Home' Australian Pharmacist : Australian Pharmacist February 2014 Contents References: 1. ATOZET Composite Pack Approved Product Information. 2. Australian Government Department of Health. Pharmaceutical Benefits Scheme (PBS). Available
from: http://www.pbs.gov.au (accessed Dec 2013). ATOZET: Copyright © 2013 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Whitehouse Station, NJ,
USA. All rights reserved. EZETROL: Copyright © 2013 MSD International GmbH, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA. All rights reserved.
Merck Sharp & Dohme (Australia) Pty Limited. Level 1 -- Building A, 26 Talavera Road, Macquarie Park NSW 2113. CARD-1101466-0004. First issued Dec 2013. Saatchi & Saatchi Health MATO0006 12/13.
PBS LISTED 1ST DECEMBER 20132
For illustrative purposes only, not an actual
visual of the ATOZET Composite Pack.
ATOZET Composite Pack/EZETROL PBS Information: Authority required (STREAMLINED).
Refer to PBS Schedule for full authority information.
Before prescribing, please review the Product Information. The Product Information can be accessed at
www.msdinfo.com.au/ezetrolpi and www.msdinfo.com.au/atozetpi
Minimum PI for EZETROL and ATOZET COMPOSITE PACK. Indications: EZETROL: Adjunctive to diet in treatment of patients with primary hypercholesterolaemia (alone or with statin); homozygous
familial hypercholesterolaemia (with statin); homozygous sitosterolaemia (phytosterolaemia). ATOZET COMPOSITE PACK: Adjunctive to diet in patients with primary hypercholesterolaemia where use of a combination
product is appropriate in those patients: not appropriately controlled with atorvastatin or ezetimibe alone; or already treated with atorvastatin and ezetimibe. Homozygous familial hypercholesterolaemia.
Contraindications: hypersensitivity; fenofibrate (gall bladder disease only); active liver disease (with statin); unexplained persistent elevations of serum transaminases (with statin); pregnancy (with
statin); lactation (with statin). ATOZET COMPOSITE PACK: myopathy secondary to other lipid lowering agents; fusidic acid. Precautions: risk of myopathy or unexplained muscle pain, tenderness or weakness;
moderate to severe hepatic insufficiency (not recommended); fibrates other than fenofibrate (not recommended); anticoagulants (warfarin, fluindione, coumarin derivatives: monitor INR); monitor liver enzymes
before treatment and periodically when clinically indicated (with statin). EZETROL: monitor cyclosporin concentrations; pregnancy; lactation; children <10 years (not recommended); limited clinical experience
in patients 10 to 17 years of age. ATOZET COMPOSITE PACK: Liver function: high alcohol use; history of liver disease. Myopathy/rhabdomyolysis: interrupt therapy in severe acute infection, hypotension, major
surgery, trauma, severe metabolic, endocrine and electrolyte disorders, and uncontrolled seizures; renal impairment (monitor CK); consider lower doses when co-administered with cyclosporin (do not exceed
10+10mg dose), erythromycin, niacin, azole antifungals, colchicine, telaprevir, or tipranavir/ritonavir. Haemorrhagic stroke; endocrine function (elevated HbA1c and fasting serum glucose); interstitial lung
disease (discontinue); women of childbearing potential (ensure adequate contraception); children; driving and operating machinery. Pregnancy: EZETROL: Category B3. ATOZET COMPOSITE PACK: Category D.
Interactions: cholestyramine. Other interactions -- see above. ATOZET COMPOSITE PACK: CYP3A4 inhibitors erythromycin/clarithromycin, protease inhibitors, itraconazole, diltiazem, grapefruit juice (>1.2L per
day); CYP3A4 inducers e.g. efavirenz, rifampicin, phenytoin; digoxin; oral contraceptives. Other interactions -- see above. Adverse events: hypersensitivity reactions; anaphylaxis; angioedema; erythema
multiform; rash; urticaria; arthralgia; myalgia; increased CPK; liver function test abnormal; cholelithiasis; cholecystitis; hepatitis; thrombocytopenia; pancreatitis; nausea; dizziness; paraesthesia; depression;
constipation; asthenia; abdominal pain; diarrhoea; flatulence; fatigue; headache; myopathy/rhabdomyolysis (with statin). ATOZET COMPOSITE PACK: dyspnoea; abdominal distension; dyspepsia; gastritis; muscle
spasms; fatigue; malaise; influenza; insomnia; sleep disorder; dysgeusia; sinus bradycardia; hot flush; abdominal discomfort; stomach discomfort; acne; back pain; muscle fatigue; muscular weakness; pain in
extremity; oedema; ALT and/or AST increased; ALP increased; GGT increased; weight increased. Others -- see full PI. Dosage: EZETROL: 10 mg once daily alone or with statin. No dosage adjustment required
for elderly, children >10 years, renal impairment or mild hepatic insufficiency. In patients with chronic kidney disease and eGFR <60 mL/min/1.73 m2, EZETROL 10 mg may be combined with simvastatin 20
mg once daily in the evening; use of higher doses of simvastatin should be closely monitored. Not recommended in children <10 years, moderate-severe liver dysfunction. ATOZET COMPOSITE PACK: one EZETROL
tablet and one MSD ATORVASTATIN tablet at the same time daily (any time of day). Starting dose 10+10mg or 10+20mg once daily, adjustment after 2 weeks if required. HoFH: 10+40mg or 10+80mg daily.
No dosage adjustment required for renal impairment or mild hepatic insufficiency. Not recommended in children, moderate-severe liver dysfunction. Take ≥2h before or ≥4h after bile acid sequestrants. Other
co-administrations -- see full PI. Overdosage: symptomatic and supportive measures should be employed. Based on EZETROL PI approved 26 July 2012 and ATOZET COMPOSITE PACK PI approved 16 May 2013.
NEW ATOZET COMPOSITE PACK1
EZETROL® (ezetimibe) and atorvastatin now side by side.1
Powerful LDL-C reductions.1
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