Rosustat
Generic Name
rosustat-10-mg-tablet
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rosustat 10 mg tablet | ৳ 20.00 | ৳ 200.00 |
Description
Overview of the medicine
Rosuvastatin is a statin medication used to lower high cholesterol and triglycerides in the blood, and to prevent cardiovascular diseases such as heart attack and stroke.
Uses & Indications
Dosage
Adults
Initial dose is usually 5-10 mg once daily. Dose may be adjusted at 2-4 week intervals. Maximum dose is 40 mg once daily.
Elderly
Starting dose of 5 mg once daily is recommended for patients >70 years old.
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 orally, once daily, with or without food, at any time of day, but preferably at a consistent time each day.
Mechanism of Action
Rosuvastatin selectively inhibits HMG-CoA reductase, an enzyme found primarily in the liver, which is responsible for the de novo synthesis of cholesterol. This inhibition leads to a reduction in cholesterol production and an increase in LDL receptors on liver cells, enhancing the uptake and catabolism of LDL-C.
Pharmacokinetics
Onset
Lipid-modifying effects are usually seen within 1 week of therapy; maximal effect is achieved by 2-4 weeks.
Excretion
Approximately 90% is excreted unchanged in the feces, and approximately 10% in the urine.
Half life
Approximately 19 hours.
Absorption
Approximately 20% absolute bioavailability. Peak plasma concentrations are reached about 3 to 5 hours after oral administration.
Metabolism
Undergoes limited hepatic metabolism (approximately 10%), primarily by CYP2C9 and CYP2A6 enzymes.
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 (CrCl <30 mL/min) for the 40 mg dose.
- Concomitant use with cyclosporine.
Drug Interactions
Warfarin
May enhance the anticoagulant effect, leading to increased INR. Monitor INR closely.
Gemfibrozil
Increases rosuvastatin exposure and risk of myopathy. Avoid concomitant use; if necessary, limit rosuvastatin to 10 mg daily.
Cyclosporine
Significant increase in rosuvastatin plasma concentrations. Concomitant use is contraindicated.
Erythromycin
Decreases rosuvastatin exposure. Consider dose adjustment.
Oral Contraceptives
Increases plasma concentrations of ethinyl estradiol and norgestrel. Monitor for adverse effects.
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 antidote for rosuvastatin overdose. In the event of an overdose, treatment should be symptomatic and supportive.
Pregnancy & Lactation
Rosuvastatin is contraindicated during pregnancy and breastfeeding. Women of childbearing potential should use effective contraception.
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 (CrCl <30 mL/min) for the 40 mg dose.
- Concomitant use with cyclosporine.
Drug Interactions
Warfarin
May enhance the anticoagulant effect, leading to increased INR. Monitor INR closely.
Gemfibrozil
Increases rosuvastatin exposure and risk of myopathy. Avoid concomitant use; if necessary, limit rosuvastatin to 10 mg daily.
Cyclosporine
Significant increase in rosuvastatin plasma concentrations. Concomitant use is contraindicated.
Erythromycin
Decreases rosuvastatin exposure. Consider dose adjustment.
Oral Contraceptives
Increases plasma concentrations of ethinyl estradiol and norgestrel. Monitor for adverse effects.
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 antidote for rosuvastatin overdose. In the event of an overdose, treatment should be symptomatic and supportive.
Pregnancy & Lactation
Rosuvastatin is contraindicated during pregnancy and breastfeeding. Women of childbearing potential should use effective contraception.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from the date of manufacture, specific to manufacturer and packaging.
Availability
Pharmacies
Approval Status
Approved
Patent Status
Generic available
Clinical Trials
Key trials include the JUPITER trial (Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin) which demonstrated rosuvastatin's efficacy in primary prevention of cardiovascular events, and the GALAXY program, a series of studies exploring various aspects of rosuvastatin's effects.
Lab Monitoring
- Liver function tests (LFTs) should be performed before initiation of therapy and periodically thereafter.
- Creatine Kinase (CK) levels should be measured at baseline and in patients who develop muscle symptoms.
Doctor Notes
- Emphasize lifestyle modifications (diet, exercise) as foundational therapy for dyslipidemia.
- Carefully assess patient history for factors predisposing to myopathy.
- Monitor liver function tests as per guidelines.
- Consider lower starting doses in specific patient populations (e.g., elderly, renal impairment, certain drug interactions).
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Report any unexplained muscle pain, tenderness, or weakness immediately.
- Continue with your cholesterol-lowering diet and exercise program.
- Avoid drinking large amounts of alcohol while taking this medicine.
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 use machines. However, some patients may experience dizziness during treatment.
Lifestyle Advice
- Maintain a heart-healthy diet low in saturated and trans fats.
- Engage in regular physical activity.
- Maintain a healthy weight.
- Quit smoking if applicable.
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