Avas® 10 mg Tablet: Each film coated tablet contains Atorvastatin Calcium Trihydrate BP 10.825 mg equivalent to Atorvastatin 12 mg.
Avas® 20 mg Tablet: Each film coated tablet contains Atorvastatin Calcium Trihydrate BP 21.65 mg equivalent to Atorvastatin 20 mg.
Avas® 40 mg Tablet: Each film coated tablet contains Atorvastatin Calcium Trihydrate BP 43.30 mg equivalent to Atorvastatin 40 mg.
Atorvastatin (Avas ) is a synthetic lipid lowering agent.
Mode of action:
The formation of Mevalonate from HMG CoA by HMG CoA reductase is inhibited by atorvastatin which is the major rate limiting step in the cholesterol synthesis pathway. Atorvastatin inhibits this enzyme and thus inhibits cholesterol synthesis.
Pharmacokinetics:
Absorption: Atorvastatin is rapidly absorbed after oral administration and maximum plasma levels achieve within 1 to 2 hours. The absolute bioavailability of atorvastatin (parent drug) is approximately 12% and the systemic availability of HMG-CoA reductase inhibitory activity is approximately 30%. Although food reduces the rate and extent of drug absorption by.
approximately 25% and 9% respectively. Distribution: Atorvastatin is approximately 98% bound to plasma proteins. Metabolism:
Atorvastatin primarily metabolize through cytochrome P4503A4 hydroxylation to form active ortho- and parahydroxylated metabolites, as well as various beta-oxidation metabolites. Elimination: The mean plasma elimination half-life of atorvastatin in humans is approximately 14 hours, but the half-life of inhibitory activity for HMG-CoA reductase is 20 to 30 hours due to the contribution of active metabolites. Less than 2% of a dose of atorvastatin is recovered in urine following oral administration.
i. Primary hypercholesterolaemia and mixed dyslipidemia ii. Hypertriglyceridemia iii. Homozygous & heterozygous familial hypercholesterolaemia.
Dosage & administration: Adult dose: The patients should be placed on a standard cholesterol lowering diet before receiving atorvastatin and should continue on this diet during treatment with atorvastatin. Hypercholesterolaemia and mixed dyslipidemia: The recommended starting dose of atorvastatin is 10 mg daily. The dosage range is 10 to 80 mg once daily. Atorvastatin can be administered as a single dose at any time of the day with or without food. Homozygous & heterozygous familial hypercholesterolaemia: The dosage of atorvastatin in patients with homozygous familial hypercholesterolaemia is 10 to 80 mg daily.
Contraindications: Patients with known hypersensitivity to atorvastatin and liver disease cannot be prescribed atorvastatin.
Side effects: Constipation, Dyspepsia, Nausea, Diarrhea, Chest pain, Jaundice, Allergy etc.
Use in pregnancy & lactation: USFDA Pregnancy Category-X. HMG-CoA reductase inhibitors are not recommended for use during pregnancy & lactation.
Precautions: HMG-CoA reductase inhibitors, like some other lipid lowering agents, have been associated with biochemical abnormalities of liver function. Liver function tests should be performed before treatment starts at 6 weeks and 12 weeks after initiation of therapy or elevation in dose, and periodically thereafter.
Drug Interactions: Erythromycin, contraceptives, cholestipol, digoxin, cyclosporine, fibric acid derivatives, azole antifungals, nacin, antacid, warfarin, cimetidine.
Over dosage: There is no specific study for atorvastatin over dosage.
Storage: Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light.
Adult dose: The patients should be placed on a standard cholesterol lowering diet before receiving atorvastatin and should continue on this diet during treatment with atorvastatin. Hypercholesterolaemia and mixed dyslipidemia: The recommended starting dose of atorvastatin is 10 mg daily. The dosage range is 10 to 80 mg once daily. Atorvastatin can be administered as a single dose at any time of the day with or without food. Homozygous & heterozygous familial hypercholesterolaemia: The dosage of atorvastatin in patients with homozygous familial hypercholesterolaemia is 10 to 80 mg daily.
Erythromycin, contraceptives, cholestipol, digoxin, cyclosporine, fibric acid derivatives, azole antifungals, niacin, antacid, warfarin, cimetidine.
Over dosage: There is no specific study for atorvastatin over dosage.
USFDA Pregnancy Category-X. HMG-CoA reductase inhibitors are not recommended for use during pregnancy & lactation.
HMG-CoA reductase inhibitors, like some other lipid lowering agents, have been associated with biochemical abnormalities of liver function. Liver function tests should be performed before treatment starts at 6 weeks and 12 weeks after initiation of therapy or elevation in dose, and periodically thereafter.
Keep out of reach of children. Store in a dry place, below 25 C temperature and protected from light.