ELIQUIS 2.5MG 60 TAB

Indications

Approved Uses

To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, Prophylaxis of deep vein thrombosis (DVT) following hip or knee replacement surgery, Treatment of DVT and pulmonary embolism (PE), To reduce the risk of recurrent DVT and PE after initial therapy.

Dosage & Administration

Dosing by Condition

Nonvalvular AF (stroke/systemic embolism prevention): 5 mg PO twice daily; reduce to 2.5 mg PO twice daily if ≥2 of age ≥80 years, weight ≤60 kg, SCr ≥1.5 mg/dL. DVT/PE treatment: 10 mg PO twice daily for 7 days, then 5 mg PO twice daily. Prevention of recurrent DVT/PE: 2.5 mg PO twice daily after at least 6 months of treatment. Post-hip replacement prophylaxis: 2.5 mg PO twice daily for 35 days. Post-knee replacement prophylaxis: 2.5 mg PO twice daily for 12 days. Start prophylaxis 12-24 hours after surgery once hemostasis achieved.

Initial Dose

2.5 mg twice daily (for DVT/PE secondary prevention and surgical prophylaxis); 10 mg twice daily for 7 days (for acute DVT/PE treatment)

Maintenance Dose

2.5 mg twice daily (prophylaxis of DVT post hip/knee surgery, reduction in risk of recurrent DVT/PE); 5 mg twice daily (NVAF, treatment of DVT/PE after initial 7 days)

Maximum Dose

Maximum labeled regimen is 10 mg twice daily (20 mg/day) for the initial 7 days of acute DVT/PE treatment, then 5 mg twice daily.

Children's Dosage

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

Dose Adjustment Notes

NVAF: use 2.5 mg twice daily if the patient has ≥2 of age ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dL; avoid/contraindicated with strong dual CYP3A4/P-gp inducers; with strong dual CYP3A4/P-gp inhibitors, reduce apixaban dose by 50% (and avoid if already on 2.5 mg BID). Renal impairment: no dose adjustment solely for renal function except the NVAF criteria; patients with CrCl <15 mL/min or on dialysis have limited evidence-follow local labeling/specialist guidance.

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 in water, or apple juice, or mixed with applesauce and administered immediately; can also be administered via nasogastric tube in 60 mL of water or 5% dextrose

Side Effects

Common Side Effects

Bleeding (e.g., bruising, epistaxis, gingival bleeding, hematuria), anemia, nausea

Side Effect Frequency

Very common (≥10%): bleeding (overall/any bleeding). Common (1-10%): anemia, nausea, contusion/bruising/hematoma, epistaxis, hematuria. Uncommon (0.1-1%): thrombocytopenia, hypotension, hypersensitivity reactions (including rash/pruritus). Rare (<0.1%): allergic edema/angioedema. Serious major bleeds (e.g., intracranial or gastrointestinal hemorrhage) are uncommon but clinically significant.

Safety & Warnings

Contraindications

Contraindications: (1) Active pathological bleeding. (2) Severe hypersensitivity reaction to apixaban (e.g., anaphylaxis).

Warnings & Precautions

Key warnings/precautions: increased risk of bleeding; boxed warning for thrombotic risk with premature discontinuation; spinal/epidural hematoma risk with neuraxial anesthesia/spinal puncture; avoid/adjust with strong CYP3A4/P-gp inhibitors/inducers; caution in renal/hepatic impairment and in elderly/low body weight; monitor clinically for bleeding (no routine coagulation monitoring).

Age Restriction

Adults only; safety and efficacy have not been established in patients <18 years.

Drug Interactions

Drug Interactions

Major interactions: strong dual CYP3A4/P-gp inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) ↑ apixaban exposure/bleeding; strong dual CYP3A4/P-gp inducers (e.g., rifampin, carbamazepine, phenytoin, St John’s wort) ↓ exposure/efficacy; other anticoagulants/antiplatelets/NSAIDs ↑ bleeding risk; SSRIs/SNRIs may ↑ bleeding risk.

