Pixabara 5 mg Film-Coated Tablet

Composition:

Each film-coated tablet contains:

• Active substance: Apixaban – 5 mg

• Excipients: Anhydrous lactose, microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate

Therapeutic Indications:

• Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery

• Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) with one or more risk factors, such as:

• Prior stroke or transient ischemic attack (TIA)

• Age ≥ 75 years

• Hypertension

• Diabetes mellitus

• Symptomatic heart failure (NYHA Class II or greater)

• Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE)

• Prevention of recurrent DVT and PE in adults
  (Information on patients with hemodynamically unstable PE can be found in the section “Special warnings and precautions for use”)

Dosage and Method of Administration:

Dosing Regimens:

• VTE Prophylaxis (following elective hip or knee replacement surgery):
  The recommended dose of apixaban is 2.5 mg orally twice daily.
  The initial dose should be taken 12–24 hours after surgery.
  Clinicians should assess the potential benefit of earlier initiation of anticoagulation against the risk of postoperative bleeding when determining the timing within this window.

• For hip replacement: Recommended treatment duration is 32–38 days

• For knee replacement: Recommended treatment duration is 10–14 days

• Prevention of stroke and systemic embolism in NVAF patients:
  The recommended dose is 5 mg orally twice daily

Dose Reduction:

For patients with NVAF and at least two of the following criteria, the recommended dose is 2.5 mg orally twice daily:

• Age ≥ 80 years

• Body weight ≤ 60 kg

• Serum creatinine ≥ 1.5 mg/dL (133 μmol/L)

Treatment should be continued long-term as medically appropriate.

Treatment of DVT, PE, and Prevention of Recurrence (VTE-L):

• For acute DVT or PE:

• 10 mg orally twice daily for the first 7 days

• Then, 5 mg orally twice daily

• For prevention of recurrent DVT and PE:

• Recommended dose is 2.5 mg orally twice daily

• This should begin after completing 6 months of treatment with apixaban 5 mg twice daily (or another anticoagulant)

According to current clinical guidelines, short-term treatment (at least 3 months) should be based on transient risk factors (e.g., recent surgery, trauma, immobilization).

Method of Administration:

• For oral use

• Tablets should be swallowed with water, with or without food

For patients unable to swallow whole tablets:
The tablets may be crushed and suspended in:

• Water

• 5% dextrose in water (D5W)

• Apple juice

• Apple purée

The mixture should be administered immediately.

Alternatively, crushed tablets may be suspended in 60 mL of water or 5% dextrose solution and administered via nasogastric tube.

Crushed tablets are stable for up to 4 hours in water, 5% dextrose, apple juice, or apple purée.

Special Storage Instructions:

• Store at a temperature not exceeding 25°C

• Keep out of the reach of children!