ALFUZOSINE 5
-
Chemical Name:
Alfuzosin HCl -
Therapeutic Category:
Urinary tract drugs -
Pharmacologic Category:
Alpha 1 Blocker -
Pharmaceutical Form:
Tablets -
Composition:
Alfuzosin HCl 5mg
Alfuzosine
Alfuzosine Hydrochloride
1-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, Alfuosine has an antihypertensive effect.
2-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.
3-INDICATIONS:
ALFUZOSINE is indicated for:
- 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.
4-CONTRA-INDICATIONS:
- Hypersensitivity to the product.
- Signs of postural hypotension.
- Concomittant use of another drug belonging to the same therapeutic class.
5-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.
6-SIDE EFFECTS:
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.
7-DRUG INTERACTIONS:
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.
8-DOSAGE AND ADMINISTRATION:
ALFUZOSINE SR :
1 tablet in the morning and evening, starting the treatment in the evening.
ALFUZOSINE-2.5:
1 tablet 3 times daily, 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.
9-PACK & COMPOSITION:
ALFUZOSINE SR:
Pack of 50 Sustained Release Film Coated Tablets.
Pack of 10 Sustained Release Film Coated Tablets .
Each Sustained Release Film Coated Tablet contains: Alfuzosine HCI 5 mg.
ALFUZOSINE-2.5:
Pack of 30 Tablets.
Each tablet contains: Alfuzosine HCI 2.5 mg.
10-Storage:
Store at temperature between(15-30rC. Protected from light.
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