LOWLIP – PLUS

COMPOSITION:
LOWLIP – PLUS 10 / 10: Each film coated tablet contains 10 mg ezetimibe and 10.9 mg atorvastatin calcium (equivalent to 10 mg atorvastatin).
LOWLIP – PLUS 10 / 20: Each film coated tablet contains 10 mg ezetimibe and 21.7 mg atorvastatin calcium (equivalent to 20 mg atorvastatin).
LOWLIP – PLUS 10 / 40: Each film coated tablet contains10 mg ezetimibe and 43.4 mg atorvastatin calcium (equivalent to 40 mg atorvastatin).

Mechanism of Action:
Ezetimibe:
Ezetimibe reduces blood cholesterol by inhibiting the absorption of cholesterol by the small intestine.
Atorvastatin:
In animal models, atorvastatin lowers plasma cholesterol and lipoprotein levels by inhibiting HMG – CoA reductase and cholesterol synthesis in the liver and by increasing the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL; atorvastatin also reduces LDL production and the number of LDL particles.

Indications:
Therapy with lipid – altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy 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.
Primary Hyperlipidemia:
LOWLIP – Plus is indicated for the reduction of elevated total cholesterol (total – C), low – density lipoprotein cholesterol (LDL – C),
apolipoprotein B (Apo B), triglycerides (TG), and non – high – density lipoprotein cholesterol (non – HDL – C), and to increase high – density lipoprotein cholesterol (HDL – C) in patients with primary (heterozygous familial and non – familial) hyperlipidemia or mixed hyperlipidemia.
Homozygous Familial Hypercholesterolemia (HoFH):
LOWLIP – Plus is indicated for the reduction of elevated total – C and LDL – C in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid – lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.

DOSAGE AND ADMINISTRATION:
Recommended Dosing:
The dosage range is 10 / 10 mg / day to 10 / 80 mg / day. The recommended starting dose of is 10 / 10 mg / day or 10 / 20 mg / day. It can be administered as a single dose at any time of the day, with or without food. The recommended starting dose for patients who require a larger reduction in LDL – C (greater than 55 %) is 10 / 40 mg / day. After initiation and / or upon titration of the drug, lipid levels should be analyzed within 2 or more weeks and dosage adjusted accordingly. Patients should swallow tablets whole. Tablets should not be crushed, dissolved, or chewed.
Patients with Homozygous Familial

Hypercholesterolemia:
The dosage of the drug in patients with homozygous familial hypercholesterolemia is 10 / 40 mg / day or 10 / 80 mg / day. The drug should be used as an adjunct to other lipid – lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.

Storage conditions:
Store between 15 – 30 C. Keep out of the reach of children.

Packaging:
LOWLIP – Plus 10 / 10: A pack contains of 30 F.C.T.
LOWLIP – Plus 10 / 20: A pack contains of 30 F.C.T.
LOWLIP – Plus 10 / 40: A pack contains of 30 F.C.T.