Aztor
Generic Name
Atorvastatin 10 mg
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| aztor 10 mg tablet | ৳ 11.60 | ৳ 116.00 |
Description
Overview of the medicine
Aztor 10 mg Tablet contains Atorvastatin, which belongs to a group of medicines called statins. It is used to lower cholesterol and other fats (triglycerides) in the blood when a low-fat diet and lifestyle changes alone have failed. It is also used to reduce the risk of heart disease in individuals with increased risk factors.
Uses & Indications
Dosage
Adults
The usual starting dose is 10 or 20 mg once daily. The dose can be titrated to 10 mg to 80 mg once daily, depending on treatment goals and response. For primary hypercholesterolemia and mixed dyslipidemia, a starting dose of 10 mg once daily is common.
Elderly
No specific dose adjustment is required in elderly patients; however, caution should be exercised due to potential increased susceptibility to myopathy.
Renal_impairment
No dose adjustment is necessary for patients with renal impairment.
How to Take
Aztor 10 mg Tablet should be taken orally once daily, with or without food. It is recommended to take it at approximately 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. It reduces cholesterol synthesis in the liver and increases the number of LDL receptors on the surface of liver cells, leading to increased uptake and catabolism of LDL. This results in a reduction of plasma cholesterol and lipoprotein levels.
Pharmacokinetics
Onset
Cholesterol reduction observed within 2 weeks, maximal effect by 4 weeks.
Excretion
Primarily excreted in bile following hepatic and/or extrahepatic metabolism. Less than 2% of the dose is recovered in urine.
Half life
Plasma elimination half-life of parent drug is approximately 14 hours; however, the half-life of HMG-CoA reductase inhibitory activity is approximately 20-30 hours due to active metabolites.
Absorption
Rapidly absorbed after oral administration, peak plasma concentrations occur within 1-2 hours. Absolute bioavailability is approximately 12%.
Metabolism
Extensively metabolized by cytochrome P450 3A4 (CYP3A4) to active ortho- and parahydroxylated metabolites and various beta-oxidation products.
Side Effects
Contraindications
- Hypersensitivity to Atorvastatin or any component of the formulation.
- Active liver disease or unexplained persistent elevations of serum transaminases.
- Pregnancy and lactation.
Drug Interactions
Warfarin
Atorvastatin may affect coagulation times; monitor INR.
Colchicine
Increased risk of myopathy/rhabdomyolysis.
Gemfibrozil and other Fibrates
Increased risk of myopathy, including rhabdomyolysis. Avoid concomitant use if possible.
Niacin (lipid-modifying doses)
Increased risk of muscle side effects.
Strong CYP3A4 Inhibitors (e.g., ciclosporin, clarithromycin, itraconazole, protease inhibitors)
May significantly increase atorvastatin plasma concentrations, increasing risk of myopathy/rhabdomyolysis. Lower atorvastatin dose or avoid concomitant use.
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 atorvastatin overdose. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required. Due to extensive drug binding to plasma proteins, 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 a patient becomes pregnant while taking this drug, treatment should be discontinued immediately.
Side Effects
Contraindications
- Hypersensitivity to Atorvastatin or any component of the formulation.
- Active liver disease or unexplained persistent elevations of serum transaminases.
- Pregnancy and lactation.
Drug Interactions
Warfarin
Atorvastatin may affect coagulation times; monitor INR.
Colchicine
Increased risk of myopathy/rhabdomyolysis.
Gemfibrozil and other Fibrates
Increased risk of myopathy, including rhabdomyolysis. Avoid concomitant use if possible.
Niacin (lipid-modifying doses)
Increased risk of muscle side effects.
Strong CYP3A4 Inhibitors (e.g., ciclosporin, clarithromycin, itraconazole, protease inhibitors)
May significantly increase atorvastatin plasma concentrations, increasing risk of myopathy/rhabdomyolysis. Lower atorvastatin dose or avoid concomitant use.
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 atorvastatin overdose. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required. Due to extensive drug binding to plasma proteins, 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 a patient becomes pregnant while taking this drug, treatment should be discontinued immediately.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by major regulatory bodies (e.g., FDA, DGDA)
Patent Status
Patent expired, generic versions available
WHO Essential Medicine
YesClinical Trials
Atorvastatin has been extensively studied in numerous large-scale clinical trials (e.g., ASCOT-LLA, CARDS, TNT, IDEAL, MIRACL) demonstrating its efficacy in reducing cardiovascular morbidity and mortality across various patient populations.
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, then semi-annually).
- Lipid panel (total cholesterol, LDL-C, HDL-C, triglycerides) should be monitored periodically to assess treatment response.
Doctor Notes
- Emphasize the importance of lifestyle modifications (diet, exercise) in conjunction with pharmacotherapy.
- Monitor LFTs and creatine kinase levels as per guidelines, especially if muscle symptoms arise.
- Counsel patients on potential drug interactions, particularly with CYP3A4 inhibitors and grapefruit juice.
- Educate patients on symptoms of myopathy and rhabdomyolysis and the need for prompt reporting.
Patient Guidelines
- Follow your prescribed diet and exercise regimen along with taking this medicine.
- Report any unexplained muscle pain, tenderness, or weakness immediately to your doctor.
- Avoid consuming large amounts of grapefruit juice while on this medication.
- Do not stop taking the medicine abruptly without consulting your doctor.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose (within 12 hours). In that case, 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 avoid such activities.
Lifestyle Advice
- Adopt a heart-healthy diet low in saturated and trans fats and cholesterol.
- Engage in regular physical activity (e.g., at least 30 minutes of moderate-intensity exercise most days of the week).
- Maintain a healthy weight and quit smoking.
- Limit alcohol consumption.
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