Atorvastatin (Atormed) 20mg Film Coated Tablet 100's

Description:
Used to lower lipids known as cholesterol and triglycerides in the blood when a low fat diet and life style changes on their own have failed.

Product Description:

Atorvastatin (Atormed) 20mg Film Coated Tablets are a statin medication used to help lower cholesterol levels in the blood. It works by blocking the enzyme HMG-CoA reductase, which is responsible for producing cholesterol in the liver. By reducing cholesterol production, Atorvastatin helps prevent the buildup of cholesterol in the arteries, which can reduce the risk of heart disease, strokes, and other cardiovascular events.

Each tablet contains 20mg of Atorvastatin and comes in a film-coated form, designed to be taken orally.

Key Features:

• Active Ingredient: Atorvastatin 20mg per tablet.

• Formulation: Film-coated tablet, making it easy to swallow.

• Mechanism of Action: Atorvastatin inhibits the enzyme HMG-CoA reductase, reducing cholesterol production in the liver.

• Indications: Used to lower total cholesterol, LDL cholesterol (bad cholesterol), and triglycerides, and to raise HDL cholesterol (good cholesterol).

• Packaging: Available in packs of 100 tablets.

Indications:

Atorvastatin (Atormed) 20mg film-coated tablets are indicated for:

1. Hypercholesterolemia:

   • To reduce total cholesterol, LDL-C (low-density lipoprotein cholesterol, also known as "bad" cholesterol), and triglycerides in adults and children aged 10 years and older with familial hypercholesterolemia or other types of primary hypercholesterolemia.

2. Prevention of Cardiovascular Events:

   • To reduce the risk of heart attack, stroke, and angina in patients with high cholesterol or other risk factors for cardiovascular disease (such as high blood pressure or diabetes).

   • To prevent major cardiovascular events in patients with existing atherosclerotic cardiovascular disease (ASCVD).

3. Dyslipidemia:

   • In addition to reducing cholesterol levels, Atorvastatin is effective in correcting abnormal lipid profiles in conditions such as mixed dyslipidemia (high levels of total cholesterol and triglycerides).

4. Primary Prevention of Cardiovascular Disease:

   • To reduce the risk of developing heart disease in patients with multiple risk factors but without established cardiovascular disease.

Dosage:

The dosage of Atorvastatin (Atormed) depends on the patient’s medical condition, cholesterol levels, and risk factors. The usual starting and maintenance dose is:

• For Adults:

  • Initial dose: 10mg to 20mg once daily, taken at any time of day, with or without food.

  • Maintenance dose: The dose can be adjusted based on the patient’s cholesterol levels, typically up to a maximum of 80mg per day. The dose can be increased after 4 weeks based on the target cholesterol level.

• For Children (aged 10-17 years):

  • Initial dose: 10mg once daily.

  • Maintenance dose: Adjusted according to the response, up to a maximum of 20mg daily.

Administration:

• Take the tablet once daily, preferably at the same time each day to help remember.

• It can be taken with or without food.

• Do not chew or crush the tablet; swallow it whole with a glass of water.

Side Effects:

Common side effects of Atorvastatin (Atormed) 20mg include:

• Headache.

• Muscle pain, muscle weakness, or cramps.

• Diarrhea or constipation.

• Nausea.

• Dizziness or fatigue.

• Abdominal pain.

Less common but serious side effects may include:

• Liver enzyme abnormalities: Elevated liver enzymes may occur, which could indicate liver damage.

• Myopathy (muscle pain or tenderness) or rhabdomyolysis (a rare but severe condition causing muscle breakdown and kidney failure).

• Allergic reactions: Rash, itching, swelling, and difficulty breathing.

• Memory loss or confusion (rare).

• Kidney issues: Kidney failure in rare cases.

If any serious side effects occur, such as severe muscle pain, weakness, or unusual tiredness, seek immediate medical attention.

Contraindications:

Atorvastatin (Atormed) should not be used in the following conditions:

1. Hypersensitivity to Atorvastatin or any of its ingredients.

2. Active liver disease or unexplained persistent elevations in liver enzymes.

3. Pregnancy: Atorvastatin is contraindicated during pregnancy due to the potential risk to the unborn child.

4. Breastfeeding: Atorvastatin is contraindicated in breastfeeding women because it passes into breast milk.

5. Severe renal impairment (kidney disease).

6. Concomitant use of strong CYP3A4 inhibitors: Such as clarithromycin, itraconazole, or HIV protease inhibitors as these can significantly increase Atorvastatin levels and increase the risk of side effects.

Warnings and Precautions:

• Liver Function: Monitor liver enzymes during treatment, especially in patients with a history of liver disease or heavy alcohol consumption.

• Muscle Symptoms: Patients should be monitored for muscle pain, tenderness, or weakness, especially if there are signs of muscle damage (e.g., dark-colored urine), which could indicate rhabdomyolysis.

• Pregnancy and Breastfeeding: Atorvastatin should not be used during pregnancy or while breastfeeding.

• Diabetes: Statins may increase blood sugar levels, so it is essential to monitor blood glucose levels regularly, especially in patients with risk factors for type 2 diabetes.

• Kidney Disease: Caution should be used when prescribing Atorvastatin to patients with moderate to severe renal impairment.

• Alcohol Use: Excessive alcohol use can increase the risk of liver problems when taking Atorvastatin.

Drug Interactions:

• CYP3A4 Inhibitors: Drugs like clarithromycin, itraconazole, ritonavir, and others may increase Atorvastatin blood levels, increasing the risk of side effects.

• CYP3A4 Inducers: Rifampicin and phenytoin may decrease Atorvastatin levels.

• Other Lipid-Lowering Agents: Combining Atorvastatin with other medications like gemfibrozil or other fibrates increases the risk of muscle side effects.

• Warfarin: Statins like Atorvastatin can enhance the effects of warfarin, increasing the risk of bleeding. Regular monitoring of INR (International Normalized Ratio) is necessary.

• Cyclosporine: Concomitant use with cyclosporine may increase the risk of statin side effects, including muscle damage.

• Grapefruit: Grapefruit or grapefruit juice may increase Atorvastatin levels due to inhibition of CYP3A4.

Storage:

• Store Atorvastatin (Atormed) tablets at room temperature (15°C to 30°C).

• Keep away from moisture, heat, and direct sunlight.

• Keep out of the reach of children.

• Do not use after the expiry date printed on the packaging.

Conclusion:

Atorvastatin (Atormed) 20mg is a widely used statin for lowering cholesterol and triglycerides levels, reducing the risk of cardiovascular diseases like heart attack and stroke. It is effective in managing hypercholesterolemia, dyslipidemia, and in preventing cardiovascular events. However, its use requires monitoring for liver and muscle side effects, and it is contraindicated during pregnancy and breastfeeding. Regular follow-up with a healthcare provider is essential to adjust the dose and manage any potential side effects.