Generic
Drospirenone
4 brands available in the market
At a glance
Drospirenone is a progestin used as an oral contraceptive in females. It prevents pregnancy primarily by suppressing ovulation. Drospirenone is a spironolactone analogue with anti-mineralocorticoid activity.
Description
Drospirenone is a synthetic progestin indicated for use by females of reproductive potential to prevent pregnancy. It is a spironolactone analogue with anti-mineralocorticoid activity. The recommended dosage is one tablet daily for 28 consecutive days: one white active tablet daily for 24 days followed by one light pink inert tablet daily for 4 days. Drospirenone has potential for hyperkalemia in high-risk females. Contraindicated in renal impairment, hepatic impairment, and adrenal insufficiency.
Indications
- Oral contraception
Therapeutic class
Oral Contraceptive preparations
Pharmacological class
Progestin (Spironolactone analogue)
Pharmacology
Drospirenone is a progestin used to prevent pregnancy primarily by suppressing ovulation. It is a spironolactone analogue with anti-mineralocorticoid activity. Drospirenone is 95-97% bound to serum albumin and is extensively metabolized. The terminal half-life is approximately 30 hours.
Mechanism of action
Drospirenone is a progestin that prevents pregnancy primarily by suppressing ovulation. It is a spironolactone analogue with anti-mineralocorticoid activity.
Dosage
Adult Dose (Oral Contraception):
One tablet daily for 28 consecutive days: one white active tablet daily for the first 24 days and one light pink inert tablet daily for the following 4 days. Take at the same time every day.
Starting (Day 1 Start): Take the first white active tablet on the first day of menses, continue for 24 days, then take one light pink inert tablet daily for 4 days, and begin the next pack.
Administration
Oral tablet. Swallow whole, once daily, at the same time every day. Can be taken irrespective of food.
Missed dose
If you miss a dose of Drospirenone, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular schedule.
Side effects
Common Side Effects:
- Acne
- Metrorrhagia
- Headache
- Breast pain
- Weight increased
- Dysmenorrhea
- Nausea
- Vaginal hemorrhage
- Libido decreased
- Breast tenderness
- Menstruation irregularity
Precautions & warnings
- Hyperkalemia: Drospirenone has anti-mineralocorticoid activity with potential for hyperkalemia in high-risk females. Contraindicated in renal impairment, hepatic impairment, and adrenal insufficiency.
- Thromboembolic Disorders: No association between progestin-only preparations and increased risk of thromboembolism.
- Bone Loss: Drospirenone leads to decreased estradiol levels; clinically relevant bone loss unknown.
- Liver Disease: Discontinue if jaundice or liver dysfunction develops.
- Ectopic Pregnancy: Be alert to possibility in females who become pregnant or complain of lower abdominal pain.
- Hyperglycemia in Diabetes: Patients with diabetes may require additional monitoring.
- Bleeding Irregularities: Unscheduled bleeding may occur especially during first 3 months.
Contraindications
- Renal impairment
- Adrenal insufficiency
- Presence or history of progestin-sensitive cancers
- Liver tumors (benign or malignant) or hepatic impairment
- Undiagnosed abnormal uterine bleeding
Drug interactions
CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, HIV/HCV protease inhibitors) may increase systemic exposure of drospirenone. Potential to increase serum potassium with ACE inhibitors, angiotensin-II receptor antagonists, potassium-sparing diuretics, potassium supplementation, heparin, aldosterone antagonists, and NSAIDs.
Food interactions
It is not known whether it is safe to consume alcohol with Drospirenone. Please consult your doctor.
Use in pregnancy
Limited data on use during pregnancy. Discontinue if pregnancy occurs, as there is no reason to use hormonal contraceptives during pregnancy.
Pregnancy Category: X — always consult a doctor before taking during pregnancy.
Use in lactation
Negligible amounts of Drospirenone are excreted in breast milk. At therapeutic doses, no effects on breastfed newborns/infants are anticipated.
Pediatric use
Safety and efficacy in children not established.
Geriatric use
Limited information available regarding dose adjustment for elderly patients.
Renal / hepatic impairment
Renal impairment: Contraindicated in renal impairment.
Hepatic impairment: Contraindicated in hepatic impairment.
Overdose effects
Overdose may cause nausea, vomiting, and vaginal bleeding. No antidotes; provide symptomatic support. Monitor serum potassium and sodium, and for evidence of metabolic acidosis.
Storage conditions
Store below 30°C in a dry place, away from light. Keep out of reach of children.
Chemical structure
Drospirenone