Torapix 2.5/Torapix 5

Torapix 2.5/Torapix 5 Dosage/Direction for Use

apixaban

Manufacturer:

Torrent Pharmaceuticals

Distributor:

Torrent
Full Prescribing Info
Dosage/Direction for Use
Apixaban can be taken with or without food.
If a dose is missed, the patient should take Apixaban immediately and continue with twice daily administration as before.
Recommended Dosage: 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.
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 deep vein thrombosis (DVT) and pulmonary embolism (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.
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.
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.
Renal Impairment: 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 under Recommended Dosage. 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 deep vein thrombosis (DVT) and pulmonary embolism (PE): 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 stroke and systemic embolism in patients with NVAF: See Recommended Dosage.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE): No dose adjustment is required.
Gender: No dose adjustment is required.
Paediatric and Adolescent: The safety and efficacy of Apixaban in children and adolescents below age 18 have not been established. No data are available.
Elderly: Prevention of stroke and systemic embolism in patients with NVAF: See Recommended Dosage.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE): No dose adjustment is required.
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.
The 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 procedure as soon as adequate hemostasis has been established.
Patients can continue taking Apixaban while being cardioverted.
Method of Administration: Apixaban should be swallowed with water and may be taken 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 apple puree and immediately administered orally. Alternatively, Apixaban tablets may be crushed and suspended in 60 mL of water or D5W and immediately delivered through a nasogastric tube.
Crushed Apixaban tablets are stable in water, D5W, apple juice, and apple puree for up to 4 hours.