Rotek
Generic Name
Rosuvastatin
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rotek 10 mg tablet | ৳ 10.00 | N/A |
Description
Overview of the medicine
Rotek 10 mg Tablet contains Rosuvastatin, a statin medication used to lower high cholesterol and triglycerides, reducing the risk of heart disease and stroke. It works by reducing the amount of cholesterol made by the liver.
Uses & Indications
Dosage
Adults
Initial dose 5-10 mg orally once daily. Maximum 40 mg once daily. Adjust dosage based on lipid levels and patient response at intervals of 2-4 weeks.
Elderly
No dosage adjustment necessary, but monitor for adverse effects. Consider a 5 mg starting dose for patients >70 years old.
Renal_impairment
Mild to moderate (CrCl ≥30 mL/min): No adjustment. Severe (CrCl <30 mL/min, not on hemodialysis): Initial 5 mg, max 10 mg once daily.
How to Take
Oral administration. Can be taken with or without food, at any time of day, but typically once daily. Swallow the tablet whole with water.
Mechanism of Action
Rosuvastatin selectively and competitively inhibits HMG-CoA reductase, the enzyme that catalyzes the rate-limiting step in cholesterol biosynthesis, primarily in the liver. This inhibition reduces cholesterol production and increases the number of hepatic LDL receptors, thereby increasing uptake and catabolism of LDL-C.
Pharmacokinetics
Onset
Lipid-lowering effects typically begin within 1 week, with maximum effect by 2-4 weeks.
Excretion
Mainly excreted unchanged in feces (approx. 90%), with minimal renal excretion.
Half life
Approximately 19 hours.
Absorption
Peak plasma concentration (Tmax) is reached in 3-5 hours. Absolute bioavailability is approximately 20%.
Metabolism
Limited metabolism, primarily by CYP2C9. Approximately 10% is metabolized.
Side Effects
Contraindications
- Active liver disease, including unexplained persistent elevations of serum transaminases
- Hypersensitivity to rosuvastatin or any component of the formulation
- Pregnancy and lactation
- Severe renal impairment (CrCl <30 mL/min) at 40 mg dose
- Concomitant use with cyclosporine
Drug Interactions
Warfarin
Potentiates anticoagulant effect; monitor INR closely upon initiation or dose change of rosuvastatin.
Gemfibrozil
Increased rosuvastatin exposure; avoid co-administration or use with caution, monitor for myopathy.
Cyclosporine
Increased rosuvastatin exposure; co-administration is contraindicated.
Erythromycin
Decreased rosuvastatin exposure.
Oral Contraceptives
Increased plasma concentrations of ethinyl estradiol and norgestrel, necessitating consideration of contraceptive dose adjustment.
Antacids (aluminum and magnesium hydroxide)
Decreased rosuvastatin plasma concentrations; take rosuvastatin 2 hours after antacid.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
No specific antidote. Treatment is symptomatic and supportive. Monitor liver function and CK levels. Hemodialysis is not expected to significantly enhance rosuvastatin clearance.
Pregnancy & Lactation
Category X in pregnancy (contraindicated due to potential fetal harm). Contraindicated during lactation as statins are excreted in breast milk and may cause serious adverse reactions in nursing infants.
Side Effects
Contraindications
- Active liver disease, including unexplained persistent elevations of serum transaminases
- Hypersensitivity to rosuvastatin or any component of the formulation
- Pregnancy and lactation
- Severe renal impairment (CrCl <30 mL/min) at 40 mg dose
- Concomitant use with cyclosporine
Drug Interactions
Warfarin
Potentiates anticoagulant effect; monitor INR closely upon initiation or dose change of rosuvastatin.
Gemfibrozil
Increased rosuvastatin exposure; avoid co-administration or use with caution, monitor for myopathy.
Cyclosporine
Increased rosuvastatin exposure; co-administration is contraindicated.
Erythromycin
Decreased rosuvastatin exposure.
Oral Contraceptives
Increased plasma concentrations of ethinyl estradiol and norgestrel, necessitating consideration of contraceptive dose adjustment.
Antacids (aluminum and magnesium hydroxide)
Decreased rosuvastatin plasma concentrations; take rosuvastatin 2 hours after antacid.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
No specific antidote. Treatment is symptomatic and supportive. Monitor liver function and CK levels. Hemodialysis is not expected to significantly enhance rosuvastatin clearance.
Pregnancy & Lactation
Category X in pregnancy (contraindicated due to potential fetal harm). Contraindicated during lactation as statins are excreted in breast milk and may cause serious adverse reactions in nursing infants.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from manufacturing date. Refer to the specific packaging for exact expiry date.
Availability
Pharmacies, hospitals, clinics
Approval Status
Approved by major regulatory bodies (e.g., FDA, EMA, DGDA)
Patent Status
Generic available (original patent expired)
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials, such as the JUPITER trial, have shown Rosuvastatin's effectiveness in reducing LDL-C and improving cardiovascular outcomes, including primary prevention of major cardiovascular events in individuals without known heart disease but with elevated CRP levels. The AURORA trial also demonstrated benefits in patients on hemodialysis.
Lab Monitoring
- Liver function tests (ALT, AST) before initiation and at 12 weeks after initiation or dose escalation, then periodically (e.g., every 6-12 months) or as clinically indicated.
- Lipid panel (total cholesterol, LDL-C, HDL-C, triglycerides) before initiation and 4-6 weeks after initiation or dose adjustment, then periodically.
- Creatine Kinase (CK) levels if muscle symptoms occur or if patient is at high risk for myopathy.
Doctor Notes
- Always assess baseline liver function and lipid profile before initiating Rosuvastatin therapy.
- Educate patients on symptoms of myopathy (muscle pain, tenderness, weakness) and the importance of reporting them immediately.
- Consider a lower starting dose (5 mg) for Asian patients due to higher plasma concentrations observed.
- Regularly monitor lipid levels and liver function as per clinical guidelines.
Patient Guidelines
- Take this medicine regularly as prescribed by your doctor, even if you feel well.
- Follow a cholesterol-lowering diet and engage in a regular exercise program as advised by your healthcare provider.
- Report any unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or dark urine, to your doctor immediately.
- Avoid consuming excessive alcohol while on this medication as it may increase the risk of liver problems.
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 continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Rosuvastatin is not expected to affect the ability to drive or use machines. However, if you experience dizziness or visual disturbances, do not drive or operate machinery until these symptoms resolve.
Lifestyle Advice
- Maintain a healthy weight through diet and exercise.
- Engage in regular physical activity, aiming for at least 30 minutes of moderate intensity exercise most days of the week.
- Eat a balanced diet rich in fruits, vegetables, whole grains, and lean proteins, while limiting saturated and trans fats.
- Quit smoking and avoid exposure to secondhand smoke.
- Manage stress through relaxation techniques or hobbies.
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