Atorvastatin Calcium (Choltrol) 40mg Film Coated Tablet 100's

Here is the detailed information for Atorvastatin Calcium (Choltrol) 40mg Film-Coated Tablet 100's:

Product Description:

Atorvastatin Calcium (Choltrol) 40mg is a lipid-lowering medication that belongs to a class of drugs called statins. It works by reducing the levels of bad cholesterol (LDL) and triglycerides in the blood while increasing good cholesterol (HDL). It is used to help lower cholesterol levels and reduce the risk of cardiovascular diseases, including heart attack, stroke, and other heart-related complications.

Each Choltrol 40mg tablet is film-coated to make it easier to swallow and to protect the active ingredient from degradation. This packaging contains 100 tablets, which is suitable for long-term treatment regimens.

Indications:

Atorvastatin (Choltrol) 40mg is indicated for:

1. Hypercholesterolemia (High Cholesterol Levels):

   • As an adjunct to diet for the treatment of primary hypercholesterolemia (elevated LDL cholesterol) or mixed dyslipidemia (elevated LDL and triglycerides) in adult patients.

2. Cardiovascular Disease Prevention:

   • To reduce the risk of myocardial infarction (heart attack), stroke, and other cardiovascular events in patients at high risk of developing heart disease, including those with hypertension, diabetes, or a history of cardiovascular events.

3. Familial Hypercholesterolemia:

   • For the treatment of familial hypercholesterolemia (an inherited condition causing high cholesterol) in both adults and children aged 10 years and older.

4. Prevention of Cardiovascular Events:

   • To reduce the risk of heart attacks, strokes, and the need for coronary revascularization in patients with existing coronary artery disease (CAD) or those at high risk for cardiovascular events.

Dosages:

The dosage of Atorvastatin (Choltrol) 40mg should be individualized based on the patient's condition and response to treatment. The usual dosage recommendations are as follows:

For Adults:

1. Primary Hypercholesterolemia or Mixed Dyslipidemia:

   • The initial dose is typically 10-20mg once daily.

   • The dose can be adjusted based on the patient's LDL levels and therapeutic response, with a usual dose range of 10mg to 80mg once daily.

2. Cardiovascular Disease Prevention (Secondary Prevention):

   • For patients at high risk of cardiovascular events, the starting dose is typically 40mg once daily.

   • Dosing can be adjusted depending on therapeutic goals, up to a maximum of 80mg daily.

3. Familial Hypercholesterolemia:

   • In children aged 10 years or older, the initial dose is typically 10mg once daily, and the dose can be increased to a maximum of 80mg based on the child's LDL levels.

Dosage Adjustment in Renal Impairment:

• Atorvastatin should be used with caution in patients with severe renal impairment. No dosage adjustment is typically required for mild to moderate kidney problems.

Dosing in the Elderly:

• For elderly patients (aged 65 years or older), the initial dose and subsequent adjustments should be based on individual cholesterol goals and tolerance.

Side Effects:

Atorvastatin (Choltrol) 40mg is generally well-tolerated, but some side effects may occur. Common side effects include:

Common Side Effects:

1. Muscle Pain (Myalgia):

   • Some patients may experience muscle pain or weakness.

2. Gastrointestinal Issues:

   • Nausea, diarrhea, constipation, flatulence, or dyspepsia (indigestion).

3. Headache:

   • A mild headache may occur in some individuals.

4. Elevated Liver Enzymes:

   • Changes in liver enzyme levels may be observed during treatment, which usually resolve after stopping the medication.

5. Rash:

   • Some patients may develop a mild rash or skin irritation.

Serious Side Effects (Less Common but Serious):

1. Rhabdomyolysis:

   • Rarely, muscle breakdown (rhabdomyolysis) can occur, leading to kidney failure. Symptoms include severe muscle pain, tenderness, and weakness.

2. Liver Toxicity:

   • Hepatitis or liver failure. Symptoms include jaundice (yellowing of the skin/eyes), dark urine, and persistent stomach pain.

3. Severe Allergic Reactions:

   • Anaphylaxis, swelling of the face, lips, tongue, or throat, which can cause breathing difficulties.

4. Cognitive Effects:

   • Some patients have reported memory loss or confusion, although these are generally rare.

5. Pancreatitis:

   • Inflammation of the pancreas (pancreatitis), which can cause severe abdominal pain, nausea, and vomiting.

Contraindications:

Atorvastatin (Choltrol) 40mg should not be used in the following situations:

1. Hypersensitivity:

   • If you are allergic to atorvastatin or any other component of the formulation.

2. Active Liver Disease:

   • Contraindicated in patients with active liver disease or unexplained persistent elevations in liver enzymes.

3. Pregnancy and Breastfeeding:

   • Atorvastatin should not be used during pregnancy due to potential harm to the fetus (Category X). Women who are pregnant or planning to become pregnant should avoid taking this medication.

   • Breastfeeding is also contraindicated, as atorvastatin can pass into breast milk and affect the nursing infant.

4. Muscle Disorders:

   • Myopathy or a history of rhabdomyolysis related to previous statin therapy is a contraindication for Atorvastatin use.

5. Severe Renal Impairment:

   • Use with caution in patients with severe renal impairment, especially when the dose is high.

6. Children:

   • Should not be used in children under 10 years of age for conditions other than familial hypercholesterolemia.

Precautions:

1. Liver Function Monitoring:

   • Regular monitoring of liver function is advised, especially during the initial months of treatment.

2. Muscle Symptoms:

   • If patients experience unexplained muscle pain, tenderness, or weakness, they should seek medical attention immediately, as these may be signs of serious muscle damage (rhabdomyolysis).

3. Drug Interactions:

   • Atorvastatin can interact with other medications such as cyclosporine, certain antibiotics, HIV protease inhibitors, and some antifungal medications. These interactions can increase the risk of muscle damage or liver toxicity.

   • Grapefruit juice should be avoided as it can increase atorvastatin levels in the blood.

4. Diabetes Risk:

   • Statins like atorvastatin have been associated with an increased risk of developing type 2 diabetes, especially in patients with other risk factors for diabetes.

5. Alcohol Use:

   • Limit alcohol consumption during treatment, as excessive alcohol can increase the risk of liver problems.

Summary:

Atorvastatin (Choltrol) 40mg is a statin used to lower cholesterol and reduce the risk of cardiovascular events such as heart attacks and strokes. It is generally dosed at 10mg to 80mg per day depending on the patient's condition and therapeutic goals. Common side effects include muscle pain, gastrointestinal symptoms, and headache, while rare but serious side effects include rhabdomyolysis and liver toxicity.

The drug is contraindicated in patients with active liver disease, pregnancy, breastfeeding, and those with a history of muscle disorders related to statins. Regular monitoring of liver function and muscle symptoms is advised during treatment.