Dalfaz SR

Dalfaz SR – the medicine applied at treatment of functional symptoms of a benign hyperplasia of a prostate.

Form of release and structure

Drug is produced in the form of tablets of the prolonged action: biconvex, round, three-layered – between two yellow layers of various intensity of coloring one white layer is located, impregnations are allowed (on 10 pieces in blisters from aluminum or polyvinylchloride, on 1 or 3 blisters in a cardboard pack).

Active ingredient: альфузозин (in the form of a hydrochloride) – 10 mg.

Auxiliary components (layer-by-layer structure of a tablet):

• I layer: the hydrogenated castor oil, a gipromelloza, ethyl cellulose 20, water colloid silicon dioxide, dye iron oxide yellow (E172), magnesium stearate;
• II layer: hydrochloride of an alfuzozin, gipromelloz, Mannitolum, microcrystallic cellulose, water colloid silicon dioxide, povidone, magnesium stearate;
• III layer: the castor hydrogenated oil, a gipromelloza, water colloid silicon dioxide, povidone, dye iron oxide yellow (E172), magnesium stearate.

Indications to use

Dalfaz SR accept for therapy of functional symptoms at a benign hyperplasia of a prostate. Drug is also used as supportive application for installation of a catheter at an acute ischuria which is connected with a benign hyperplasia of a prostate.

Contraindications

• Heavy disturbances of work of a liver;
• Renal failure with clearance of creatinine less than 30 ml/min.;
• Orthostatic hypotension;
• Intestinal impassability (because of contents in tablets of castor oil);
• Hypersensitivity to the alfuzozin and/or other substances which are a part of drug.

Route of administration and dosage

Dalfaz SR accept inside, entirely, without chewing, it is more preferable – after meal.

The recommended dose for therapy of functional symptoms at a benign hyperplasia of a prostate: 10 mg (1 tablet) daily.

The recommended dose for use as supportive application in case of installation of a catheter at the acute ischuria connected with a benign hyperplasia of a prostate: 10 mg (1 tablet) a day, since first day of catheterization. Drug is accepted for 3-4 days (2-3 days during use of a catheter and 1 more day after its removal).

Side effects

• Digestive tract: dryness in a mouth, pain in epigastriums, nausea, diarrhea;
• Cardiovascular system: orthostatic hypotension, tachycardia; patients with coronary heart disease have an aggravation of symptoms of stenocardia;
• Central Nervous System (CNS): dizziness, headache, weakness, drowsiness, unconscious states, asthenic syndrome, syncope;
• Allergic reactions: enanthesis, itch;
• Others: dermahemia, hypostases.

Characteristic symptom of overdose is the lowering of arterial pressure. In this case the patient should be hospitalized in a prone position for performing standard treatment of hypotension: introductions of vasoconstrictors and solutions of high-molecular substances for increase in volume of the circulating blood. Dialysis will be inefficient owing to high extent of linkng of an alfuzozin with proteins.

Special instructions

At some persons, in particular at the patients receiving hypotensive treatment for several hours after reception Dalfaza SR, as well as other blockers _{α1-адренорецепторов}, development of postural hypotension with symptoms or without them is possible (fatigue, dizziness, sweating). The patient has to be in horizontal position before total disappearance of symptoms. Such phenomena usually temporary also meet only in an initiation of treatment, do not render on continuation of therapy of influence, but the patient needs to be warned about them.

Patients with coronary insufficiency are not recommended to appoint альфузозин in monotherapy. It is necessary to continue treatment of coronary insufficiency, and at return or deterioration in stenocardia reception of an alfuzozin needs to be stopped.

Patients have to be informed that tablets need to be swallowed entirely. They cannot get to the core, chew, to be crushed, pounded in powder as such actions can become the reason of inappropriate release and absorption of active ingredient that can lead to bystry development of by-effects.

At control of motor transport and occupation the types of activity demanding the increased concentration of attention and high speed of response it is necessary to observe extra care owing to the by-effects, such as dizziness, an adynamy, vision disorders which are found generally at the beginning of therapy.

Medicinal interaction

Dalfaz SR in a combination with blockers _{α1-рецепторов} (Prazozinum, minoksidit, urapidit) is not recommended to accept, it can lead to strengthening of hypotensive effect and to become the reason of development of heavy postural hypotension.

In case of reception of an alfuzozin with hypotensive drugs strengthening of hypotensive effect and risk of postural hypotension (the additive action) is possible.

At use Dalfaza SR with CYP3A4 system inhibitors (кетоконазол, ритонавир, итраконазол) increase in concentration of an alfuzozin in blood is probable.

Terms and storage conditions

To store in the dry dark place unavailable to children, at a temperature not above 25 °C.

Period of validity – 3 years.