Atova 40 mg

Description

Atova 40 mg Tablet

Indications Atova is prescribed as an adjunct to dietary measures to lower elevated levels of total cholesterol, LDL cholesterol, apolipoprotein B (Apo-B), and triglycerides in patients where diet and other non-pharmacological interventions are insufficient. It is used for:

• Reducing total and LDL cholesterol in patients with heterozygous and homozygous familial hypercholesterolemia.
• Lowering elevated cholesterol and triglycerides in mixed dyslipidemia (Fredrickson Type Ia and Ib).
• Managing elevated serum triglyceride levels in hypertriglyceridemia (Fredrickson Type IV).
• Treating dysbetalipoproteinemia (Fredrickson Type III).
• Reducing cardiac ischemic events in individuals with asymptomatic or mild to moderate coronary artery disease and elevated LDL cholesterol levels.
• Managing hypercholesterolemia associated with or worsened by diabetes mellitus or renal transplantation.

Pharmacology Atorvastatin, the active ingredient in Atova, is a selective HMG-CoA reductase inhibitor. This enzyme plays a critical role in converting HMG-CoA to mevalonate, a precursor in cholesterol biosynthesis. By inhibiting this enzyme, Atorvastatin reduces plasma cholesterol and lipoprotein levels while increasing the number of hepatic LDL receptors, enhancing LDL uptake and breakdown.

• Absorption: Rapidly absorbed after oral administration, reaching peak plasma concentration within 1-2 hours. The extent of absorption increases proportionally with the dose. The absolute bioavailability is approximately 14%, while the systemic availability of HMG-CoA reductase inhibitory activity is around 30%.
• Distribution: The average volume of distribution is approximately 381 liters. About 98% of the drug binds to plasma proteins. Studies indicate that Atorvastatin may be secreted in human milk.
• Metabolism: It is extensively metabolized into ortho- and parahydroxylated derivatives and beta-oxidation products. Approximately 70% of circulating inhibitory activity comes from these active metabolites. The metabolism occurs primarily via cytochrome P450 3A4.
• Excretion: Eliminated mainly via bile after hepatic metabolism, with minimal enterohepatic recirculation. The plasma elimination half-life is approximately 14 hours, while the inhibitory activity lasts 20-30 hours due to active metabolites. Less than 2% is excreted via urine.

Dosage & Administration

• Primary Hypercholesterolemia & Combined Hyperlipidemia:
  • Adults: Initial dose of 10 mg once daily, adjustable to a maximum of 80 mg daily at four-week intervals.
  • Children (10-18 years): Start with 10 mg daily, increasing up to a maximum of 20 mg daily if needed.
• Familial Hypercholesterolemia:
  • Adults: Start with 10 mg daily, increasing up to 40 mg daily, or 80 mg daily if necessary.
  • Children (10-18 years): Start with 10 mg daily, increasing to a maximum of 80 mg daily in increments of at least four weeks.
• Prevention of Cardiovascular Events:
  • Adults: Begin with 10 mg once daily, adjusting based on response.

Patients should follow a cholesterol-lowering diet before and during treatment. Lipid levels should be checked within 2 to 4 weeks of initiation, with dosage adjustments as needed.

Drug Interactions

• Increased Risk of Myopathy: When taken with cyclosporine, fibric acid derivatives, niacin, erythromycin, or azole antifungals.
• Antacids: Reduce Atorvastatin plasma concentrations by about 35%, though LDL-lowering efficacy remains unchanged.
• Colestipol: Decreases Atorvastatin plasma concentrations by 25% but enhances LDL reduction when used together.
• Digoxin: Co-administration increases steady-state plasma digoxin levels by 20%.
• Erythromycin: Increases Atorvastatin plasma concentration by approximately 40%.
• Oral Contraceptives: Raises norethindrone and ethinyl estradiol levels by 30% and 20%, respectively.
• Warfarin: No clinically significant effects on prothrombin time.

Contraindications Atova should not be used in patients with:

• Hypersensitivity to any component.
• Active liver disease or unexplained persistent serum transaminase elevation.
• A history of serious adverse reactions to HMG-CoA reductase inhibitors.

Side Effects Atova is generally well-tolerated, but possible side effects include:

• Common: Constipation, flatulence, dyspepsia, abdominal pain.
• Others: Infection, headache, back pain, rash, asthenia, joint pain, muscle pain.

Pregnancy & Lactation

• Pregnancy: Contraindicated. Atorvastatin may cause fetal harm, and its use should be discontinued during pregnancy.
• Lactation: Not recommended, as Atorvastatin and its metabolites may be excreted in breast milk.

Precautions & Warnings

• Liver Function: Liver function tests should be conducted before starting treatment and periodically thereafter. Caution is advised in patients with a history of liver disease or alcohol consumption.
• Myopathy: Discontinue Atova if there is significant elevation in CPK levels or suspected muscle damage.

Use in Special Populations

• Elderly: Plasma levels are higher in individuals over 65 years of age.
• Pediatric: Pharmacokinetic data for pediatric patients is limited.
• Renal Impairment: No dose adjustment is required.
• Hemodialysis: Unlikely to enhance Atova clearance due to extensive plasma protein binding.
• Hepatic Impairment: Plasma concentrations are significantly increased in patients with chronic liver disease.

Overdose Management No specific treatment is available. Supportive care should be provided, including monitoring liver function and serum CK levels. Hemodialysis is unlikely to be effective.

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

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

Frequently Asked Questions

• What is Atova 40 mg Tablet used for? It is used for lowering cholesterol and triglycerides and for preventing heart attacks and cardiovascular diseases.
• How should I take Atova 40 mg Tablet? Take once daily, at the same time each day, with or without food.
• Can Atova 40 mg Tablet cause diabetes? It may slightly increase blood sugar levels in patients with type 2 diabetes; regular monitoring is recommended.
• Is Atova 40 mg Tablet safe for long-term use? Yes, if taken as prescribed by a doctor.
• Does it cause weight loss? Weight loss is not a reported side effect.
• Can I stop taking Atova 40 mg Tablet abruptly? No, discontinuing without medical advice can worsen the condition.
• Does Atova 40 mg Tablet cause memory loss? This is a rare side effect; consult a doctor if experienced.
• Can it be used in children? It is approved for children over 10 years, but caution is advised.
• Is Atova 40 mg Tablet a blood thinner? No, it lowers cholesterol but does not thin the blood.