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Apixaban Atlanta Medicare

Apixaban Atlanta Medicare Dosage/Direction for Use

apixaban

Manufacturer:

Natco Pharma

Distributor:

Atlanta Medicare
Full Prescribing Info
Dosage/Direction for Use
Posology: Prevention of VTE: Elective hip or knee replacement surgery: The recommended dose of apixaban is 2.5 mg taken orally twice daily. The initial dose should be taken 12 to 24 hours after surgery.
In patients undergoing hip replacement surgery: The recommended duration of treatment is 32 to 38 days.
In patients undergoing knee replacement surgery: The recommended duration of treatment is 10 to 14 days.
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.
Dose reduction: The recommended dose of Apixaban is 2.5 mg taken orally twice daily in patients with NVAF and at least 2 of the following characteristics: age ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dL (133 micromole/L).
Therapy should be continued long-term.
Treatment of DVT and PE: The recommended dose of Apixaban for the treatment of DVT and PE is 10 mg taken orally twice daily for the first 7 days followed by 5 mg taken orally twice daily.
Prevention of recurrent DVT and PE: The recommended dose of Apixaban for the prevention of recurrent DVT and PE is 2.5 mg taken orally twice daily after at least 6 months of treatment for DVT or PE.
Missed dose: If a dose is missed, the patient should take Apixaban immediately and then continue with twice daily intake as before.
Renal impairment: For the prevention of VTE in elective hip or knee replacement surgery: No dose adjustment is necessary in patients with mild, moderate or severe (creatinine clearance 15-29 mL/min) renal impairment (see Pharmacology: Pharmacokinetics under Actions). Because there is limited clinical experience in patients with creatinine clearance <15 mL/min and no data in patients undergoing dialysis, apixaban is not recommended in these patients (see Precautions and Pharmacology: Pharmacokinetics under Actions).
For the prevention of stroke and systemic embolism in patients with NVAF: No dose adjustment is recommended in patients with creatinine clearance 15 to 29 mL/min, except as described previously. Because there is no clinical experience in patients with creatinine clearance <15 mL/min, a dosing recommendation cannot be provided.
There are no data in patients undergoing dialysis, therefore, apixaban is not recommended in these patients (see Pharmacology: Pharmacokinetics under Actions).
For treatment of VTE: No dose adjustment is necessary in patients with mild, moderate or severe (creatinine clearance 15-29 mL/min) renal impairment (see Pharmacology: Pharmacokinetics under Actions). Because there is limited clinical experience in patients with creatinine clearance <15 mL/min and no data in patients undergoing dialysis, apixaban is not recommended in these patients (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: Apixaban may be used with caution in patients with mild or moderate hepatic impairment (Child Pugh A or B). No dose adjustment is required in patients with mild or moderate hepatic impairment (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Body weight: Prevention of VTE: elective hip or knee replacement surgery: No dose adjustment required (see Pharmacology: Pharmacokinetics under Actions).
Prevention of stroke and systemic embolism: NVAF: see as previously mentioned.
Treatment of VTE: No dose adjustment required (see Pharmacology: Pharmacokinetics under Actions).
Gender: No dose adjustment required (see Pharmacology: Pharmacokinetics under Actions).
Elderly: Prevention of VTE: elective hip or knee replacement surgery: No dose adjustment required (see Pharmacology: Pharmacokinetics under Actions).
Prevention of stroke and systemic embolism: NVAF: as previously mentioned.
Treatment of VTE: No dose adjustment required (see Pharmacology: Pharmacokinetics under Actions).
Switching: Switching treatment from parenteral anticoagulants to Apixaban (and vice versa) can be done at the next scheduled dose (see Interactions).
Switching from vitamin K antagonist (VKA) therapy to Apixaban: When converting patients from warfarin or other VKA therapy to Apixaban, warfarin or other VKA therapy be discontinued and Apixaban started when the international normalised ratio (INR) is <2.
Switching from Apixaban to VKA therapy: When converting patients from Apixaban to warfarin or other VKA therapy, administration of Apixaban be continued for 48 hours after the first dose of warfarin or other VKA therapy.
Surgery and invasive procedures: Apixaban should be discontinued at least 48 hours prior to elective surgery or invasive procedure with a moderate or high risk of unacceptable or clinically significant bleeding. Apixaban should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be non-critical in location and easily controlled. If surgery or invasive procedures cannot be delayed, exercise appropriate caution taking into consideration an increased high risk of bleeding. This risk of bleeding should be weighed against the urgency of intervention. In non-valvular atrial fibrillation patients, bridging anticoagulation during the 24 to 48 hours after stopping apixaban and prior to the intervention is not generally required. Apixaban should be restarted after the surgical or other procedures as soon as adequate hemostasis has been established.
Patients can continue taking apixaban while being cardioverted.
Paediatric population: The safety and efficacy of Apixaban in children and adolescents below age 18 have not been established. No data are available.
Method of administration: Oral use.
Apixaban should be swallowed with water, with or without food.
For patients who are unable to swallow whole tablets, Apixaban tablets may be crushed and suspended in water, or 5% dextrose in water (D5W), or apple juice or mixed with applesauce and promptly administered orally (see Pharmacology: Pharmacokinetics under Actions). Alternatively, Apixaban tablets may be crushed and suspended in 60 mL of water or D5W and promptly delivered through a nasogastric tube (see Pharmacology: Pharmacokinetics under Actions).
Crushed Apixaban tablets are stable in water, D5W, apple juice, and applesauce for up to 4 hours.
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