action

Prasterone is converted in the vaginal epithelium to androgens and estrogens, which help restore vaginal tissue vitality and elasticity, alleviating atrophic symptoms.

Dosage and Administration

Adult: Insert one 6.5 mg vaginal insert daily at bedtime for 14 days, then as needed for maintenance.

Pediatric: Not indicated.

Geriatric: Use as directed, with attention to menopausal status.

Renal Impairment: No specific adjustment needed.

Hepatic Impairment: Use with caution; no specific dosing guidelines established.

Pharmacokinetics

Absorption: Minimal systemic absorption; localized effect.

Distribution: Primarily local in vaginal tissues.

Metabolism: Converted locally to active androgens and estrogens.

Excretion: Primarily local; systemic metabolites excreted in urine.

Half Life: Data not specified; local effects predominate.

Contraindications

Hormone-sensitive cancers (e.g., breast, endometrial cancer)
Vaginal bleeding of unknown cause
Active vaginal infections

Precautions

History of hormone-related neoplasia
Liver dysfunction
Thromboembolic disorders

Adverse Reactions - Common

Vaginal discharge (Unknown)
Vaginal irritation or discomfort (Unknown)

Adverse Reactions - Serious

Endometrial hyperplasia or cancer (Rare)
Vaginal bleeding or spotting (Rare)

Drug-Drug Interactions

N/A

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Assess severity of vaginal atrophy symptoms and rule out vaginal infections or bleeding.

Diagnoses:

Risk for endometrial hyperplasia or carcinoma

Implementation: Administer vaginal insert as prescribed, educate patient on proper insertion technique.

Evaluation: Monitor symptom relief, signs of adverse effects, and vaginal bleeding.

Patient/Family Teaching

Use as directed and advise patient to report abnormal vaginal bleeding or symptoms of infection.
Discuss the importance of regular follow-up appointments.

Special Considerations

Black Box Warnings: N/A

Genetic Factors: None specified.

Lab Test Interference: No significant interference reported.

Overdose Management

Signs/Symptoms: No specific overdose symptoms identified; general hormone excess effects possible.

Treatment: Supportive care; notify healthcare provider.

Storage and Handling

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

Stability: Stable under recommended storage conditions.