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Rozustat 20mg Tab

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10 TABLETProduct code 253861

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Product information

Manufacturer
Macleods Pharmaceuticals Ltd.
Category
Allopathy
Composition
Not provided
Packaging
10 TABLET
Box / case pack
1 / —
Description

ROZUSTAT 20MG Tablet

Name

  • Brand Name: ROZUSTAT 20MG TAB
  • Common Name: Rosuvastatin (a statin)

Composition

ROZUSTAT 20MG Tablet contains 20 mg of Rosuvastatin as its active ingredient.

Uses

ROZUSTAT 20MG Tablet is primarily used to manage and lower high cholesterol and triglyceride levels in the blood (hyperlipidemia). It works by blocking an enzyme in the liver responsible for cholesterol production, thereby reducing "bad" cholesterol (LDL) and triglycerides, and increasing "good" cholesterol (HDL). This action helps to reduce the risk of cardiovascular diseases such as heart attacks and strokes.

Dosage and Administration

  • Adults: The typical initial dose is 5 or 10 mg once daily, which may be increased at 4-week intervals up to 20 mg daily as per the condition. The maximum recommended dose is 40 mg once daily.
  • Children (over 10 years): An initial dose of 5 mg once daily, with a maximum dose of 20 mg once daily.
  • The tablet can be taken with or without food, at any time of the day, but it is advisable to take it at the same time each day for consistency.
  • Swallow the tablet whole with a glass of water; do not crush, chew, or break it.

Side Effects

Common Side Effects:

  • Nausea or vomiting
  • Headache
  • Dizziness
  • Constipation
  • Weakness (asthenia)
  • Muscle pain (myalgia)
  • Joint pain
  • Abdominal pain
  • Fatigue

Serious Side Effects:

  • Liver problems (patients with active liver disease should avoid this medicine)
  • Muscle disorders such as myopathy and rhabdomyolysis, potentially leading to kidney damage
  • Slight increase in blood sugar levels, which may increase the risk of developing type 2 diabetes in at-risk individuals

Precautions

  • Contraindications: ROZUSTAT 20MG Tablet is contraindicated in individuals allergic to rosuvastatin or its components, those with severe kidney or active liver disease, a history of muscle disorders, and during pregnancy or breastfeeding.
  • Pregnancy and Breastfeeding: Avoid use during pregnancy as it can harm the fetus. Women of childbearing age should use appropriate birth control methods. It is also not recommended for use by breastfeeding mothers as it may pass into breast milk.
  • Alcohol: Alcohol consumption should be avoided during treatment as it can increase the risk of liver damage and elevate triglyceride levels.
  • Medical Conditions: Caution is advised for patients with pre-existing conditions such as diabetes (requiring regular blood glucose monitoring), hypothyroidism, or kidney problems.
  • Drug Interactions: Inform your doctor about all other medications you are taking, as ROZUSTAT 20MG can interact with immunosuppressants (e.g., cyclosporine), blood thinners (e.g., warfarin), lipid-regulating medications (e.g., gemfibrozil), fusidic acid, antacids, and certain anti-HIV medicines (e.g., lopinavir, ritonavir).
  • Monitoring: Regular monitoring of lipid profiles and liver enzyme tests is recommended during treatment.
  • Pediatric Use: Not recommended for children below 6 years of age.

Storage

Store ROZUSTAT 20MG Tablet at or below 25°C (room temperature). Keep it in a cool, dry place, protected from moisture and direct sunlight, and out of reach of children and pets.

Frequently asked questions

ROZUSTAT 20MG Tablet (Rosuvastatin 20mg) - Frequently Asked Questions

What is ROZUSTAT 20MG Tablet used for?

ROZUSTAT 20MG Tablet, containing Rosuvastatin, is primarily used to lower high levels of cholesterol and triglycerides (fats) in the blood. It helps reduce "bad" cholesterol (LDL and total cholesterol) and triglycerides while increasing "good" cholesterol (HDL). By doing so, it significantly reduces the risk of heart disease, heart attack, and stroke. It is also prescribed for patients with familial hypercholesterolemia, a genetic condition causing very high cholesterol.

How does ROZUSTAT 20MG Tablet work?

ROZUSTAT 20MG Tablet belongs to a class of medicines called statins (HMG-CoA reductase inhibitors). It works by blocking an enzyme in the liver called HMG-CoA reductase, which is essential for the production of cholesterol. By inhibiting this enzyme, the medicine reduces the amount of cholesterol the body makes. Additionally, it enhances the liver's ability to remove low-density lipoprotein (LDL) cholesterol (often called "bad" cholesterol) from the bloodstream.

