Alfumax ER 10 mg

INDICATIONS

Alfuzosin Hydrochloride is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia(BPH), lower urinary tract symptoms (LUTS) including urinary frequency, nocturia, incomplete emptying and urinary hesitancy associated with BPH.

PHARMACOLOGY

Alfuzosin Hydrochloride is a selective antagonist of post-synaptic a1 adrenoreceptors, which are located in the prostate, bladder base, bladder neck, prostatic capsule, and prostatic urethra. Alfuzosin Hydrochloride relaxes the tone of the prostate smooth muscle, prostate capsule, bladder neck and proximal urethra. It competitively and selectively binds to the post synaptic a1-adrenergic receptors in the lower urinary tract. It also relaxes sympathetic nervous stimulation, reduces resting urethral pressure and inhibits urethral hypertonia-induced sympathetic nervous stimulation. As an uroselective agent, Alfuzosin Hydrochloride preferentially binds to prostatic a1 receptors, blockage of these receptors result in reduction of BPH symptoms, improvement of urine flow and decreased potential for hypertensive events.

DOSAGE

Benign prostatic hyperplasia (BPH): The recommended dose is 10 mg to be taken once daily after a meal. Acute urinary retention (AUR): In patients 65 years and older, 10 mg  daily after a meal to be taken from the first day of catheterisation. The treatment should be administered for 3-4 days, 2-3 days during catheterisation and 1 day after its removal. In this indication no benefit has been established in patients under 65 years of age or if treatment is extended beyond 4 days.

INTERACTION

Combinations contra-indicated: Alpha-1-receptor blockers. Combinations to be taken into account: Antihypertensive drugs, nitrates, potent CYP3A4 inhibitors such as ketoconazole, itraconazole and ritonavir. Repeated 200mg daily dosing of ketoconazole, for seven days resulted in a 2.1-fold increase in Cmax and a 2.5-fold increase in exposure of Alfuzosin Hydrochloride 10mg when administered as a single dose under fed conditions (high fat meal). Other parameters such as tmax and t1/2 were not modified. Cmax and AUC of Alfuzosin Hydrochloride 10mg, when administered as a single dose under fed conditions, increased 2.3- fold and 3.0- fold, respectively following 8-day repeated 400mg ketoconazole daily dosing. The administration of general anaesthetics to patients receiving Alfuzosin Hydrochloride could cause profound hypotension. It is recommended that the tablets be withdrawn 24 hours before surgery.Other forms of interaction: No pharmacodynamic or pharmacokinetic interaction has been observed in healthy volunteers between Alfuzosin Hydrochloride and the following drugs: warfarin, digoxin, hydrochlorothiazide and atenolol.

SIDE EFFECTS

Classification of expected frequencies: Very common (<1/10), common (<1/100 to <1/10), uncommon (<1/1,000 to <1/100), rare (<1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Nervous system disorders: Common: faintness/dizziness, headache; Uncommon: syncope, vertigo, malaise, drowsiness. Eye disorders: Uncommon: vision abnormal; Not known: intraoperative floppy iris syndrome. Cardiac disorders: Uncommon: tachycardia, palpitations, hypotension (postural); Very rare: New onset, aggravation or recurrence of angina pectoris in patients with pre-existing coronary artery disease; Not known: atrial fibrillation. Vascular disorders: Uncommon: hypotension (postural), flushing. Blood and lymphatic system disorders: Not known: neutropenia, thrombocytopenia. Respiratory, thoracic and mediastinal disorders: Uncommon: rhinitis. Gastro-intestinal disorders: Common: nausea, abdominal pain; Uncommon: diarrhoea, dry mouth, vomiting; Not known: vomiting. Hepatobiliary disorders: Frequency unknown: hepatocellular injury, cholestatic liver disease. Skin and subcutaneous tissue disorders: Uncommon: rash, pruritus; Very rare: urticaria, angioedema. Reproductive system and breast disorders: Frequency unknown: priapism. General disorders and administration site conditions: Common: asthenia; Uncommon: flushes, oedema, chest pain.

PREGNANCY & LACTATION

Due to the type of indication this is not applicable.

PRECAUTIONS & WARNINGS

The administration of general anesthetics to patients receiving Alfuzosin could cause profound hypotension. It is recommended that the tablets be withdrawn 24 hours before surgery. If symptoms of angina pectoris start or get worse, taking Alfuzosin should be stopped.

USE IN SPECIAL POPULATIONS

Paediatric Population: Efficacy of Alfuzosin Hydrochloride has not been demonstrated in children aged 2 to 16 years. Therefore Alfuzosin Hydrochloride is not indicated for use in the paediatric population.

THERAPEUTIC CLASS

BPH/ Urinary retention/ Urinary incontinence

STORAGE CONDITIONS

Store in a cool and dry place, protected from light