1- Primary Hypercholesterolemia:
CAZET is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C,
Apo B, TG, and non-HDL-C and to increase HDL-C in patients with primary (heterozygous familial &
non-familial) hypercholesterolemia or mixed hyperlipidemia.
2- Homozygous Familial Hypercholesterolemia (HoFH):
CAZET 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. Lipid-altering agents should be used in addition to an appropriate diet
(including restriction of saturated fat and cholesterol).
– Hypersensitivity to any component of this medication.
– Active liver disease or unexplained persistent elevations of serum transaminases.
* Pregnancy and lactation:
– CAZET is contraindicated during pregnancy and in nursing mothers. CAZET should be administered to
women of childbearing age only when such patients are highly unlikely to conceive. If the patient
becomes pregnant while taking this drug, CAZET should be discontinued immediately and the patient
should be apprised of the potential hazard to the fetus.
– It is not known whether ezetimibe or simvastatin are excreted into human breast milk. Because a small
amount of another drug in the same class as simvastatin is excreted in human milk and because of the
potential for serious adverse reactions in nursing infants, women who are nursing should not take CAZET.
– Hepatic Impairment:
Due to the unknown effects of the increased exposure to ezetimibe in patients with moderate or severe
hepatic insufficiency. CAZET is not recommended in these patients.
– Pediatric use:
– There are insufficient data for the safe and effective use of CAZET in pediatric patients.
– Ezetimibe: Treatment with ezetimibe in children (<10 years) is not recommended.
– Simvastatin: Simvastatin has not been studied in patients younger than 10 years of age, nor in
– Myopathy / Rhabdomylosis:
Simvastatin, like other inhibitors of HMG-CoA reductase, occasionally causes myopathy. CAZET therapy
should be discontinued immediately if myopathy is diagnosed or suspected.
– Therapy with CAZET should be temporarily stopped a few days prior to elective major surgery and when
any major medical or surgical condition supervenes.
– Liver Enzymes:
The elevations in transaminases appeared to be dose-related and ere generally asymptomatic, no association
with cholestasis, and returned to baseline after discontinuation of therapy or with continued treatment.
Should an increase in AST or ALT of 3 X ULN or greater persist, withdrawal of therapy with CAZET is
CAZET should be used with caution in patients who consume substantial quantities of alcohol and/or have
a past history of liver disease.
Information for patients: Patients should be advised about substances they should not take concomitantly
with CAZET and be advised to report promptly unexplained muscle pain, tenderness, or weakness
(Myopathy / Rhabdomyolysis). Patients should also be advised to inform other physicians prescribing
a new medication that they are taking CAZET.
* Dosage and Administration:
– The patient should be placed on a standard cholesterol-lowering diet before receiving CAZET. CAZET should
be taken as a single daily dose in the evening, with or without food.
– 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.
– Patients with Homozygous Familial Hypercholesterolemia: The recommended dosage is CAZET 10/40 mg/day.
– Renal insufficiency: No dosage adjustment is necessary in patients with mild or moderate renal insufficiency.
However, for patients with severe renal insufficiency, CAZET should not be started unless the patient has
already tolerated treatment with simvastatin at a dose of 5 mg or higher. Caution should be exercised when
CAZET is administered to these patients and they should be closely monitored.
– Hepatic Impairment: No dosage adjustment is necessary in patients with mild hepatic insufficiency.
– Coadministration with Bile Acid Sequestrants: Dosing of CAZET should occur either >/= 2 hours before or
>/= 4 hours after administration of a bile acid sequestrant.
– Geriatrics: No dosage adjustment is required in geriatric patients.
– Patients taking Cyclosporine or Danazol: Caution should be exercised when initiating CAZET in the setting of
cyclosporine or danazol. In patients taking cyclosporine or danazol, CAZET should not be started unless
the patient has already tolerated treatment with simvastatin at a dose of 5 mg or higher. The dose of CAZET
should not exceed 10/10 mg/day.
– Patients taking Amiodarone or Verapamil: In patients taking amiodarone or verapamil concomitantly with CAZET,
the dose should not exceed 10/20 mg/day.
* Store at a temperature not exceeding 30 degrees C.
* Produced by: Jedco Co., for: 4A Pharma – Egypt.