Crestor 40 Mg Tablet ( 10 Tab )

CRESTOR 40 MG TABLET is a medication used to manage high cholesterol and related lipid disorders. It is manufactured by ASTRAZENECA PHARMA INDIA LIMITED.

Name

• Brand Name: CRESTOR 40 MG TABLET
• Common Name: Rosuvastatin (as Rosuvastatin Calcium)

Composition

Each film-coated tablet contains Rosuvastatin (as Rosuvastatin Calcium) equivalent to 40 mg rosuvastatin. Non-medicinal ingredients include lactose monohydrate.

Uses

CRESTOR is prescribed as an adjunct to diet to:

• Lower elevated levels of "bad" cholesterol (LDL-C), total cholesterol, and triglycerides.
• Increase "good" cholesterol (HDL-C).
• Treat primary hyperlipidemia, mixed dyslipidemia, heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia, hypertriglyceridemia, and primary dysbetalipoproteinemia.
• Slow the progression of atherosclerosis (buildup of fatty deposits in arteries).
• Reduce the risk of major cardiovascular events such as heart attack and stroke in adults with risk factors for coronary heart disease.

Dosage and Administration

CRESTOR 40 MG TABLET is taken orally once daily, with or without food, at any time of day. The tablet should be swallowed whole. The 40 mg dose is typically reserved for patients who have not achieved their LDL-C goal with a 20 mg dose. Dosage adjustments are usually made at intervals of four weeks or more. For patients of Asian descent, a lower starting dose may be recommended due to increased rosuvastatin exposure, and the 40 mg dose may be contraindicated. CRESTOR 40 mg is not suitable for children and adolescents under 18 years of age.

Side Effects

• Common Side Effects: Headache, nausea, constipation, muscle aches (myalgia), joint pain, weakness, dizziness, and stomach pain.
• Serious Side Effects: Include rhabdomyolysis (severe muscle breakdown that can lead to kidney damage), liver problems (indicated by unusual tiredness, loss of appetite, upper belly pain, dark urine, or yellowing of skin/eyes), severe allergic reactions (swelling of face, lips, tongue, difficulty breathing), pancreatitis, and elevated blood sugar levels which can lead to type 2 diabetes.

Precautions

• Contraindications: CRESTOR is contraindicated in pregnant or breastfeeding women, individuals with active liver disease, severe kidney problems, or those with unexplained muscle pain. Women of childbearing potential should use adequate contraception.
• Drug Interactions: Exercise caution when co-administering with cyclosporine, gemfibrozil, certain antiviral medications (e.g., sofosbuvir/velpatasvir/voxilaprevir), and some protease inhibitors, as these can increase rosuvastatin levels and the risk of myopathy. Antacids containing aluminum and magnesium hydroxide should be taken at least 2 hours after CRESTOR.
• Monitoring: Regular cholesterol checks, liver function tests, and blood sugar monitoring are essential during treatment.

Storage

Store CRESTOR 40 MG TABLET below 30°C (room temperature, 20-25°C). Keep the bottle tightly closed to protect from moisture and out of the sight and reach of children.

CRESTOR 40 MG TABLET: Frequently Asked Questions

What is CRESTOR used for?

CRESTOR (rosuvastatin) 40 mg tablet is primarily used to lower high levels of cholesterol and triglycerides (fats) in the blood. It helps reduce "bad" cholesterol (LDL-C) and increases "good" cholesterol (HDL-C). This, in turn, helps to reduce the risk of serious cardiovascular events such as heart attack, stroke, and the need for heart procedures in adults, especially those with existing risk factors for heart disease or certain inherited cholesterol disorders. It can also slow the progression of atherosclerosis (buildup of fatty deposits in arteries).

How does CRESTOR work?

CRESTOR belongs to a class of medications 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, CRESTOR reduces the amount of cholesterol the body makes. It also increases the number of LDL receptors on liver cells, which helps remove more "bad" cholesterol from the bloodstream, and inhibits the synthesis of very low-density lipoprotein (VLDL).

