Rozy Ds

• Contraception
• Postmenopausal climacteric syndrome (hot flushes, sweating, sleep disorders, depressed mood, nervousness)
• Atrophic urogenital conditions
• Prevention of postmenopausal osteoporosis

17β-estradiol is chemically and biologically identical to endogenous human E2. Drospirenone is a synthetic progestin with antimineralocorticoid and antiandrogenic activity. Drospirenone opposes estrogen-induced endometrial hyperplasia.

Adult Dose (Hormone Replacement Therapy): One tablet orally daily.

Hepatic Dose: Well tolerated in mild/moderate hepatic impairment; contraindicated in severe liver disease.

Renal Dose: Slight increase in DRSP exposure in mild/moderate renal impairment but not clinically relevant; contraindicated in severe renal disease.

Common Side Effects:

• Nausea
• Stomach pain
• Headache
• Weight gain
• Breast pain
• Irregular uterine bleeding

Highly unsafe during pregnancy. Studies on pregnant women and animals have shown significant harmful effects to the developing baby.

• Consider all risk factors before initiating HRT.
• Venous thromboembolism: Risk increases with personal history, family history, severe obesity and age. Temporarily discontinue with prolonged immobilization, major surgery or trauma.
• Discontinue if migraine, cholestatic jaundice or symptoms of thrombotic event occur.
• Do not use in undiagnosed abnormal genital bleeding, breast cancer, liver tumors or severe liver disease.

Acute toxicity studies indicate no acute toxicity risk even with multiple therapeutic doses. Clinical studies up to 100 mg DRSP and 4 mg E2 were well tolerated.

Store below 30°C, away from light & moisture. Keep out of reach of children.