Droslyn
Generic Name
Drospirenone
Manufacturer
Beximco Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| droslyn 4 mg tablet | ৳ 400.00 | N/A |
Description
Overview of the medicine
Droslyn 4 mg Tablet contains Drospirenone, a synthetic progestin. It is used for contraception, treatment of moderate to severe premenstrual dysphoric disorder (PMDD), and moderate acne in women who desire oral contraception. It also possesses anti-mineralocorticoid and anti-androgenic properties.
Uses & Indications
Dosage
Adults
One 4 mg tablet orally once daily, continuously.
Elderly
Not indicated for postmenopausal women for contraception. For other indications, dose adjustment may be required based on renal/hepatic function.
Renal_impairment
Contraindicated in severe renal insufficiency. Mild to moderate renal impairment requires caution and monitoring of serum potassium levels.
How to Take
Take one tablet orally at the same time each day, with or without food. Do not skip tablets, and start a new pack immediately after finishing the last one, without a break.
Mechanism of Action
Drospirenone suppresses ovulation by inhibiting gonadotropin secretion, causes changes in the cervical mucus, and thins the endometrium. Its anti-mineralocorticoid activity counteracts estrogen-induced fluid retention, and its anti-androgenic effects contribute to reducing acne and hirsutism.
Pharmacokinetics
Onset
Contraceptive effects typically within 7 days of consistent use. Therapeutic effects for PMDD or acne may take several cycles.
Excretion
Excreted primarily in urine and feces as metabolites.
Half life
Terminal elimination half-life is approximately 30-34 hours.
Absorption
Rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations are reached within 1-2 hours.
Metabolism
Extensively metabolized in the liver, primarily via hydroxylation and sulfation, with involvement of the cytochrome P450 3A4 (CYP3A4) enzyme system.
Side Effects
Contraindications
- Hypersensitivity to drospirenone or any component of the tablet
- Renal insufficiency (severe)
- Adrenal insufficiency
- Hepatic insufficiency or active liver disease
- Undiagnosed abnormal genital bleeding
- Known or suspected hormone-sensitive malignancies
- Current or history of arterial or venous thrombotic/thromboembolic events (e.g., DVT, pulmonary embolism, stroke, MI)
Drug Interactions
Certain antiepileptic drugs (e.g., topiramate, lamotrigine)
Potential for reduced efficacy of hormonal contraception.
CYP3A4 Inducers (e.g., rifampicin, phenytoin, carbamazepine)
May decrease drospirenone plasma concentrations, potentially reducing contraceptive efficacy.
CYP3A4 Inhibitors (e.g., ketoconazole, itraconazole, clarithromycin)
May increase drospirenone plasma concentrations, potentially increasing the risk of hyperkalemia.
Potassium-sparing diuretics, ACE inhibitors, Angiotensin II receptor blockers, NSAIDs, Heparin
May increase serum potassium levels due to drospirenone's anti-mineralocorticoid activity. Monitor serum potassium during the first cycle.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
No serious adverse effects have been reported from overdose of drospirenone. Symptoms may include nausea, vomiting, and vaginal bleeding in females. There is no specific antidote; treatment should be symptomatic and supportive.
Pregnancy & Lactation
Droslyn is contraindicated during pregnancy. If pregnancy occurs while taking Droslyn, discontinue use immediately. Small amounts of drospirenone may pass into breast milk; consider the risks and benefits before use during lactation.
Side Effects
Contraindications
- Hypersensitivity to drospirenone or any component of the tablet
- Renal insufficiency (severe)
- Adrenal insufficiency
- Hepatic insufficiency or active liver disease
- Undiagnosed abnormal genital bleeding
- Known or suspected hormone-sensitive malignancies
- Current or history of arterial or venous thrombotic/thromboembolic events (e.g., DVT, pulmonary embolism, stroke, MI)
Drug Interactions
Certain antiepileptic drugs (e.g., topiramate, lamotrigine)
Potential for reduced efficacy of hormonal contraception.
CYP3A4 Inducers (e.g., rifampicin, phenytoin, carbamazepine)
May decrease drospirenone plasma concentrations, potentially reducing contraceptive efficacy.
CYP3A4 Inhibitors (e.g., ketoconazole, itraconazole, clarithromycin)
May increase drospirenone plasma concentrations, potentially increasing the risk of hyperkalemia.
Potassium-sparing diuretics, ACE inhibitors, Angiotensin II receptor blockers, NSAIDs, Heparin
May increase serum potassium levels due to drospirenone's anti-mineralocorticoid activity. Monitor serum potassium during the first cycle.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
No serious adverse effects have been reported from overdose of drospirenone. Symptoms may include nausea, vomiting, and vaginal bleeding in females. There is no specific antidote; treatment should be symptomatic and supportive.
Pregnancy & Lactation
Droslyn is contraindicated during pregnancy. If pregnancy occurs while taking Droslyn, discontinue use immediately. Small amounts of drospirenone may pass into breast milk; consider the risks and benefits before use during lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years (refer to product packaging for exact date)
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Generic available
Clinical Trials
Drospirenone has been extensively studied in clinical trials for its efficacy in contraception, PMDD, and acne. Studies confirm its progestational, anti-mineralocorticoid, and anti-androgenic effects.
Lab Monitoring
- Serum potassium levels (especially in patients at risk of hyperkalemia or on concomitant potassium-increasing drugs)
- Renal function tests (e.g., serum creatinine, eGFR)
Doctor Notes
- Prior to prescribing Droslyn, thoroughly assess patient's medical history for risk factors of thromboembolism, hyperkalemia, and liver/renal impairment.
- Counsel patients on proper administration, missed dose management, and potential side effects, particularly signs of VTE.
- Monitor serum potassium in patients at risk or on concomitant medications that can increase potassium levels, especially during the first cycle.
Patient Guidelines
- Take Droslyn at the same time every day to maximize effectiveness.
- Do not skip tablets. If you miss a dose, follow the instructions carefully and consider using a backup birth control method.
- Inform your doctor about all medications, supplements, and herbal products you are taking.
- Report any unusual or severe side effects, especially signs of blood clots (e.g., severe leg pain, chest pain, shortness of breath, sudden vision changes).
- This medication does not protect against HIV/AIDS or other sexually transmitted infections.
Missed Dose Advice
If you miss a dose by less than 12 hours, take it as soon as you remember and continue with your next dose at the usual time. If you miss a dose by more than 12 hours, take the most recent missed tablet as soon as you remember, discard any other missed tablets, and continue with your next dose at the usual time. Use a backup birth control method (e.g., condoms) for the next 7 days, especially if you had unprotected sex in the past 5 days.
Driving Precautions
Droslyn generally does not affect the ability to drive or operate machinery. However, if you experience side effects like dizziness or vision changes, avoid these activities.
Lifestyle Advice
- Smoking significantly increases the risk of serious cardiovascular side effects (e.g., blood clots) with hormonal contraceptives; it is strongly advised to quit smoking.
- Maintain a healthy diet and regular exercise regimen.
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