Divastin
Generic Name
Atorvastatin Calcium
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
divastin 10 mg tablet | ৳ 12.00 | ৳ 168.00 |
Description
Overview of the medicine
Divastin 10 mg Tablet contains Atorvastatin, which belongs to a class of medicines called statins. It is used to reduce high levels of cholesterol and other fats (triglycerides) in the blood when diet and lifestyle changes alone have not been enough.
Uses & Indications
Dosage
Adults
The usual starting dose is 10 mg once daily. The dose can be adjusted based on lipid levels, up to a maximum of 80 mg once daily.
Elderly
No dosage adjustment required.
Renal_impairment
No dosage adjustment required.
How to Take
Divastin tablets should be taken orally, once daily, with or without food. It can be taken at any time of the day, but consistency is recommended.
Mechanism of Action
Atorvastatin selectively inhibits HMG-CoA reductase, an enzyme that plays a crucial role in cholesterol synthesis in the liver. By reducing cholesterol production, it lowers levels of LDL-cholesterol (bad cholesterol) and triglycerides, and can also slightly increase HDL-cholesterol (good cholesterol).
Pharmacokinetics
Onset
Significant lipid-lowering effects generally observed within 2 weeks of therapy.
Excretion
Primarily excreted via biliary excretion following hepatic and/or extrahepatic metabolism. Less than 2% of a dose is recovered in urine.
Half life
The elimination half-life of atorvastatin from plasma is approximately 14 hours, but the half-life of inhibitory activity for HMG-CoA reductase is approximately 20-30 hours due to active metabolites.
Absorption
Rapidly absorbed after oral administration; peak plasma concentrations achieved within 1-2 hours. Absolute bioavailability is approximately 12-14%.
Metabolism
Extensively metabolized in the liver by cytochrome P450 3A4 (CYP3A4) to active ortho- and para-hydroxylated metabolites and various beta-oxidation products.
Side Effects
Contraindications
- Active liver disease, including unexplained persistent elevations of serum transaminases.
- Pregnancy and lactation.
- Hypersensitivity to the active substance or to any of the excipients.
Drug Interactions
Antacids
Simultaneous co-administration of atorvastatin with an oral antacid suspension decreased plasma concentrations of atorvastatin. However, LDL-C reduction was not affected.
Warfarin
Concomitant administration of atorvastatin and warfarin may lead to a slight increase in prothrombin time (INR). INR should be monitored.
Gemfibrozil and other fibrates
Concomitant use with fibrates may increase the risk of myopathy and rhabdomyolysis.
Strong CYP3A4 inhibitors (e.g., ciclosporin, clarithromycin, itraconazole, protease inhibitors)
May significantly increase atorvastatin plasma concentrations, increasing the risk of myopathy/rhabdomyolysis. Co-administration should be avoided or used with caution with dose adjustment.
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
Divastin is contraindicated during pregnancy and lactation. Women of childbearing potential should use adequate contraception during treatment.
Side Effects
Contraindications
- Active liver disease, including unexplained persistent elevations of serum transaminases.
- Pregnancy and lactation.
- Hypersensitivity to the active substance or to any of the excipients.
Drug Interactions
Antacids
Simultaneous co-administration of atorvastatin with an oral antacid suspension decreased plasma concentrations of atorvastatin. However, LDL-C reduction was not affected.
Warfarin
Concomitant administration of atorvastatin and warfarin may lead to a slight increase in prothrombin time (INR). INR should be monitored.
Gemfibrozil and other fibrates
Concomitant use with fibrates may increase the risk of myopathy and rhabdomyolysis.
Strong CYP3A4 inhibitors (e.g., ciclosporin, clarithromycin, itraconazole, protease inhibitors)
May significantly increase atorvastatin plasma concentrations, increasing the risk of myopathy/rhabdomyolysis. Co-administration should be avoided or used with caution with dose adjustment.
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
Divastin is contraindicated during pregnancy and lactation. Women of childbearing potential should use adequate contraception during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture.
Availability
Pharmacies, Hospitals
Approval Status
Approved
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, total cholesterol, and triglycerides, and its role in reducing the risk of cardiovascular events, including myocardial infarction and stroke.
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 treatment efficacy.
- Creatine kinase (CK) levels should be measured if a patient reports muscle pain, tenderness, or weakness.
Doctor Notes
- Assess lipid profile and liver function tests at baseline and periodically during treatment.
- Educate patients about symptoms of myopathy (muscle pain, tenderness, weakness) and advise them to report these promptly.
- Consider drug interactions, especially with strong CYP3A4 inhibitors and fibrates, and adjust doses accordingly.
- The decision to use Divastin in children and adolescents should be made by a specialist after careful consideration of benefits and risks.
Patient Guidelines
- Take Divastin once daily, preferably at the same time each day, with or without food.
- Do not stop taking the medicine without consulting your doctor, even if your cholesterol levels improve.
- Report any unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or dark urine, to your doctor immediately.
- Avoid consuming large quantities of grapefruit juice while on this medication.
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
Divastin is generally not expected to affect the ability to drive or use machines. However, some patients may experience dizziness, which could impair these abilities.
Lifestyle Advice
- Maintain a cholesterol-lowering diet, including low saturated fat and cholesterol. Continue this diet during treatment.
- Engage in regular physical activity as advised by your healthcare provider.
- If you smoke, consider quitting. Limit alcohol intake.
- Maintain a healthy weight.
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