What is the usual dosage for ROZUSTAT 20MG Tablet?

The usual starting dose for adults is typically 5 to 20 mg once a day, though a specialist might prescribe up to 40 mg daily for patients at high cardiovascular risk who do not achieve target cholesterol levels with lower doses. For children and adolescents with familial hypercholesterolemia, dosages vary by age and condition (e.g., 5-20 mg daily for those 10-17 years old). It should be taken once daily, with or without food, preferably at the same time each day for consistent effect. Patients of Asian descent may require a lower starting dose. Always follow your doctor's specific instructions.

What are the possible side effects of ROZUSTAT 20MG Tablet?

Common side effects can include muscle pain (myalgia), headache, nausea, abdominal pain, dizziness, constipation, and general weakness or fatigue.

More serious, but rare, side effects that require immediate medical attention include:

  • Unexplained muscle pain, tenderness, weakness, or dark urine, which could indicate a serious muscle problem like rhabdomyolysis leading to kidney issues.
  • Symptoms of liver problems such as yellowing of the skin or eyes, dark urine, pale stools, or pain in the upper stomach.
  • Allergic reactions like rash, itching, hives, or swelling of the face, lips, tongue, or throat.
  • Increased blood sugar levels, which may slightly increase the risk of developing type 2 diabetes, especially in those already at high risk.

Is ROZUSTAT 20MG Tablet safe during pregnancy or breastfeeding?

Pregnancy: ROZUSTAT 20MG Tablet is highly unsafe and not recommended during pregnancy as it can harm the unborn baby. If you are pregnant, planning a pregnancy, or suspect you are pregnant, you must stop taking this medicine immediately and consult your doctor to discuss safer alternatives.

Breastfeeding: This medicine is generally not recommended while breastfeeding. Small amounts of rosuvastatin can pass into breast milk, and its effects on a nursing infant are not fully established, though it's unlikely to cause significant side effects. Your doctor will help you decide if you should stop taking the medicine or consider a safer alternative.

Can ROZUSTAT 20MG Tablet be taken with other medications?

ROZUSTAT 20MG Tablet can interact with other medicines. It is crucial to inform your doctor about all prescription, over-the-counter medications, herbal remedies, and supplements you are currently taking.

Notable interactions include:

  • Certain HIV medications (e.g., protease inhibitors like lopinavir, ritonavir, atazanavir) and cyclosporine (an immunosuppressant) can increase the levels of rosuvastatin in your body, raising the risk of side effects.
  • Other cholesterol-lowering drugs such as fibrates (e.g., gemfibrozil, fenofibrate) and niacin can increase the risk of muscle problems when taken with rosuvastatin.
  • Antacids containing aluminum and magnesium should be taken at least 2 hours after ROZUSTAT 20MG Tablet to avoid reduced absorption of rosuvastatin.
  • Warfarin (a blood thinner) can have its effects altered by rosuvastatin, requiring careful monitoring.
  • Colchicine (for gout) may increase the risk of muscle problems.
  • Some antibiotics (like erythromycin, fusidic acid), contraceptive pills, and hormone replacement therapy can also interact.

Your doctor may adjust your ROZUSTAT dose or recommend alternative medications if interactions are a concern.

What precautions should be taken while on ROZUSTAT 20MG Tablet?

It is very important for your doctor to monitor your progress with regular blood tests, including liver function tests and lipid profiles, to ensure the medicine is working effectively and to check for any unwanted effects.

Inform your doctor if you have:

  • Kidney disease or liver disease (the medicine is not recommended for severe or active liver disease).
  • Diabetes, as blood sugar levels may need to be monitored more closely.
  • Thyroid problems (especially inadequately treated hypothyroidism) or a history of muscle disorders.
  • A history of alcohol abuse.

Lifestyle modifications are crucial, including a healthy, low-fat diet, regular exercise, maintaining a healthy weight, and avoiding smoking and excessive alcohol consumption. You may need to temporarily stop the medication before major surgery or if you experience a major injury or serious health problem.

What happens if a dose of ROZUSTAT 20MG Tablet is missed?

If you miss a dose of ROZUSTAT 20MG Tablet, take it as soon as you remember on the same day. However, if it is 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 make up for the missed one, as this could increase the risk of side effects. If you frequently miss doses, speak to your doctor or pharmacist.

How should ROZUSTAT 20MG Tablet be stored?

ROZUSTAT 20MG Tablet should be stored in a cool, dry place, typically below 25°C or 30°C. Protect it from moisture and direct sunlight. Always keep the medicine out of the reach and sight of children and pets.