Apiklot Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Apixaban

Indications/Uses

Prevention of VTE in adults who have undergone elective hip or knee replacement surgery; stroke & systemic embolism in adult w/ non-valvular atrial fibrillation (NVAF) w/ ≥1 risk factor eg, stroke or TIA, ≥75 yr, HTN, DM, symptomatic heart failure (NYHA class ≥II). DVT & pulmonary embolism (PE). Prevention of recurrent DVT & PE in adult.

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Dosage/Direction for Use

Prevention of VTE (VTEp) in elective hip or knee replacement surgery 2.5 mg bid initiated 12-24 hr after surgery. Patient undergoing hip replacement surgery Duration of treatment: 32-38 days. Patient undergoing knee replacement surgery Duration of treatment: 10-14 days. Prevention of stroke & systemic embolism in patient w/ AF: NVAF 5 mg bid. Patient w/ at least 2 of the following characteristics: ≥80 yr, ≤60 kg or serum creatinine ≥1.5 mg/dL 2.5 mg bid. DVT & PE 10 mg bid for 7 days followed by 5 mg bid. Prevention of recurrent DVT & PE 2.5 mg bid after at least 6 mth of treatment. Patient undergoing cardioversion & not previously treated w/ anticoagulants 5 mg bid for at least 2.5 days (5 single doses) before cardioversion to ensure adequate anticoagulation. If cardioversion is required before 5 doses of apixaban: 10 mg loading dose followed by 5 mg bid. Reduce to 5 mg loading dose followed by 2.5 mg bid if the patient meets criteria for dose reduction. Loading dose should be given at least 2 hr before cardioversion.

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Overdosage

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Administration

May be taken with or without food: Swallow w/ water.

Contraindications

Hypersensitivity (ie, anaphylactic reactions). Active pathological bleeding.

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Special Precautions

Increased risk of thrombotic events w/ discontinuation in the absence of adequate alternative anticoagulation. Discontinue if there is a risk of thrombotic events/pathological bleeding/hemorrhage. Increased risk of bleeding w/ concomitant use of aspirin & other antiplatelets, other anticoagulants, heparin, thrombolytics, SSRI, SNRI & NSAIDs. Not recommended in patients w/ prosthetic heart valves. Avoid during pregnancy. Discontinue breastfeeding or discontinue/abstain from therapy when breastfeeding. Safety & efficacy in childn & adolescent <18 yr has not been established.

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Use In Pregnancy & Lactation

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Adverse Reactions

Anaemia; hemorrhage, hematoma; epistaxis; nausea, GI/rectal hemorrhage, gingival bleeding; increased γ-glutamyl transferase; hematuria; contusion. Prevention of stroke & systemic embolism in adults w/ NVAF, w/ ≥1 risk factors (NVAF): Eye hemorrhage; hypotension including postural hypotension.

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Drug Interactions

Increased exposure & risk of bleeding w/ CYP3A4 & P-gp inhibitors. Decreased exposure & increased risk of stroke w/ CYP3A4 & P-gp inducers. Avoid coadministration w/ strong dual inhibitors of CYP3A4 & P-gp (eg, ketoconazole, itraconazole, ritonavir or clarithromycin) & strong dual inducers of CYP3A4 & P-gp (eg, rifampin, carbamazepine, phenytoin, St John's wort). Increase risk of bleeding w/ antiplatelets, fibrinolytics, heparin, aspirin & chronic NSAID use.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Apiklot detailed prescribing information

Storage

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Description

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Action

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MIMS Class

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

ATC Classification

B01AF02 - apixaban ; Belongs to the class of direct factor Xa inhibitors. Used in the treatment of thrombosis.

Regulatory Classification

Presentation/Packing

Form

Apiklot FC tab 2.5 mg

Packing/Price

30's

Form

Apiklot FC tab 5 mg

Packing/Price

30's

Apiklot

apixaban

Manufacturer:

Unison Pharmaceutical

Distributor:

Cathay YSS