Rozavel 10mg Tab (15tabs)

ROZAVEL 10MG Tablet

ROZAVEL 10MG Tablet is a widely prescribed medication belonging to the group of medicines called statins, primarily used to manage high cholesterol and triglyceride levels. It is manufactured by Sun Pharmaceutical Industries Ltd..

• Name:

  • Brand Name: ROZAVEL 10MG Tablet
  • Common Name: Rosuvastatin Calcium

• Composition:

  • Active Ingredient: Rosuvastatin (10 mg)

• Uses: ROZAVEL 10MG Tablet is primarily used to lower high levels of cholesterol and triglycerides in the blood. It is prescribed for:

  • Primary Hyperlipidemia and Mixed Dyslipidemia
  • Homozygous Familial Hypercholesterolemia (HoFH)
  • Heterozygous Familial Hypercholesterolemia (HeFH)
  • Hypertriglyceridemia
  • Primary Dysbetalipoproteinemia (Type III hyperlipoproteinemia)
  • Reducing the risk of cardiovascular events such as heart attacks and strokes.
  • Slowing the progression of atherosclerosis. It works by blocking an enzyme (HMG-CoA reductase) in the liver responsible for producing cholesterol, thereby lowering "bad" LDL cholesterol and triglycerides while increasing "good" HDL cholesterol.

• Dosage and Administration:

  • The typical starting dose for managing high cholesterol is 10 mg once daily.
  • The dose range is generally 5-40 mg once daily, with adjustments made by a doctor based on cholesterol levels and treatment goals.
  • For pediatric patients (8-17 years old) with HeFH, the dose can range from 5-20 mg/day; for HoFH patients (7-17 years old), it's typically 20 mg/day.
  • It can be taken with or without food, at any time of day, but taking it at the same time daily is recommended for consistency. Swallow the tablet whole without chewing, crushing, or breaking it.

• Side Effects: ROZAVEL 10MG Tablet is generally well tolerated, but some side effects can occur.

  • Common Side Effects: Headache, muscle pain (myalgia), constipation, asthenia (lack of energy/weakness), abdominal pain, nausea, dizziness, joint pain, and stomach discomfort.
  • Serious Side Effects (rare): Muscle breakdown (rhabdomyolysis), liver damage, unexplained muscle pain, tenderness or weakness, dark urine, severe allergic skin reactions, or signs of liver problems like unusually dark urine or yellowing of the skin/eyes. Patients should report these symptoms immediately to their doctor.

• Precautions:

  • Contraindications:
    • Known hypersensitivity to rosuvastatin or any product components.
    • Severe liver disease or unexplained persistent elevations in hepatic transaminase levels.
    • Pregnancy and breastfeeding. Women of childbearing age should use reliable contraception.
    • Unexplained muscle pain.
    • Concomitant use with cyclosporine (dose should not exceed 5 mg once daily).
  • Warnings:
    • Skeletal Muscle Effects: Risk increases with higher doses (especially 40 mg), advanced age (>65 years), hypothyroidism, renal impairment, and combination with certain drugs (cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir, fibrates, niacin products). Patients should report unexplained muscle pain or weakness.
    • Liver Enzyme Abnormalities: Persistent elevations can occur. Liver enzymes should be monitored before and during treatment.
    • Kidney Problems: Use with caution; dose adjustment may be required. Not recommended for severe kidney disease.
    • Diabetes: Use with caution, as it may slightly increase blood sugar levels. Regular monitoring of blood sugar is recommended.
    • Alcohol Consumption: Caution is advised. Regular excessive alcohol intake increases risks.
    • Drug Interactions: Consult a doctor if taking cyclosporine, gemfibrozil, lopinavir/ritonavir, atazanavir/ritonavir, coumarin anticoagulants (e.g., warfarin), fibrates, niacin products, antibiotics, antifungal medications, antacids, oral contraceptives, anti-cancer drugs, or anti-HIV drugs.

• Storage: Store below 30°C, protected from light and moisture. Keep out of the reach of children and pets.

