Rosicard
Generic Name
Rosuvastatin
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
rosicard 10 mg tablet | ৳ 20.00 | ৳ 200.00 |
Description
Overview of the medicine
Rosuvastatin is a statin medicine used to lower 'bad' cholesterol (LDL) and triglycerides and raise 'good' cholesterol (HDL) in the blood. It helps reduce the risk of heart attack, stroke, and other heart problems.
Uses & Indications
Dosage
Adults
Initial dose 5-10 mg orally once daily. Maximum dose 40 mg once daily. Adjust dosage at 2-4 week intervals based on lipid levels and treatment goals.
Elderly
No specific dose adjustment is needed based on age; however, a starting dose of 5 mg may be considered in patients >70 years.
Renal_impairment
Mild to moderate impairment: No dose adjustment. Severe impairment (CrCl <30 mL/min): Initiate with 5 mg once daily, maximum 10 mg once daily.
How to Take
Take Rosicard 10 mg tablet orally, once daily, with or without food. It can be taken at any time of the day, but consistency in timing is recommended.
Mechanism of Action
Rosuvastatin selectively inhibits HMG-CoA reductase, an enzyme found primarily in the liver. This inhibition reduces cholesterol production in the liver, leading to an increase in LDL receptors on liver cells, which in turn increases the uptake and breakdown of LDL cholesterol from the blood.
Pharmacokinetics
Onset
Lipid-lowering effects are seen within 1 week, with maximal effect achieved by 2-4 weeks.
Excretion
Approximately 90% is excreted unchanged in the feces, with the remainder excreted in the urine.
Half life
Approximately 19 hours.
Absorption
Approximately 20% absolute bioavailability. Peak plasma concentrations are reached about 3-5 hours after oral administration.
Metabolism
Limited metabolism; primarily by CYP2C9 to an inactive N-desmethyl metabolite.
Side Effects
Contraindications
- Hypersensitivity to rosuvastatin or any component of the tablet.
- Active liver disease or unexplained persistent elevations of serum transaminases.
- Pregnancy and lactation.
- Severe renal impairment (CrCl <30 mL/min) at the 40 mg dose.
- Concomitant administration with cyclosporine.
Drug Interactions
Warfarin
Potentiates anticoagulant effect; monitor INR closely.
Gemfibrozil
Increases rosuvastatin exposure; use lowest effective dose of rosuvastatin.
Cyclosporine
Significant increase in rosuvastatin exposure; co-administration is contraindicated.
Erythromycin
Decreases rosuvastatin exposure.
Aluminum/Magnesium Hydroxide Antacids
Decreases rosuvastatin plasma concentration; take antacids 2 hours after rosuvastatin.
Protease Inhibitors (e.g., Atazanavir/Ritonavir, Lopinavir/Ritonavir)
Significantly increase rosuvastatin exposure; dose adjustment required.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
There is no specific treatment for Rosuvastatin overdose. In the event of an overdose, symptomatic and supportive measures should be implemented. Monitor liver function and CK levels.
Pregnancy & Lactation
Rosuvastatin is contraindicated during pregnancy and breastfeeding. Women of childbearing potential should use effective contraception during treatment. It is unknown if rosuvastatin is excreted in human milk.
Side Effects
Contraindications
- Hypersensitivity to rosuvastatin or any component of the tablet.
- Active liver disease or unexplained persistent elevations of serum transaminases.
- Pregnancy and lactation.
- Severe renal impairment (CrCl <30 mL/min) at the 40 mg dose.
- Concomitant administration with cyclosporine.
Drug Interactions
Warfarin
Potentiates anticoagulant effect; monitor INR closely.
Gemfibrozil
Increases rosuvastatin exposure; use lowest effective dose of rosuvastatin.
Cyclosporine
Significant increase in rosuvastatin exposure; co-administration is contraindicated.
Erythromycin
Decreases rosuvastatin exposure.
Aluminum/Magnesium Hydroxide Antacids
Decreases rosuvastatin plasma concentration; take antacids 2 hours after rosuvastatin.
Protease Inhibitors (e.g., Atazanavir/Ritonavir, Lopinavir/Ritonavir)
Significantly increase rosuvastatin exposure; dose adjustment required.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
There is no specific treatment for Rosuvastatin overdose. In the event of an overdose, symptomatic and supportive measures should be implemented. Monitor liver function and CK levels.
Pregnancy & Lactation
Rosuvastatin is contraindicated during pregnancy and breastfeeding. Women of childbearing potential should use effective contraception during treatment. It is unknown if rosuvastatin is excreted in human milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture. Check the expiry date on the packaging.
Availability
Pharmacies, Hospitals
Approval Status
FDA/DGDA approved
Patent Status
Off-patent (Generics available)
Clinical Trials
Extensive clinical trials, such as the JUPITER trial (Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin), have demonstrated the efficacy and safety of rosuvastatin in reducing cardiovascular events in patients with elevated CRP but normal LDL-C.
Lab Monitoring
- Liver function tests (ALT/AST) should be performed before starting treatment and periodically thereafter, or as clinically indicated.
- Lipid panel (total cholesterol, LDL-C, HDL-C, triglycerides) should be monitored to assess treatment response.
- Creatine Kinase (CK) levels should be measured if a patient reports muscle pain, tenderness, or weakness.
Doctor Notes
- Emphasize the importance of lifestyle modifications (diet, exercise) as foundational to lipid management.
- Educate patients on symptoms of myopathy (muscle pain, tenderness, weakness) and advise immediate reporting.
- Monitor liver function tests (LFTs) before initiation and as clinically indicated, especially with dose escalation.
- Consider genetic testing for SLCO1B1 variants in patients experiencing unexplained muscle symptoms, particularly at higher doses.
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor, usually once daily.
- Do not stop taking Rosicard without consulting your doctor, even if you feel well.
- Report any unexplained muscle pain, tenderness, or weakness to your doctor immediately.
- Maintain a healthy diet, exercise regularly, and manage weight as advised by your doctor.
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 generally not expected to affect the ability to drive or operate machinery. However, dizziness has been reported in some patients, which could impair driving ability. Patients should be aware of how they react to the medication before driving or operating machinery.
Lifestyle Advice
- Adopt a cholesterol-lowering diet, rich in fruits, vegetables, and whole grains, and low in saturated and trans fats.
- Engage in regular physical activity, aiming for at least 30 minutes of moderate-intensity exercise most days of the week.
- Maintain a healthy body weight. Losing excess weight can help lower cholesterol levels.
- Avoid smoking and limit alcohol consumption, as these can negatively impact lipid levels and cardiovascular health.
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