PIXAR APIXABAN 5MG 60 TAB

Indications

Approved Uses

Reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation, treatment of deep vein thrombosis (DVT), treatment of pulmonary embolism (PE), reduction in the risk of recurrent DVT and PE, prophylaxis of DVT following hip or knee replacement surgery

Dosage & Administration

Dosing by Condition

Non-valvular AF: 5 mg twice daily (2.5 mg twice daily if ≥2 of: age ≥80 years, weight ≤60 kg, serum creatinine ≥1.5 mg/dL); DVT/PE treatment: 10 mg twice daily for 7 days, then 5 mg twice daily; DVT/PE secondary prevention: 2.5 mg twice daily after ≥6 months of treatment; Hip replacement prophylaxis: 2.5 mg twice daily for 32-38 days; Knee replacement prophylaxis: 2.5 mg twice daily for 10-14 days

Initial Dose

5 mg twice daily (for AF); 10 mg twice daily for 7 days (for DVT/PE treatment)

Maintenance Dose

5 mg twice daily (AF and DVT/PE treatment); 2.5 mg twice daily (DVT/PE secondary prevention and surgical prophylaxis)

Maximum Dose

10 mg twice daily (during initial DVT/PE treatment phase)

Children's Dosage

Apixaban is approved for pediatric patients from birth and older for treatment of VTE and reduction in risk of recurrent VTE after at least 5 days of initial anticoagulant treatment; dosing is weight-based

Dose Adjustment Notes

Reduce to 2.5 mg twice daily in AF patients with ≥2 of: age ≥80 years, weight ≤60 kg, serum creatinine ≥1.5 mg/dL; dose reduction for severe renal impairment in AF; not recommended in severe hepatic impairment

How to Take

Swallow tablet whole with or without food; for patients unable to swallow, tablet may be crushed and suspended in water, 5% dextrose, or apple juice, or mixed with applesauce and administered immediately

Safety & Warnings

Contraindications

Active pathological bleeding; severe hypersensitivity to apixaban or any component of the formulation.

Warnings & Precautions

Risk of serious and fatal bleeding - use with caution in patients with bleeding risk factors; premature discontinuation increases risk of thrombotic events; spinal/epidural hematoma risk with neuraxial anesthesia or spinal puncture; use with caution in severe renal impairment (CrCl <15 mL/min); not recommended in severe hepatic impairment or hepatic disease associated with coagulopathy; no routine anticoagulation monitoring required but specific assays (anti-Xa) can be used; reversal agent andexanet alfa is available for life-threatening bleeding

Age Restriction

Approved for pediatric patients from birth and older for treatment of VTE and reduction in risk of recurrent VTE after at least 5 days of initial anticoagulant treatment; approved for adults for other indications

Drug Interactions

Drug Interactions

Strong dual inhibitors of CYP3A4 and P-gp (ketoconazole, itraconazole, ritonavir, clarithromycin - increase apixaban exposure); strong dual inducers of CYP3A4 and P-gp (rifampicin, carbamazepine, phenytoin, St. John's Wort - decrease apixaban exposure); other anticoagulants, antiplatelets, NSAIDs, SSRIs/SNRIs (increased bleeding risk); aspirin, clopidogrel (additive bleeding risk)

Special Populations

Children

Apixaban is approved for pediatric patients from birth and older for treatment of VTE and reduction in risk of recurrent VTE after at least 5 days of initial anticoagulant treatment; dosing is weight-based

Elderly

Apply dose reduction criteria for AF (age ≥80 years is one of three criteria); monitor renal function regularly; standard dosing otherwise unless criteria met

Kidney Impairment

CrCl ≥30 mL/min (AF): standard dosing with dose reduction criteria applied; CrCl 15-29 mL/min (AF): 2.5 mg twice daily; CrCl <15 mL/min or dialysis: not recommended (limited data); DVT/PE treatment: avoid if CrCl <25 mL/min

Storage & Patient Advice

Missed Dose

Take as soon as remembered on the same day; do not take two doses in one day to make up for a missed dose

Stopping the Medicine

Do not stop abruptly without physician guidance - premature discontinuation significantly increases risk of stroke and thromboembolism; transition to alternative anticoagulation if discontinuation is required

Overdose

Symptoms: excessive bleeding, hemorrhage. Management: discontinue apixaban, provide supportive care, consider activated charcoal if ingestion within 2-3 hours, andexanet alfa (specific reversal agent) for life-threatening or uncontrolled bleeding; seek immediate medical attention

Patient Counseling

Take apixaban exactly as prescribed, twice daily, with or without food. Do not stop taking this medication without consulting your doctor, as stopping suddenly can increase your risk of stroke or blood clot. Report any unusual bleeding immediately, including prolonged bleeding from cuts, blood in urine or stools, coughing up blood, or severe headache. Inform all healthcare providers including dentists that you are taking apixaban before any procedure or surgery. Avoid activities with high risk of injury. Limit alcohol consumption as it increases bleeding risk. Inform your doctor of all other medications including over-the-counter drugs and supplements, especially aspirin, NSAIDs, or herbal products like St. John's Wort. If you miss a dose, take it the same day as soon as you remember; never double up doses.

Monitoring Requirements

No routine coagulation monitoring required; periodic renal function assessment (especially in elderly); hemoglobin/hematocrit monitoring for signs of bleeding; hepatic function assessment before initiation

Pharmacology

Mechanism of Action

Selective, reversible direct inhibitor of free and clot-bound Factor Xa, which interrupts the intrinsic and extrinsic coagulation cascade, inhibiting thrombin generation and thrombus development without directly inhibiting thrombin

Onset of Action

3-4 hours (peak plasma concentration)

Duration of Effect

12 hours (twice-daily dosing maintains consistent anticoagulation)

Half-Life

Approximately 12 hours

Bioavailability

Approximately 50% (for 10 mg dose); ~66% for 2.5 mg and 5 mg doses

Product Information

Available Dosage Forms

Film-coated tablet

Composition per Dose

Each film-coated tablet: Apixaban 5 mg

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Cv Drug Class

Anticoagulant

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