DONIFOXATE 80/MG FC TAB 30/FC TAB

Indications

Approved Uses

Chronic management of hyperuricemia in adult patients with gout.

Off-Label Uses

Off‑label: asymptomatic hyperuricemia (generally not recommended routinely); hyperuricemia in CKD when allopurinol is not tolerated/ineffective (use is individualized).

Dosage & Administration

Dosing by Condition

Gout/chronic hyperuricemia (adults): 40 mg orally once daily initially; if serum urate remains >6 mg/dL after ~2 weeks, increase to 80 mg once daily (this product strength is 80 mg per SFDA).

Initial Dose

Initial dose is typically 80 mg once daily; 40 mg may be used in certain circumstances but 80 mg is the standard starting dose

Maintenance Dose

80mg once daily

Maximum Dose

80mg once daily

Dose Adjustment Notes

Assess serum urate after ~2 weeks; if target not achieved, increase dose (e.g., 40 mg to 80 mg once daily); use flare prophylaxis with colchicine/NSAID when starting urate‑lowering therapy for at least 3-6 months (often up to 6 months).

How to Take

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

Side Effects

Common Side Effects

Gout flares (especially at initiation), liver function test abnormalities, nausea, arthralgia, rash, diarrhea, headache.

Side Effect Frequency

Common (≥1% to <10%): liver function test elevations, nausea, rash, arthralgia, diarrhea; gout flares are common during initiation (often reported among the most frequent adverse effects).

Safety & Warnings

Contraindications

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

Warnings & Precautions

Key warnings/precautions: increased CV mortality risk in patients with established CV disease; gout flares may increase on initiation (use flare prophylaxis); serious hypersensitivity reactions (stop immediately); monitor liver function tests; use caution in severe renal impairment and avoid with azathioprine/mercaptopurine.

Drug Interactions

Drug Interactions

Major: azathioprine and mercaptopurine (contraindicated); important: theophylline (avoid/caution with monitoring), didanosine (avoid), and other xanthine-oxidase-metabolized drugs; antacids may reduce absorption (separate dosing).

Food Interaction

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

Special Populations

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.

Liver Impairment

Child-Pugh A or B: no dose adjustment; Child-Pugh C: use with caution (limited data) and monitor liver tests.

Storage & Patient Advice

Stopping the Medicine

Do not stop without clinician advice; stopping can raise urate and precipitate gout flares, and urate-lowering therapy is typically long-term.

Overdose

Limited overdose data; manage with symptomatic/supportive care, consider GI decontamination if appropriate, and monitor renal/hepatic function; dialysis is unlikely to be effective due to high protein binding.

Patient Counseling

Take once daily consistently (with or without food) and continue even when symptom‑free; gout flares may increase initially-use/continue prescribed prophylaxis; seek urgent care for chest pain/shortness of breath or stroke symptoms; stop and seek care for severe rash; report signs of liver injury (jaundice, dark urine, RUQ pain); avoid azathioprine/mercaptopurine and discuss all medicines with the prescriber; attend follow‑up labs for urate and liver tests.

Monitoring Requirements

Monitor serum uric acid (as early as 2 weeks after initiation and after dose changes until at goal, then periodically) and liver function tests at baseline and periodically; assess renal function and cardiovascular risk/clinical status.

Pharmacology

Mechanism of Action

A non-purine, selective inhibitor of xanthine oxidase, the enzyme responsible for the conversion of hypoxanthine to xanthine and then to uric acid. By blocking this enzyme, it reduces the production of uric acid in the body.

Onset of Action

Within 24 hours (initial serum uric acid reduction begins after the first dose; full effect may take up to 2 weeks).

Duration of Effect

Approximately 24 hours (supports once‑daily dosing).

Half-Life

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

Bioavailability

Oral bioavailability: at least ~84%.

Metabolism

Hepatic metabolism mainly via glucuronidation (UGT1A1, UGT1A3, UGT1A9, UGT2B7) and oxidation via CYP1A2, CYP2C8, and CYP2C9; CYP3A4 is not a major pathway.

Protein Binding

Approximately 99% (highly protein bound, mainly to albumin).

Product Information

Available Dosage Forms

Film-coated tablet.

Composition per Dose

Each film-coated tablet: Febuxostat 80mg

OTC Alternatives

For acute gout pain relief: NSAIDs (e.g., ibuprofen, naproxen). For lowering uric acid: No OTC alternative.

Urological Condition

Kidney Stones

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