Divastin
Generic Name
Rosuvastatin
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| divastin 20 mg tablet | ৳ 20.00 | ৳ 280.00 |
Description
Overview of the medicine
Divastin 20 mg tablet contains Rosuvastatin, a statin used to lower high cholesterol and triglycerides, thereby reducing the risk of heart disease and stroke.
Uses & Indications
Dosage
Adults
The usual starting dose is 5 mg or 10 mg once daily. For severe hypercholesterolemia and high cardiovascular risk, a starting dose of 20 mg once daily may be considered. The 20 mg dose is a common maintenance dose, adjusted according to lipid levels and treatment goal. Max dose is 40 mg.
Elderly
No specific dose adjustment is required. However, a starting dose of 5 mg is recommended for patients over 70 years of age.
Renal_impairment
For patients with mild to moderate renal impairment, no dose adjustment is necessary. For patients with severe renal impairment (creatinine clearance <30 mL/min), the initial dose should be 5 mg once daily and should not exceed 10 mg once daily.
How to Take
Divastin 20 mg tablet should be taken orally, once daily, with or without food. It is recommended to take the tablet at the same time each day for consistent effect.
Mechanism of Action
Rosuvastatin selectively inhibits HMG-CoA reductase, an enzyme that catalyzes an early rate-limiting step in cholesterol biosynthesis, primarily in the liver. This inhibition reduces hepatic cholesterol synthesis and increases the number of LDL receptors on the hepatocyte surface, enhancing LDL uptake and catabolism.
Pharmacokinetics
Onset
Lipid-lowering effects are evident within 1 week of therapy and usually maximal by 2-4 weeks. This effect is maintained during long-term therapy.
Excretion
Rosuvastatin and its metabolites are primarily excreted in feces (approximately 90%) with about 10% excreted in urine.
Half life
The elimination half-life of rosuvastatin is approximately 19 hours.
Absorption
Peak plasma concentrations are achieved approximately 3-5 hours after oral administration. Absolute bioavailability is approximately 20%.
Metabolism
Rosuvastatin undergoes limited metabolism (approximately 10%). The main metabolite is N-desmethyl rosuvastatin, which has approximately half the HMG-CoA reductase inhibitory activity of the parent compound. Metabolism is primarily mediated by CYP2C9, and to a lesser extent by CYP2A6. CYP3A4 is minimally involved.
Side Effects
Contraindications
- Hypersensitivity to rosuvastatin or any of the excipients
- Active liver disease, including unexplained persistent elevations of serum transaminases
- Pregnancy and lactation, and in women of childbearing potential not using appropriate contraceptive measures
- Severe renal impairment (creatinine clearance <30 mL/min) with 20 mg or 40 mg doses
- Concomitant use with cyclosporine
Drug Interactions
Cyclosporine
Concomitant use significantly increases rosuvastatin exposure; contraindicated.
Erythromycin
Decreased rosuvastatin exposure.
Gemfibrozil and other fibrates
Increased risk of myopathy and rhabdomyolysis due to increased rosuvastatin plasma concentrations. Use with caution, dose adjustment may be necessary.
Warfarin and other coumarin anticoagulants
May potentiate the anticoagulant effect, leading to increased INR. Regular monitoring of INR is recommended.
Antacids (aluminum and magnesium hydroxide)
Decreased rosuvastatin plasma concentrations when taken concomitantly. Administer rosuvastatin at least 2 hours after antacid.
Protease inhibitors (e.g., Atazanavir, Lopinavir/Ritonavir)
Significantly increased rosuvastatin exposure; dose adjustment and careful monitoring are required.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
There is no specific treatment for rosuvastatin overdose. In the event of an overdose, the patient should be treated symptomatically and supportive measures instituted as required. Liver function tests and CK levels should be monitored.
Pregnancy & Lactation
Divastin 20 mg is contraindicated during pregnancy and lactation. It may cause fetal harm and is excreted in breast milk. Women of childbearing potential should use effective contraception.
Side Effects
Contraindications
- Hypersensitivity to rosuvastatin or any of the excipients
- Active liver disease, including unexplained persistent elevations of serum transaminases
- Pregnancy and lactation, and in women of childbearing potential not using appropriate contraceptive measures
- Severe renal impairment (creatinine clearance <30 mL/min) with 20 mg or 40 mg doses
- Concomitant use with cyclosporine
Drug Interactions
Cyclosporine
Concomitant use significantly increases rosuvastatin exposure; contraindicated.
Erythromycin
Decreased rosuvastatin exposure.
Gemfibrozil and other fibrates
Increased risk of myopathy and rhabdomyolysis due to increased rosuvastatin plasma concentrations. Use with caution, dose adjustment may be necessary.
Warfarin and other coumarin anticoagulants
May potentiate the anticoagulant effect, leading to increased INR. Regular monitoring of INR is recommended.
Antacids (aluminum and magnesium hydroxide)
Decreased rosuvastatin plasma concentrations when taken concomitantly. Administer rosuvastatin at least 2 hours after antacid.
Protease inhibitors (e.g., Atazanavir, Lopinavir/Ritonavir)
Significantly increased rosuvastatin exposure; dose adjustment and careful monitoring are required.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
There is no specific treatment for rosuvastatin overdose. In the event of an overdose, the patient should be treated symptomatically and supportive measures instituted as required. Liver function tests and CK levels should be monitored.
Pregnancy & Lactation
Divastin 20 mg is contraindicated during pregnancy and lactation. It may cause fetal harm and is excreted in breast milk. Women of childbearing potential should use effective contraception.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2 to 3 years from the date of manufacture, specific details on packaging.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by major regulatory bodies
Patent Status
Off-patent (for generic Rosuvastatin)
WHO Essential Medicine
YesClinical Trials
Rosuvastatin has been extensively studied in numerous large-scale clinical trials (e.g., JUPITER trial, ASTEROID trial) demonstrating its efficacy in reducing LDL-C and cardiovascular events.
Lab Monitoring
- Liver function tests (LFTs) should be performed before the initiation of treatment and periodically thereafter.
- Lipid panel should be monitored regularly to assess the efficacy of treatment and adjust dosage if necessary.
- Creatine kinase (CK) levels should be measured if muscle symptoms (pain, tenderness, or weakness) occur.
Doctor Notes
- Emphasize the importance of lifestyle modifications (diet, exercise) as foundational to lipid management.
- Monitor liver function tests (LFTs) at baseline and periodically as clinically indicated. Monitor creatine kinase (CK) if muscle symptoms develop.
- Advise patients to report any muscle pain, tenderness, or weakness promptly to rule out myopathy/rhabdomyolysis.
- Consider genetic testing for SLCO1B1 variants in selected patients, especially those who develop muscle symptoms at standard doses.
Patient Guidelines
- Take Divastin 20 mg tablet exactly as prescribed by your doctor.
- Continue with your prescribed diet and exercise regimen while taking this medication.
- Report any unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or malaise, to your doctor immediately.
- Do not stop taking this medicine without consulting your doctor, even if you feel well.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to make up for a missed one.
Driving Precautions
Divastin 20 mg tablet is generally not expected to impair the ability to drive or operate machinery. However, some patients may experience dizziness as a side effect, in which case caution should be exercised.
Lifestyle Advice
- Adopt a heart-healthy diet low in saturated and trans fats and cholesterol.
- Engage in regular physical activity, at least 30 minutes most days of the week.
- Maintain a healthy weight.
- Avoid excessive alcohol consumption and quit smoking.
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