ELIQUIS 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 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, weight ≤60 kg, serum creatinine ≥1.5 mg/dL); DVT/PE treatment: 10 mg twice daily for 7 days, then 5 mg twice daily; Prevention of recurrent DVT/PE: 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 non-valvular 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 (recurrent DVT/PE prevention and surgical prophylaxis)

Maximum Dose

10 mg twice daily (during initial DVT/PE treatment phase for first 7 days)

Children's Dosage

Approved for pediatric patients from birth and older for VTE treatment after initial therapy (specific weight-based dosing); not recommended <2.6 kg

Dose Adjustment Notes

Reduce to 2.5 mg twice daily in AF patients with ≥2 of the following: age ≥80 years, body weight ≤60 kg, serum creatinine ≥1.5 mg/dL; no dose adjustment required for mild-to-moderate renal impairment alone; avoid in severe hepatic impairment; avoid in patients with CrCl <15 mL/min or on dialysis (limited data)

How to Take

Swallow tablet whole with or without food and water; for patients unable to swallow, tablets 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 (bruising, nosebleed, gum bleeding, hematuria), nausea, anemia, contusion

Safety & Warnings

Contraindications

Active pathological bleeding, severe hypersensitivity to apixaban, clinically significant active bleeding, lesions or conditions at significant risk of major bleeding, concomitant use of other anticoagulants except in specific switching situations, prosthetic heart valves requiring anticoagulation, antiphospholipid syndrome with triple positive antibodies

Warnings & Precautions

Risk of serious and potentially fatal bleeding; avoid in patients with active bleeding; spinal/epidural hematoma risk with neuraxial anesthesia or spinal puncture - monitor for neurological impairment; premature discontinuation increases risk of thrombotic events; use with caution in patients with severe renal impairment (CrCl 15-29 mL/min); avoid in severe hepatic impairment or hepatic disease associated with coagulopathy; no routine reversal agent widely available (andexanet alfa is approved for reversal in life-threatening bleeding); use with caution in patients at high bleeding risk; not recommended in patients with prosthetic heart valves

Age Restriction

Not approved under 18 years

Drug Interactions

Drug Interactions

Strong dual inhibitors of CYP3A4 and P-gp (ketoconazole, itraconazole, ritonavir, clarithromycin - increase apixaban exposure, reduce dose or avoid); strong dual inducers of CYP3A4 and P-gp (rifampicin, carbamazepine, phenytoin, St. John's Wort - decrease apixaban exposure, avoid combination); other anticoagulants, antiplatelets, NSAIDs, SSRIs/SNRIs (increase bleeding risk); aspirin and P2Y12 inhibitors (additive bleeding risk)

Interaction Severity

MAJOR: Rifampicin, carbamazepine, phenytoin, St. John's Wort (strong CYP3A4/P-gp inducers - significantly reduce apixaban levels, avoid combination); Ketoconazole, itraconazole, ritonavir (strong CYP3A4/P-gp inhibitors - significantly increase apixaban exposure, reduce apixaban dose to 2.5 mg twice daily or avoid); Other anticoagulants including heparin, warfarin, dabigatran (additive bleeding risk, avoid concurrent use except during switching). MODERATE: Aspirin, clopidogrel, prasugrel, ticagrelor (increased bleeding risk, use with caution); NSAIDs including ibuprofen, naproxen (increased bleeding risk); SSRIs and SNRIs (increased bleeding risk). MINOR: Diltiazem, naproxen at standard doses (mild P-gp/CYP3A4 inhibition, monitor)

Food Interaction

No restriction

Special Populations

Pregnancy

Not assigned (Risk Summary: Avoid use unless maternal benefit outweighs fetal risk)

Children

Approved for pediatric patients from birth and older for VTE treatment after initial therapy (specific weight-based dosing); not recommended <2.6 kg

Elderly

Standard adult dosing applies; in AF patients aged ≥80 years with body weight ≤60 kg or serum creatinine ≥1.5 mg/dL, reduce dose to 2.5 mg twice daily; monitor renal function at least annually

Kidney Impairment

CrCl ≥30 mL/min: no adjustment required (apply dose reduction criteria for AF); CrCl 15-29 mL/min: use with caution, limited data; CrCl <15 mL/min or dialysis: avoid use (not recommended due to insufficient data)

Liver Impairment

Mild (Child-Pugh A): no adjustment needed; Moderate (Child-Pugh B): use with caution; Severe (Child-Pugh C): contraindicated

Storage & Patient Advice

Missed Dose

Take the missed dose 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, apply mechanical compression for accessible bleeding sites; andexanet alfa (Factor Xa inhibitor reversal agent) is approved for reversal of life-threatening or uncontrolled bleeding; activated charcoal may reduce absorption if given within 6 hours of ingestion; apixaban is not dialyzable; seek immediate emergency medical attention

Patient Counseling

Take apixaban exactly as prescribed, twice daily, with or without food. Do not stop taking this medication without talking to your doctor first - stopping suddenly can increase your risk of stroke or blood clot. Tell all your healthcare providers (including dentists and surgeons) that you are taking apixaban before any procedure. Watch for unusual bleeding such as prolonged bleeding from cuts, blood in urine or stool, coughing up blood, or unexpected bruising, and report these immediately. Avoid taking NSAIDs (like ibuprofen) or aspirin unless directed by your doctor. Limit alcohol consumption as it increases bleeding risk. If you miss a dose, take it as soon as you remember on the same day - never double up doses. Store tablets below 30°C. This medication requires a prescription and should not be shared with others.

Monitoring Requirements

No routine coagulation monitoring required; monitor renal function periodically (at least annually); monitor for signs and symptoms of bleeding; assess hepatic function before initiation; CBC as clinically indicated

Pharmacology

Mechanism of Action

Selective, reversible direct inhibitor of Factor Xa that blocks the prothrombinase complex, inhibiting both free and clot-bound Factor Xa, thereby reducing thrombin generation and thrombus formation without requiring antithrombin as a cofactor

Onset of Action

3-4 hours (peak plasma concentration)

Duration of Effect

12 hours (supports twice-daily dosing)

Half-Life

Approximately 12 hours

Bioavailability

Approximately 50% (for 5 mg dose); up to 88% for 2.5 mg dose

Metabolism

Hepatic via CYP3A4/5 (major), CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2J2 (minor); also substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP)

Excretion

Fecal/biliary (approximately 56%), renal (approximately 27%), other (approximately 17%)

Protein Binding

Approximately 87%

Product Information

Available Dosage Forms

Film-coated tablet

Composition per Dose

Each film-coated tablet: 5 mg apixaban

Generic Availability

No

OTC Alternatives

No OTC alternative

Cv Drug Class

Anticoagulant

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