Alfuzosin HCL 10mg Extended Release Tablets
Each uncoated extended release tablet contains:
Alfuzosin Hydrochloride BP 10mg
White colored, oblong, uncoated extended release tablet with break line on one side.
Pediatric: Not intended for use in children.
Pregnancy: Category B
Nursing Mother: It is not known whether FUZON is excreted in breast milk.
Storage: Store the tablets at room temperature (15-30°C) away from direct heat and light; Protect from moisture; Keep out of reach of children.
Missed dose: Take the missed dose as soon as you remember; Skip the missed dose if it is almost time for your next scheduled dose; Do not take extra medicine to make up the missed dose.
Pharmacotherapeutic Group: α1-adrenoreceptor antagonists; alpha blockers
Pharmacodynamic properties: FUZON (Alfuzosin) is an orally active quinazoline derivative which exhibits selectivity for α1-adrenergic receptors in the lower urinary tract. Blockade of these adrenoreceptors causes relaxation of smooth muscle in the bladder neck and urethra, resulting in improvement in urine flow and a reduction in symptoms of Benign Prostatic Hyperplasia (BPH) and Bladder Outlet Obstruction (BOO).
Absorption: Readily absorbed; Bioavailability: Approx 49%; Time to peak plasma concentration: 8 hr
Distribution: Plasma protein binding: 90%
Metabolism: Extensively metabolized in the liver to inactive metabolites
Excretion: Majority of the metabolites (which are inactive) is excreted in the faeces (75-90%); Around 10% of the dose is eliminated as unchanged drug in the urine; Elimination half-life: 10 hr
Benign Prostatic Hyperplasia; Primary Bladder Neck Obstruction
The dose of FUZON is 10mg to be taken once daily after a meal.
Hypersensitivity; History of orthostatic hypotension; Severe hepatic impairment; Concurrent use with potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir); Combination with other α1 blocker.
Patient with acquired or congenital QT prolongation; Symptomatic hypotension; Coronary insufficiency; Prostate carcinoma; Renal and mild to moderate hepatic impairment; Pregnancy and lactation; Intra-operative floppy iris syndrome (IFIS).
ADVERSE DRUG REACTIONS
Postural hypotension, tachycardia, angina pectoris in patient with pre-existing coronary artery disease, chest pain, oedema, diarrhoea, upper respiratory tract infection, bronchitis, hepatocellular and cholestatic liver injury including jaundice, dizziness, headache, fatigue, rash, pruritus, urticaria. Rarely: Priapism can occur.
Additive effect on QT interval prolongation when used with QT prolonging drugs; Concomitant administration with other α1-adrenergic blocking agents, atenolol or diltiazem may result in additive CV effects; Increased plasma alfuzosin concentrations with cimetidine. Potentially Fatal: Concurrent use with potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir) increase plasma alfuzosin levels.
Each box contains 10 blister packs of 10 tablets per strip with an inner catch cover per strip.