Alfuprost MR tabs 10mg #30

Instruction for use of Alfuprost MR

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Release form and composition

Dosage form - tablets of prolonged action: from white to almost white, round biconvex, engraving "RY 10" is placed on one side (in a cardboard box 1–3 or 6 blisters of 10 tablets each and instructions for use of Alfuprost MR).
Composition of 1 tablet:
    active substance: alfuzosin hydrochloride - 10 mg;
    granules (auxiliary components): colloidal silicon dioxide - 2 mg; anhydrous lactose - 70 mg; PVP-K30 (povidone) - 2 mg; magnesium stearate - 0.5 mg; talc - 0.5 mg;
    mixture for the manufacture of a tablet by means of compression (auxiliary components): hyprolosis - 155 mg; hypromellose - 85 mg; anhydrous lactose - 7 mg; PVP-K30 (povidone) - 13 mg; colloidal silicon dioxide - 1 mg; magnesium stearate - 2 mg; talc - 2 mg.

Pharmacodynamics

Alfuzosin - the active substance of Alfuprost MR, belongs to the number of quinazoline derivatives that are active when taken orally, is a selective antagonist of postsynaptic α-1-adrenergic receptors.
When conducting pharmacological tests, the selectivity of the effect of alfuzosin on α-1-receptors, which are located at the bottom of the bladder, in the prostate gland and the prostate part of the urethra, was established. Direct influence on the smooth muscles of the tissues of the prostate gland decreases the resistance to the outflow of urine by α-1-blockers.
Alfuzosin helps to improve the parameters of urination and facilitate the emptying of the bladder, which is provided by a decrease in the tone of the urethra and resistance to outflow from the bladder.
Effects of alfuzosin in patients with benign prostatic hyperplasia:
    significant increase in Qmax (maximum flow rate): in patients with Qmax <15 ml / s, the average value of this indicator increases by 30%. This improvement is noted from the moment of taking the first dose of Alfuprost MR;
    a pronounced decrease in resistance to the flow of urine against the background of an increase in the volume of excreted urine;
    a significant decrease in the residual volume of urine.

Pharmacokinetics

The value of the relative bioavailability is on average 104.4% in comparison with the immediate release form of alfuzosin (2.5 mg 2 times a day) in healthy middle-aged volunteers. Cmax (maximum concentration) in plasma is achieved 1 hour after taking the immediate-release substance and 9 hours after taking alfuzosin with prolonged action.
T1 / 2 (half-life) of alfuzosin - 9.1 hours. According to the studies, the AUC value (area under the concentration-time curve) when taking Alfuprost MR after meals is comparable to the results when taking alfuzosin before meals. Thus, it can be concluded that food intake does not affect the pharmacokinetic profile of a substance. In comparison with healthy middle-aged volunteers, the pharmacokinetic parameters do not change in elderly patients.
In patients with renal insufficiency, in comparison with patients without impaired renal function, the average values ​​of the maximum concentration of AUC are moderately increased, while T1 / 2 does not change. This change in the pharmacokinetic profile of the substance is not considered clinically significant, and therefore, dose adjustment is not required for this group of patients.
Alfuzosin binds to plasma proteins at a level of approximately 90%. The metabolism of the substance occurs in the liver in almost full volume.
Only 11% of unchanged alfuzosin is found in urine. Most metabolites (75–90%) are not active and are excreted in the feces.
In chronic heart failure, the pharmacokinetic profile of alfuzosin remains unchanged.

Indications for use

Alfuprost MR is prescribed for the treatment of functional disorders of urination that occur in patients with benign prostatic hyperplasia.

Contraindications

    orthostatic hypotension;
    severe impairment of liver or kidney function (in patients with creatinine clearance <30 ml / min);
    congenital lactase deficiency, glucose-galactose malabsorption, lactose intolerance;
    individual intolerance to the components of the drug.

Instructions for use: method and dosage

Alfuprost MR tablets are intended for oral administration.
The recommended daily dose is 10 mg (1 tablet). The drug is taken daily, preferably after meals.
The tablets should not be crushed, chewed, bitten, or powdered; they should be taken whole. This method of administration ensures the appropriate release and absorption of the active substance and, accordingly, minimizes the likelihood of side effects.

Side effects

Possible adverse reactions (> 10% - very often;> 1% and <10% - often;> 0.1% and <1% - infrequently;> 0.01% and <0.1% - rarely; <0, 01% - very rare):
    cardiovascular system: infrequently - fainting, tachycardia, orthostatic hypotension, palpitations; very rarely - atrial fibrillation, angina pectoris in patients with coronary heart disease;
    central nervous system and psyche: often - headache, weakness, general discomfort; infrequently - dizziness, drowsiness, cerebral ischemia (develops in patients with ischemic brain disease);
    digestive system: often - abdominal pain, nausea, xerostomia; infrequently - diarrhea; very rarely - liver disease with cholestasis, damage to hepatocytes;
    respiratory organs: infrequently - rhinitis;
    allergic and skin reactions: infrequently - itching, rash; very rarely - angioedema, urticaria;
    others: often - asthenia; infrequently - edema, flushing of the skin, chest pain; very rarely - priapism.

Overdose

    symptoms: lowering blood pressure;
    therapy: hospitalization is indicated, the patient should be in the supine position; symptomatic treatment of hypotension is carried out, which includes the use of drugs with a vasoconstrictor effect and plasma substitutes (in order to increase the volume of circulating blood); due to the high degree of binding of alfuzosin to proteins, dialysis is ineffective.

Special instructions

In some cases (in particular, this applies to patients receiving antihypertensive therapy), for several hours after taking Alfuprost MR, like other α-1-blockers, postural hypotension with / without symptoms (in the form of dizziness, fatigue, increased sweating). When these signs appear, the patient is advised to lie down until they completely disappear. As a rule, these violations are temporary in nature, occur at the beginning of treatment and do not affect the continuation of treatment in most cases. The patient should be warned about the possibility of developing such phenomena.
In case of coronary insufficiency, alfuzosin should not be used as monotherapy. It is necessary to continue treatment for coronary insufficiency. If angina pectoris worsens or returns, Alfuprost MR is canceled.
Influence on the ability to drive vehicles and complex mechanisms
When driving vehicles, patients should take into account the likelihood of developing such adverse reactions as visual impairment, dizziness and asthenia, especially at the beginning of the use of Alfuprost MR.

With impaired renal function

Alfuprost MR in severe renal failure (in patients with creatinine clearance <30 ml / min) is contraindicated.

For violations of liver function

Alfuprost MR tablets are contraindicated for severe hepatic impairment.

Drug interactions

    blockers of α-1-receptors (urapidil, prazosin, minoxidil): there is an increase in the hypotensive effect, while the likelihood of severe postural hypotension increases; the combination is not recommended;
    drugs with hypotensive effect: the hypotensive effect increases simultaneously with an increase in the risk of postural hypotension (additive effect); combined use requires caution;
    inhibitors of the isoenzyme CYP3A4 (itraconazole, ketoconazole, ritonavir): the concentration of alfuzosin in the blood increases; combined use requires caution.

Terms and conditions of storage

Store in a place protected from light and moisture at temperatures up to 25 ° C. Keep out of the reach of children.
Shelf life is 3 years.

Reviews about Alfuprost MR

In terms of reviews about Alfuprost MR, patients indicate its high efficacy and good tolerance. However, many people find that symptoms return after stopping the drug. In other cases, they talk about the development of pronounced side effects that needed to be treated.

Terms of sell

You can buy Alfuprost MR without a prescription.