Rosu
Generic Name
Rosuvastatin
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rosu 5 mg tablet | ৳ 12.50 | ৳ 125.00 |
Description
Overview of the medicine
Rosuvastatin is an HMG-CoA reductase inhibitor used to lower high cholesterol and triglyceride levels, reducing the risk of heart disease and stroke.
Uses & Indications
Dosage
Adults
Initial dose is typically 5 mg or 10 mg once daily. Dosage can be adjusted after 2-4 weeks, up to a maximum of 40 mg once daily, depending on lipid levels and therapeutic goals. For 5 mg tablet, it's usually the starting dose.
Elderly
No dose adjustment is necessary for patients >70 years old; however, a starting dose of 5 mg is recommended.
Renal_impairment
For patients with moderate renal impairment (CrCl < 60 mL/min), a starting dose of 5 mg once daily is recommended. The 40 mg dose is contraindicated in patients with severe renal impairment (CrCl < 30 mL/min).
How to Take
Rosuvastatin tablets should be taken orally once daily, with or without food, at any time of day.
Mechanism of Action
Rosuvastatin selectively inhibits HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol. This inhibition 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
Significant lipid-lowering effects observed within 1 week, with maximal effect usually achieved within 2-4 weeks of starting therapy.
Excretion
Approximately 90% is excreted in the feces, predominantly as unchanged drug. About 5% is excreted in the urine.
Half life
Approximately 19 hours.
Absorption
Rapidly absorbed after oral administration, with peak plasma concentrations occurring 3-5 hours post-dose. Absolute bioavailability is approximately 20%.
Metabolism
Limited metabolism, primarily by CYP2C9 (10%) and to a lesser extent CYP2D6. The major metabolite, N-desmethyl rosuvastatin, is about half as active as the parent drug.
Side Effects
Contraindications
- Hypersensitivity to rosuvastatin or any component of the formulation.
- Active liver disease, including unexplained persistent elevations of serum transaminases.
- Pregnancy and lactation.
- Severe renal impairment (creatinine clearance < 30 mL/min).
Drug Interactions
Warfarin
May increase INR (International Normalized Ratio); monitor INR closely.
Gemfibrozil
Increases rosuvastatin exposure; co-administration is not recommended.
Cyclosporine
Concomitant use significantly increases rosuvastatin exposure; avoid this combination.
Erythromycin
Decreases rosuvastatin exposure.
Oral Contraceptives
May increase levels of ethinyl estradiol and norgestrel.
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 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
Rosuvastatin is contraindicated during pregnancy and breastfeeding. Women of childbearing potential should use effective contraception during treatment.
Side Effects
Contraindications
- Hypersensitivity to rosuvastatin or any component of the formulation.
- Active liver disease, including unexplained persistent elevations of serum transaminases.
- Pregnancy and lactation.
- Severe renal impairment (creatinine clearance < 30 mL/min).
Drug Interactions
Warfarin
May increase INR (International Normalized Ratio); monitor INR closely.
Gemfibrozil
Increases rosuvastatin exposure; co-administration is not recommended.
Cyclosporine
Concomitant use significantly increases rosuvastatin exposure; avoid this combination.
Erythromycin
Decreases rosuvastatin exposure.
Oral Contraceptives
May increase levels of ethinyl estradiol and norgestrel.
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 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
Rosuvastatin is contraindicated during pregnancy and breastfeeding. Women of childbearing potential should use effective contraception during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from manufacturing date.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Generic available
Clinical Trials
Rosuvastatin has been extensively studied in various clinical trials, including JUPITER (Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin) and ASTEROID (A Study to Evaluate the Effect of Rosuvastatin on Intravascular Ultrasound-Derived Coronary Atheroma Burden), demonstrating its efficacy in lipid lowering and cardiovascular event reduction.
Lab Monitoring
- Liver function tests (ALT and AST) should be performed at baseline and periodically thereafter (e.g., at 3 and 12 months after initiation or dose escalation, then annually).
- Creatine kinase (CK) levels should be measured at baseline and if muscle pain, tenderness, or weakness occurs.
Doctor Notes
- Ensure baseline liver function tests and lipid profiles are obtained before initiating therapy.
- Counsel patients on the importance of lifestyle modifications alongside medication.
- Advise patients to report any muscle pain or weakness promptly.
Patient Guidelines
- Take Rosu exactly as prescribed by your doctor.
- Do not stop taking the medicine without consulting your doctor, even if you feel well.
- Report any unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or dark urine, to your doctor immediately.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs, herbal supplements, and vitamins.
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
Rosuvastatin is not expected to impair the ability to drive or operate machinery. However, patients should be aware of possible side effects like dizziness that might occur during treatment.
Lifestyle Advice
- Maintain a low-cholesterol, low-fat diet.
- Engage in regular physical activity.
- Quit smoking and limit alcohol consumption.
- Manage other health conditions like diabetes and high blood pressure.
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