Rostatin
Generic Name
Rosuvastatin 5 mg Tablet
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rostatin 5 mg tablet | ৳ 8.00 | ৳ 112.00 |
Description
Overview of the medicine
Rostatin 5 mg Tablet contains Rosuvastatin, an HMG-CoA reductase inhibitor, used to lower high cholesterol and triglyceride levels in the blood, thereby reducing the risk of heart attack and stroke.
Uses & Indications
Dosage
Adults
The usual starting dose is 5 mg once daily. The dose can be adjusted after 2-4 weeks, if necessary. The maximum dose is 40 mg once daily.
Elderly
A starting dose of 5 mg is recommended for patients >70 years of age.
Renal_impairment
For patients with severe renal impairment (creatinine clearance <30 mL/min), a starting dose of 5 mg once daily is recommended and the maximum dose should not exceed 10 mg once daily.
How to Take
Take Rostatin 5 mg Tablet orally, once daily, with or without food. It should be swallowed whole with water.
Mechanism of Action
Rosuvastatin selectively and competitively inhibits HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor for cholesterol. This inhibition leads to a reduction in hepatic cholesterol synthesis and an increase in LDL receptors on the hepatocyte surface, enhancing uptake and catabolism of LDL-C.
Pharmacokinetics
Onset
Lipid-lowering effects are evident within 1 week of therapy, and maximal effect is usually achieved by 2-4 weeks.
Excretion
Approximately 90% of a rosuvastatin dose is excreted unchanged in the feces, with the remainder (about 5%) excreted in the urine.
Half life
The mean plasma elimination half-life is approximately 19 hours.
Absorption
Peak plasma concentrations are achieved approximately 3-5 hours post oral administration. Absolute bioavailability is approximately 20%.
Metabolism
Rosuvastatin undergoes limited metabolism (approximately 10%), primarily by CYP2C9. N-desmethyl rosuvastatin is the major metabolite.
Side Effects
Contraindications
- Hypersensitivity to rosuvastatin or any component of the formulation
- Active liver disease, including unexplained persistent elevations of serum transaminases
- Severe renal impairment (creatinine clearance <30 mL/min)
- Pregnancy and lactation
- Concomitant use with cyclosporine
Drug Interactions
Gemfibrozil
Increases rosuvastatin exposure and risk of myopathy. Max rosuvastatin dose with gemfibrozil is 10 mg/day.
Cyclosporine
Concomitant use significantly increases rosuvastatin exposure (up to 7-fold). Avoid co-administration.
Erythromycin
May decrease rosuvastatin exposure.
Coumarin anticoagulants (e.g., Warfarin)
May potentiate the anticoagulant effect. Monitor INR/PT more frequently.
Antacids (aluminum and magnesium hydroxide)
Decreases rosuvastatin plasma concentration. Administer antacids 2 hours after rosuvastatin.
Storage
Store below 30°C in a dry place, protected 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. Hemodialysis is unlikely to be of benefit.
Pregnancy & Lactation
Rostatin 5 mg Tablet is contraindicated during pregnancy and lactation. Women of childbearing potential should use adequate contraceptive measures. If pregnancy occurs, discontinue Rostatin immediately.
Side Effects
Contraindications
- Hypersensitivity to rosuvastatin or any component of the formulation
- Active liver disease, including unexplained persistent elevations of serum transaminases
- Severe renal impairment (creatinine clearance <30 mL/min)
- Pregnancy and lactation
- Concomitant use with cyclosporine
Drug Interactions
Gemfibrozil
Increases rosuvastatin exposure and risk of myopathy. Max rosuvastatin dose with gemfibrozil is 10 mg/day.
Cyclosporine
Concomitant use significantly increases rosuvastatin exposure (up to 7-fold). Avoid co-administration.
Erythromycin
May decrease rosuvastatin exposure.
Coumarin anticoagulants (e.g., Warfarin)
May potentiate the anticoagulant effect. Monitor INR/PT more frequently.
Antacids (aluminum and magnesium hydroxide)
Decreases rosuvastatin plasma concentration. Administer antacids 2 hours after rosuvastatin.
Storage
Store below 30°C in a dry place, protected 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. Hemodialysis is unlikely to be of benefit.
Pregnancy & Lactation
Rostatin 5 mg Tablet is contraindicated during pregnancy and lactation. Women of childbearing potential should use adequate contraceptive measures. If pregnancy occurs, discontinue Rostatin immediately.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from the date of manufacture.
Availability
Pharmacies, Hospitals
Approval Status
Approved by major regulatory bodies (e.g., FDA, DGDA)
Patent Status
Generally off-patent
Clinical Trials
Extensive clinical trials, such as the JUPITER study, have demonstrated rosuvastatin's efficacy in reducing LDL-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 initiation of therapy and periodically thereafter, or when clinically indicated.
- Lipid profile (Total-C, LDL-C, HDL-C, TG) should be monitored to assess treatment response.
- Creatine Kinase (CK) levels should be measured at baseline and if muscle symptoms develop.
Doctor Notes
- Prior to initiating rosuvastatin, assess lipid profile and exclude secondary causes of hyperlipidemia.
- Counsel patients on the importance of adhering to diet and exercise in conjunction with medication.
- Monitor liver function tests at baseline and periodically. Discontinue if transaminase levels persist above 3 times the upper limit of normal.
- Advise patients to report any unexplained muscle pain, tenderness, or weakness promptly.
Patient Guidelines
- Take Rostatin exactly as prescribed by your doctor.
- Inform your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or dark urine.
- Avoid becoming pregnant while taking this medication. Use effective birth control methods.
- Maintain a healthy diet and exercise regimen as advised by 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 resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Rostatin is generally not expected to affect the ability to drive or operate machinery. However, some individuals may experience dizziness, so caution is advised until you know how the medication affects you.
Lifestyle Advice
- Adopt a heart-healthy diet low in saturated and trans fats and cholesterol.
- Engage in regular physical activity, at least 30 minutes most days of the week.
- Quit smoking and limit alcohol intake.
- Maintain a healthy weight.
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