Drug Description

Presentation

Indications

Treatment of the functional symptoms of benign prostatic hypertrophy (BPH).

Adult Dosage

Besavar XL tablets should be swallowed whole.

BPH: The recommended dose is one 10mg tablet to be taken once daily after a meal.

AUR: In patients 65 years and older, one 10 mg tablet 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.

Contra Indications

• Hypersensitivity to the active substance or any of the excipients.

• History of orthostatic hypotension.

• Combination with other -alpha-1 receptor blockers.

• Hepatic insufficiency.

Special Precautions

Warnings

Intraoperative Floppy Iris Syndrome (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with alpha-1 blockers. Although the risk of this event with alfuzosin appears very low, ophthalmic surgeons should be informed in advance of cataract surgery of current or part use of alpha-1-blockers, as IFIS may lead to increased procedural complications.

As with all alpha₁-blockers in some subjects, in particular patients receiving antihypertensive medications or nitrates, postural hypotension with or without symptoms (dizziness, fatigue, sweating) may develop within a few hours following administration. In such cases, the patient should lie down until the symptoms have completely disappeared. These effects are transient and do not usually prevent the continuation of treatment after adjustment of the dose. The patient should be warned of the possible occurrence of such events.

As with all alpha1-receptor blockers, alfuzosin should be used with caution in patients with acute cardiac failure.

Patients with congenital QTc prolongation, with a known history of acquired QTc prolongation or who are taking drugs known to increase the QTc interval should be evaluated before and during the administration of alfuzosin.

Precautions

Care should be taken when alfuzosin is administered to patients who have a pronounced hypotensive response to another alpha 1-blocker. Treatment should be initiated gradually in patients with hypersensitivity to α-1-blockers. Besavar XL 10mg Tablets should be administered carefully to patients being treated with antihypertensives. Blood pressure should be monitored regularly, especially at the beginning of treatment.

In patients with coronary insufficiency specific anti-anginal therapy should be continued, but if the angina reappears or worsens Besavar XL 10mg Tablets should be discontinued.

As there are no clinical safety data available in patients with severe renal impairment (creatinine clearance < 30ml/min), Besavar XL 10mg Tablets should not be administered to this patient group.

Patients should be warned that the tablet should be swallowed whole. Any other mode of administration, such as crunching, crushing, chewing, grinding or pounding to powder should be prohibited. These actions may lead to inappropriate release and absorption of the drug and therefore possible early adverse reactions.

Besavar XL 10mg Tablets contain hydrogenated castor oil which may cause stomach upset and diarrhoea.

Interactions

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 since blood levels are increased.

The administration of general anaesthetics to patients receiving Besavar XL 10mg Tablets 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 and the following drugs: warfarin, digoxin, hydrochlorothiazide and atenolol.

Adverse Reactions

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).

• Cardiac disorders

Uncommon: tachycardia

Very rare: new onset, aggravation or recurrence of angina pectoris in patients with pre-existing coronary artery disease 

Not known: atrial fibrillation

• Eye disorders

Uncommon: vision abnormal

Not known: intraoperative floppy iris syndrome 

• General disorders and administration site conditions

Common: asthenia

Uncommon: oedema, chest pain

• Gastro-intestinal disorders

Common: nausea, abdominal pain

Uncommon: diarrhoea

Not known: vomiting

• Hepatobiliary disorders

Not known: hepatocellular injury, cholestatic liver disease

• Nervous system disorders

Common: faintness/dizziness, headache

Uncommon: syncope, vertigo, drowsiness

• Reproductive system and breast disorders

Not known: priapism

• Respiratory, thoracic and mediastinal disorders

Uncommon: rhinitis

• Skin and subcutaneous tissue disorders

Uncommon: rash, pruritus

Very rare: urticaria, angiœdema

• Vascular disorders

Uncommon: hypotension (postural), flushing

• Blood and lymphatic system disorders

Not known: neutropenia

Manufacturer

Drug Availability

Updated