Rosunor
Generic Name
Rosuvastatin 5 mg tablet
Manufacturer
Renata Limited
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rosunor 5 mg tablet | ৳ 10.00 | ৳ 100.00 |
Description
Overview of the medicine
Rosunor 5 mg Tablet contains Rosuvastatin, which is used to lower high cholesterol and triglyceride levels in the blood. It also helps to reduce the risk of heart attack, stroke, and certain heart procedures in patients at high risk.
Uses & Indications
Dosage
Adults
Initial dose is 5 mg once daily. For primary hypercholesterolemia, usual dose is 5-20 mg once daily. Max dose is 40 mg once daily, used only for patients with severe hypercholesterolemia and high cardiovascular risk who have not achieved their treatment goal on 20 mg and who will be routinely monitored.
Elderly
A starting dose of 5 mg once daily is recommended for patients >70 years old. No other dosage adjustment is typically needed unless severe renal impairment.
Renal_impairment
Severe renal impairment (CrCl <30 mL/min): Start with 5 mg once daily, max 10 mg once daily. No dose adjustment needed for mild to moderate renal impairment.
How to Take
Take orally, once daily, with or without food. May be taken at any time of day, but it is often recommended to take it at the same time each day to maintain consistency.
Mechanism of Action
Rosuvastatin is an HMG-CoA reductase inhibitor. It selectively and competitively inhibits HMG-CoA reductase, an enzyme that catalyzes the early rate-limiting step in cholesterol biosynthesis. This leads to a decrease in hepatic cholesterol synthesis and an increase in the number of LDL receptors on liver cells, enhancing LDL catabolism.
Pharmacokinetics
Onset
Significant lipid-lowering effect seen within 1 week, maximal effect achieved within 2-4 weeks.
Excretion
Primarily via feces (90%), with about 5% excreted in urine.
Half life
Approximately 19 hours.
Absorption
Peak plasma concentration (Cmax) occurs 3-5 hours post-dose. Absolute bioavailability is approximately 20%.
Metabolism
Minimal metabolism, primarily by CYP2C9 (approximately 10% of metabolism). The main metabolite is N-desmethyl rosuvastatin.
Side Effects
Contraindications
- Patients with active liver disease, which may include unexplained persistent elevations of serum transaminases.
- Pregnancy and lactation.
- Severe renal impairment (creatinine clearance <30 mL/min).
- Concomitant use with ciclosporin.
- Known hypersensitivity to rosuvastatin or any component of the formulation.
- Patients with myopathy.
Drug Interactions
Ezetimibe
Concomitant use may increase the risk of myopathy.
Ciclosporin
Concomitant use significantly increases rosuvastatin exposure (AUC) and is contraindicated.
Gemfibrozil
Increases rosuvastatin exposure; co-administration should be avoided.
Warfarin and other Vitamin K antagonists
May enhance anticoagulant effect; INR should be monitored when starting or stopping rosuvastatin.
Antacids (aluminum and magnesium hydroxide)
Administer rosuvastatin at least 2 hours after antacid administration as antacids decrease rosuvastatin plasma concentration.
Protease inhibitors (e.g., ritonavir-boosted lopinavir)
May significantly increase rosuvastatin exposure; dose adjustment or discontinuation may be necessary.
Storage
Store in a cool, dry place below 30°C. Protect 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
Rosuvastatin is contraindicated during pregnancy and lactation. Women of childbearing potential should use effective contraception during treatment. If a patient becomes pregnant while taking this drug, it should be discontinued immediately.
Side Effects
Contraindications
- Patients with active liver disease, which may include unexplained persistent elevations of serum transaminases.
- Pregnancy and lactation.
- Severe renal impairment (creatinine clearance <30 mL/min).
- Concomitant use with ciclosporin.
- Known hypersensitivity to rosuvastatin or any component of the formulation.
- Patients with myopathy.
Drug Interactions
Ezetimibe
Concomitant use may increase the risk of myopathy.
Ciclosporin
Concomitant use significantly increases rosuvastatin exposure (AUC) and is contraindicated.
Gemfibrozil
Increases rosuvastatin exposure; co-administration should be avoided.
Warfarin and other Vitamin K antagonists
May enhance anticoagulant effect; INR should be monitored when starting or stopping rosuvastatin.
Antacids (aluminum and magnesium hydroxide)
Administer rosuvastatin at least 2 hours after antacid administration as antacids decrease rosuvastatin plasma concentration.
Protease inhibitors (e.g., ritonavir-boosted lopinavir)
May significantly increase rosuvastatin exposure; dose adjustment or discontinuation may be necessary.
Storage
Store in a cool, dry place below 30°C. Protect 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
Rosuvastatin is contraindicated during pregnancy and lactation. Women of childbearing potential should use effective contraception during treatment. If a patient becomes pregnant while taking this drug, it should be discontinued immediately.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months
Availability
Pharmacies, hospitals
Approval Status
Approved by FDA and DGDA
Patent Status
Patent expired for generic Rosuvastatin
Clinical Trials
Extensive clinical trials, such as JUPITER and ASTEROID studies, have demonstrated the efficacy of rosuvastatin in lowering LDL-C and reducing cardiovascular events in various patient populations.
Lab Monitoring
- Liver function tests (ALT, AST) should be performed before initiation of rosuvastatin and as clinically indicated thereafter, particularly if symptoms suggestive of liver injury develop.
- Creatine kinase (CK) levels should be measured prior to initiation in patients with predisposing factors for myopathy, and if any symptoms of muscle pain, tenderness, or weakness occur.
- Lipid panel (total cholesterol, LDL-C, HDL-C, triglycerides) should be monitored regularly to assess treatment efficacy.
Doctor Notes
- Emphasize the importance of patient adherence to both medication and lifestyle modifications for optimal therapeutic outcomes.
- Counsel patients on prompt reporting of any unexplained muscle pain, tenderness, or weakness to rule out myopathy.
- Monitor lipid profile and liver function tests regularly according to clinical guidelines.
Patient Guidelines
- Take Rosunor 5 mg Tablet exactly as prescribed by your doctor, even if you feel well.
- Inform your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or dark urine.
- Do not consume grapefruit or grapefruit juice while taking this medication as it may interact with the drug.
- Maintain a healthy diet and exercise regimen as advised by your doctor to achieve the best results.
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 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, if dizziness or any other side effect that may impair concentration occurs, exercise caution.
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).
- Quit smoking and limit alcohol consumption.
- Maintain a healthy weight.
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