Avas 10 mg

Description

Indications:

Avas is indicated as an adjunct to diet for the reduction of elevated total cholesterol, LDL cholesterol, apolipoprotein B (Apo-B), and triglyceride levels in patients with conditions where diet and other non-pharmacological measures are insufficient.

• To reduce total cholesterol and LDL cholesterol in patients with heterozygous and homozygous familial hypercholesterolemia.
• To reduce elevated cholesterol and triglycerides in patients with mixed dyslipidemia (Fredrickson Type Ia and Ib).
• To treat elevated serum triglyceride levels in patients with hypertriglyceridemia (Fredrickson Type IV).
• To treat patients with dysbetalipoproteinemia (Fredrickson Type III).
• To reduce cardiac ischemic events in patients with asymptomatic or mild to moderate symptomatic coronary artery disease with elevated LDL-cholesterol levels.
• To reduce total and LDL-cholesterol concentrations in patients with hypercholesterolemia associated with or exacerbated by diabetes mellitus or renal transplantation.

Take the medicine as advised by a registered physician.

Pharmacology:

Atorvastatin is a selective inhibitor of HMG-CoA reductase, the enzyme responsible for converting HMG-CoA to mevalonate, a precursor of sterols including cholesterol. By inhibiting HMG-CoA reductase, atorvastatin lowers plasma cholesterol and lipoprotein levels, and increases the number of hepatic LDL receptors, promoting the uptake and breakdown of LDL cholesterol.

• Absorption: Atorvastatin is rapidly absorbed after oral administration, with peak plasma concentrations occurring within 1 to 2 hours. Absorption increases proportionally with dose. The absolute bioavailability of atorvastatin (the parent drug) is approximately 14%, and the systemic availability of HMG-CoA reductase inhibition is about 30%.

• Distribution: The mean volume of distribution is approximately 381 liters, and atorvastatin is 98% bound to plasma proteins. It is unlikely to penetrate red blood cells significantly. Based on animal studies, atorvastatin is likely excreted in human milk.

• Metabolism: Atorvastatin undergoes extensive metabolism into ortho- and parahydroxylated derivatives, along with various beta-oxidation products. These metabolites inhibit HMG-CoA reductase similarly to atorvastatin. About 70% of the circulating inhibitory activity is due to these active metabolites. The metabolism of atorvastatin involves cytochrome P450 3A4, and its plasma concentration may increase if co-administered with erythromycin, a P450 3A4 inhibitor.

• Excretion: Atorvastatin and its metabolites are mainly excreted in bile, following hepatic and/or extra-hepatic metabolism. The plasma half-life of atorvastatin is approximately 14 hours, while the half-life of its inhibitory effect is 20 to 30 hours due to the active metabolites. Less than 2% of atorvastatin is excreted in urine.

Dosage & Administration:

• Primary Hypercholesterolemia & Combined Hyperlipidemia:

  • Adults: 10 mg once daily, with a maximum dose of 80 mg per day after at least 4 weeks if necessary.
  • Children (10-18 years): Start at 10 mg once daily, potentially increasing to a maximum of 20 mg once daily after 4-week intervals.

• Familial Hypercholesterolemia:

  • Adults: Start at 10 mg daily, which can be increased to 40 mg after 4 weeks; if needed, further increase to 80 mg daily (or combine with anion-exchange resin for heterozygous familial hypercholesterolemia).
  • Children (10-18 years): Start at 10 mg once daily, which can be increased to 80 mg daily after 4 weeks.

• Prevention of Cardiovascular Events:

  • Adults: Start at 10 mg once daily and adjust based on response.

For optimal results, patients should follow a cholesterol-lowering diet before starting Atorvastatin and maintain this diet during treatment. After initiating treatment, lipid levels should be assessed within 2 to 4 weeks to adjust the dosage.

In pediatric patients (10-17 years), the recommended starting dose is 10 mg/day, with a maximum dose of 20 mg/day. Dosage adjustments should be made at intervals of at least 4 weeks.

Take the medicine as advised by a registered physician.

