Starbac
Generic Name
Rosuvastatin
Manufacturer
ACI Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| starbac 5 mg tablet | ৳ 4.50 | N/A |
Description
Overview of the medicine
Starbac 5 mg Tablet contains Rosuvastatin, a statin medication used to lower high cholesterol and triglycerides. It works by reducing the production of cholesterol in the liver. It's prescribed to reduce the risk of heart attack, stroke, and other cardiovascular problems in patients with risk factors.
Uses & Indications
Dosage
Adults
Initial dose is usually 5 mg once daily, adjusted based on LDL-C response. Maximum dose 40 mg daily.
Elderly
Starting dose 5 mg once daily; no dose adjustment needed for patients >65 years, but careful monitoring advised.
Renal_impairment
For mild to moderate renal impairment, no dose adjustment is necessary. For severe renal impairment (CrCl <30 mL/min), initial dose is 5 mg once daily, not to exceed 10 mg once daily.
How to Take
Take orally once daily, with or without food, at any time of day, but it's often recommended to take it at the same time each day.
Mechanism of Action
Rosuvastatin selectively and competitively inhibits HMG-CoA reductase, an enzyme that catalyzes the rate-limiting step in cholesterol biosynthesis. This inhibition reduces hepatic cholesterol synthesis, leading to an upregulation of LDL receptors on hepatocyte surfaces, which increases the uptake and catabolism of LDL. It also reduces VLDL and triglyceride levels.
Pharmacokinetics
Onset
Lipid-lowering effect begins within 1 week; maximum effect usually by 2-4 weeks.
Excretion
Approximately 90% is excreted unchanged in feces, primarily via biliary excretion. Approximately 5% is excreted in urine.
Half life
Approximately 19 hours.
Absorption
Absolute bioavailability is approximately 20%. Peak plasma concentrations are achieved approximately 3-5 hours after oral administration.
Metabolism
Limited hepatic metabolism (approximately 10%), primarily by CYP2C9. N-desmethyl rosuvastatin is the main metabolite.
Side Effects
Contraindications
- Hypersensitivity to rosuvastatin or any component of the formulation.
- Active liver disease, including unexplained persistent elevations of serum transaminases.
- Pregnancy and lactation.
- Severe renal impairment (CrCl <30 mL/min) for doses >10 mg.
Drug Interactions
Gemfibrozil
Coadministration increases rosuvastatin exposure; avoid coadministration if possible, or limit rosuvastatin to 10 mg once daily.
Cyclosporine
Coadministration significantly increases rosuvastatin exposure; avoid coadministration or limit rosuvastatin to 5 mg once daily with careful monitoring.
Erythromycin
May decrease rosuvastatin exposure.
Coumarin anticoagulants (e.g., Warfarin)
May increase INR; monitor INR closely upon initiation, dose adjustment, or discontinuation of rosuvastatin.
Protease inhibitors (e.g., Atazanavir/Ritonavir)
Increased rosuvastatin exposure; refer to specific dosing recommendations for concomitant use.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
No specific antidote. In case of overdose, supportive and symptomatic measures should be undertaken. Hemodialysis is not expected to be beneficial due to high protein binding.
Pregnancy & Lactation
Category X in pregnancy (contraindicated) due to risk of fetal harm. Contraindicated during breastfeeding as it is excreted in milk and may cause adverse effects in infants.
Side Effects
Contraindications
- Hypersensitivity to rosuvastatin or any component of the formulation.
- Active liver disease, including unexplained persistent elevations of serum transaminases.
- Pregnancy and lactation.
- Severe renal impairment (CrCl <30 mL/min) for doses >10 mg.
Drug Interactions
Gemfibrozil
Coadministration increases rosuvastatin exposure; avoid coadministration if possible, or limit rosuvastatin to 10 mg once daily.
Cyclosporine
Coadministration significantly increases rosuvastatin exposure; avoid coadministration or limit rosuvastatin to 5 mg once daily with careful monitoring.
Erythromycin
May decrease rosuvastatin exposure.
Coumarin anticoagulants (e.g., Warfarin)
May increase INR; monitor INR closely upon initiation, dose adjustment, or discontinuation of rosuvastatin.
Protease inhibitors (e.g., Atazanavir/Ritonavir)
Increased rosuvastatin exposure; refer to specific dosing recommendations for concomitant use.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
No specific antidote. In case of overdose, supportive and symptomatic measures should be undertaken. Hemodialysis is not expected to be beneficial due to high protein binding.
Pregnancy & Lactation
Category X in pregnancy (contraindicated) due to risk of fetal harm. Contraindicated during breastfeeding as it is excreted in milk and may cause adverse effects in infants.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from manufacturing date, check specific packaging.
Availability
Pharmacies, hospitals, clinics
Approval Status
Approved by major regulatory bodies (e.g., FDA, EMA, DGDA)
Patent Status
Generics available (patent expired for original compound)
WHO Essential Medicine
YesClinical Trials
Extensively studied in clinical trials like JUPITER (Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin) which demonstrated significant reduction in cardiovascular events in high-risk individuals.
Lab Monitoring
- Lipid panel (LDL-C, HDL-C, Total Cholesterol, Triglycerides) should be monitored at baseline and periodically.
- Liver function tests (ALT, AST) should be performed at baseline and periodically or if symptoms of liver injury develop.
- Creatine Kinase (CK) should be measured at baseline and in patients presenting with myalgia.
Doctor Notes
- Emphasize the importance of lifestyle modifications (diet, exercise) alongside medication.
- Counsel patients on muscle pain symptoms and when to report them.
- Routine monitoring of liver function and lipid profile is crucial.
Patient Guidelines
- Take exactly as prescribed by your doctor, usually once daily.
- Do not stop taking the medication without consulting your doctor, even if you feel well.
- Maintain a healthy diet low in saturated and trans fats, and engage in regular exercise.
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 continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Rosuvastatin is not expected to affect the ability to drive or operate machinery. However, patients should be aware of possible side effects like dizziness.
Lifestyle Advice
- Adopt a heart-healthy diet rich in fruits, vegetables, and whole grains.
- Increase physical activity and maintain a healthy weight.
- Avoid smoking and limit alcohol consumption.
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