Universal reference book for medicines
Product name: DALFAZ ® SR (DALFAZ ® SR)

Active substance: alfuzosin

Type: A drug used for urination disorders associated with benign prostatic hyperplasia.
Alpha 1- adrenoblocker
Manufacturer: SANOFI WINTHROP INDUSTRIE (France)
Composition, form of production and packaging
Tablets of prolonged action are
round, biconvex, three-layer (one white layer between two yellow layers with different intensity of coloring);
inclusions are allowed.
1 tab.

alfuzosin hydrochloride 10 mg

The composition of the first layer of the tablet: hypromellose, hydrogenated castor oil, ethylcellulose 20, iron oxide, yellow oxide (E172), silicon dioxide colloidal water, magnesium stearate.

The composition of the second layer of the tablet: alfuzosin hydrochloride, mannitol, hypromellose, microcrystalline cellulose, povidone, silicon dioxide colloidal water, magnesium stearate.

The composition of the third layer of the tablet: hypromellose, hydrogenated castor oil, povidone, iron oxide, yellow oxide (E172), silicon dioxide colloidal water, magnesium stearate.

10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

Alpha 1 -adrenoblocker, a derivative of quinazoline.
Selectively affects the postsynaptic? 1- adrenoreceptors. In vitro studies showed the selectivity of the action of alfuzosin on? 1- adrenoreceptors located in the prostate gland, in the region of the bottom of the bladder and in the prostatic part of the urethra.
As a result of direct effects on the smooth muscles of the prostate gland tissue, it reduces resistance to urine outflow.

Alfuzosin improves the parameters of urination, reducing the tone of the urethra and the resistance of outflow from the bladder, and facilitates the emptying of the bladder.

In placebo-controlled studies of alfuzosin, patients with benign prostatic hyperplasia showed a significant increase in the maximum current (Q max ) of urine by an average of 30% in patients with Q max ≤ 15 mL / s.
This improvement was noted after taking the first dose of the drug. There was also a significant decrease in resistance to urine flow and an increase in the volume of excreted urine; a significant decrease in the residual volume of urine was observed.
PHARMACOKINETICS

Suction and distribution

When taking the drug Dalfaz ® SR due to the characteristics of the dosage form providing prolonged release of alfuzosin hydrochloride, the average bioavailability in healthy middle-aged volunteers is 104.4% compared to the immediate-release form (with 2.5 mg 2 times / day intake).

C max is achieved 9 hours after taking the drug compared to 1 hour for an immediate-release form.
Binding to plasma proteins is about 90%.
Metabolism and excretion

Alfuzosin undergoes significant metabolism in the liver, only 11% of the dose taken is excreted unchanged in the urine;
most of the inactive metabolites (75-90%) with feces.
T 1/2 is 9.1 hours.

Pharmacokinetics in special clinical cases

In elderly patients, pharmacokinetic parameters (C max and AUC) do not increase.

In patients with renal insufficiency, Cmax and AUC are moderately increased (which has no clinical significance and does not require a change in the dosing regimen), while T 1/2 does not change.

The pharmacokinetic profile of the drug does not change in patients with chronic heart failure.

INDICATIONS

- treatment of functional symptoms of benign prostatic hyperplasia;

- as an aid in the use of a catheter for acute urinary retention associated with benign prostatic hyperplasia.

DOSING MODE

The drug is taken orally after a meal.

In the treatment of functional symptoms of benign prostatic hyperplasia, the recommended dose is 1 tab.
(10 mg) 1 time / day.
As an aid in the use of a catheter for acute urinary retention associated with benign prostatic hyperplasia , the recommended dose is 1 tablet.
(10 mg) 1 time / day, starting from the first day of catheterization. The drug is used for 3-4 days, i.e. 2-3 days on the background of the application of the catheter and 1 day after its removal.
Tablets should be taken as a whole.

SIDE EFFECT

On the part of the digestive system: nausea, epigastric pain, diarrhea, dry mouth.

From the side of the central nervous system: headache, dizziness, weakness, drowsiness, asthenic syndrome, syncope, syncope.

From the cardiovascular system: tachycardia, orthostatic hypotension, in patients with IHD - exacerbation of symptoms of angina.

Allergic reactions: rarely - skin rash, itching.

Other: swelling, skin hyperemia.

CONTRAINDICATIONS

- Orthostatic hypotension;

severe hepatic impairment;

- renal failure of severe degree (CK <30 ml / min);

- intestinal obstruction (in connection with the content of castor oil in the preparation);

- hypersensitivity to alfuzosin and / or other components of the drug.

APPLICATION FOR FUNCTIONS OF THE LIVER

In patients with renal insufficiency, Cmax and AUC are moderately increased, without an appreciable increase in T 1/2 (these changes are not clinically significant and do not require a change in the dosing regimen).

The drug is contraindicated in patients with severe renal insufficiency (CC <30 ml / min).

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindicated in severe violations of liver function.

SPECIAL INSTRUCTIONS

In some cases, especially in patients receiving antihypertensive therapy, postural hypotension with or without symptoms (dizziness, fatigue, increased sweating) may develop within a few hours after taking the drug (as well as other? 1- adrenoreceptor blockers).
In such situations, the patient should lie until the symptoms disappear completely. These reactions are usually temporary, occur at the beginning of treatment and usually do not affect the continuation of therapy. The patient should be warned about the possibility of such reactions.
Patients with coronary insufficiency should not be prescribed Dalfaz ® SR as monotherapy.
It is necessary to continue treatment of coronary insufficiency. If angina attacks persist or worsen their course, then the drug should be discontinued.
Patients should be warned that the tablet should be swallowed whole.
Violation of the integrity of the tablet can lead to inappropriate release and absorption of the active substance and, accordingly, to adverse reactions that can quickly develop.
Impact on the ability to drive vehicles and manage mechanisms

Side effects such as dizziness, visual impairment and asthenia can occur mostly at the beginning of treatment.
This should be taken into account when driving and working on machines.
OVERDOSE

Symptoms: arterial hypotension.

Treatment: hospitalization is indicated, the patient should be lying down.
The treatment of arterial hypotension (introduction of vasoconstrictors, solutions and high-molecular substances, measures aimed at increasing the BCC) is performed. Dialysis is ineffective due to the high degree of binding of alfuzosin to plasma proteins.
DRUG INTERACTION

Unsupported combinations

With blockers?
1- adrenoreceptors (prazosin, urapidil, minoxidil): increased hypotensive effect, risk of severe postural hypotension.
Combinations that should be taken into account

With antihypertensive drugs: strengthening the hypotensive effect and the risk of postural hypotension (additive effect).

With inhibitors of the CYP3A4 system (ketoconazole, itraconazole, ritonavir): an increase in the concentration of alfuzosin in the blood.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 25 ° C.
Shelf life - 3 years.
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