Drug Interactions:

The risk of myopathy increases when atorvastatin is coadministered with certain drugs, such as cyclosporine, fibric acid derivatives, niacin, erythromycin, and azole antifungals.

• Antacid: Co-administration of atorvastatin with an antacid suspension reduces atorvastatin plasma concentrations by approximately 35%, but LDL-C reduction remains unaffected.
• Colestipol: Co-administration decreases atorvastatin plasma concentrations by about 25%, but LDL-C reduction is greater when both drugs are taken together than when either is taken alone.
• Digoxin: When co-administered with atorvastatin, plasma digoxin concentrations may increase by about 20%.
• Erythromycin: Plasma concentrations of atorvastatin increase by 40% when taken with erythromycin, an inhibitor of cytochrome P450 3A4.
• Oral Contraceptives: A combination of atorvastatin and oral contraceptives may increase the plasma levels of norethindrone and ethinyl estradiol by 30% and 20%, respectively.
• Warfarin: Atorvastatin does not significantly affect prothrombin time in patients on chronic warfarin therapy.

Contraindications:

Atorvastatin is contraindicated in patients with hypersensitivity to any of its components, active liver disease, unexplained persistent elevation of serum transaminases, or a history of serious adverse reactions to prior use of HMG-CoA reductase inhibitors.

Side Effects:

Avas is generally well-tolerated. Common side effects include constipation, flatulence, dyspepsia, and abdominal pain. Other possible side effects include infection, headache, back pain, rash, fatigue, muscle or joint pain.

Pregnancy & Lactation:

• Pregnancy: Atorvastatin is contraindicated during pregnancy. Its safety has not been established in pregnant women, and animal studies show reproductive toxicity. Atorvastatin may decrease fetal mevalonate levels, a precursor to cholesterol biosynthesis. It should not be used in pregnant women or women planning to become pregnant.

• Lactation: It is unknown whether atorvastatin is excreted in human milk. Due to potential serious side effects, women taking atorvastatin should not breastfeed.

Precautions & Warnings:

• Liver Function: Liver function tests should be performed before starting treatment and periodically thereafter. Avas should be used with caution in individuals who consume significant amounts of alcohol or have a history of liver disease. Treatment should be discontinued if there are signs of myopathy or significantly elevated CPK levels.

• Geriatric: Plasma concentrations of Avas are higher in elderly individuals (65+ years), with greater LDL-lowering effects observed compared to younger adults.

• Pediatric: Limited pharmacokinetic data in the pediatric population. The drug should be used with caution in children.

• Renal Insufficiency: No dosage adjustments are necessary for patients with renal dysfunction.

• Hepatic Insufficiency: Plasma concentrations may be significantly increased in patients with chronic alcoholic liver disease.

Overdose Effects:

In the event of an overdose, specific treatment is unavailable. Symptomatic treatment and supportive care should be provided, and liver function and serum CK levels should be monitored.

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

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

Chemical Structure:

• Molecular Formula: C33H35FN2O5
• Chemical Structure: Atorvastatin Calcium Structure

Common Questions about Avas 10 mg Tablet:

• What is Avas 10 mg Tablet?
  Avas 10 mg Tablet is a statin used to reduce cholesterol levels and prevent heart attacks. It also treats conditions such as Mixed Dyslipidemia and Hypertriglyceridemia.

• How should I take Avas 10 mg Tablet?
  Take it once daily, with or without food, at the same time each day.

• What are the uses of Avas 10 mg Tablet?
  It is used to treat high cholesterol, mixed dyslipidemia, hypertriglyceridemia, and to prevent heart attacks.

• What are the side effects?
  Common side effects include constipation, flatulence, and abdominal pain. Consult a doctor if you experience serious effects such as muscle pain or weakness.

• How should Avas 10 mg Tablet be stored?
  Store it in a cool, dry place, away from direct sunlight and heat.

• Can Avas 10 mg Tablet cause weight loss?
  There are no studies indicating that this medication causes weight loss. If you experience unexpected weight loss, consult your doctor.

• Can I stop taking Avas 10 mg Tablet?
  Do not stop taking the medication without consulting your doctor, as this could worsen your condition.