INEGY 10 MG / 20 MG 14 TAB

* INEGY (ezetimibe/simvastatin) 10 mg/20 mg 14 Tablets.
* Indications:
– Primary Hypercholesterolemia:
INEGY is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density
lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), & non-high-density lipoprotein cholesterol
(non-HDL-C), & to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial &
non-familial) hypercholesterolemia or mixed hyperlipidemia.
– Homozygous Familial Hypercholesterolemia (HoFH):
INEGY is indicated for the reduction of elevated total-C levels in patients with HoFH. Patients may also receive
adjunctive treatments (e.g. LDL apheresis).
* Dosage & Administration:
– The patient should be placed on a standard cholesterol-lowering diet before receiving INEGY & should continue on this diet
treatment with INEGY.
– The dosage should be individualized according to the baseline LDL-C level, the recommended goal of therapy, & response.
– INEGY should be taken as a single daily dose in the evening, with or without food.
– The dosage range is 10/10 mg/day through 10/80 mg/day. The recommended usual starting dose is 10/20 mg/day.
Initiation of therapy with 10/10 mg/day may be considered for patients requiring less aggressive LDL-C reductions.
Patients who require a larger reduction in LDL-C (greater than 55%) may be started at 10/40 mg/day.
After initiation or titration of INEGY, Lipid levels may be analyzed after 2 or more weeks & dosage adjusted, if needed.
– Dosage in Patients with Homozygous Familial Hypercholesterolemia: The recommended dosage is INEGY 10/40 mg/day
or 10/80 mg/day in the evening. INEGY should be used as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis)
in these patients or if such treatments are unavailable.
– Use in the elderly: No dosage adjustment is required for elderly patients.
* Contraindications:
– Hypersensitivity to the active substances or to any of the excipients.
Active liver disease or unexplained persistent elevations of serum transaminases.
– Pregnancy and nursing.
* Precautions:
Myopathy / Rhabdomylosis:
– Simvastatin, like other inhibitors of HMG-CoA reductase, occasionally causes myopathy, Rhabdomylosis
mainfested as muscle pain, tenderness or weakness with creatine kinase (CK) above 10X the upper limit
of normal (ULN).
– The risk of myopathy / rhabdomylosis is increased by concomitant use of INEGY with the following:
Potent inhibitors of CYP3A4, e.g., itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin,
HIV protease inhibitors, or nefazodone, particularly with higher doses of INEGY.
* Store at Temperature not exceeding 30 degrees C. Store in the original package in order to protect from moisture and light.