Description
Generics: Atorvastatin Calcium.
Dosage Form: Tablet.
Indications:
Atorvastatin is indicated as an adjunct to diet to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B (Apo-B) and triglycerides levels in following diseases when response to diet and other non-pharmacological measures is inadequate.
- To reduce total cholesterol and LDL cholesterol in patients with heterozygous and homozygous familial hypercholesterolaemia.
- To reduce elevated cholesterol and triglycerides in patient with mixed dyslipidemia (Fredrickson Type Ia and Ib).
- For the treatment of patients with elevated serum triglyceride levels in hypertriglyceridaemia (Fredrickson Type IV).
- For the treatment of patients with dysbetalipoproteinaemia (Fredrickson Type III).
- To reduce cardiac ischaemic events in patients with asymptomatic or mild to moderate symptomatic coronary artery disease with elevated LDL-cholesterol level.
- To reduce total and LDL-cholesterol concentrations patients with hypercholesterolemia associated with or exacerbated by diabetes mellitus or renal transplantation.
Pharmacology:
Atorvastatin is a selective HMGCoA reductase inhibitor. This enzyme is the limiting enzyme responsible for converting HMGCoA to mevalonate, which is the precursor to sterols (including cholesterol). Atorvastatin reduces plasma levels of cholesterol and lipoproteins by inhibiting HMGCoA reductase and cholesterol synthesis in the liver, and increases the number of hepatic LDL receptors on the cell surface to enhance absorption and catabolism of LDL.
Dosage guideline:
One times in daily.
Primary hypercholesterolemia and combined hyperlipidemia
- adults: usually 10 mg daily; if necessary, it can be increased to at least every 4 weeks. 80 mg once a day.
- children (10 to 18 years): Initially 10 mg per day, increasing to the usual maximum dose every at least 4 weeks if necessary. 20 mg once a day.
Familial hypercholesterolemia
- Adults: Initially 10 mg per day, increasing to 40 mg per day every at least 4 weeks; if necessary, increase further to the maximum. 80 mg once daily (or 40 mg once daily in combination with anion exchange resin in heterozygous familial hypercholesterolaemia).
- children (10 to 18 years): Initially 10 mg per day, increasing to the usual maximum dose every at least 4 weeks if necessary. 80 mg once a day.
Prevention of cardiovascular events
- Adults: Initially 10 mg per day, adjusted for response.
Route of administration: Orally.
Interaction:
The risk of myopathy during treatment with Aztor 10 increases with simultaneous administration of cyclosporine, fibric acid derivatives, erythromycin, azole antifungals and niacin. When atorvastatin was used in combination with antihypertensive or hypoglycemic drugs, no clinically significant interactions were observed. If atorvastatin is added to digoxin, erythromycin, oral contraceptives, colestipol, antacids, and warfarin, the patient should be closely monitored.
Contraindications:
Aztor 10 should not be used in patients who are allergic to any component of the drug. Aztor 10 is contraindicated for active liver disease or continuous and unexplained increase in serum transaminase. It is also contraindicated in patients with a history of serious adverse reactions to the previous use of HMGCoA reductase inhibitors.
Side Effects:
Aztor 10 is usually well tolerated. The most common side effects of atorvastatin are constipation, flatulence, indigestion, and abdominal pain. Other side effects include infection, headache, back pain, skin rash, weakness, joint pain, and myalgia.
Pregnancy & Lactation:
Pregnancy: Atorvastatin is contraindicated during pregnancy. The safety of pregnant women has not been determined. No controlled clinical trials of atorvastatin have been conducted in pregnant women. Rare reports of birth defects have been received after intrauterine exposure to HMGCoA reductase inhibitors. Animal studies have shown that it is toxic to reproduction. Treatment of mothers with atorvastatin may reduce the level of mevalonate in the fetus, which is a precursor of cholesterol biosynthesis. Atorvastatin should not be used in women who are pregnant, trying to become pregnant, or are suspected of becoming pregnant. Atorvastatin treatment should be stopped during pregnancy or before it is determined that the woman is not pregnant.
Lactation period: It is unknown whether atorvastatin or its metabolites are excreted from human milk. In rats, the plasma concentrations of atorvastatin and its active metabolite are similar to those in milk. Due to the possibility of serious adverse reactions, women taking atorvastatin should not breastfeed their babies. Atorvastatin is contraindicated during lactation.
Precautions & Warnings:
Liver effect: liver function tests should be performed regularly before and after treatment. Patients who drink a lot of alcohol or have a history of liver disease should use atorvastatin with caution. If there is a significant increase in CPK levels or myopathy is diagnosed or suspected, treatment with atorvastatin should be discontinued.
Therapeutic Class:
Other Anti-anginal & Anti-ischaemic drugs, Statins
Storage Conditions:
Keep in a dry place, away from light and heat. Keep out of the reach of children.
Manufactured by: Sun Pharmaceutical Industries Ltd.
