ANZITOR 20 mg

Description

Indications
Anzitor is prescribed alongside a cholesterol-lowering diet to manage elevated cholesterol and lipid levels, including total cholesterol, LDL cholesterol, apolipoprotein B (Apo-B), and triglycerides, in the following conditions where diet and other non-pharmacological measures alone are insufficient:

Familial Hypercholesterolemia: To lower total cholesterol and LDL cholesterol in patients with heterozygous or homozygous familial hypercholesterolemia.
Mixed Dyslipidemia (Fredrickson Type Ia and Ib): For the reduction of elevated cholesterol and triglycerides in individuals with mixed dyslipidemia.
Hypertriglyceridemia (Fredrickson Type IV): For the treatment of patients with high serum triglyceride levels.
Dysbetalipoproteinaemia (Fredrickson Type III): For managing patients with this condition.
Cardiovascular Risk Reduction: To reduce the risk of cardiac ischemic events in patients with mild to moderate coronary artery disease who have elevated LDL cholesterol, especially those with asymptomatic conditions.
Hypercholesterolemia in Diabetes and Renal Transplantation: To lower total and LDL cholesterol levels in patients with hypercholesterolemia associated with or worsened by diabetes or renal transplantation.
Important Note: Always use this medication as prescribed by a registered healthcare professional.

Pharmacology
Anzitor contains atorvastatin, a potent selective inhibitor of HMG-CoA reductase, an enzyme involved in the synthesis of cholesterol. By inhibiting this enzyme, atorvastatin reduces cholesterol levels in the bloodstream and enhances the liver’s ability to clear LDL cholesterol by increasing the number of LDL receptors on liver cells.

Absorption: Atorvastatin is rapidly absorbed after oral administration, with peak plasma concentrations occurring 1 to 2 hours post-dose. The absorption is dose-dependent, with higher doses resulting in greater absorption. The absolute bioavailability of atorvastatin is around 14%, with the systemic availability of HMG-CoA reductase inhibitory activity at about 30%.

Distribution: Atorvastatin has a mean volume of distribution of approximately 381 liters and is 98% bound to plasma proteins. It has limited penetration into red blood cells.

Metabolism: Atorvastatin undergoes extensive metabolism in the liver and other tissues, producing active metabolites that contribute significantly to its cholesterol-lowering effect. The metabolism involves the cytochrome P450 3A4 enzyme system.

Excretion: Atorvastatin and its metabolites are primarily excreted in the bile. Only a small fraction (less than 2%) is excreted in the urine. The plasma elimination half-life of atorvastatin is about 14 hours, but the half-life for its cholesterol-lowering activity is 20 to 30 hours due to its active metabolites.

Dosage and Administration
Primary Hypercholesterolemia and Combined Hyperlipidaemia:

Adults: Typically 10 mg once daily. The dose can be increased in intervals of at least 4 weeks up to a maximum of 80 mg daily.
Children (10-18 years): Initially 10 mg once daily, with potential increases to a maximum of 20 mg daily after 4 weeks.
Familial Hypercholesterolemia:

Adults: Start with 10 mg daily, with increments every 4 weeks up to 40 mg daily; in some cases, the dose may be increased to 80 mg.
Children (10-18 years): Start with 10 mg daily, with possible increases up to 80 mg daily.
Prevention of Cardiovascular Events:

Adults: Starting dose of 10 mg daily, adjusted based on response.
Anzitor should be taken once daily, at the same time each day, with or without food. It is important to follow the prescribed cholesterol-lowering diet during treatment.

Interactions
Increased Risk of Myopathy: Concurrent use with cyclosporine, fibrates, niacin, erythromycin, or azole antifungals increases the risk of muscle-related side effects.
Antacids: When coadministered with antacid suspension, atorvastatin plasma concentrations decrease by approximately 35%, though LDL-C reduction remains unaffected.
Colestipol: Reduces atorvastatin plasma levels by 25%, but increases LDL-C reduction when combined.
Erythromycin: Co-administration with erythromycin, a P450 3A4 inhibitor, may increase atorvastatin plasma levels by about 40%.
Warfarin: Anzitor does not significantly affect prothrombin time in patients on chronic warfarin therapy.
Contraindications
Hypersensitivity to atorvastatin or any of its components.
Active liver disease or unexplained persistent elevations in serum transaminases.
History of serious adverse reactions to other statin medications.
Side Effects
Anzitor is generally well tolerated. Common side effects may include:

Constipation
Flatulence
Dyspepsia (indigestion)
Abdominal pain
Headache
Back pain
Rash
Muscle pain (myalgia), weakness (myopathy)
Asthenia (fatigue)
Rare side effects may include more severe muscle issues, liver problems, or allergic reactions.

Pregnancy and Lactation
Pregnancy: Atorvastatin is contraindicated during pregnancy. No controlled studies have been conducted in pregnant women, and animal studies suggest potential reproductive toxicity. Maternal use may reduce fetal cholesterol biosynthesis. Do not use this medication during pregnancy or if planning to become pregnant.
Lactation: It is unknown if atorvastatin is excreted in human milk. Since there is a potential for serious adverse reactions in breastfed infants, breastfeeding is not recommended during treatment with atorvastatin.
Precautions and Warnings
Liver Function: Regular liver function tests should be done before starting treatment and periodically thereafter. Anzitor should be used cautiously in patients with a history of liver disease or those who consume large amounts of alcohol.
Muscle Symptoms: If you experience unexplained muscle pain, tenderness, or weakness, inform your doctor immediately.
Diabetes: Anzitor may slightly raise blood sugar levels, so patients with diabetes should have their blood glucose monitored regularly.
Use in Special Populations
Geriatric: Elderly individuals may experience higher plasma concentrations of atorvastatin, but the drug remains effective in this population with no additional side effects.
Pediatric: Safety and efficacy in children below 10 years have not been established. In children aged 10-17, the maximum recommended dose is 20 mg per day.
Overdose
In case of overdose, treatment should be symptomatic and supportive. Liver function tests and serum creatine kinase levels should be monitored. Hemodialysis is unlikely to enhance clearance due to the drug’s extensive protein binding.

Therapeutic Class
Statins (Other Anti-anginal & Anti-ischemic drugs)
Storage
Store in a dry place, away from light and heat. Keep out of reach of children.

Chemical Information
Molecular Formula: C33H35FN2O5
Chemical Structure: Atorvastatin calcium
Frequently Asked Questions (FAQ)
What is Anzitor 20 mg Tablet?
Anzitor 20 mg Tablet is a statin used to lower cholesterol and triglycerides in the blood. It is commonly prescribed to manage conditions like hypercholesterolemia and prevent heart attacks.

How should I take Anzitor 20 mg Tablet?
Take one tablet daily, preferably at the same time each day, with or without food.

What are the side effects of Anzitor 20 mg Tablet?
Some common side effects include constipation, gas, indigestion, and muscle pain. Serious side effects should be reported immediately.

Can Anzitor 20 mg Tablet be prescribed to children?
Anzitor can be prescribed to children aged 10 years and above, but caution should be exercised. It is not recommended for children under 10 years.

Is Anzitor 20 mg Tablet safe for long-term use?
Yes, Anzitor is safe for long-term use when taken as prescribed by a doctor. Regular check-ups are recommended to monitor liver function and cholesterol levels.

Can Anzitor 20 mg Tablet cause weight loss?
Weight loss is not a typical side effect of Anzitor. Consult your doctor if you experience any unusual weight changes.