INCEPTA PHARMACEUTICALS LTD.
Alfuzosin is used for the treatment of functional symptoms of Benign Prostatic Hyperplasia (BPH). It is also used as a short term treatment of acute urinary retention (AUR) related to BPH patients (over 65 years) in association with catheterization.
BPH/ Urinary retention/ Urinary incontinence
The symptoms associated with benign prostatic hyperplasia (BPH) such as urinary frequency, nocturia, weak stream, hesitancy and incomplete emptying are related to two components, anatomical (static) and functional (dynamic). The static component is related to the prostate size. But prostate size alone does not correlate with symptom severity. The dynamic component is a function of the smooth muscle tone in the prostate and its capsule, the bladder neck and the bladder base as well as the prostatic urethra. The smooth muscle tone is regulated by alpha-adrenergic receptors. Alfuzosin is an orally active quinazoline derivative, peripherally acting antagonist, exhibits selectivity for postsynaptic alpha-1 adrenergic receptors in the lower urinary tract. Blockade of these adrenoceptors can cause smooth muscle in the bladder neck and prostate to relax, resulting in an improvement in urine flow and a reduction in symptoms of BPH.
Benign prostatic hyperplasia: The recommended dose is 10 mg to be taken once daily after a meal. Acute Urinary Retention: 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. Alfuzosin Hydrochloride tablet should be swallowed whole.
Alfuzosin may interact with other alpha-blockers, Atenolol, Cimetidine, Diltiazem, Ketoconazole and Ritonavir.
Alfuzosin Hydrochloride tablet is contraindicated for hypersensitivity to Alfuzosin Hydrochloride, history of orthostatic hypotension, combination with other alpha-1 receptor blockers, hepatic insufficiency.
Dizziness, Headache, Fatigue, Vertigo, Malaise, Tachycardia, Palpitation, Nausea, Abdominal pain, Rash, Diarrhea, Postural hypotension, Syncope, Dry mouth.
Due to the type of indication this is not applicable and should not be used by women.
In case of overdosage, the patient should be hospitalised, kept in the supine position, and conventional treatment of hypotension should take place. In case of significant hypotension, the appropriate corrective treatment may be a vasoconstrictor that acts directly on vascular muscle fibres.
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.
Store in a cool and dry place, protected from light