Dalfaz, retard pills 5mg, 56pcs

Composition

Alfuzosin hydrochloride 5,0 phmiracleliving cellulose 42,000 mpolygon 7,000 mccalla the hydrogen phosphate, dihydrate 65,000 ggmania stearate 1,400 mggidrirovannoe castor oil 19,600 mypromise 4,158 mgpropranolol of mgtitle 0,416 0,416 Multa dioxide iron oxide * 0,010 Machimana water (lost in coverage) q. s. * contains 1,764% red iron oxide

Pharmacological action of

Pharmacodynamically is a derivative of chinazoline, active by oral use of primenenie selective antagonist of postsynaptic alpha 1-adrenergic receptors with peripheral site of action Pharmacological tests in vitro showed the selectivity of alfuzosin action on alpha-1-adrenergic receptors located in the prostate gland, in the triangle of the bladder and in the prostatic part of the urethra. As a result of direct action on the smooth muscles of prostate tissues, alpha-1-adrenoblockers reduce the resistance to urine flow. Alfuzosin improves discharge parameters, reducing urethral tone and resistance to outflow from the bladder, and facilitates emptying the bladder. In placebo-controlled trials of alfuzosin in patients with benign prostatic hypertrophy, it was found that: :

• A significant increase in the maximum flow rate (Qmax) by an average of 30% in patients with Qmax < 15 ml / sec. This improvement was observed starting with the first dose.
• A significant decrease in resistance to the flow of urine and an increase in the volume of urine released, causing the urge to urinate.
• Significant reduction in residual urine volume.

Pharmacokinetics:

The maximum concentration in the blood plasma is reached approximately 3 hours after ingestion of the drug. The binding of alfuzosin hydrochloride to plasma proteins is about 90%. The half-life of the drug is 8 hours.

The bioavailability of retard tablets is approximately 15% lower compared to 2.5 mg of alfuzosin. Food intake does not affect the absorption of the Active ingredient.

Alfuzosin is mainly metabolized in the liver, only 11% is excreted unchanged in the urine. Most of the metabolites (which have no activity) are excreted in the faeces (75-91%). In individuals over 75 years of age, absorption is faster, and maximum concentrations and bioavailability are higher. The volume of distribution is reduced. The elimination half-life does not change.

The pharmacokinetic profile of alfuzosin does not change when the drug is taken with food. The volume of distribution and clearance of alfuzosin are increased in patients with renal insufficiency, both with and without dialysis. There is no need to modify the dosage in patients with impaired renal function and creatinine clearance > 30 ml/min.

In patients with severe hepatic insufficiency, the elimination half-life is prolonged. Bioavailability, compared with healthy volunteers, is increased. The pharmacokinetic profile of alfuzosin does not change in chronic heart failure.

Indications

Treatment of functional symptoms of benign prostatic hyperplasia.

Contraindications

• Hypersensitivity to alfuzosin and/or other components of the drug;
• orthostatic hypotension;
• severe hepatic impairment (Child-Pugh class C);
• severe renal impairment (Cl creatinine
• intestinal obstruction (due to the presence of castor oil in the drug);
• simultaneous use of other alpha_-1-blockers.

With caution:

• patients receiving antihypertensive drugs;
• elderly patients;
• patients with the hypotonic response to alpha₁-adrenergic blocking agents;
• patients with clinical symptoms of orthostatic hypotension (possibility of orthostatic hypotension);
• patients with coronary heart disease, angina (become more frequent and worsening of angina);
• patients with symptomatic and asymptomatic manifestations of coronary artery disease of the brain (risk of cerebral ischemia on the background of hypotension).

Side effects

From the central nervous system and the psyche: often-weakness, dizziness, general discomfort, headache; rarely-drowsiness, brain ischemia (in patients with ischemic brain disease).

From the side of the visual organs: infrequently-visual impairment.

From the cardiovascular system: often-hypotension (orthostatic); infrequently-tachycardia, palpitations, syncope; very rarely-angina pectoris in patients with coronary heart disease, atrial fibrillation.

