Apixan Tablet 5mg
10 tabletsProduct Information
APIXAN
Apixan®
Presentation
Apixan 2.5: Each film-coated Tablet contains Apixaban INN 2.5 mg.
Apixan 5: Each film-coated Tablet contains Apixaban INN 5 mg.
Indications and usage :
* To reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF)
* For the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE
following initial therapy .
* For the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone
hip or knee replacement surgery
Dosage & Administration :
* Reduction of risk of stroke and systemic embolism in nonvalvular atrial fibrillation:
The recommended dose: 5 mg orally twice daily. Dose adjustment for NVAF patients: 2.5 mg twice daily is recommended for patients
with at least 2 of the following characteristics: age greater than or equal to 80 years, body weight less than or equal to 60 kg,
or
serum creatinine greater than or equal to 1.5 mg/dL.
* Prophylaxis of DVT following hip or knee replacement surgery: The recommended dose is 2.5 mg orally twice daily.
* Treatment of DVT and PE: The recommended dose is 10 mg taken orally twice daily for 7 days, followed by 5 mg taken orally twice
daily.
* Reduction in the risk of recurrent DVT and PE following initial therapy: The recommended dose is 2.5 mg taken orally twice
daily.
Contra-indications, warnings, etc.
Contra-indications:
Active pathological bleeding and severe hypersensitivity reaction to Apixaban.
Warnings & Precautions:
Apixaban can cause serious, potentially fatal bleeding. Promptly evaluate signs and symptoms of blood loss. An agent to reverse
the anti-factor Xa activity of Apixaban is available.
Prosthetic heart valves:
Apixaban is not recommended. Increased risk of thrombosis in patients with Triple Positive Antiphospholipid Syndrome: Apixaban is
not recommended. Severe Hepatic impairment: Not recommended. Use in pregnancy and lactation: Pregnancy Category B. There are no
adequate and well-controlled studies of Apixaban in pregnant women. Treatment is likely to increase the risk of hemorrhage during
pregnancy and delivery. Apixaban should be used during pregnancy only if the potential benefit outweighs the potential risk to the
mother and fetus. Nursing Mother: It is unknown whether Apixaban or its metabolites are excreted in human milk. Women should be
instructed either to discontinue breastfeeding or to discontinue Apixaban therapy, taking into account the importance of the drug
to the mother. Pediatric Use: Safety and effectiveness of Apixaban in pediatric patients have not been established. Drug
Interactions: Combined P-gp and strong CYP3A4 inhibitors increase blood levels of Apixaban. Reduce Apixaban dose or avoid
coadministration. Simultaneous use of combined P-gp and strong CYP3A4 inducers reduces blood levels of Apixaban: Avoid concomitant
use. Side effects: Apixaban can cause a skin rash or severe allergic reaction.
Pharmaceutical Precautions :
Protect from light, store below 30°C. Keep out of reach of children.
Commercial pack :
Apixan 2.5: Each box contains blister strips of 30 tablets. Apixan 5: Each box contains blister strips of 20 tablets.
Manufactured by :
UniMed UniHealth Pharmaceuticals Limited
BK Bari, Gazipur, Bangladesh
® Registered trademark