Generic : Atorvastatin
Therapeutic : Atorvastatin

Tigilo

Atorvastatin

Composition :

Tigilo 10 Tablet : Each film coated tablet contains Atorvastatin 10 mg as Atorvastatin  Calcium USP.

Description :

Tigilo is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme responsible for the conversion of 3-hydroxy-3-methyl-glutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol. Tigilo lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL. Tigilo reduces LDL production and the number of LDL particles.

Indications :

Tigilo is indicated as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in patients with-

• Primary hypercholesterolemia

• Elevated serum TG levels

• Primary dysbetalipoproteinemia (Fredrickson type III) who do not respond adequately to diet

• Homozygous familial hypercholesterolemia

• Prevention of cardiovascular events in patients at high risk of a first cardiovascular event

Dosage and Administration :

Patients should be placed on a standard cholesterol-lowering diet before receiving Tigilo. The usual starting dose for all the indications is 10 mg once daily. The dosage range is 10 to 80 mg once daily. Doses should be individualised according to baseline LDL-C levels, the goal of therapy and patient response. Adjustment of dosage should be made at intervals of 4 weeks or more. Doses may be given at anytime of day with or without food.

Side effects :

Atorvastatin is generally well tolerated. Adverse reactions have usually been mild and transient. Reversible myositis is rare but significant side effect of the statins. The statins also cause headache, altered liver-function tests and gastro-intestinal effects including abdominal pain, flatulence, diarrhoea, nausea and vomiting. Thrombocytopenia, rash and hypersensitivity reactions have been reported rarely. Other side effects reported with Atorvastatin therapy include insomnia, angioedema, anorexia, asthenia, paraesthesia, peripheral neuropathy, alopecia, pruritus, rash, impotence, chest pain, hypoglycemia and hyperglycemia.

Use in special group :     

Pregnancy and Lactation :

Atorvastatin is contraindicated in pregnancy and while breast-feeding. Women of child bearing potential should use appropriate contraceptive measures. If the women become pregnant while taking Atorvastatin, it should be discontinued.

Contraindications :

Atorvastatin is contraindicated in patients with hypersensitivity to any component of this medication, active liver disease or unexplained persistent elevations of serum transaminases, during pregnancy, while breast-feeding and in women of child-bearing potential not using appropriate contraceptive measures.

Precautions :

Liver effects: Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease.

Skeletal muscle effects: Uncomplicated myalgia has been reported in Atorvastatin- treated patients. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.

Drug Interaction :

The risk of myopathy during treatment with other drugs in this class is increased with concurrent administration of cyclosporin, fibric acid derivatives, erythromycin, azole antifungals or niacin (nicotinic acid). These risks may also occur when combining these drugs with Atorvastatin. No clinically significant interactions were seen when Atorvastatin was administered with antihypertensives and or hypoglycemic agents. Caution should also be exercised when Atorvastatin is administered with inhibitors of P450 3A4 (macrolide antibiotics and azole antifungals).

Storage :

Store in a cool and dry place, away from light. Keep out of the reach of children.

Commercial Pack :

Tigilo 10 Tablet : Each box contains 3 X 10 tablets in Alu-Alu blister pack.

Tigilo 20 Tablet : Each box contains 3 X 10 tablets in Alu-Alu blister pack.

Medicine are subject to availability and supply from the production company. The information provided herein is accurate, updated and complete as per the best practices of the Company. Please note that this information should not be treated as a replacement for physical medical consultation or advice with a doctor. We do not guarantee the accuracy and the completeness of the information so provided. The absence of any information and/or warning to any drug shall not be considered and assumed as an implied assurance of the Company. We do not take any responsibility for the consequences arising out of the aforementioned information and strongly recommend you for a physical consultation in case of any queries or doubts.