Drospirenone + Ethinyl Estradiol + Levomefolate

Drospirenone + Ethinyl Estradiol + Levomefolate is a combined oral contraceptive containing drospirenone (progestin with antimineralocorticoid activity), ethinyl estradiol (synthetic estrogen), and levomefolate (active form of folic acid). It is indicated for oral contraception, PMDD, moderate acne in women ≥14 years, and folate supplementation to reduce neural tube defect risk. The pack contains 24 pink active tablets (DRSP/EE/levomefolate) and 4 light orange tablets (levomefolate only). Take one tablet daily at the same time. Contraindicated in renal impairment, adrenal insufficiency, thrombosis risk, liver disease, and pregnancy.

• Oral contraception
• Premenstrual Dysphoric Disorder (PMDD)
• Moderate acne vulgaris (women ≥14 years)
• Folate supplementation (to reduce neural tube defect risk)

Drospirenone is a progestin with antimineralocorticoid activity. Ethinyl estradiol is a synthetic estrogen. Levomefolate is the active form of folic acid that raises folate levels. This combination prevents ovulation and alters cervical mucus to prevent pregnancy.

Drospirenone + Ethinyl Estradiol prevents ovulation and alters cervical mucus to prevent pregnancy. Levomefolate raises folate levels to reduce neural tube defect risk.

Adult Dose: One tablet orally daily. The pack contains 24 pink active tablets (DRSP/EE/levomefolate) and 4 light orange tablets (levomefolate only). Take 24 days of active tablets, then 4 days of light orange tablets. Take at the same time every day.

Oral tablet. Take in the dose and duration as advised. One tablet daily at the same time. Can be taken with or without food, but preferably after evening meal or at bedtime with liquid.

If 1 pink active tablet missed: Take as soon as remembered and next tablet at scheduled time (even if 2 tablets in one day).

If 2+ pink tablets missed in Week 1 or 2: Take one missed tablet and current tablet (2 tablets in one day), discard other missed tablets. Use backup contraception for 7 days.

If 2 pink tablets missed in Week 3: Take one missed tablet and current tablet, discard other missed tablets. Finish active tablets and start new pack next day. Use backup contraception for 7 days.

If 1+ light orange tablets missed: Skip missed days and continue one tablet daily.

Common Side Effects (≥2%):

• Headache/migraine (5.9%)
• Menstrual irregularities (4.1%)
• Nausea/vomiting (3.5%)
• Breast pain/tenderness (3.2%)

PMDD Clinical Trials (≥2%):

• Menstrual irregularities (24.9%)
• Nausea (15.8%)
• Headache (13.0%)
• Breast tenderness (10.5%)
• Fatigue (4.2%)
• Irritability (2.8%)
• Decreased libido (2.8%)
• Weight increased (2.5%)
• Affect lability (2.1%)

• Vascular risks: Discontinue if thrombotic event occurs. Stop 4 weeks before major surgery and through 2 weeks after. Start no earlier than 4 weeks after delivery.
• 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 uncontrolled hypertension or hypertension with vascular disease.
• Carbohydrate and lipid effects: Monitor prediabetic and diabetic women.
• Headache: Evaluate significant changes and discontinue if indicated.
• Uterine bleeding: Evaluate irregular bleeding or amenorrhea.

• Renal impairment
• Adrenal insufficiency
• High risk of arterial or venous thrombotic diseases
• Undiagnosed abnormal uterine bleeding
• Breast cancer or other estrogen- or progestin-sensitive cancer
• Liver tumors or liver disease
• Pregnancy

CYP3A4 inhibitors (e.g., ketoconazole, itraconazole) may increase systemic exposure of drospirenone. CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampicin) may decrease contraceptive efficacy.

Caution is advised when consuming alcohol with Drospirenone + Ethinyl Estradiol + Levomefolate. Please consult your doctor.

Do not use during pregnancy. Discontinue if pregnancy occurs.

Not recommended for nursing mothers; can decrease milk production.

Use before menarche is not indicated. Safety and efficacy established in females of reproductive potential.

Not studied in postmenopausal females and not indicated in this population.

Renal impairment: Contraindicated in renal impairment.

Hepatic impairment: Discontinue if jaundice occurs; contraindicated in liver tumors or liver disease.

Overdose may cause nausea, vomiting, and severe headaches. Thromboembolic complications and vaginal bleeding reported rarely. Monitor serum potassium and sodium, and for metabolic acidosis.

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

Drospirenone + Ethinyl Estradiol + Levomefolate