APIXABAN MACLEODS

Posology Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) The recommended dose of apixaban is 5 mg taken orally twice daily. 5 mg/dL (133 micromole/L). Therapy should be continued long-term.

Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTEt) The recommended dose of apixaban for the treatment of acute DVT and treatment of PE is 10 mg taken orally twice daily for the first 7 days followed by 5 mg taken orally twice daily.

, recent surgery, trauma, immobilisation). 5 mg taken orally twice daily. 1). 4). Missed dose If a dose is missed, the patient should take Apixaban Macleods immediately and then continue with twice daily intake as before. 5). These medicinal products should not be administered simultaneously.

Switching from vitamin K antagonist (VKA) therapy to Apixaban Macleods When converting patients from vitamin K antagonist (VKA) therapy to Apixaban Macleods, warfarin or other VKA therapy should be discontinued and Apixaban started when the international normalised ratio (INR) is < 2.

Switching from Apixaban to VKA therapy When converting patients from Apixaban Macleods to VKA therapy, administration of Apixaban Macleods should be continued for at least 2 days after beginning VKA therapy. After 2 days of coadministration of Apixaban with VKA therapy, an INR should be obtained prior to the next scheduled dose of Apixaban.

Coadministration of Apixaban Macleods and VKA therapy should be continued until the INR is ≥ 2. 2). 2). 2). 5 mg/dL (133 micromole/L) associated with age ≥80 years or body weight ≤60 kg, a dose reduction is necessary and described above.

2). 5 mg twice daily. 3). 4. 2). It should be used with caution in patients with mild or moderate hepatic impairment (Child Pugh A or B). 2). 5 x ULN were excluded in clinical studies. 2). Prior to initiating Apixaban Macleods, liver function testing should be performed.

2). 2). 2). 5). Patients undergoing cardioversion Apixaban can be initiated or continued in NVAF patients who may require cardioversion. g. transesophogeal echocardiography (TEE) or computed tomographic scan (CT)) prior to cardioversion should be considered, in accordance with established medical guidelines.

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1). Common adverse reactions were haemorrhage, contusion, epistaxis, and haematoma (see Table 2 for adverse reaction profile and frequencies by indication). 6% in the apixaban vs acetylsalicylic acid study. 76%/year. 18%/year. 1). Tabulated list of adverse reactions Table 2 shows the adverse reactions ranked under headings of system organ class and frequency using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data) for NVAF, and VTEt respectively.

, haemorrhagic stroke or putamen, cerebellar, intraventricular, or subdural haemorrhages). , haemorrhagic stroke or putamen, cerebellar, intraventricular, or subdural haemorrhages). Description of selected adverse reactions The use of apixaban may be associated with an increased risk of occult or overt bleeding from any tissue or organ, which may result in posthaemorrhagic anaemia.

1). Known complications secondary to severe bleeding such as anticoagulant-related nephropathy has occasionally been reported in patients receiving anticoagulants in the post-marketing setting. In patients with pre-existing kidney disease, ARN may occur, possibly in relation to episodes of excessive anticoagulation and haematuria.

4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App […]

Haemorrhage risk As with other anticoagulants, patients taking apixaban are to be carefully observed for signs of bleeding. It is recommended to be used with caution in conditions with increased risk of haemorrhage. 9). 1). An agent to reverse the anti-factor Xa activity of apixaban is available.

3). 5). Care is to be taken if patients are treated concomitantly with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), or non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid.

5). In patients with atrial fibrillation and conditions that warrant mono or dual antiplatelet therapy, a careful assessment of the potential benefits against the potential risks should be made before combining this therapy with Apixaban Macleods.

6% per year. 1). A clinical study enrolled patients with atrial fibrillation with ACS and/or undergoing PCI and a planned treatment period with a P2Y12 inhibitor, with or without ASA, and oral anticoagulant (either apixaban or VKA) for 6 months.

1). 04% per year). 5). Patients with prosthetic heart valves Safety and efficacy of apixaban have not been studied in patients with prosthetic heart valves, with or without atrial fibrillation. Therefore, the use of apixaban is not recommended in this setting.

Patients with antiphospholipid syndrome Direct acting Oral Anticoagulants (DOACs) including apixaban are not recommended for patients with a history of thrombosis who are diagnosed with antiphospholipid syndrome. In particular for patients that are triple positive (for lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein I antibodies), treatment with DOACs could be associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy.

Surgery and invasive procedures Apixaban should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of bleeding. This includes interventions for which the probability of clinically significant bleeding cannot be excluded or for which the risk of bleeding would be unacceptable.

1. • Active clinically significant bleeding. 2). • Lesion or condition if considered a significant risk factor for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.

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