COMPOSITION:

LOW-LIP 10 mg: Each film coated tablet contains: 10.845 mg Atorvastatin calcium 3 H2O equivalent to

10 mg Atorvastatin.

LOW-LIP 20 mg: Each film coated tablet contains: 21.69 mg Atorvastatin calcium 3 H2O equivalent to 20

mg Atorvastatin.

LOW-LIP 40 mg: Each film coated tablet contains: 43.385 mg Atorvastatin calcium 3 H2O equivalent to

40 mg Atorvastatin.

LOW-LIP 80 mg: Each film coated tablet contains: 86.76 mg Atorvastatin calcium 3 H2O equivalent to 80

mg Atorvastatin.

PHARMACOLOGICAL CLASSIFICATIONS

Lipid regulating drug.

INDICATIONS AND USAGE

LOW-LIP is indicated at significantly increased risk for atherosclerotic vascular disease due to

hypercholesterolemia.

LOW-LIP is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and

cholesterol and other nonpharmacologic measures alone has been inadequate.

LOW-LIP can be started simultaneously with diet in patients with CHD or multiple risk factors for CHD.

Prevention of Cardiovascular Disease:

– In patients without clinically evident coronary heart disease, but with multiple risk factors for coronary

heart disease such as age, smoking, low HDL-C, hypertension or a family history of early coronary heart

disease, LOW-LIP is indicated to:

• Reduce the risk of myocardial infarction.
• Reduce the risk of stroke.
• Reduce the risk for revascularization procedures and angina.

– In patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple

risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, LOWLIP

is indicated to:

• Reduce the risk of myocardial infarction
• Reduce the risk of stroke

– In patients with clinically evident coronary heart disease, LOW-LIP is indicated to:

• Reduce the risk of non-fatal myocardial infarction
• Reduce the risk of fatal and non-fatal stroke
• Reduce the risk for revascularization procedures
• Reduce the risk of hospitalization for CHF
• Reduce the risk of angina

LOW-LIP is also indicated in cases of Hyperlipidemia.

DOSAGE AND ADMINISTRATION

Hyperlipidemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Types

IIa and IIb):

The recommended starting dose of LOW-LIP is 10 or 20 mg once daily.

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

The dosage range of LOW-LIP is 10 to 80 mg once daily.

LOW-LIP can be administered as a single dose at any time of the day, with or without food.

The starting dose and maintenance doses of LOW-LIP should be individualized according to patient

characteristics such as goal of therapy and response. After initiation and/or upon titration of LOW-LIP, lipid

levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly.

Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 – 17 years of age)

The recommended starting dose of LOW-LIP is 10 mg/day; the maximum recommended dose is 20 mg/day.

Doses should be individualized according to the recommended goal of therapy and adjustments should be

made at intervals of 4 weeks or more.

Homozygous Familial Hypercholesterolemia

The dosage of LOW-LIP in patients with homozygous FH is 10 to 80 mg daily. LOW-LIP should be used as

an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments

are unavailable.

In Patients with Renal Impairment

Renal disease does not affect the plasma concentrations or LDL-C reduction of LOW-LIP; thus, dosage

adjustment in patients with renal dysfunction is not necessary.

Concomitant Lipid-Lowering Therapy

HOW SUPPLIED

Low-lip 10 mg: Pack of 10 film coated tablets.

Low-lip 10 mg: Pack of 20 film coated tablets.

Low-lip 10 mg: Pack of 30 film coated tablets.

Low-lip 20 mg: Pack of 10 film coated tablets.

Low-lip 20 mg: Pack of 30 film coated tablets.

Low-lip 40 mg: Pack of 10 film coated tablets.

Low-lip 40 mg: Pack of 20 film coated tablets.

Low-lip 80 mg: Pack of 10 film coated tablets.