AGOUT 40/MG FC TAB 30/FC TAB

Indications

Approved Uses

Chronic management of hyperuricemia in adult patients with gout.

Off-Label Uses

Not recommended for asymptomatic hyperuricemia; off-label use may include tumor lysis syndrome-related hyperuricemia management when standard options are unsuitable (specialist-directed).

Dosage & Administration

Dosing by Condition

Gout/Hyperuricemia: Initial 40 mg once daily; if serum uric acid >6 mg/dL after 2-4 weeks, increase to 80 mg once daily; maximum 80 mg once daily (120 mg used in some guidelines)

Initial Dose

40 mg once daily

Maintenance Dose

40mg to 80mg once daily.

Maximum Dose

80 mg once daily (120 mg per day in some international guidelines)

Children's Dosage

Not approved for children under 18 years

Dose Adjustment Notes

Titrate based on serum uric acid (check after ~2-4 weeks and after dose changes); use flare prophylaxis with colchicine/NSAID (or low-dose steroid if needed) for up to 6 months when initiating ULT.

How to Take

Swallow tablet whole with water once daily; may be taken with or without food; take consistently at the same time each day.

Side Effects

Common Side Effects

Gout flares (especially at initiation), liver function test elevations, nausea, rash, arthralgia/joint pain, diarrhea, headache.

Safety & Warnings

Contraindications

Contraindicated with azathioprine or mercaptopurine; contraindicated in patients with hypersensitivity to febuxostat/excipients.

Warnings & Precautions

Key warnings/precautions: increased risk of cardiovascular death (especially in established CVD); monitor for CV symptoms; hepatic effects-check LFTs at baseline and if symptomatic; gout flares often increase on initiation-use anti-inflammatory prophylaxis and do not stop during flares; discontinue if serious hypersensitivity occurs; caution/limited data in severe renal or hepatic impairment.

Age Restriction

Pediatric use (<18 years): safety and efficacy not established; not indicated for pediatric patients.

Drug Interactions

Food Interaction

No clinically significant food restriction; can be taken with or without food.

Special Populations

Children

Not approved for children under 18 years

Elderly

Standard adult dosing. No clinically significant differences in safety or effectiveness were observed, but greater sensitivity cannot be ruled out.

Liver Impairment

Mild-moderate hepatic impairment (Child-Pugh A or B): no dose adjustment. Severe hepatic impairment (Child-Pugh C): use not recommended/insufficient data (if used, extreme caution).

Storage & Patient Advice

Stopping the Medicine

Do not stop without prescriber advice; if a gout flare occurs, continue febuxostat and treat the flare.

Patient Counseling

Take once daily (same time each day) with or without food; not for treating an acute gout attack; early gout flares can occur-continue therapy and use prescribed prophylaxis; seek urgent care for chest pain/shortness of breath or stroke symptoms; report rash or signs of liver injury (dark urine, jaundice, persistent abdominal pain/fatigue); avoid azathioprine/mercaptopurine; keep follow-up labs for urate and liver tests.

Pharmacology

Mechanism of Action

Selective, non-purine xanthine oxidase inhibitor that reduces uric acid production by blocking xanthine oxidase, the enzyme responsible for converting hypoxanthine to xanthine and xanthine to uric acid

Onset of Action

Serum uric acid begins to decrease within hours after a dose; clinically meaningful reduction is typically seen within 1-2 weeks, with assessment/titration commonly at 2-4 weeks.

Duration of Effect

Urate-lowering effect begins within hours of a dose and persists for at least 24 hours (supports once-daily dosing); steady-state urate reduction is maintained with continued daily therapy.

Half-Life

Approximately 5-8 hours (terminal elimination half-life).

Bioavailability

Oral bioavailability is approximately 85%, not 49%

Excretion

Eliminated via both renal and fecal routes (approximately ~49% in urine and ~45% in feces, largely as metabolites).

Product Information

Available Dosage Forms

Film-coated tablet.

Composition per Dose

Each film-coated tablet: 40 mg febuxostat

OTC Alternatives

No OTC alternative for lowering uric acid. NSAIDs (e.g., ibuprofen) can be used for acute gout flare pain.

Urological Condition

Kidney Stones

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