Rostatin
Generic Name
Rosuvastatin Calcium
Manufacturer
XYZ Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rostatin 10 mg tablet | ৳ 11.00 | ৳ 154.00 |
Description
Overview of the medicine
Rostatin 10 mg Tablet contains Rosuvastatin, a statin medication used to lower high cholesterol and triglyceride levels in the blood, reducing the risk of cardiovascular diseases like heart attack and stroke.
Uses & Indications
Dosage
Adults
The usual starting dose is 5-10 mg orally once daily. The dose can be adjusted after 2-4 weeks if needed. Maximum dose is 40 mg daily.
Elderly
No dose adjustment is usually required for elderly patients with normal renal function.
Renal_impairment
For patients with severe renal impairment (creatinine clearance < 30 mL/min) not on hemodialysis, the starting dose is 5 mg once daily, and should not exceed 10 mg once daily.
How to Take
Take Rostatin 10 mg Tablet orally once daily, at any time of day, with or without food. Swallow the tablet whole with water.
Mechanism of Action
Rosuvastatin selectively and competitively inhibits HMG-CoA reductase, an enzyme that catalyzes the rate-limiting step in cholesterol biosynthesis. This leads to a decrease in hepatic cholesterol synthesis and an increase in the number of hepatic LDL receptors on the cell surface, enhancing uptake and catabolism of LDL-C.
Pharmacokinetics
Onset
Therapeutic response is usually evident within 1 week of therapy, and maximal response is generally achieved within 2-4 weeks.
Excretion
Approximately 90% of the rosuvastatin dose is excreted unchanged in the feces, with about 5% excreted in the urine.
Half life
The elimination half-life of rosuvastatin is approximately 19 hours.
Absorption
Peak plasma concentrations are achieved approximately 3-5 hours following oral administration. Absolute bioavailability is approximately 20%.
Metabolism
Rosuvastatin undergoes limited metabolism, approximately 10% of the dose is metabolized, primarily by CYP2C9.
Side Effects
Contraindications
- Hypersensitivity to rosuvastatin or any component of the formulation.
- Patients with active liver disease, including unexplained persistent elevations of serum transaminases.
- Patients with severe renal impairment (creatinine clearance < 30 mL/min).
- Patients with myopathy.
- Concomitant administration of ciclosporin.
- Pregnancy and lactation.
Drug Interactions
Warfarin
Co-administration may result in significant increases in INR. INR should be monitored when rosuvastatin is started or discontinued.
Ciclosporin
Concomitant use is contraindicated as ciclosporin significantly increases rosuvastatin exposure.
Gemfibrozil
Concomitant use may increase rosuvastatin exposure. Rosuvastatin dose should not exceed 10 mg once daily with gemfibrozil.
Antacids (Aluminum and Magnesium hydroxide)
Administer rosuvastatin 2 hours after antacid to avoid reduced rosuvastatin plasma concentrations.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
There is no specific treatment for rosuvastatin overdose. In the event of overdose, the patient should be treated symptomatically, and supportive measures instituted as required. Liver function tests and CK levels should be monitored.
Pregnancy & Lactation
Rostatin is contraindicated during pregnancy and lactation. Women of childbearing potential should use adequate contraceptive measures. If a patient becomes pregnant while taking this drug, treatment should be discontinued immediately.
Side Effects
Contraindications
- Hypersensitivity to rosuvastatin or any component of the formulation.
- Patients with active liver disease, including unexplained persistent elevations of serum transaminases.
- Patients with severe renal impairment (creatinine clearance < 30 mL/min).
- Patients with myopathy.
- Concomitant administration of ciclosporin.
- Pregnancy and lactation.
Drug Interactions
Warfarin
Co-administration may result in significant increases in INR. INR should be monitored when rosuvastatin is started or discontinued.
Ciclosporin
Concomitant use is contraindicated as ciclosporin significantly increases rosuvastatin exposure.
Gemfibrozil
Concomitant use may increase rosuvastatin exposure. Rosuvastatin dose should not exceed 10 mg once daily with gemfibrozil.
Antacids (Aluminum and Magnesium hydroxide)
Administer rosuvastatin 2 hours after antacid to avoid reduced rosuvastatin plasma concentrations.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
There is no specific treatment for rosuvastatin overdose. In the event of overdose, the patient should be treated symptomatically, and supportive measures instituted as required. Liver function tests and CK levels should be monitored.
Pregnancy & Lactation
Rostatin is contraindicated during pregnancy and lactation. Women of childbearing potential should use adequate contraceptive measures. 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
24 months from the date of manufacture.
Availability
Pharmacies, Hospitals
Approval Status
Approved by regulatory authorities (e.g., FDA, DGDA)
Patent Status
Generics available
Clinical Trials
Extensive clinical trials, such as the JUPITER study and the GALAXY program, have demonstrated the efficacy of rosuvastatin in reducing LDL-C, increasing HDL-C, and significantly lowering the risk of major cardiovascular events in various patient populations.
Lab Monitoring
- Liver function tests (ALT, AST) should be performed before the initiation of treatment and periodically thereafter.
- Creatine Kinase (CK) levels should be measured prior to treatment initiation and if muscle symptoms occur.
- Lipid panel (Total-C, LDL-C, HDL-C, triglycerides) to monitor efficacy and guide dosage adjustments.
Doctor Notes
- Emphasize the importance of complementary lifestyle modifications (diet, exercise) along with statin therapy for optimal lipid management.
- Counsel patients thoroughly on the symptoms of myopathy and rhabdomyolysis (unexplained muscle pain, weakness, dark urine) and instruct them to report immediately.
- Monitor liver function tests at baseline and as clinically indicated, and consider dose adjustment or discontinuation if transaminase levels exceed 3 times the upper limit of normal.
- Caution with concomitant use of drugs known to interact with rosuvastatin, especially ciclosporin (contraindicated) and gemfibrozil (max 10 mg rosuvastatin).
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor, preferably at the same time each day.
- Continue with your prescribed diet and exercise program while taking Rostatin.
- Report any unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or dark urine, to your doctor immediately.
- Do not stop taking Rostatin without consulting your doctor.
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
Rostatin is not expected to affect the ability to drive or operate machinery. However, if dizziness occurs, patients should be cautious.
Lifestyle Advice
- Maintain a healthy, low-fat diet.
- Engage in regular physical activity.
- Avoid smoking and excessive alcohol consumption.
- Manage stress effectively.
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