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Apiklot

Apiklot Dosage/Direction for Use

apixaban

Manufacturer:

Unison Pharmaceutical

Distributor:

Cathay YSS
Full Prescribing Info
Dosage/Direction for Use
Prevention of VTE (VTEp): 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.
Physicians may consider the potential benefits of earlier anticoagulation for VTE prophylaxis as well as the risks of post-surgical bleeding in deciding on the time of administration within this time window.
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 AF: NVAF: The recommended dose of Apixaban is 5 mg taken orally twice daily.
Age, body weight, serum creatinine: In patients with at least 2 of the following characteristics, age ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dL (133 micromole/L), the recommended dose of Apixaban is 2.5 mg twice daily.
Treatment of DVT and PE: The recommended dose of Apixaban is 10 mg taken orally twice daily for 7 days, followed by 5 mg taken orally twice daily.
Prevention of recurrent DVT and PE: The recommended dose of Apixaban is 2.5 mg taken orally twice daily after at least 6 months of treatment for DVT or PE.
Renal Impairment: Prevention of VTE in surgical patients: 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. 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.
Prevention of stroke and systemic embolism in patients with AF: NVAF: No dose adjustment is recommended in patients with creatinine clearance 15 to 29 mL/min, except as described in Recommended Dosage: Prevention of stroke and systemic embolism in patients with AF: NVAF as previously mentioned. 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.
Treatment of VTE: No dose adjustment is necessary in patients with mild, moderate, or severe (creatinine clearance 15-29 mL/min) renal impairment. 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.
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. Apixaban is not recommended in patients with severe hepatic impairment).
Body Weight: Prevention of VTE in surgical patients: Elective hip or knee replacement surgery: No dose adjustment required.
Prevention of stroke and systemic embolism in patients with AF: NVAF: See Recommended Dosage: Prevention of stroke and systemic embolism in patients with AF: NVAF as previously mentioned.
Treatment of VTE: No dose adjustment required.
Gender: No dose adjustment required.
Pediatric and Adolescent: The efficacy and safety of Apixaban in children below age 18 have not been established. No data are available.
Elderly: Prevention of VTE in surgical patients: Elective hip or knee replacement surgery: No dose adjustment required.
Prevention of stroke and systemic embolism in patients with AF: NVAF: See Recommended Dosage: Prevention of stroke and systemic embolism in patients with AF: NVAF as previously mentioned.
Treatment of VTE: No dose adjustment required (see Pharmacology: Pharmacokinetics under Actions).
Converting from or to Parenteral Anticoagulants: In general, switching treatment from parenteral anticoagulants to Apixaban (and vice versa) can be done at the next scheduled dose.
Converting from or to Warfarin or Other Vitamin K Antagonists (VKA): When converting patients from warfarin or other VKA therapy to Apixaban, discontinue warfarin or other VKA therapy and start Apixaban when the international normalized ratio (INR) is below 2.0.
When converting from Apixaban to warfarin or other VKA therapy, continue Apixaban 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 procedures 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 risk of bleeding. This risk of bleeding should be weighed against the urgency of intervention. In nonvalvular 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.
Apixaban can be initiated or continued in NVAF patients who may require cardioversion. For patients not previously treated with anticoagulants, at least 5 doses of Apixaban 5 mg twice daily [2.5 mg twice daily in patients who qualify for a dose reduction (see as previously mentioned)] should be given before cardioversion to ensure adequate anticoagulation. If cardioversion is required before 5 doses of Apixaban can be administered, a 10 mg loading dose should be given, followed by 5 mg twice daily. The dosing regimen should be reduced to a 5 mg loading dose followed by 2.5 mg twice daily if the patient meets the criteria for dose reduction (see as previously mentioned). The administration of the loading dose should be given at least 2 hours before cardioversion.
Confirmation should be sought prior to cardioversion that the patient has taken Apixaban as prescribed. Decisions on initiation and duration of treatment should take established guideline recommendations for anticoagulant treatment in patients undergoing cardioversion into account.
Method of administration: Oral use.
Apixaban should be swallowed with water, with or without food.
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