Starbac
Generic Name
Atorvastatin 10 mg
Manufacturer
Medico Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| starbac 10 mg tablet | ৳ 8.00 | N/A |
Description
Overview of the medicine
Starbac 10 mg tablet contains Atorvastatin, a medication used to lower high cholesterol levels and triglycerides in the blood. It helps reduce the risk of heart attack, stroke, and other heart-related conditions.
Uses & Indications
Dosage
Adults
The usual starting dose is 10 mg once daily. The dose may be adjusted at 2- to 4-week intervals to a maximum of 80 mg once daily, depending on the patient's response and tolerability.
Elderly
No dose adjustment is generally required in elderly patients. However, caution should be exercised due to potentially increased systemic exposure.
Renal_impairment
No dose adjustment is necessary for patients with renal impairment.
How to Take
Starbac tablet should be taken orally once daily, at any time of day, with or without food. It is recommended to take it at the same time each day.
Mechanism of Action
Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase, an enzyme that catalyzes the rate-limiting step in cholesterol biosynthesis. By inhibiting HMG-CoA reductase, atorvastatin reduces cholesterol synthesis in the liver, which leads to an increase in hepatic LDL receptors and subsequent increased uptake and catabolism of LDL from the blood.
Pharmacokinetics
Onset
Lipid-lowering effects observed within 2 weeks, maximum effect generally achieved within 4 weeks.
Excretion
Primarily excreted in the bile following hepatic metabolism. Less than 2% of a dose is recovered in urine.
Half life
Effective elimination half-life for HMG-CoA reductase inhibitory activity is approximately 20-30 hours due to active metabolites.
Absorption
Rapidly absorbed after oral administration; peak plasma concentrations reached within 1-2 hours. Absolute bioavailability is approximately 12%.
Metabolism
Extensively metabolized by cytochrome P450 3A4 (CYP3A4) to ortho- and parahydroxylated derivatives and various beta-oxidation products. These metabolites account for approximately 70% of systemic HMG-CoA reductase inhibitory activity.
Side Effects
Contraindications
- Active liver disease or unexplained persistent elevations of serum transaminases.
- Pregnancy and lactation.
- Hypersensitivity to any component of this medication.
Drug Interactions
Colchicine
Cases of myopathy, including rhabdomyolysis, have been reported with coadministration of atorvastatin and colchicine.
Gemfibrozil and other Fibrates
Increased risk of myopathy when coadministered with atorvastatin.
Strong CYP3A4 Inhibitors (e.g., cyclosporine, telithromycin, clarithromycin, HIV protease inhibitors, itraconazole, ketoconazole)
Coadministration may significantly increase atorvastatin plasma concentrations, increasing the risk of myopathy/rhabdomyolysis. Dose reduction of atorvastatin and careful monitoring are recommended.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
There is no specific treatment for Atorvastatin overdose. In the event of an overdose, symptomatic treatment and supportive measures should be instituted as required. Due to extensive protein binding, hemodialysis is not expected to significantly enhance atorvastatin clearance.
Pregnancy & Lactation
Atorvastatin is contraindicated during pregnancy and breastfeeding. Women of childbearing potential should use effective contraception during treatment. If pregnancy occurs, the medication should be discontinued immediately.
Side Effects
Contraindications
- Active liver disease or unexplained persistent elevations of serum transaminases.
- Pregnancy and lactation.
- Hypersensitivity to any component of this medication.
Drug Interactions
Colchicine
Cases of myopathy, including rhabdomyolysis, have been reported with coadministration of atorvastatin and colchicine.
Gemfibrozil and other Fibrates
Increased risk of myopathy when coadministered with atorvastatin.
Strong CYP3A4 Inhibitors (e.g., cyclosporine, telithromycin, clarithromycin, HIV protease inhibitors, itraconazole, ketoconazole)
Coadministration may significantly increase atorvastatin plasma concentrations, increasing the risk of myopathy/rhabdomyolysis. Dose reduction of atorvastatin and careful monitoring are recommended.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
There is no specific treatment for Atorvastatin overdose. In the event of an overdose, symptomatic treatment and supportive measures should be instituted as required. Due to extensive protein binding, hemodialysis is not expected to significantly enhance atorvastatin clearance.
Pregnancy & Lactation
Atorvastatin is contraindicated during pregnancy and breastfeeding. Women of childbearing potential should use effective contraception during treatment. If pregnancy occurs, the medication should be discontinued immediately.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from the date of manufacture, specific to manufacturer's instructions.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by DGDA, FDA
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Atorvastatin has been extensively studied in numerous clinical trials demonstrating its efficacy in reducing LDL-C and cardiovascular event rates across various patient populations, including the ASCOT-LLA, MIRACL, and TNT studies.
Lab Monitoring
- Liver function tests (LFTs) should be performed before the initiation of Atorvastatin, and periodically thereafter (e.g., at 6 and 12 weeks after initiation or dose escalation, and annually).
- Lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides) should be checked periodically to assess treatment response.
Doctor Notes
- Counsel patients on lifestyle modifications, including diet and exercise, as these are crucial adjuncts to pharmacotherapy.
- Monitor liver enzymes (ALT) before starting and periodically during treatment. If ALT > 3x ULN persists, consider dose reduction or discontinuation.
- Assess for muscle symptoms and monitor CK levels if myopathy is suspected.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not stop taking the medicine without consulting your doctor, even if you feel better.
- Inform your doctor immediately if you experience muscle pain, tenderness, or weakness, especially if accompanied by fever or dark urine.
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
Atorvastatin is generally not expected to impair the ability to drive or operate machinery. However, if you experience dizziness or visual disturbances, you should exercise caution.
Lifestyle Advice
- Adopt a cholesterol-lowering diet, rich in fruits, vegetables, and whole grains, and low in saturated and trans fats.
- Engage in regular physical activity as advised by your doctor.
- Maintain a healthy weight.
- Limit alcohol consumption.
- Quit smoking.
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