U-Tovas
Generic Name
Rosuvastatin 10 mg Tablet
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| u tovas 10 mg tablet | ৳ 8.00 | ৳ 80.00 |
Description
Overview of the medicine
U-Tovas 10 mg Tablet contains Rosuvastatin, a medication belonging to the statin class. It is primarily used to lower high cholesterol and triglyceride levels in the blood, thereby reducing the risk of heart attack, stroke, and other cardiovascular diseases.
Uses & Indications
Dosage
Adults
The usual starting dose is 5 mg or 10 mg once daily. For primary hypercholesterolemia, the usual dose is 10 mg once daily. Dosage adjustments should be made at intervals of 2 to 4 weeks. The maximum recommended dose is 40 mg once daily for patients not achieving target LDL-C with 20 mg and who are under specialist supervision.
Elderly
No dose adjustment is necessary for patients over 70 years. However, a starting dose of 5 mg is recommended for patients ≥70 years.
Renal_impairment
For patients with mild to moderate renal impairment, no dose adjustment is necessary. For patients with severe renal impairment (creatinine clearance <30 mL/min), a starting dose of 5 mg once daily should be considered, and the dose should not exceed 10 mg once daily.
How to Take
Take U-Tovas 10 mg Tablet orally once daily, with or without food. It is recommended to take it at the same time each day to maintain consistent blood levels.
Mechanism of Action
Rosuvastatin selectively and competitively inhibits HMG-CoA reductase, an enzyme that catalyzes the rate-limiting step in cholesterol biosynthesis. This inhibition decreases hepatic cholesterol synthesis, leading to an upregulation of LDL receptors on the hepatocyte surface, increasing the uptake and catabolism of LDL. It also inhibits hepatic synthesis of VLDL, thereby reducing total cholesterol, LDL-C, ApoB, and triglycerides, and increasing HDL-C.
Pharmacokinetics
Onset
Significant reduction in LDL-C is evident within 1 week, and 90% of the maximum response is usually achieved within 2 weeks. The maximum response is generally attained by 4 weeks.
Excretion
Approximately 90% of the administered dose is excreted unchanged in the feces, with the remainder excreted in the urine. Renal excretion accounts for approximately 5% of the dose.
Half life
The plasma elimination half-life is approximately 19 hours.
Absorption
Peak plasma concentrations are achieved approximately 3 to 5 hours following oral administration. Absolute bioavailability is approximately 20%.
Metabolism
Rosuvastatin undergoes limited metabolism, primarily by cytochrome P450 enzyme CYP2C9 (approximately 10%). The major metabolite is N-desmethyl rosuvastatin.
Side Effects
Contraindications
- Hypersensitivity to Rosuvastatin or any component of the formulation
- Active liver disease, including unexplained persistent elevations of serum transaminases
- Severe renal impairment (creatinine clearance <30 mL/min)
- Pregnancy and lactation
- Concomitant use of ciclosporin
Drug Interactions
Warfarin
Co-administration with warfarin may result in increases in INR (International Normalized Ratio); regular monitoring is advised.
Ciclosporin
Concomitant use with ciclosporin significantly increases rosuvastatin exposure (AUC 7.1-fold), necessitating contraindication.
Gemfibrozil
Concomitant use with gemfibrozil increases rosuvastatin exposure; dose should not exceed 10 mg daily.
Antacids (aluminum and magnesium hydroxide)
Antacids should be taken at least 2 hours after rosuvastatin as they decrease rosuvastatin plasma concentration.
Storage
Store in a dry place below 30°C, protected 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 measures should be instituted as required. Liver function tests and CK levels should be monitored.
Pregnancy & Lactation
U-Tovas is contraindicated during pregnancy and breastfeeding. Women of childbearing potential should use effective contraception during treatment. If pregnancy occurs, discontinue the medication immediately.
Side Effects
Contraindications
- Hypersensitivity to Rosuvastatin or any component of the formulation
- Active liver disease, including unexplained persistent elevations of serum transaminases
- Severe renal impairment (creatinine clearance <30 mL/min)
- Pregnancy and lactation
- Concomitant use of ciclosporin
Drug Interactions
Warfarin
Co-administration with warfarin may result in increases in INR (International Normalized Ratio); regular monitoring is advised.
Ciclosporin
Concomitant use with ciclosporin significantly increases rosuvastatin exposure (AUC 7.1-fold), necessitating contraindication.
Gemfibrozil
Concomitant use with gemfibrozil increases rosuvastatin exposure; dose should not exceed 10 mg daily.
Antacids (aluminum and magnesium hydroxide)
Antacids should be taken at least 2 hours after rosuvastatin as they decrease rosuvastatin plasma concentration.
Storage
Store in a dry place below 30°C, protected 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 measures should be instituted as required. Liver function tests and CK levels should be monitored.
Pregnancy & Lactation
U-Tovas is contraindicated during pregnancy and breastfeeding. Women of childbearing potential should use effective contraception during treatment. If pregnancy occurs, discontinue the medication immediately.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from manufacturing date.
Availability
Available in pharmacies nationwide in Bangladesh
Approval Status
Approved by FDA and DGDA
Patent Status
Generic available, patent expired for Rosuvastatin calcium
WHO Essential Medicine
YesClinical Trials
Rosuvastatin has been extensively studied in numerous clinical trials, including major studies like 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, and METEOR (Measuring Effects on intima media Thickness: An Evaluation Of Rosuvastatin) which showed it could slow the progression of atherosclerosis.
Lab Monitoring
- Liver function tests (ALT, AST) before treatment and periodically thereafter, or as clinically indicated. Creatine kinase (CK) levels should be measured before treatment and if muscle symptoms occur.
Doctor Notes
- Regularly monitor lipid profile (LDL-C, HDL-C, Total-C, Triglycerides) to ensure therapeutic efficacy.
- Monitor liver function tests (ALT, AST) before initiating therapy and periodically thereafter. Discontinue if transaminase levels persist at >3x ULN.
- Assess creatine kinase (CK) levels prior to treatment and advise patients to report any unexplained muscle pain or weakness.
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor, usually once daily.
- Inform your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or dark urine.
- Continue to follow a cholesterol-lowering diet and exercise program recommended by your doctor while taking this medication.
- Do not stop taking this medicine without consulting your doctor.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. However, if it is almost time for your 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
U-Tovas is generally not expected to impair the ability to drive or operate machinery. However, some individuals may experience dizziness during treatment, which could affect their ability. Patients should be aware of their reaction to the drug before driving or operating machinery.
Lifestyle Advice
- Adopt a heart-healthy diet low in saturated and trans fats, and cholesterol. Emphasize fruits, vegetables, whole grains, and lean proteins.
- Engage in regular physical activity for at least 30 minutes most days of the week.
- Maintain a healthy weight to reduce cardiovascular risk.
- If you smoke, aim to quit, as smoking significantly increases the risk of heart disease.
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