Composition

Each Lipolysin 40 mg film-coated tablet contains:  

• Atorvastatin calcium: 40 mg.
• Excipients: S.Q. for one film-coated tablet.

Indications

Prevention of Cardiovascular Disease

In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age ≥ 55 years, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, Lipolysin is indicated to:

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

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, Lipolysin is indicated to:

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

In patients with clinically evident coronary heart disease, Lipolysin 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.

Hyperlipidemia

Lipolysin is indicated:

• As an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb).
• As an adjunct to diet for the treatment of patients with elevated serum Triglycerides levels (Fredrickson type IV).
• For the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet.
• To reduce 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 treatment are unavailable.
• As an adjunct to diet to reduce total-C, LDL-C, and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present:
  • LDL-C remains ≥ 190mg/dL or
  • LDL-C remains ≥ 160mg/dL and:
  • There is a positive family history of premature cardiovascular  disease or.
  • Two or more than cardiovascular disease (CVD) risk factors are present in the pediatric patient.

Therapy with lipid-altering agents should be a component of multiple-risk-factor intervention in individual at increased risk for atherosclerotic vascular disease due to hypercholesterolemia.

After the LDL-C goal has been achieved, if the triglycerides are still ≥ 200 mg/dL, non-HDL-C (total-C minus HDL-C) becomes a secondary target of therapy. Non-HDL-C goals are set 30 mg/dL higher than LDL-C goals for each risk category.

For patients with triglycerides (TG) < 400 mg/dL, LDL-C can be estimated using the following equation: LDL-C = (total-C) – (0.20 X [TG] + HDL-C). For TG levels > 400 mg/dL, this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation.

Atorvastatin has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).

The classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature cardiovascular disease is summarized below:

Dosage & Administration

A standard cholesterol-lowering diet should be performed by the patient before receiving Lipolysin, and should continue on this diet during treatment with Lipolysin.

Hyperlipidemia (Heterozygous Familial and Nonfamilial) and mixed Dyslipidemia (Fredrickson Types IIa and IIb)

The recommended starting dose 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 is 10 to 80 mg once daily. Lipolysin can be administered as a single dose at any time of the day, with or without food. After initiation and / or upon titration of Lipolysin, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly since the goal of the treatment is to lower LDL-C, the LDL-C levels are used now to initiate and assess treatment response. Only if LDL-C levels are not available, should total-C be used to monitor therapy.

Heterozygous Familial Hypercholesterolemia in Pediatric Patients

(10 – 17 years of age)

The recommended starting dose of Lipolysin is 10 mg/day; the maximum recommended dose is 20 mg / day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy. Adjustments should be made at intervals of 4 weeks or more.

Homozygous Familial Hypercholesterolemia

The dosage of Lipolysin in patients with homozygous FH is 10 mg to 80 mg daily.

Lipolysin should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.

Concomitant Therapy:

Atorvastatin may be used in combination with a bile acid binding resin for additive effect. The combination of HMG-CoA reductase inhibitors and fibrates should generally be avoided.

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.

Dosage in Patients Taking Cyclosporine, Clarithromycin, Itraconazole, or a Combination of Ritonavir Plus Saquinavir or Lopinavir Plus Ritonavir:

In patients taking cyclosporine, therapy should be limited to Lipolysin – 10 mg once daily. In patients taking clarithromycin, itraconazole, or in patients with HIV taking a combination of ritonavir plus saquinavir or lopinavir plus ritonavir, for doses of Lipolysin exceeding 20 mg, appropriate clinical assessment is recommended to ensure that the lowest dose necessary of Lipolysin is employed.