AGOUT 80/MG FC TAB 30/FC TAB

Indications

Approved Uses

Chronic management of hyperuricemia in patients with gout.

Dosage & Administration

Dosing by Condition

Chronic gout with hyperuricemia: start 40 mg orally once daily; if serum urate remains >6 mg/dL after ~2 weeks, increase to 80 mg once daily (usual max 80 mg/day per many labels; higher doses such as 120 mg are used only where specifically approved).

Initial Dose

40 mg once daily

Maintenance Dose

80 mg once daily

Maximum Dose

80 mg once daily (120 mg once daily in some guidelines for refractory hyperuricemia)

Children's Dosage

Not approved for children under 18 years

Dose Adjustment Notes

Titrate to serum urate target (generally <6 mg/dL; <5 mg/dL in severe tophaceous disease) and use flare prophylaxis with colchicine/NSAID (or low-dose steroid if needed) for at least 3-6 months when starting urate-lowering therapy.

How to Take

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

Side Effects

Common Side Effects

Gout flares (especially at initiation), liver function test elevations, nausea, arthralgia, rash; headache and diarrhea are also common.

Side Effect Frequency

Very common: gout flares during initiation. Common (≈1-10%): liver function test elevations, nausea, rash, arthralgia, headache, diarrhea, edema. Rare/uncommon: serious hypersensitivity reactions (including SJS/TEN), severe hepatotoxicity; cardiovascular risk signal noted in labeling (especially in patients with established CVD).

Safety & Warnings

Warnings & Precautions

Cardiovascular risk (especially in established CV disease; monitor for MI/stroke), hepatic effects (monitor LFTs), gout flares on initiation (use flare prophylaxis), and discontinue for serious hypersensitivity/skin reactions; caution/limit dose in severe renal impairment.

Age Restriction

Not approved under 18 years.

Drug Interactions

Interaction Severity

MAJOR/Contraindicated: azathioprine, mercaptopurine (risk of severe toxicity due to xanthine oxidase inhibition). MODERATE: theophylline (potential increased exposure-avoid or monitor closely), didanosine (avoid where applicable). MINOR: antacids (Al/Mg) may reduce Cmax/delay absorption-separate if needed.

Food Interaction

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

Special Populations

Children

Not approved for children under 18 years

Elderly

Standard adult dosing; no dose adjustment required based on age alone, but monitor renal and hepatic function

Kidney Impairment

CrCl 30-89 mL/min: no adjustment. CrCl <30 mL/min: do not exceed 40 mg once daily (80 mg not recommended).

Liver Impairment

Child-Pugh A or B: no dose adjustment. Child-Pugh C: use not recommended / avoid due to insufficient data (if used, only with extreme caution).

Storage & Patient Advice

Stopping the Medicine

Do not stop without consulting the prescriber; stopping can increase urate and precipitate gout flares.

Patient Counseling

Take once daily consistently (with or without food); expect possible increased gout flares early-continue febuxostat and use prescribed prophylaxis; do not stop during a flare unless told; report rash or signs of liver injury; report chest pain/shortness of breath or stroke symptoms urgently; avoid azathioprine/mercaptopurine (and generally avoid/monitor theophylline if used); attend follow-up labs for urate and LFTs.

Monitoring Requirements

Monitor serum urate (as early as 2 weeks after initiation and after dose changes, then periodically) and liver function tests (baseline and periodically); assess cardiovascular risk and monitor for symptoms of MI/stroke; monitor renal function as clinically indicated.

Pharmacology

Mechanism of Action

A non-purine, selective inhibitor of xanthine oxidase, which works by blocking the enzyme responsible for converting hypoxanthine to xanthine and then to uric acid, thereby reducing the production of uric acid.

Onset of Action

Serum urate reduction begins within hours after a dose; measurable lowering is seen within 24 hours, with steady-state/maximum effect typically reached within about 1-2 weeks.

Duration of Effect

Approximately 24 hours (supports once-daily dosing).

Half-Life

Approximately 5-8 hours.

Excretion

Eliminated via both urine and feces after hepatic metabolism; approximately ~49% recovered in urine and ~45% in feces (mostly as metabolites, with a smaller fraction as unchanged drug).

Product Information

Available Dosage Forms

Film-coated tablet.

Composition per Dose

Each film-coated tablet: 80 mg febuxostat

Generic Availability

Yes

Urological Condition

Kidney Stones

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