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Apixaban 5 PDF

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A) Drug Description: H) Indication in FUKKM:

5mg, pink, oval-shaped, bi- Prevention of stroke and systemic embo-


convex, film coated tablets
lism in adult patients with non-valvular
atrial fibrillation (NVAF), with one or
B) Class: more risk factors, such as prior stroke
Anticoagulant (Factor Xa inhibitor) or transient ischaemic attack (TIA);
Age ≥75 years; hypertension; diabetes
mellitus; symptomatic heart failure
C) Registration No. :
(NYHA Class ≥ II). Restriction: only for
MAL31085063ARZ renal patients.

D) Price: I) Dose in FUKKM:


RM 65.10/box i) 5mg taken orally BD.
Ii) Dose reduction: 2.5mg taken orally
E) Department: BD in NVAF patients with at least two of
the following characteristics: age ≥ 80
Cardiology
years old, body weight ≤ 60kg, or serum
creatinine ≥ 1.5mg/dL (133 µmole/L)
F) Prescriber Category:
A* (Consultant/Specialists for specific
J) Administration:
indication only)
Oral Nasogastric Tube
swallow whole tablets or may be crushed and
G) Mechanism of action:
5 mg and 2.5 mg may be suspended in 60 mL of
Apixaban is a highly selective, orally bio- crushed and suspended water or D5W and
available inhibits thrombin production, in water, 5% dextrose in promptly delivered
conversion of fibrinogen to fibrin and through a nasogastric
water (D5W), or apple tube Crushed ELIQUIS
thrombus formation via selective and
juice, or mixed with ap- tablets are stable in
reversible inhibition of factor Xa (FXa), a
plesauce and promptly water, D5W, apple
part of the promthrombinase complex
administered orally juice, and applesauce
which catalyses the conversion of pro-
thrombin to thrombin. for up to 4 hours.
K) Adverse Drug Reactions:
i) significant: Thromboembolic events (premature discontinuation), bleeding, spinal or epidural
haematoma resulting to long term or permanent paralysis.
Ii) Blood & lymphatic system disorders: anaemia, thrombocytopenia
Iii) Gastrointestinal disorders: nausea, mouth or gingival haemorrhage, GI and rectal haemor-
rhage
iV) injury, poisoning and procedural complications : contusion
V) Reproductive system and breast disorders: vaginal and urogenital haemorrhage
Vi) vascular disorders: epistaxis, hematoma
Vii) potentially fatal: serious bleeding

L) Contraindications: N) Monitoring parameters:


Active pathological bleeding, hepatic dis- CBC,aPTT, PT, SCr, LFT prior initiation or
ease associated with coagulopathy & clini- clinically indicated, and atl least annualy
cally relevant bleeding risks, conditions or thereafter. Signs & symptoms of bleeding or
lesions with significant risk for major anemia.
bleeding. Concomitant use with parenteral
anticoagulants except when given to main-
O) Storage:
tain an open central venous or aterial cath-
eter, or during catheter ablation, oral anti- Store at room temperate (20°C-25°C)
coagulant except when switching to oral
anticoagulant theraphy.
P) References:
M) Use in specific Population: Product leaflet, Micromedex, FUKKM, Mims-
gateway, NPRA
Lactation: not recommended
Pregnancy: US FDA (B)
Paediatric: not established
Prepared by:
Renal impairment: 2.5mg BD (refer I (ii))
Nur Syazwanie bt Ahmad Hassan Basri
Hepatic impairment: no adjustment in mild,
not recommended in severe.

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