What is the usual dosage of CRESTOR 40 mg?

For adults, the typical dosage range for CRESTOR is 5 mg to 40 mg taken once daily. The 40 mg dose is the maximum recommended daily dose and is generally reserved for patients with very high cholesterol levels or those who have not achieved their target LDL-C goals with a 20 mg dose. It can be taken orally at any time of day, with or without food. Dosage adjustments are usually made by a doctor, often after assessing cholesterol levels as early as 4 weeks after starting treatment.

What are the possible side effects of CRESTOR?

Common mild side effects of CRESTOR may include headache, nausea, constipation, stomach pain, muscle pain or weakness, and dizziness. More serious, though rare, side effects can include:

• Liver problems: Symptoms like unusual tiredness, loss of appetite, upper belly pain, dark urine, or yellowing of the skin or eyes.
• Severe muscle problems (myopathy or rhabdomyolysis): This can involve unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or unusual tiredness, and can rarely lead to kidney damage.
• Increased blood sugar levels: This can potentially increase the risk of developing Type 2 diabetes. If you experience any severe or persistent side effects, you should contact your doctor immediately.

Is CRESTOR safe during pregnancy or breastfeeding?

CRESTOR is generally not recommended during pregnancy. Cholesterol is crucial for fetal development, and statins like CRESTOR may interfere with this process. If you become pregnant while taking CRESTOR, you should contact your doctor immediately. It is also generally advised to avoid breastfeeding while taking CRESTOR. The medication may pass into breast milk and could pose a risk to the baby. Your doctor can help determine the best course of action based on your individual health needs.

Can CRESTOR be taken with other medications?

CRESTOR can interact with several other medications, which may increase the risk of side effects or reduce its effectiveness. Important interactions include:

• Cyclosporine: Can significantly increase CRESTOR levels in the blood, potentially increasing side effects.
• Warfarin (a blood thinner): CRESTOR can increase the effect of warfarin, raising the risk of bleeding. Close monitoring of INR (International Normalized Ratio) is required.
• Certain Antacids (containing aluminum and magnesium hydroxide): These can reduce the absorption of CRESTOR. It's recommended to take CRESTOR at least 2 hours before taking such antacids.
• Fibrates (e.g., gemfibrozil, fenofibrate) and Niacin: Combining these with CRESTOR can increase the risk of severe muscle problems. Concomitant use with gemfibrozil should generally be avoided or the CRESTOR dose limited.
• Certain HIV/HCV protease inhibitors: These medications can increase rosuvastatin exposure, and the CRESTOR dose may need to be limited to 10 mg once daily. Always inform your doctor about all medications, supplements, and herbal products you are taking.

What precautions should be taken while taking CRESTOR?

Several precautions are important:

• Liver and Kidney Problems: CRESTOR is not recommended if you have active liver disease or severe kidney problems. Your doctor will perform blood tests to check your liver function before and during treatment.
• Muscle Pain: Report any unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or fatigue, to your doctor immediately.
• Diabetes: CRESTOR may increase blood sugar levels. If you have diabetes, your blood sugar may need to be monitored more frequently.
• Alcohol Consumption: Consuming large amounts of alcohol can increase the risk of liver problems when taking CRESTOR.
• Asian Descent: Individuals of Asian descent may have higher levels of CRESTOR in their blood, increasing the risk of side effects. A lower starting dose may be recommended.
• Age: Patients over 65 years of age may have an increased risk of muscle-related side effects.

What happens if a dose of CRESTOR is missed?

If you miss a dose of CRESTOR, take it as soon as you remember. However, if it is almost time for your next scheduled dose (e.g., within 12 hours), skip the missed dose and continue with your regular dosing schedule. Do not take a double dose or an extra dose to make up for a missed one.

How should CRESTOR be stored?

CRESTOR tablets should be stored at room temperature, typically between 20-25°C (68-77°F). It should be protected from light and moisture and kept in a dry place. Always keep CRESTOR, and all medicines, out of the reach and sight of children. Do not freeze the medication.