Rosu
Generic Name
Rosuvastatin
Manufacturer
Example Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rosu 10 mg tablet | ৳ 24.00 | ৳ 240.00 |
Description
Overview of the medicine
Rosuvastatin is a statin medication used to lower high cholesterol and triglyceride levels, reducing the risk of cardiovascular diseases such as heart attack and stroke. It works by reducing the amount of cholesterol made by the liver.
Uses & Indications
Dosage
Adults
Initial dose 5-10 mg once daily. For 10 mg tablet, commonly 10 mg once daily. Max 40 mg once daily.
Elderly
No general dosage adjustment required, but an initial dose of 5 mg is recommended for patients >70 years.
Renal_impairment
Mild to moderate impairment: No dosage adjustment needed. Severe impairment (CrCl <30 mL/min): Initial dose 5 mg once daily, max 10 mg once daily.
How to Take
Take orally, once daily, with or without food. It is recommended to take the tablet at the same time each day for better adherence.
Mechanism of Action
Rosuvastatin selectively inhibits HMG-CoA reductase, an enzyme responsible for catalyzing the rate-limiting step in cholesterol biosynthesis. This inhibition decreases hepatic cholesterol synthesis and increases the number of LDL receptors on the surface of liver cells, enhancing the uptake and catabolism of LDL (low-density lipoprotein) cholesterol.
Pharmacokinetics
Onset
Lipid-modifying effects are evident within 1 week of starting therapy, with maximal effect generally observed by 2 to 4 weeks.
Excretion
Approximately 90% of a 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 to 5 hours after oral administration. Absolute bioavailability is approximately 20%.
Metabolism
Rosuvastatin undergoes limited metabolism, primarily by cytochrome P450 (CYP2C9). N-desmethyl rosuvastatin is the major metabolite.
Side Effects
Contraindications
- Active liver disease, including unexplained persistent elevations of serum transaminases.
- Severe renal impairment (CrCl <30 mL/min).
- Myopathy or predisposition to myopathy.
- Concurrent administration of cyclosporine.
- Pregnancy and lactation.
- Hypersensitivity to rosuvastatin or any component of the formulation.
Drug Interactions
Cyclosporine
Concurrent use increases rosuvastatin exposure significantly and is contraindicated.
Erythromycin
Decreases rosuvastatin exposure.
Oral contraceptives
May increase AUC of ethinyl estradiol and norgestrel; consider this when selecting contraceptive method.
Gemfibrozil or other fibrates
Increases rosuvastatin exposure and risk of myopathy; concurrent use should be avoided or dose limited.
Warfarin and other Vitamin K antagonists
May increase INR (International Normalized Ratio); monitor INR closely.
Antacids (aluminum & magnesium hydroxide)
Decreases rosuvastatin plasma concentration; take 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 case of an overdose, treatment should be symptomatic and supportive. Liver function and CK levels should be monitored. Hemodialysis is unlikely to be of benefit.
Pregnancy & Lactation
Rosuvastatin is contraindicated during pregnancy due to the potential for fetal harm. Women of childbearing potential should use effective contraception. It is also contraindicated during lactation as it may pass into breast milk and potentially harm the infant.
Side Effects
Contraindications
- Active liver disease, including unexplained persistent elevations of serum transaminases.
- Severe renal impairment (CrCl <30 mL/min).
- Myopathy or predisposition to myopathy.
- Concurrent administration of cyclosporine.
- Pregnancy and lactation.
- Hypersensitivity to rosuvastatin or any component of the formulation.
Drug Interactions
Cyclosporine
Concurrent use increases rosuvastatin exposure significantly and is contraindicated.
Erythromycin
Decreases rosuvastatin exposure.
Oral contraceptives
May increase AUC of ethinyl estradiol and norgestrel; consider this when selecting contraceptive method.
Gemfibrozil or other fibrates
Increases rosuvastatin exposure and risk of myopathy; concurrent use should be avoided or dose limited.
Warfarin and other Vitamin K antagonists
May increase INR (International Normalized Ratio); monitor INR closely.
Antacids (aluminum & magnesium hydroxide)
Decreases rosuvastatin plasma concentration; take 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 case of an overdose, treatment should be symptomatic and supportive. Liver function and CK levels should be monitored. Hemodialysis is unlikely to be of benefit.
Pregnancy & Lactation
Rosuvastatin is contraindicated during pregnancy due to the potential for fetal harm. Women of childbearing potential should use effective contraception. It is also contraindicated during lactation as it may pass into breast milk and potentially harm the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture when stored under recommended conditions.
Availability
Pharmacies, Hospitals
Approval Status
Approved by regulatory bodies (e.g., FDA/DGDA)
Patent Status
Generically available
WHO Essential Medicine
YesClinical Trials
Rosuvastatin has been extensively studied in large-scale clinical trials such as JUPITER (Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin) which demonstrated its efficacy in primary prevention of cardiovascular events in individuals with normal LDL-C but elevated hs-CRP.
Lab Monitoring
- Liver function tests (ALT, AST) before initiating treatment and as clinically indicated.
- Creatine kinase (CK) levels if muscle symptoms (e.g., pain, tenderness, weakness) develop.
- Lipid panel (Total cholesterol, LDL-C, HDL-C, Triglycerides) to monitor treatment efficacy.
Doctor Notes
- Emphasize the importance of lifestyle modifications (diet, exercise) alongside medication for optimal outcomes.
- Monitor liver function tests (LFTs) before initiation and if clinically indicated. Advise patients to report any unexplained muscle pain or weakness promptly.
- Counsel patients on potential drug interactions, especially with cyclosporine, fibrates, and warfarin, and adjust therapy accordingly.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor, usually once daily.
- Do not stop taking Rosu without consulting your doctor, even if you feel well.
- Report any unexplained muscle pain, tenderness, or weakness to your doctor immediately.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for the 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
Rosuvastatin is not expected to impair the ability to drive or operate machinery. However, dizziness has been reported in rare cases. If affected, caution should be exercised.
Lifestyle Advice
- Combine medication with a healthy lifestyle including a low-fat, low-cholesterol diet.
- Engage in regular physical activity as advised by your doctor.
- Maintain a healthy weight and quit smoking to maximize the benefits of the medication.
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