Febuxostat

Drug #2221

Febuxostat is a non-purine xanthine oxidase inhibitor for the treatment of chronic hyperuricaemia. It is 2-[3-cyano-4-(2-methylpropoxy) phenyl]-4-methylthiazole-5-carboxylic acid. The empirical formula is C16H16N2O3S.

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Primary Characteristics

Molecular Weight: 316.38 · Solubility in Water: practically insoluble in water · Solubility in Alcohol: springly soluble in ethanol, slightly soluble in methanol and acetonitrile · Non-proprietary name: Febuxostat.

Pharmacokinetics

Absorption: Febuxostat has an oral bioavailability is 64.5% (±15.5%).

Distribution: Febuxostat has a volume of distribution is 50L. plasma protein binding is 99.2%.

Elimination: it is metabolised via by UGT & CYP P450 enzymes, plasma half-life is 5-8 Hours, renal excretion is 49% and 45% in feces.

Indications

Febuxostat is primarily indicated in conditions like Gout, Hyperuricemia.

Contraindications

Febuxostat is contraindicated in conditions like Severe liver impairment, Severe renal impairment.

Dosage

Febuxostat's dosage details are as follows:

Dose	Single Dose	Frequency	Route	Instructions
Adult Dosage
40 mg	40 mg	Every 24h	PO	This is the starting dose for hyperuricemia patients with gout. It can be taken with or without food.
80 mg	80 mg	Every 24h	PO	This is the dose for patients who do not achieve a serum uric acid less then 6mg/dl after 2 weeks with 40mg dose. It can be taken with or without food.
Paediatric Dosage (20kg)
No data.
Neonatal Dosage (3kg)
No data.

Drug Interactions

Major1 interaction

Always consult your physician for the change of dose regimen or an alternative drug of choice that may strictly be required.

Side Effects

Febuxostat in overdosage may give rise to further complications which include Fever , Neutropenia , Thrombocytopenic purpura , Angina , Slurred speech , Blurred vision , Irregular heart beat, Leukopenia.

Febuxostat is known to cause more or less tolerable side effects which are usually transient. These include Abdominal pain, Arthralgia, Asthenia , Constipation , Diarrhea, Dizziness, Dry mouth, Dyspepsia , Edema, Flatulence, Gastritis, gout flares, Headache, Joint stiffness or swelling, Liver function abnormalities, Mouth ulcers, Muscle cramps, Nausea, Rashes , Vomiting .

Warnings / Precautions

It may cause gout flare. Gout flare prophylaxis with NSAID or chlchicine for at least six months is recommended. Liver function test is recommended before initiating treatment and 2 and 4 minths following initiation of febuxostat and periodically thereafter.. Monitor signs and symptoms of Myocardial infarction (MI) and stroke. Use is not recommended in patients with a greatly increased rate of urate formation (eg, malignant disease and its treatment). Caution should be exercised when febuxostat is administered to nursing women. It is not recommended in less then 18 years of age. There are insufficient data in patients with severe renal impairment (Clcr less than 30 mL per min); therefore, caution should be exercised in these patients No studies have been conducted in patients with severe hepatic impairment; therefore, caution should be exercised in these patients

Available Brands

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Single Ingredient

Tabs

120 mg 40 mg 80 mg

Storage Conditions

Febuxostat should be stored Tablet.

Drug Classification

1.2.3 — Antigout preparations

Manufacturers

Manufacturers of Febuxostat in Pakistan:

Atco CCL Efroze Genome Getz Helix Pharmevo S.J.& G