Rosebac
Generic Name
Rosuvastatin
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
rosebac 1 gm injection | ৳ 1,300.00 | N/A |
rosebac 500 mg injection | ৳ 700.00 | N/A |
Description
Overview of the medicine
Rosebac (Rosuvastatin) is an HMG-CoA reductase inhibitor used to lower high cholesterol levels and reduce the risk of cardiovascular events such as heart attack and stroke.
Uses & Indications
Dosage
Adults
Initial dose 5-10 mg orally once daily; can be adjusted up to 40 mg once daily.
Elderly
No specific dosage adjustment required, but start with lower doses in patients >70 years old.
Renal_impairment
For severe renal impairment (CrCl <30 mL/min), start with 5 mg once daily and do not exceed 10 mg once daily.
How to Take
Administer orally, once daily, with or without food, at any time of day.
Mechanism of Action
Rosuvastatin selectively inhibits HMG-CoA reductase, an enzyme that catalyzes the rate-limiting step in cholesterol biosynthesis. This inhibition reduces hepatic cholesterol synthesis and increases the number of hepatic LDL receptors on the cell surface, enhancing uptake and catabolism of LDL.
Pharmacokinetics
Onset
Lipid-lowering effects observed within 1 week, maximal effect generally achieved within 2-4 weeks.
Excretion
Approximately 90% excreted in feces, 10% in urine.
Half life
Elimination half-life is approximately 19 hours.
Absorption
Rapidly absorbed after oral administration, peak plasma concentrations reached in 3-5 hours. Absolute bioavailability is approximately 20%.
Metabolism
Limited metabolism, primarily by cytochrome P450 (CYP2C9) isoenzyme.
Side Effects
Contraindications
- Hypersensitivity to Rosuvastatin or any component
- Active liver disease, including unexplained persistent elevations of serum transaminases
- Pregnancy
- Breastfeeding
Drug Interactions
Niacin
Increased risk of myopathy/rhabdomyolysis
Warfarin
Increased INR/bleeding risk
Gemfibrozil
Increased risk of myopathy/rhabdomyolysis
Cyclosporine
Significantly increased rosuvastatin exposure
Protease Inhibitors (e.g., Lopinavir/Ritonavir)
Increased rosuvastatin exposure
Storage
Store below 30°C, protected from light and moisture. Keep out of reach of children.
Overdose
No specific antidote. In case of overdose, provide symptomatic and supportive measures as needed. Monitor liver function and CK levels.
Pregnancy & Lactation
Contraindicated during pregnancy and breastfeeding. Women of childbearing potential should use effective contraception.
Side Effects
Contraindications
- Hypersensitivity to Rosuvastatin or any component
- Active liver disease, including unexplained persistent elevations of serum transaminases
- Pregnancy
- Breastfeeding
Drug Interactions
Niacin
Increased risk of myopathy/rhabdomyolysis
Warfarin
Increased INR/bleeding risk
Gemfibrozil
Increased risk of myopathy/rhabdomyolysis
Cyclosporine
Significantly increased rosuvastatin exposure
Protease Inhibitors (e.g., Lopinavir/Ritonavir)
Increased rosuvastatin exposure
Storage
Store below 30°C, protected from light and moisture. Keep out of reach of children.
Overdose
No specific antidote. In case of overdose, provide symptomatic and supportive measures as needed. Monitor liver function and CK levels.
Pregnancy & Lactation
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 months from manufacturing date
Availability
Pharmacies nationwide
Approval Status
Approved by DGDA
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have demonstrated Rosuvastatin's efficacy and safety in lipid-lowering and cardiovascular risk reduction.
Lab Monitoring
- Liver function tests (ALT, AST) before initiation and as clinically indicated
- Creatine Kinase (CK) levels if muscle symptoms occur
- Lipid panel (Total-C, LDL-C, HDL-C, TG) for monitoring efficacy
Doctor Notes
- Counsel patients on lifestyle modifications.
- Monitor LFTs at baseline and as clinically appropriate.
- Be alert for muscle symptoms and CK elevation.
Patient Guidelines
- Take exactly as prescribed, do not stop without consulting doctor
- Report any unexplained muscle pain, tenderness, or weakness immediately
- Maintain a cholesterol-lowering diet and regular exercise as advised by your doctor
Missed Dose Advice
If a dose is missed, 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 double the dose.
Driving Precautions
Rosuvastatin is generally not expected to impair the ability to drive or operate machinery. However, patients should be aware of possible side effects like dizziness.
Lifestyle Advice
- Adopt a healthy diet low in saturated and trans fats
- Engage in regular physical activity
- Maintain a healthy weight
- Quit smoking and reduce alcohol intake
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Global Brand Names
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