It is primarily used in hypercholesterolaemia, heterozygous familial hypercholesterolaemia or combined (mixed) hyperlipidaemia and primary prevention in type II diabetes. Drug therapy is recommended as an adjunct to diet when the response to a diet is restricted in saturated fat and cholesterol and...
The patient should be placed on a standard cholesterol-lowering diet before receiving atorvastatin and should continue on this diet during treatment with atorvastatin. Atorvastatin can be administered with or without food. Doses should be individualized according to the recommended goal of therapy. ...
Hypercholesterolemia (Heterozygous Familial and Non-familial) and Mixed Dyslipidemia (Fredrickson Types IIa and IIb):
Initial dose: 10 - 20 mg/day
Maximum daily dose: 80 mg.
Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10-17 years of age):
Initial dose: 10 mg/day.
Maximum daily dose: 20 mg
Homozygous Familial Hypercholesterolemia:
Initial dose: 10 mg/day.
Maximum daily dose: 80 mg
Atorvastatin should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.
Dosage in Patients with Renal Insufficiency: Renal disease does not affect the plasma concentrations nor LDL-C reduction of atorvastatin; thus, dosage adjustment in patients with renal dysfunction is not necessary.
Use in Children for homozygous familial hypercholesterolemia:
Children > 9 years: Doses up to 80 mg/day. (Limited for duration of one year)
Each film-coated caplet contains:
Atorvastatin Calcium Trihydrate equivalent to Atorvastatin .... 10 mg.
It is HMG Co-A reductase inhibitor, lipid-regulating drug. Atorvastatin Calcium Trihydrate is calcium (3R,5R)-7-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxy-heptanoate trihydrate. Its molecular formula is C66H68CaF2N4O10,3H2O and molecular weight i...
Atorvastatin competitively inhibits 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase. By preventing the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin may increase the number of LDL receptors on the surface of hepatic cells an...
In patients with homozygous or heterozygous familial hypercholesterolemia, mixed dyslipidemia, isolated hypertriglyceridemia, or nonfamilial hypercholesterolemia, atorvastatin has been shown to reduce total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B), very...
Atorvastatin is rapidly absorbed after oral administration with a peak plasma concentration at 1 to 2 hours. Extent of absorption increases in proportion to atorvastatin dose. The absolute bioavailability of atorvastatin (parent drug) is approximately 14% and the systemic availability of HMG-CoA red...
It is contraindicated in patient with hypersensitivity to atorvastatin and patient with active liver disease or unexplained persistent elevations of serum transaminases.
Atorvastatin should be used with caution in patients with liver dysfunction; alcoholic patients and / or who have a history of liver disease.
It is recommended that liver function tests should be performed prior to and at 12 weeks following both the initiating of therapy and any elevation of dose, and periodically (e.g. semi-annually) thereafter. Atorvastatin therapy should be discontinued if markedly elevated CPK (Creatine Phosphokinase)...
Atorvastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards. An interval of 1 month should be allowed from stopping atorvastatin treatment to conception in the event of planning a pregnancy.
In rare case, atorvastatin therapy should be temporarily withheld or discontinued in any patient with an acute, serious conditions suggestive of a myopathy or having a risk factor predisposing to the development of renal failure secondary to rhabdomyolysis (e.g. severe acute infection, hypotension, ...
Common adverse effects are diarrhea, upset stomach, muscle and joint pain. The other side effects include headache, cold-like symptoms, nausea, dyspepsia, flatulence, constipation, spasm, insomnia, urinary tract infection, myalgia and asthenia.
Cyclosporine, Niacin (Acid), Erythromycin, Fibric Acid derivatives, and Azole Antifungals: Concurrent administration of atorvastatin may increase the toxicity of atorvastatin and increase the risk of myopathy.
Digoxin: Atorvastatin may increase the level or effect of digoxin when used concurrently.
Oral Contraceptives: The rate and extent of absorption of oral contraceptives containing norethindrone and ethinyl estradiol is increased when co-administered with atorvastatin.
Antacids: Decreased plasma concentrations of atorvastatin may occur when administered along with antacids; however, LDL cholesterol reduction is not altered.
Colestipol: Plasma concentrations of atorvastatin decreased approximately 25% when colestipol and atorvastatin were co-administered. However, LDL-C reduction was greater when atorvastatin and colestipol were co-administered than when either drug was given alone.
Store below 30°C in cool and dry place. Protect from light and moisture. Keep out of reach and sight of children.
10 x 10’s Alu-Alu Blisters.