Composition
Each tablet contains:
Atorvastatin (as atorvastatin calcium)                 10 mg

Properties and Mode of Action
ATOR, atorvastatin, is a synthetic inhibitor of 3-hydroxy -3-methylglutaryl coenzyme-A reductase thus inhibiting the formation of mevalonate which is a precursor of sterols including cholesterol. Through the inhibition of 3-hydroxy -3-methylglutaryl co-enzyme-A, plasma cholesterol and lipoprotein levels especially LDL (low density lipoprotein) are lowered.
ATOR is effective in reducing LDL in cases of patients with homozygous familial hypercholesterolaemia which do not normally respond to lipid-lowering medications.
Some metabolites of ATOR are pharmacologically active.
ATOR is rapidly absorbed from the gastrointestinal tract after oral administration to give peak plasma concentrations within 1 - 2 hours of administration.
ATOR is strongly bound to plasma proteins (about 98%) and is extensively metabolized to ortho- and parahydroxylated derivatives and various beta-oxidation products.
ATOR and its metabolites are eliminated primarily in bile following hepatic and /or extrahepatic metabolism but less than 2% of a dose of ATOR is recovered in urine.
Mean plasma elimination half-life of ATOR is approximately 14 hours.

Indications
As an adjunct to diet for the reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in cases of primary hypercholesterolaemia, combined hyperlipidaemia and heterozygous and homozygous familial hypercholesterolaemia when response to diet and other pharmacological means are inadequate.

Dosage and Administration
The patient should take cholesterol-lowering diet before beginning therapy with ATOR and should continue during the therapy.
Normal dose of 10 mg (one tablet) once daily independent of mealtimes is sufficient to control primary hypercholesterolaemia and combined (mixed) hyperlipidaemia to give an evident response within 2 weeks with a maximum response within 4 weeks.
The dose can be increased gradually if needed at 4 - 6 weeks intervals up to 80 mg once daily.
For homozygous familial hypercholesterolaemia, most patients respond to 80 mg (8 tablets) once daily.
Geriatric patients or patients with renal insufficiency take the normal dose (10 mg once daily).

Precautions
Hypercholesterolaemia should be tried to be controlled with appropriate diet, exercise and weight reduction in obese patients and treating other underlying medical problems before beginning therapy with ATOR.
ATOR may cause elevation of creatine phosphokinase and transaminase levels.
Liver function tests should be performed before beginning therapy with ATOR and periodically thereafter.
Patients having any unexplained muscle aching or muscle weakness in conjunction with increase in creatine phosphokinase values especially if it is accompanied with malaise or fever, must consult the physician.

Drug Interactions
Concurrent administration of cyclosporine, fibric acid derivatives, erythromycin, niacin, azole antifungals or immunosuppressive drugs with ATOR may raise the risk of myopathy.
ATOR if co-administered with oral antacid suspension containing magnesium and aluminium hydroxides may decrease ATOR concentrations in plasma.
Colestipol when co-administered with ATOR may result in a greater lipid-reducing effect than when either drug is taken alone.
Concurrent administration of ATOR and digoxin increases steady - state plasma digoxin concentrations, thus the digoxin dose should be monitored appropriately.
Co-administration of erythromycin with ATOR causes a higher plasma concentration of ATOR.
The concomitant administration of oral contraceptives (containing norethindrone and ethinyl estradiol) and ATOR causes increased AUC values for norethindrone and ethinyl estradiol.

Contra_indications
Hypersensitivity to the drug.
Active liver disease.
Pregnancy or breast-feeding.

Side effects
The side effects of ATOR are mild, transient, few or rare and they include constipation, flatulence, dyspepsia, abdominal pain, headache, nausea, myalgia, asthenia, diarrhoea, insomnia, angioneurotic oedema, muscle cramps, myositis, myopathy, parasthesia, peripheral neuropathy, pancreatitis, anorexia, vomiting, alopecia, pruritus, rash, impotence, hyperglycaemia or hypoglycaemia.

Presentation
Box of 1 strip of 7 tablets.