Drospirenone + Estetrol Monohydrate

Drospirenone + Estetrol Monohydrate is a combined oral contraceptive containing drospirenone (a spironolactone analogue with antimineralocorticoid activity) and estetrol monohydrate (a natural estrogen with minimal hepatic effects). It prevents pregnancy by inhibiting ovulation. The pack contains 24 pink active tablets (3 mg drospirenone/14.2 mg estetrol) and 4 white inactive tablets. Take one tablet daily at the same time: 24 days of active tablets followed by 4 days of inactive tablets. Contraindicated in thrombosis risk, hormone-sensitive malignancies, liver disease, renal impairment, and adrenal insufficiency.

• Oral contraception

Drospirenone + Estetrol Monohydrate is an oral contraceptive containing synthetic progestin (drospirenone) and synthetic estrogen (estetrol) that prevents pregnancy by inhibiting ovulation.

Drospirenone + Estetrol Monohydrate prevents ovulation and alters cervical mucus to prevent pregnancy.

Adult Dose: One tablet daily for 28 days: one pink active tablet (3 mg drospirenone/14.2 mg estetrol) daily for the first 24 days and one white inactive tablet daily for the following 4 days. Take at the same time every day.

Oral tablet. One tablet daily for 28 days. Take 24 days of pink active tablets followed by 4 days of white inactive tablets. Take at the same time every day.

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

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 non-hormonal 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+ white inactive tablets missed: Skip missed days and continue one tablet daily.

Common Side Effects (≥2%):

• Bleeding irregularities
• Mood disturbance
• Headache
• Breast symptoms (pain, tenderness)
• Dysmenorrhea
• Acne
• Weight increased
• Libido decreased

• Thromboembolic Disorders: Discontinue if thrombotic or thromboembolic event occurs. Start no earlier than 4 weeks after delivery.
• Hyperkalemia: DRSP has antimineralocorticoid activity. Check serum potassium during first cycle in women on medications that may increase potassium.
• Hypertension: Monitor blood pressure and stop if significant increase.
• Migraine: Discontinue if new, recurrent, persistent or severe migraines occur.
• Liver Disease: Withhold or permanently discontinue for persistent or significant elevation of liver enzymes.
• Glucose Tolerance and Hypertriglyceridemia: Monitor glucose in prediabetic or diabetic women.

• High risk of arterial or venous thrombotic diseases
• Current or history of hormone-sensitive malignancy (e.g., breast cancer)
• Hepatic adenoma, hepatocellular carcinoma, acute hepatitis or decompensated cirrhosis
• Co-administration with hepatitis C drugs containing ombitasvir/paritaprevir/ritonavir
• Undiagnosed abnormal uterine bleeding
• Renal impairment
• Adrenal insufficiency

CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampicin) may decrease contraceptive efficacy and increase breakthrough bleeding. Potential to increase serum potassium with ACE inhibitors, angiotensin-II receptor antagonists, potassium-sparing diuretics.

Caution is advised when consuming alcohol with Drospirenone + Estetrol Monohydrate. Please consult your doctor.

Discontinue if pregnancy occurs, as there is no reason to use hormonal contraceptives during pregnancy.

Contraceptive hormones and/or metabolites are present in human milk. COCs can reduce milk production. When possible, advise using other contraception until breastfeeding is discontinued.

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: Contraindicated in hepatic adenoma, hepatocellular carcinoma, acute hepatitis or decompensated cirrhosis.

Overdose may cause nausea, vomiting, and severe headaches. Thromboembolic complications and vaginal bleeding reported rarely. Consider short-term prophylactic anticoagulation for high VTE risk. Monitor serum potassium, sodium, and for metabolic acidosis.

Store at 20°C-25°C in a frost-free place, away from light. Excursions permitted to 15°C-30°C. Keep out of reach of children.

Drospirenone + Estetrol Monohydrate