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