Drospirenone + Ethinylestradiol

Drospirenone + Ethinylestradiol is a combined oral contraceptive containing synthetic progestin (drospirenone) and synthetic estrogen (ethinylestradiol). It prevents pregnancy by inhibiting ovulation, thickening cervical mucus, and making the endometrium unsuitable for implantation. Drospirenone has antimineralocorticoid and antiandrogenic activity. Available as 21-day pack (3 mg/0.03 mg EE) or 24-day pack (3 mg/0.02 mg EE). Take one tablet daily at the same time, then have a tablet-free break. Contraindicated in pregnancy, thrombosis, severe hepatic/renal disease, and hormone-sensitive malignancies.

• Contraception

Drospirenone + Ethinylestradiol is a combined oral contraceptive containing synthetic progestin (drospirenone) and synthetic estrogen (ethinylestradiol). Drospirenone has antimineralocorticoid and antiandrogenic activity. Its contraceptive effect is based on inhibition of ovulation and changes in cervical secretion.

Drospirenone + Ethinylestradiol prevents ovulation and alters cervical mucus to block sperm penetration, and makes the endometrium unsuitable for implantation.

Adult Dose (Contraception): 1 active tablet (3 mg drospirenone/0.03 mg EE) PO daily for 21 days, THEN 1 inert tablet PO daily for 7 days. OR 1 active tablet (3 mg drospirenone/0.02 mg EE) PO daily for 24 days, THEN 1 inert tablet PO daily for 4 days.

PMDD: 1 active tablet (3 mg drospirenone/0.02 mg EE) PO daily for 24 days, THEN 1 inert tablet PO daily for 4 days.

Child Dose (14 years): Same as adult dosing.

Renal Dose: CrCl <50 mL/min: Avoid use.

Hepatic Dose: Avoid use.

Oral tablet. Take in the dose and duration as advised. Swallow whole. Do not chew, crush or break. Take at the same time every day. Take with water if necessary.

If less than 12 hours late: Take as soon as remembered and next tablets at usual time. If more than 12 hours late: Contraceptive efficacy may be reduced.

1 tablet missed in Week 1: Take missed tablet as soon as remembered (even if 2 tablets at once), use extra contraception for next 7 days.

1 tablet missed in Week 2: Take missed tablet as soon as remembered, no extra precautions needed.

1 tablet missed in Week 3: Take missed tablet as soon as remembered and start next pack immediately, or have tablet-free break of 7 days.

Common Side Effects:

• Nausea
• Abdominal pain
• Vomiting
• Diarrhea
• Weight increased
• Fluid retention
• Headache
• Migraine
• Depressed mood
• Breast pain and tenderness
• Libido decreased
• Breast hypertrophy
• Rash, urticaria
• Venous and arterial thromboembolic disorders (rare)

• Thromboembolic Disorders: Increased risk of MI, DVT, PE and CVA.
• Hyperkalemia: Risk with ACE inhibitors, angiotensin II receptor antagonists, potassium-sparing diuretics.
• Liver Disease: Discontinue if jaundice or liver dysfunction develops.
• Blood Pressure: Monitor regularly.
• Diabetes: Do not use if vascular involvement.

• Pregnancy
• Undiagnosed abnormal genital bleeding
• Renal insufficiency
• Hepatic dysfunction or tumor
• Adrenal insufficiency
• Cholestatic jaundice of pregnancy
• Jaundice with prior COC use
• Major surgery with prolonged immobilisation
• Heavy smoking (>15 cigarettes/day) in patients >35 y
• Thrombophlebitis or VTE history
• Arterial thromboembolic disease (within 1 year)
• Cerebrovascular disease, CAD
• Severe hypertension
• Valvular heart disease with thrombogenic complications
• Diabetes with vascular involvement
• Headache with focal neurological symptoms
• Breast carcinoma or estrogen-dependent neoplasms

Increased risk of hyperkalemia with ACE inhibitors, angiotensin II receptor antagonists, aldosterone antagonists, potassium salts or NSAIDs. Aminoglutethimide may increase hepatic metabolism of progestins. Efficacy may be reduced by acitretin, carbamazepine, felbamate, oxcarbazepine, phenobarbital, phenytoin, topiramate, barbiturates, griseofulvin, modafinil. May reduce efficacy of protease inhibitors and lamotrigine.

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

Highly unsafe during pregnancy. Studies have shown significant harmful effects to the developing baby.

Probably unsafe during breastfeeding. Limited human data suggests drug may pass into breastmilk and harm the baby. Nonhormonal and progestin-only contraceptives preferred.

Safety and efficacy in children not established.

No dose adjustment needed for elderly patients.

Renal impairment: CrCl <50 mL/min: Avoid use; severe renal disease: Contraindicated.

Hepatic impairment: Severe hepatic disease: Contraindicated.

Overdose may cause nausea, vomiting or vaginal bleeding. No serious harmful effects reported.

Store below 30°C. Keep out of reach of children.

Drospirenone + Ethinylestradiol