Lipid-Lowering drugs
Atorvastatin (calcium) 40 mg /1 C.Tab
20Coated Tablets
T64
299/2008
18/12/2008
INDICATIONS | : Atorvastatin used for reduction of elevated cholesterol and triglyceride values which do not respond adequately to other measures (such as change in diet, physical exercise, weight loss) in patients with: - Elevated blood cholesterol values (primarily hypercholesterolemia). -Concurrently elevated cholesterol and triglyceride values in the blood (mixed hyperlipidemia). - Genetically determined elevated blood cholesterol values in familiar hypercholesterolemia. |
CONTRAINDICATIONS | - Hypersensitivity to any of its ingredients. - In liver disease I persistent elevations of hepatic function values (serum transaminases) has been found. - Suffering from disease of the skeletal muscles. - Pregnancy and nursing mothers. |
Side EFFECTS | : Atorvastatin 10 mg is usually well-tolerated. Side effects are usually mild. As with other drugs of this class, increase in the liver values (transaminases) have been observed among patients with Atorvastatin 10 mg. The changes were usually slight and transient and did not require termination of therapy. The following side effects were reported by more than 1% of patients taking Atorvastatin: constipation, flatulence, indigestion, stomach ache, headache, nausea, muscle pain (myalgias), muscle disease (myopathy), tingling (paresthesia), noninflammatory disease of the nerves (peripheral neuropathy), inflammation of the pancreas, inflammation of the liver, jaundice, loss of appetite, vomiting, loss of hair, itching, skin rash, impotence, elevated of reduced blood sugar. Chest pain, dizziness and allergic reactions have also been observed in isolated cases |
WARNINGS | : Liver function should be tested prior to the start of therapy and then at regular intervals. If the liver function values should increase to more than triple the normal level and persist over longer periods, dose reduction to atorvastatin 10 mg or withdrawal of therapy is recommended. If muscle pain sensitivity or weakness occurs please inform your doctor. |
DRUG INTERACTIONS | - Related medication of this substance class (HMG-CoA-reductase inhibitor) have been found to interact with drugs that suppress the body's defense reactions (such as cyclosporine), with other medications to reduce elevated blood lipid values (such as fibrate, nicotinic acid derivatives), with the antibiotic erythromycin and certain drugs against fungus infections (azol-type). - These interactions are experienced, among other things, as muscle pain and elevation of the muscle enzyme CPK. In rare cases, disintegration of the skeletal muscle cells (rhabdomyolysis) with renal failure have been observed. - These medications and macrolide type antibiotics should be taken at the same time with Atorvastatin 10 mg only on the express instructions of your doctor. - Concurrent administration of Atorvastatin and digoxin as well as certain oral contraceptives (the pill) results in moderate elevation of the plasma concentration of these medications. - Concurrent administration of drugs to reduce gastric acid (antacids containing magnesium or aluminum) results in a reduction in the Atorvastatin plasma concentration without any reduction in the cholesterol-reducing effect. Concurrent administration of erythromycin increases the plasma concentration of Atorvastatin. - Concurrent use of Atorvastatin 10 mg and warfarin, a drug to reduce viscosity of the blood, should be made under careful supervision by your doctor, especially at the start of therapy. |
Dosage And Administration | : The usual initial dose of 10 mg Atorvastatin once daily, the dose may be increased to maximum of 80 mg Atorvastatin per day. Atorvastatin can be taken with some liquid at any time of day, independent of mealtimes. |
Storage Conditions | “Keep medicaments out of reach of children” |