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Posology: Hypercholesterolaemia: The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with VYTORIN.
Route of administration is oral. The dosage range of VYTORIN is 10/10 mg/day through ezetimbe/simvastatin 10/80 mg/day in the evening. All dosages may not be available in Hong Kong. The typical dose is 10/20 mg/day or 10/40 mg/day given as a single dose in the evening.
The 10/80 mg dose of ezetimibe/simvastatin should be used only in patients who have been taking this dose for 12 months or more without evidence of muscle toxicity.
The 10/80 mg dose of ezetimibe/simvastatin should not be started in new patients, including patients already taking lower doses of the drug.
The patient's low-density lipoprotein cholesterol (LDL-C) level, coronary heart disease risk status, and response to current cholesterol-lowering therapy should be considered when starting therapy or adjusting the dose.
The dose of VYTORIN should be individualized based on the known efficacy of the various dose strengths of VYTORIN (see Pharmacology: Pharmacodynamics under Actions - Table 1) and the response to the current cholesterol-lowering therapy. Adjustments of dosage, if required, should be made at intervals of not less than 4 weeks. VYTORIN can be administered with or without food. The tablet should not be split.
Patients with Coronary Heart Disease and ACS Event History: In the cardiovascular events risk reduction study (IMPROVE-IT), the starting dose was 10/40 mg once a day in the evening.
The 10/80 mg dose of ezetimibe/simvastatin should be used only in patients who have been taking this dose for 12 months or more without evidence of muscle toxicity.
The 10/80 mg dose of ezetimibe/simvastatin should not be started in new patients, including patients already taking lower doses of the drug.
Homozygous Familial Hypercholesterolaemia: The recommended starting dosage for patients with homozygous familial hypercholesterolaemia is VYTORIN 10/40 mg/day in the evening.
The 10/80 mg dose of ezetimibe/simvastatin should be used only in patients who have been taking this dose for 12 months or more without evidence of muscle toxicity.
The 10/80 mg dose of ezetimibe/simvastatin should not be started in new patients, including patients already taking lower doses of the drug.
VYTORIN may 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 taking lomitapide concomitantly with VYTORIN, the dose of VYTORIN must not exceed 10/40 mg/day (see Contraindications, Precautions and Interactions).
Co-administration with other medicines: Dosing of VYTORIN should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant.
In patients taking verapamil or diltiazem concomitantly with VYTORIN, the dose of VYTORIN should not exceed 10/10 mg/day (see Precautions and Interactions).
In patients taking amiodarone, amlodipine, ranolazine, or products containing elbasvir or grazoprevir concomitantly with VYTORIN, the dose of VYTORIN should not exceed 10/20 mg/day (see Precautions and Interactions).
In patients taking lipid-lowering doses (≥ 1 g/day) of niacin concomitantly with VYTORIN, the dose of VYTORIN should not exceed 10/20 mg/day (see Precautions and Interactions).
Elderly: No dosage adjustment is required for elderly patients (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: Initiation of treatment must be performed under review of a specialist.
Adolescents ≥ 10 years (pubertal status: boys Tanner Stage II and above and girls who are at least one year post-menarche): The clinical experience in paediatric and adolescent patients (aged 10-17 years old) is limited. The recommended usual starting dose is 10/10 mg once a day in the evening. The recommended dosing range is 10/10 to a maximum of 10/40 mg/day (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Children < 10 years: VYTORIN is not recommended for use in children below age 10 due to insufficient data on safety and efficacy (see Pharmacology: Pharmacokinetics under Actions). The experience in pre-pubertal children is limited.
Patients with Hepatic Impairment: No dosage adjustment is required in patients with mild hepatic impairment (Child-Pugh score 5 to 6). Treatment with VYTORIN is not recommended in patients with moderate (Child-Pugh score 7 to 9) or severe (Child-Pugh score > 9) liver dysfunction. (See Precautions and Pharmacology: Pharmacokinetics under Actions.)
Patients with Renal Impairment: No modification of dosage should be necessary in patients with mild renal impairment (estimated glomerular filtration rate ≥60 ml/min/1.73 m2). In patients with chronic kidney disease and estimated glomerular filtration rate <60 ml/min/1.73 m2, the recommended dose of VYTORIN is 10/20 mg once a day in the evening (see Precautions and Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions). Higher doses should be implemented cautiously.
Method of Administration: VYTORIN is for oral administration. VYTORIN can be administered as a single dose in the evening.
