Rosen Star0.02mg/3mg/0.451mg

• Contraception: Used as a combined oral contraceptive pill for prevention of pregnancy.
• PMDD: Used for treatment of symptoms of premenstrual dysphoric disorder.
• Acne: Used for treatment of moderate acne in women at least 14 years of age.
• Folate Supplementation: Used to raise folate levels in women using oral contraception (to reduce risk of neural tube defects).

Adult Dose:

• 1 tablet daily by mouth at the same time every day.
• 24 active orange tablets, then 4 light orange non-hormonal tablets.
• Start on the first day of menstruation (Day 1 Start) or first Sunday after onset (Sunday Start).

Common Side Effects (>=2%):

• Headache/migraine (5.9%)
• Menstrual irregularities (4.1%)
• Nausea/vomiting (3.5%)
• Breast pain/tenderness (3.2%)
• Fatigue (4.2%)
• Irritability (2.8%)
• Decreased libido (2.8%)
• Weight gain (2.5%)

In PMDD trials: Menstrual irregularities (24.9%), nausea (15.8%), headache (13.0%), breast tenderness (10.5%).

Precautions:

• Vascular risks: Stop if thrombotic event occurs; stop 4 weeks before major surgery and start 2 weeks after.
• DRSP-containing COCs may be associated with higher risk of VTE.
• Hyperkalemia: DRSP has antimineralocorticoid activity; do not use in patients predisposed to hyperkalemia.
• Liver disease: Discontinue if jaundice occurs.
• High blood pressure: Do not prescribe for women with uncontrolled hypertension.
• Lactation: When possible, advise nursing mother to use other forms of contraception until weaned.