Source: Pharmaceutical Benefits Scheme (AU) Revision Year: 2021 Publisher: Lupin Australia Pty Ltd, Suite 2, Level 2, 19-23 Prospect Street, Box Hill, VIC, 3128 Distributor: Arrotex Pharmaceuticals Pty Ltd, 15-17 Chapel Street, Cremorne, VIC, 3121, Australia
EZETAST is indicated in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) taking their maximum tolerated dose of atorvastatin and in need of additional lowering of LDL-C in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see Section 5.1 Pharmacodynamic Properties – Clinical Trials).
EZETAST is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients:
EZETAST is indicated in patients with HoFH. Patients may also receive adjunctive treatments (eg. LDL apheresis).
This combination product is not indicated for first-line use.
Patient should be on an appropriate lipid‐lowering diet and should continue on this diet during treatment with EZETAST.
EZETAST can be administered within the dosage range of 10/10 mg to 10/80 mg as a single daily dose. The recommended starting dose of EZETAST is 10/10 mg or 10/20 mg once daily. EZETAST can be administered at any time of the day, with or without food. Therapy should be individualised according to the target lipid levels, the recommended goal of therapy, and the patient’s response. After initiation and/or upon titration of EZETAST, lipid levels should be re‐analysed within 2 or more weeks and dosage adjusted according to the patient’s response.
Therapy can be commenced for patients with CHD and a history of ACS who are taking their maximum tolerated dose of atorvastatin and have not achieved recommended target lipid levels. The recommended starting dose of EZETAST in patients already treated with atorvastatin should provide ezetimibe dosed as 10 mg daily and the dose of atorvastatin already being taken. EZETAST is not indicated for first-line use.
Note that in the cardiovascular events risk reduction study (IMPROVE-IT), the starting dose was 10/40 mg ezetimibe/simvastatin once a day in the evening (see Section 4.4 Special Warnings and Precautions for Use and Section 5.1 Pharmacodynamic Properties – Clinical Trials).
To prevent accidental excessive dosing due to inadvertent duplication of administration of ezetimibe and/or atorvastatin, patients currently taking ezetimibe and/or atorvastatin should be advised that EZETAST replaces these medications and therefore the current ezetimibe and/or atorvastatin medication(s) should no longer be taken. Patients should also be advised to take any remaining medication(s) to the pharmacy for appropriate disposal.
The dosage of EZETAST in patients with homozygous familial hypercholesterolemia is 10/40 mg or 10/80 mg daily. EZETAST should be used as an adjunct to other treatments (eg., LDL apheresis) in these patients or if such treatments are unavailable.
No dosage adjustment is required for renally impaired patients.
No dosage adjustment is required in patients with mild hepatic insufficiency (Child Pugh A or score 5 to 6). Treatment with EZETAST is not recommended in patients with moderate (Child Pugh B or score 7 to 9) or severe (Child Pugh C or score >9) liver dysfunction. The benefits of therapy should be weighed against the risks when EZETAST is to be given to patients with hepatic insufficiency (see Section 5 Pharmacological Properties, Section 4.3 Contraindications, and Section 4.4 Special Warnings and Precautions for Use).
Dosing of EZETAST should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant.
In patients taking ciclosporin or the HIV protease inhibitors tipranavir plus ritonavir or the hepatitis C protease inhibitor telaprevir, therapy with EZETAST should be avoided. In patients with HIV taking lopinavir plus ritonavir, caution should be used when prescribing EZETAST and the lowest dose necessary employed. In patients taking clarithromycin, itraconazole, or the hepatitis C antiviral agents boceprevir, elbasvir, grazoprevir, or in patients with HIV taking a combination of saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir or fosamprenavir plus ritonavir, therapy with EZETAST should be limited to 10/20 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of atorvastatin is employed. In patients taking the HIV protease inhibitor nelfinavir, therapy with EZETAST should be limited to 10/40 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of EZETAST is employed (see Section 4.4 Special Warnings and Precautions for Use – Skeletal Muscle, and Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
No dosage adjustment is required for elderly patients for EZETAST (see Section 5.2 Pharmacokinetic Properties – Characteristics in Patients, (Special Populations)).
Treatment with EZETAST is not recommended.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
No specific treatment of overdosage with EZETAST can be recommended. In the event of an overdose, symptomatic and supportive measures should be employed. In symptomatic patients, monitor serum creatinine, BUN, creatinine phosphokinase and urine myoglobin for indications of renal impairment secondary to rhabdomyolysis. Liver function tests should be performed in symptomatic patients.
In clinical studies, administration of ezetimibe, 50 mg/day to 15 healthy subjects for up to 14 days, 40 mg/day to 18 patients with primary hypercholesterolaemia for up to 56 days was generally well tolerated.
A few cases of overdosage have been reported; most have not been associated with adverse experiences. Reported adverse experiences have not been serious.
If there has been significant ingestion, consider administration of activated charcoal. Activated charcoal is most effective when administered within 1-hour of ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via nasogastric tube once the airway is protected.
For rhabdomyolysis, administer sufficient 0.9% saline to maintain urine output of 2 to 3 mL/kg/hr. Diuretics may be necessary to maintain urine output. Urinary alkalinisation is not routinely recommended. Due to extensive drug binding to plasma proteins, haemodialysis is not expected to significantly enhance atorvastatin clearance.
In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.
Store below 25°C in a dry place.
EZETAST tablets are packed in blisters of Cold form Alu-Alu as forming (base) material and 0.025 hard tampered heat-sealed lacquer coated plain Aluminium foil as the lidding material.
Available as 30 tablet blister (aluminium/aluminium) packs.
In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.
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