Here are some frequently asked questions about ROZAVEL 10MG TAB:

What is ROZAVEL 10MG TAB used for?

ROZAVEL 10MG TAB, which contains rosuvastatin, is primarily used to lower high levels of "bad" cholesterol (LDL) and triglycerides in the blood, while also increasing "good" cholesterol (HDL). It is prescribed to reduce the risk of cardiovascular events such as heart attacks and strokes, especially in individuals with high cholesterol, a history of heart disease, or other risk factors like diabetes. It also helps manage hyperlipidemia (high levels of fat in the blood) and prevent the buildup of fatty deposits in blood vessels (atherosclerosis).

How does ROZAVEL 10MG TAB work?

ROZAVEL 10MG TAB is a type of medicine called a statin. It works by selectively and competitively inhibiting an enzyme in the liver called HMG-CoA reductase. This enzyme is crucial for the body to produce cholesterol. By blocking it, ROZAVEL 10MG TAB reduces the production of unhealthy fats, decreases LDL cholesterol and triglycerides, and increases HDL cholesterol, thereby helping to clear cholesterol from your blood and promote better heart health.

What is the usual dosage of ROZAVEL 10MG TAB?

The usual starting dose for managing high cholesterol is ROZAVEL 10MG TAB once daily. Your doctor may adjust the dose based on your cholesterol levels and individual needs, with doses ranging from 5-40 mg once daily. For pediatric patients with Heterozygous Familial Hypercholesterolemia (HeFH) aged 10 to 17 years, the dose range is typically 5-20 mg/day. It can be taken with or without food, at any time of day, but it is often recommended to take it at a fixed time, preferably at bedtime, for optimal benefits.

What are the possible side effects of ROZAVEL 10MG TAB?

ROZAVEL 10MG TAB is generally well-tolerated. Common side effects may include muscle pain (myalgia), headache, constipation, asthenia (weakness), abdominal pain, nausea, and dizziness. In some cases, there might be an increase in blood sugar levels and elevated liver enzyme levels. More serious, though rare, side effects can include severe muscle breakdown (rhabdomyolysis) and liver damage. It's important to report any unexplained muscle pain, tenderness, weakness, dark urine, or yellowing of the skin or eyes to your doctor immediately.

Is ROZAVEL 10MG TAB safe during pregnancy or breastfeeding?

No, ROZAVEL 10MG TAB is considered unsafe and is contraindicated during pregnancy and breastfeeding. Taking this medicine while pregnant can be harmful to the fetus, and it is not known whether it is excreted in human milk. Women of childbearing age should use effective contraceptive methods while taking this medicine.

Can ROZAVEL 10MG TAB be taken with other medications?

ROZAVEL 10MG TAB can interact with several other medications. For instance, combining it with cyclosporine, gemfibrozil, lopinavir/ritonavir, or atazanavir/ritonavir can increase its exposure and risk of side effects, requiring dose adjustments or avoidance. It can also prolong the International Normalized Ratio (INR) when taken with coumarin anticoagulants like warfarin. Antacids containing aluminum and magnesium can reduce its absorption if taken within 2 hours. Always inform your doctor about all medicines, supplements, or herbal products you are currently taking to avoid potential interactions.

What precautions should be taken while taking ROZAVEL 10MG TAB?

Precautions include informing your doctor if you have liver or kidney problems, diabetes, hypothyroidism, or a history of muscle disorders. Liver function tests should be monitored before and during treatment. Caution is advised with excessive alcohol consumption as it may increase the risk of liver damage. Avoid or limit grapefruit and grapefruit juice, as they can increase the medicine's levels in the blood, potentially increasing side effects. Patients should promptly report any unexplained muscle pain, tenderness, or weakness.

What happens if a dose of ROZAVEL 10MG TAB is missed?

If you miss a dose of ROZAVEL 10MG TAB, take it as soon as you remember. However, if it's almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to compensate for the missed one, and do not take two doses within 12 hours.

How should ROZAVEL 10MG TAB be stored?

ROZAVEL 10MG TAB should be stored below 30°C, protected from light and moisture, and kept out of the reach of children and pets.