Interaction Severity

MAJOR: Strong dual CYP3A4/P-gp inhibitors (e.g., ketoconazole, itraconazole, ritonavir/cobicistat) ↑ apixaban exposure/bleeding; strong dual CYP3A4/P-gp inducers (e.g., rifampin, carbamazepine, phenytoin, St John’s wort) ↓ exposure/efficacy-avoid. Additive bleeding risk with other anticoagulants/antithrombotics (antiplatelets, NSAIDs) is clinically significant. MODERATE: SSRIs/SNRIs and other agents affecting hemostasis may increase bleeding risk.

Food Interaction

No restriction.

Special Populations

Pregnancy

Consult Doctor

Children

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

Elderly

Dose reduction to 2.5 mg twice daily in AF patients aged ≥80 years if also meeting one additional criterion (weight ≤60 kg or serum creatinine ≥1.5 mg/dL); otherwise standard adult dosing; monitor renal function periodically

Kidney Impairment

NVAF: 5 mg twice daily; reduce to 2.5 mg twice daily if any 2 of: age ≥80 years, weight ≤60 kg, serum creatinine ≥1.5 mg/dL. ESRD on dialysis: US label allows 5 mg BID (reduce to 2.5 mg BID if age ≥80 or weight ≤60), but evidence is limited. VTE treatment/prophylaxis: no routine renal dose adjustment; use caution in severe impairment and avoid if CrCl <15 mL/min due to limited data.

Liver Impairment

Child-Pugh A: no dose adjustment. Child-Pugh B: use with caution (limited data). Child-Pugh C or hepatic disease associated with coagulopathy/clinically relevant bleeding risk: not recommended/avoid.

Storage & Patient Advice

Missed Dose

If a dose is missed, take it as soon as possible on the same day and then continue with twice-daily dosing; do not take a double dose to make up for a missed dose.

Stopping the Medicine

Do not stop apixaban without clinician guidance; if discontinuation is necessary, transition to an alternative anticoagulant to reduce thrombotic risk.

Overdose

Overdose increases bleeding risk; stop apixaban, provide supportive/local hemostatic measures, consider activated charcoal if recent ingestion, and use andexanet alfa (or 4-factor PCC where andexanet is unavailable) for life-threatening/uncontrolled bleeding; hemodialysis is ineffective.

Patient Counseling

Take exactly as prescribed twice daily with or without food; do not stop without medical advice; inform all healthcare providers/dentists; watch for and promptly report signs of bleeding; avoid unnecessary NSAIDs/antiplatelets and limit alcohol; missed dose: take same day ASAP without doubling; store below 30°C.

Monitoring Requirements

No routine coagulation monitoring (e.g., INR) is required; monitor clinically for bleeding and periodically assess renal function, hepatic function as appropriate, and CBC/hemoglobin/hematocrit. Anti-Factor Xa (apixaban-calibrated) levels may be considered only in special situations (e.g., overdose, urgent surgery, extremes of body size, suspected accumulation).

Pharmacology

Mechanism of Action

Selective, reversible, direct Factor Xa inhibitor that reduces thrombin generation and clot formation (does not require antithrombin).

Onset of Action

Peak effect ~3-4 hours after an oral dose.

Duration of Effect

Approximately 12 hours per dose (supports twice-daily dosing); anticoagulant activity declines over ~24-48 hours after the last dose depending on renal/hepatic function.

Half-Life

Approximately 12 hours.

Bioavailability

Approximately 50%.

Metabolism

Metabolized primarily by CYP3A4/5, with minor contributions from other CYP enzymes; also subject to P-gp/BCRP transport.

Excretion

Elimination via multiple pathways: renal excretion ~27% of total clearance; the remainder via biliary/fecal and intestinal excretion and metabolism.

Protein Binding

Approximately 87%.

Product Information

Available Dosage Forms

Film-coated tablet (oral)

Composition per Dose

Each film-coated tablet: 2.5 mg apixaban

Generic Availability

No

OTC Alternatives

No OTC alternative

Cv Drug Class

Anticoagulant

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