ROSUVASTATIN CALCIUM 10MG 30'S TAB (ROSADOC-10)

Product Description:

Rosuvastatin Calcium 10mg (Rosadoc-10) Tablet 30's is a medication belonging to the statin class of drugs, used primarily for lowering cholesterol and improving overall cardiovascular health. It works by inhibiting the action of the enzyme HMG-CoA reductase, which plays a key role in the production of cholesterol in the liver. By reducing cholesterol production, Rosuvastatin helps lower low-density lipoprotein (LDL) cholesterol (often called "bad" cholesterol), raise high-density lipoprotein (HDL) cholesterol (the "good" cholesterol), and reduce triglyceride levels in the blood.

Each tablet of Rosadoc-10 contains 10 mg of Rosuvastatin Calcium, and the product comes in a pack containing 30 tablets. This medication is typically used alongside dietary changes, exercise, and other lifestyle modifications to treat hyperlipidemia (high cholesterol) and to prevent cardiovascular diseases such as heart attack, stroke, and coronary artery disease.

Indications:

Rosuvastatin Calcium (Rosadoc-10) is indicated for:

• Hyperlipidemia: To lower elevated levels of total cholesterol, LDL cholesterol, and triglycerides in individuals with primary hyperlipidemia or mixed dyslipidemia.

• Prevention of cardiovascular events: To reduce the risk of heart attack, stroke, angina, and the need for heart surgery in individuals with cardiovascular risk factors, including hypertension, diabetes, and smoking.

• Atherosclerosis: To prevent the progression of atherosclerosis (plaque buildup in arteries) and reduce the risk of cardiovascular events in patients with known coronary artery disease (CAD).

• Familial Hypercholesterolemia: For the treatment of individuals with inherited high cholesterol levels.

• Primary prevention: In individuals at risk for developing cardiovascular diseases due to factors such as diabetes, high blood pressure, and elevated cholesterol.

Dosage:

The dosage of Rosuvastatin Calcium (Rosadoc-10) will depend on the patient’s cholesterol levels, cardiovascular risk, and response to treatment. Rosadoc-10 should be taken once daily, with or without food.

For Adults:

• Initial Dose: Typically, the starting dose for most patients is 10 mg once daily.

• Maintenance Dose: The dose may be adjusted after 4 weeks based on response to therapy. The usual maintenance dose ranges from 10 mg to 20 mg once daily.

• Maximum Dose: The maximum dose is 40 mg per day, although higher doses are typically used in patients with severe hyperlipidemia or those with higher cardiovascular risk.

For Children (ages 10-17 years):

• Starting Dose: For children with familial hypercholesterolemia, the starting dose is typically 5 mg daily.

• Usual Dose: The dose may be adjusted based on response, but it should not exceed 20 mg daily.

Renal or Hepatic Impairment:

• Renal Impairment: Dosage adjustment may be needed for patients with severe renal dysfunction.

• Hepatic Impairment: The medication should be used with caution in patients with liver disease, and dose adjustments may be required.

Side Effects:

Common side effects of Rosuvastatin Calcium (Rosadoc-10) may include:

• Headache.

• Muscle pain, tenderness, or weakness (myalgia).

• Abdominal pain or discomfort.

• Constipation or nausea.

• Fatigue or general weakness.

• Dizziness.

• Rash or itching.

Less common but serious side effects include:

• Rhabdomyolysis (severe muscle breakdown): Can lead to kidney damage, usually associated with muscle pain, tenderness, and weakness.

• Liver problems: Symptoms may include yellowing of the skin or eyes (jaundice), dark urine, or unusual fatigue.

• Kidney problems: Such as decreased urine output or swelling in the legs and ankles.

• Severe allergic reactions: Including swelling of the face, lips, tongue, or throat, and difficulty breathing (anaphylaxis).

• Elevated blood sugar levels: Rosuvastatin may increase the risk of developing diabetes.

• Memory loss or confusion: Rare but reported with statins.

• Heart issues: In rare cases, arrhythmias or abnormal heart rhythms may occur.

If any of these serious side effects occur, contact a healthcare provider immediately.

Contraindications:

Rosuvastatin Calcium (Rosadoc-10) should be avoided in the following situations:

• Hypersensitivity to Rosuvastatin or any other component of the formulation.

• Active liver disease: Including hepatitis, cirrhosis, or unexplained persistent elevation of liver enzymes.

• Pregnancy: Rosuvastatin is contraindicated during pregnancy due to potential harm to the fetus. Women who are pregnant or planning to become pregnant should not take Rosuvastatin.

• Breastfeeding: Rosuvastatin is contraindicated during breastfeeding as it may pass into breast milk and harm the infant.

• Severe renal impairment: In patients with severe kidney disease (especially those on dialysis), Rosuvastatin should be avoided or used with caution.

• Concurrent use with certain drugs: Rosuvastatin should not be used with cyclosporine, as this may significantly increase the risk of muscle-related side effects. Caution is also advised when used with gemfibrozil or other drugs that can increase the risk of muscle problems.

Precautions:

• Liver function: Liver function should be monitored before starting therapy and periodically during treatment. If liver enzymes increase significantly, discontinuation of the drug should be considered.

• Muscle symptoms: If you experience unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or malaise, it may indicate myopathy or rhabdomyolysis, and the medication should be discontinued immediately.

• Diabetes: Statins may increase blood sugar levels, and patients with diabetes or at high risk for diabetes should be monitored regularly.

• Alcohol consumption: Excessive alcohol consumption should be avoided during treatment with Rosuvastatin, as it can increase the risk of liver damage.

• Older adults: Patients over the age of 65 may be at higher risk for side effects like muscle pain, rhabdomyolysis, and liver dysfunction.

• Drug interactions: Always inform your doctor about other medications you are taking, including over-the-counter drugs, herbal supplements, and vitamins, as certain medications can interact with Rosuvastatin, leading to serious side effects.

Important Note: Rosuvastatin Calcium (Rosadoc-10) is typically used as part of a comprehensive treatment plan that includes diet and exercise. It is important to follow your healthcare provider's instructions closely regarding dosage, dietary changes, and exercise to achieve optimal cholesterol levels. Regular follow-up visits may be necessary to monitor cholesterol levels and any potential side effects.

Always consult your doctor or healthcare provider before starting or adjusting your medication regimen.