From the respiratory system: infrequently-rhinitis.

From the gastrointestinal tract: often — nausea, abdominal pain, diarrhea, dry mouth; very rarely-damage to hepatocytes, liver diseases with cholestasis.

Skin and allergic reactions: infrequently-rash, pruritus; very rarely-urticaria, angioedema.

From the whole body: often-asthenia; infrequently-hyperemia of the skin, swelling, chest pain; very rarely-priapism.

Interaction

Concomitant use of Dalphaz with calcium channel blockers increases the risk of arterial (including orthostatic) hypotension and collapse.

When Dalfaz is co-administered with general anaesthetic agents, blood pressure instability is likely to develop during anaesthesia.

There was no clinically significant interaction of Dalfaz with warfarin, digoxin, hydrochlorothiazide, or atenolol.

How to take, course of use and dosage

Inside, swallowing whole, with about 1 glass of water,1 tablet (5 mg) 2 times a day (morning and evening).

Adults: the recommended dose is 1 tablet (5 mg) 2 times a day (morning and evening).

Elderly patients and / or patients with arterial hypertension receiving antihypertensive agents

As a precautionary measure, when prescribing alfuzosin to these categories of patients, it is recommended to start treatment with 1 table (5 mg) in the evening, increasing the dose in accordance with the clinical response, but not exceeding the dose — 1 table. 2 times a day.

Patients with renal insufficiency

If creatinine clearance exceeds 30 ml/min, no dosage adjustment is required.

Patients with hepatic insufficiency

It is necessary to take into account the prolongation of T_1/2 of the drug and the possibility of increasing its bioavailability, so treatment should begin with a dose of 2.5 mg 1 time per day, which can increase depending on the clinical response, but should not exceed 2.5 mg 2 times a day.

Tablets should not be crushed, chewed, ground or ground to a powdery state, because violation of the tablet structure can lead to accelerated absorption of the Active ingredient, which can contribute to the development of side effects.

Overdose

Symptoms: hypotension, reflex tachycardia.

Treatment: hospitalization of the patient, constant monitoring of blood pressure. With a decrease in blood pressure, the introduction of vasoconstrictors and plasma substitutes (to increase BCC) is recommended. After the restoration of blood pressure (elimination of hypotension), it should be monitored for at least another day.

Hemodialysis is not effective (due to the high degree of binding of alfuzosin to plasma proteins).

Special instructions

Some individuals, especially those receiving antihypertensive medications, may develop orthostatic hypotension within a few hours after taking alfuzosin (as well as after taking other alpha_-1blockers), with or without clinical symptoms (dizziness, sudden weakness, cold sweat).

Orthostatic hypotension is usually transient and usually occurs at the beginning of taking the drug and usually does not require discontinuation of treatment.

When these phenomena occur, the patient should be in a horizontal position until they completely disappear. Before starting treatment, the patient should be warned about the possibility of such phenomena.

Caution should be exercised when prescribing alfuzosin to patients with orthostatic hypotension with clinical symptoms, patients with a history of severe hypotensive reaction in response to the use of other alpha_-1— blockers-more careful monitoring of blood pressure is necessary, including when moving from a horizontal position to a vertical one, especially at the beginning of treatment.

Antianginal therapy should be continued in patients with CHD. Treatment with alfuzosin should be discontinued if angina persists or becomes more severe.

Influence on the ability to drive vehicles and work with mechanisms. Especially at the beginning of treatment, you should take into account the possibility of developing dizziness and asthenic state, which may affect the ability to drive vehicles and work with mechanisms.

Form of production

Long-acting coated tablets

Storage conditions

The drug should be stored in a cool, dry place.

Shelf

life is 3 years.

Active ingredient

Alfuzosin

Conditions of release from pharmacies

By prescription

Dosage form

long-acting tablets

Purpose

For adults

Indications

Prostatic Hyperplasia