Aztor 20 mg

Description

Indications
Aztor 10 mg Tablet is prescribed to help reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B (Apo-B), and triglyceride levels in patients who have not responded adequately to dietary and non-pharmacological measures alone. It is indicated for:

• Reducing total and LDL cholesterol levels in patients with heterozygous and homozygous familial hypercholesterolemia.
• Managing mixed dyslipidemia (Fredrickson Type Ia and Ib) to lower cholesterol and triglyceride levels.
• Treating elevated triglycerides in hypertriglyceridemia (Fredrickson Type IV).
• Managing dysbetalipoproteinemia (Fredrickson Type III).
• Reducing the risk of ischemic cardiac events in patients with high LDL cholesterol levels and mild to moderate symptomatic coronary artery disease.
• Controlling cholesterol levels in individuals with hypercholesterolemia associated with diabetes mellitus or post-renal transplantation.

Pharmacology
Aztor 10 mg contains atorvastatin, an HMG-CoA reductase inhibitor that reduces cholesterol synthesis in the liver. This leads to lower LDL cholesterol levels by increasing LDL receptor expression and enhancing LDL clearance from the bloodstream.

• Absorption: Rapidly absorbed, reaching peak plasma concentrations within 1-2 hours. Bioavailability is approximately 14%.
• Distribution: Volume of distribution is around 381 liters, and atorvastatin is 98% bound to plasma proteins.
• Metabolism: Extensively metabolized by cytochrome P450 3A4, with active metabolites contributing to its effect.
• Excretion: Eliminated via bile following hepatic metabolism. Half-life is about 14 hours, but inhibitory activity persists for 20-30 hours.

Dosage & Administration

• Primary Hypercholesterolemia & Mixed Dyslipidemia:
  • Adults: Start with 10 mg once daily, with dose adjustments at intervals of 4 weeks, up to a maximum of 80 mg daily.
  • Children (10-18 years): Starting dose of 10 mg daily, adjustable up to 20 mg daily.
• Familial Hypercholesterolemia:
  • Adults: Initial dose of 10 mg daily, increasing as needed up to 40 mg daily or 80 mg in severe cases.
  • Children (10-18 years): Start with 10 mg daily, adjustable up to 80 mg as required.
• Cardiovascular Event Prevention:
  • Adults: Initial dose of 10 mg daily, adjusted based on response.

Lipid levels should be monitored 2-4 weeks after starting therapy, with adjustments made accordingly. Patients should follow a cholesterol-lowering diet throughout treatment.

Drug Interactions

• Myopathy Risk: Increased when taken with cyclosporine, fibrates, niacin, erythromycin, or azole antifungals.
• Antacids: May reduce atorvastatin plasma concentration by about 35%, but the LDL-lowering effect remains unchanged.
• Colestipol: Lowers atorvastatin levels by approximately 25%, but combined therapy enhances LDL reduction.
• Digoxin: Increases steady-state plasma levels by 20%.
• Erythromycin: Raises atorvastatin plasma concentration by about 40%.
• Oral Contraceptives: Increases norethindrone and ethinyl estradiol levels by 30% and 20%, respectively.
• Warfarin: No significant effect on prothrombin time.

Contraindications

• Hypersensitivity to atorvastatin or its components.
• Active liver disease or persistent unexplained serum transaminase elevation.
• History of severe reactions to HMG-CoA reductase inhibitors.

Side Effects
Common side effects include constipation, flatulence, dyspepsia, and abdominal pain. Other possible effects include infections, headaches, back pain, skin rash, fatigue, joint pain, and muscle pain.

Pregnancy & Lactation

• Pregnancy: Contraindicated due to potential risks to fetal development.
• Lactation: Not recommended as it is unknown if atorvastatin is excreted in human milk.

Precautions & Warnings

• Liver Function: Monitor liver enzymes before and during treatment, especially in patients with liver disease or heavy alcohol use.
• Myopathy Risk: Discontinue use if unexplained muscle pain, weakness, or significant creatine kinase (CK) elevation occurs.

Special Populations

• Elderly: Higher plasma concentrations but similar efficacy.
• Pediatrics: Safety in children under 10 years not well established.
• Renal Impairment: No dose adjustment required.
• Hepatic Impairment: Plasma atorvastatin levels may be elevated in patients with liver disease.

Overdose Management
No specific antidote exists. Treatment should be supportive, with liver function and CK levels monitored. Hemodialysis is unlikely to be beneficial due to high plasma protein binding.

Therapeutic Class
Statins, Other Anti-anginal & Anti-ischemic Drugs

Storage Instructions
Store in a cool, dry place, away from direct heat and light. Keep out of reach of children.

Common Questions About Aztor 10 mg Tablet

• What is Aztor 10 mg used for? It helps lower high cholesterol and triglycerides and reduces the risk of cardiovascular events.
• How should I take it? Take once daily, with or without food, preferably at the same time each day.
• Can it cause diabetes? It may slightly raise blood sugar levels, so diabetics should monitor glucose levels.
• Is it safe for long-term use? Yes, if taken as prescribed.
• Can it be used by children? Approved for children over 10 years, with medical supervision.
• Does it thin the blood? No, it is a cholesterol-lowering drug, not a blood thinner.

Quick Tips

• Take it with food if it causes stomach discomfort.
• Report any persistent muscle pain or weakness.
• Regular liver function tests are recommended.
• Avoid use during pregnancy and breastfeeding.
• Maintain a healthy diet and lifestyle while on treatment.