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HELP PREVENT STROKES1– 3
REDUCE BRAIN BLEEDS1– 3
Please review Product Information before prescribing. The Product Information can be accessed at
PRADAXA® (dabigatran etexilate) 110 mg and 150 mg capsules. MINIMUM PRODUCT INFORMATION. INDICATION: Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least
one additional risk factor for stroke. CONTRAINDICATIONS: Known hypersensitivity to dabigatran, dabigatran etexilate or excipient (e.g. sunset yellow FCF CI15985); severe renal impairment (CrCL < 30mL/min); haemorrhagic
manifestations, bleeding diathesis, spontaneous or pharmacological impairment of haemostasis; organ lesions at risk of clinically significant bleeding (including haemorrhagic stroke within the last 6 months, active peptic ulcer
disease with recent bleeding); indwelling spinal or epidural catheter and during the first two hours after removal; hepatic impairment or liver disease expected to have any impact on survival; history of intracranial,intraocular, spinal,
retroperitoneal or atraumatic intra-articular bleeding; gastrointestinal haemorrhage within the past year unless the cause has been permanently eliminated; conditions associated with increased risk of bleeding; concomitant
treatment with systemic ketoconazole or dronedarone*; simultaneous initiation of treatment with dabigatran etexilate and oral verapamil; prosthetic heart valve replacement*. PRECAUTIONS: Haemorrhagic risk: moderate
renal impairment (CrCL 30-50 mL/min), congenital or acquired coagulation disorders, thrombocytopenia or functional platelet defects, active ulcerative gastrointestinal disease, recent gastrointestinal bleeding, recent biopsy
or major trauma, brain, spinal or ophthalmic surgery, bacterial endocarditis, age ≥ 75 years, fibrinolytic agents*. Myocardial infarction. Concomitant administration with: acetylsalicylic acid, NSAIDs, clopidogrel, unfractionated
heparins and heparin derivatives, low molecular weight heparins, fondaparinux, desirudin, thrombolytic agents, GPIIb/IIIa receptor antagonists, ticlopidine, dextran, sulfinpyrazone, rivaroxaban, prasugrel, ticagrelor, vitamin
K antagonists, selective serotonin re-uptake inhibitors, *selective serotonin norepinephrine re-uptake inhibitors, P-gp inhibitors: amiodarone, verapamil, itraconazole, tacrolimus, cyclosporin, ritonavir, tipranavir, nelfinavir,
saquinavir, quinidine*, clarithromycin*, P-gp inducers. Surgical interventions may require temporary discontinuation and *anticoagulant monitoring is warranted; *clearance in patients with renal impairment may take longer.
Not recommended in patients undergoing hip fracture surgery. Pregnancy (Category C). Lactation. Children. Patients < 50 kg. See full PI available at www.boehringer-ingelheim.com.au/PI. ADVERSE REACTIONS: Bleeding
and signs of bleeding, dyspepsia, gastritis-like symptoms, diarrhoea, nausea, constipation, flatulence, dysphagia, nasopharyngitis, dyspnoea, cough, dyspnoea exertional, upper respiratory tract infection, bronchitis,
pneumonia, influenza, sinusitis, urinary tract infection, dizziness, headache, syncope, atrial fibrillation, cardiac failure congestive, cardiac failure, palpitations, angina pectoris, hypertension, hypotension, rash, gout, arthralgia,
back pain, pain in extremity, osteoarthritis, musculoskeletal pain, oedema peripheral, fatigue, asthenia, chest pain, chest discomfort, fall, abnormal liver function tests. Less common adverse reactions see full PI available at
www.boehringer-ingelheim.com.au/PI. DOSAGE: Assess renal function *(Cockcroft-Gault method) prior to treatment initiation, in clinical situations that could lead to renal function decline and at least once a year in
patients ≥ 75 years or with moderate renal impairment. Swallow capsule whole with water, with or without food. Recommended dose: 300 mg (one 150 mg capsule twice daily). Age ≥ 75 years: reduced dose of 220 mg
(one 110 mg capsule twice daily). Moderate renal impairment, higher risk of bleeding: reduced dose of 220 mg (one 110 mg capsule twice daily) may be considered. Special populations see full PI available at
www.boehringer-ingelheim.com.au/PI. References: 1. Connolly SJ et al. N Engl J Med 2009 ;361:1139 –51. 2. Connolly SJ et al. N Engl J Med 2010;363:1875–6 . 3. Pradaxa Approved Product Information, available at
www.boehringer-ingelheim.com.au/PI. Pradaxa® is a registered trademark of Boehringer Ingelheim Pty Limited, ABN 52 000 452 308, 78 Waterloo Road, North Ryde NSW 2113. AUS/PRA-141370. BIAP0263/AFP/OCH. August 2014.
†NVAF, non-valvular atrial fibrillation.
*Please note changes in Product Information.
PBS Information: Authority required (STREAMLINED) for the prevention of stroke or systemic embolism in patients with non-valvular atrial
fibrillation and one or more risk factors for developing stroke or systemic embolism. Authority required (STREAMLINED) for prevention of venous
thromboembolism in a patient undergoing total hip replacement or total knee replacement. Refer to PBS Schedule for full authority information.
STREAMLINED AUTHORITY CODE 4269 for stroke prevention in non-valvular atrial fibrillation
Pradaxa more than halves the risk of
intracranial bleeding vs warfarin in NVAF†1-3
19/08/2014 3:33 pm
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