| Indications: |
| Treatment of Benign Prostatic Hypertrophy |
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| Description |
Alfuzosine HCl
PHARMACOLOGY:
Alfuzosine is a quinazoline derivative, efficient when administered in oral form.
It is a selective-antagonist of alpha – 1 post-synaptic adrenergic receptors.
In Vitro studies confirmed the specificity of Alfuzosine toward receptors situated at the level of vesical trigone, ureter and prostata.
In Vivo studies indicated that Alfuzosine decreases the uretral pressures and then the resistance to the miction’s flow.
On the Cardiovascular level, Alfuzosine has an antihypertensive effect.
PHARMACOKINETICS :
- Alfuzosine is readily absorbed after oral administration.
- Peak plasma concentrations generally occur 3 hours after an oral dose.
- Bioavailability is about 64 % .
- It is metabolised in the liver and excreted primarily in faeces via the bile.
- About 11 % of a dose is excreted unchanged in the urine.
- Plasma elimination half-life is of 3 to 5 hours.
- It is 90 % bound to plasma proteins.
- The metabolites have no pharmacodynamic action.
- In older patients, the absorption of Alfuzosine is faster and bioavailability values
are increased, however the elimination rate is not affected.
- In renal failure the Alfuzosine clearance increases due to an increase in
the free portion.
- Chronic severe renal failure (creatinine clearance between 15 – 40 ml /min)
is not worsened by the use of Alfuzosine.
- The pharmacokinetic profile of Alfuzosine is not modified in case of
chronic cardiac failure.
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| Composition |
Each Sustained Release Film Coated tablet contains: Alfuzosine HCl 5 mg |
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| Detailed Indications: |
- Symptomatic treatment of the functional disorders of benign
prostatic hypertrophy especially where surgery should be delayed .
- Evolutive increases of the adenoma, which increase the symptomatic
effect especially in older patients.
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| Contraindications: |
- Hypersensitivity to the product.
- Signs of postural hypotension.
- Concomittant use of another drug belonging to the same therapeutic class.
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| Packing: |
It may cause: nausea, stomach pain, dizziness, and headache.
It may rarely cause: dry mouth, fatigue, pruritus, and flushes.
Few other rare side effects are: palpitation, postural hypotension, and oedema.
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| Drug Interaction: |
Hypotensive effects of Alfuzosine may be enhanced by the concomittant use of diuretics and other antihypertensive agents ( in particular, the calcium antagonist
class ).
General anaesthetic could lead to a disturbance in the pressure.
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| Dosage & Administration: |
Usual Dosage: 1 tablet of ALFUZOSINE SR 5 mg in the morning and evening, starting the treatment in the evening.
As a systematic precaution in patients over 65 years old or in treated hypertensive patients the initial dose should be reduced. The daily dose should not be more than 10 mg.
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| Storage: |
Bottle of 50 sustained release film coated Tablets |
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| Precautions: |
- Doctor should investigate if patient is taking anti-hypertensive drug because of the possibility of having orthostatic hypotension in the hours following the administration of the drug. If this happens, patient should lay down until all symptoms disappear (dizziness, weakness, etc. )
These symptoms are momentaneous and treatment can be continued
in adapting the dosage.
- In case of surgery, the anesthetist should be warned that patient is taking this drug.
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