ALSWISS Tablet

-Adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B and triglycerides in adults and children aged 10 years or older with primary hypercholesterolaemia including familial hypercholesterolaemia or combined (mixed) hyperlipidaemia

- Prevention of cardiovascular events in adult patients estimated to have a high risk for a first cardiovascular event, as an adjunct to correction of other risk factors.

Dosage

10-20mg once daily. Patients who require a large reduction in LDL-C (more than 45%) may be started at 40mg once daily.

In patients;

- with hypersensitivity to the active substance or to any of the excipients

- with active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal.

The commonest adverse effects are gastrointestinal disturbances. Other adverse effects reported include headache, skin rashes, dizziness, blurred vision, insomnia and dysgeusia. Reversible increase in serum-aminotransferase concentrations may occur and liver function should be monitored. Hepatitis and pancreatitis have been reported. Hypersensitivity reactions including anaphylaxis and angioedema have also occurred. Myopathy, characterized by myalgia and muscle weakness and associated with increased creatine phosphokinase concentration, has been reported.

Rarely rhabdomyolysis with acute renal failure may develop.

Products that may interact with this atorvastatin include: cyclosporine, gemfibrozil, telaprevir, tipranavir plus ritonavir. Other medications can affect the removal of atorvastatin from our body, which may affect the mechanism include colchicine, telithromycin, certain azole antifungals (such as itraconazole, ketoconazole, posaconazole).

Pregnancy

It should be avoided during pregnancy since there is a possibility that they could interfere with fetal sterol synthesis.

Breast-feeding

Because of the potential of serious adverse reactions, women taking atorvastatin should not breast feed their infants. Atorvastatin in contraindicated in breast feeding.

It should not be given to patients with active liver disease or renal impairment. It should not be used in patients with unexplained persistently raised serum-aminotransferase concentrations and should be stopped if marked or persistent increases. They should be used in caution in patients at risk of rhabdomyolysis and particularly in patients taking drugs that increase plasma concentration. Atorvastatin should be stopped if creatine phosphokinase increases significantly or if myopathy is diagnosed.

Atorvastatin calcium is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 2-hydroxy-e-methyl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol. Cholesterol and triglycerides circulate in the bloodstream as part of lipoprotein complexes. With ultracentrifugation, these complexes separate into HDL, IDL, LDL and VLDL fractions. Triglycerides (TG) and cholesterol in the liver are incorporated into VLDL and released into the plasma for delivery to peripheral tissues. LDL is formed from VLDL and is catabolized primarily through the high-affinity LDL receptor. Clinical and pathologic studies show that elevated plasma levels of total cholesterol (total-C), LDL-cholesterol, and apolipoprotein B promote human atherosclerosis and are risk factors for developing cardiovascular disease, while increased levels of HDL-C are associated with a decreased cardiovascular risk.