Vezikar

Vezikar – the medicine reducing a tone of smooth muscles of urinary tract, applied to treatment of urological diseases.

Form of release and structure

Dosage form – tablets, film coated: round, convex from two parties, light yellow (tablets of 5 mg) or light pink (tablets of 10 mg) colors, with a logo of the company and marking "150" (tablets of 5 mg) or "151" (tablets of 10 mg) on one party (on 10 pieces in the blister, in a cardboard pack 1 or 3 blisters).

Active ingredient of Vezikar: a solifenatsina succinate, in 1 tablet – 5 or 10 mg.

Excipients: gipromelloza 3 мПа×с, starch corn, magnesium stearate, lactoses monohydrate.

Structure of a film cover of tablets of 5 mg: опадрай yellow 03F12967 (macrogoal 8000, talc, gipromelloza 6 мПа×с, titanium dioxide and ferrous oxide yellow).

Structure of a film cover of tablets of 10 mg: опадрай pink 03F14895 (macrogoal 8000, talc, gipromelloza 6 мПа×с, titanium dioxide and ferrous oxide red).

Indications to use

Vezikar is applied to treatment of an imperative (urgentny) incontience of urine, imperative (urgentny) desires to an urination and the speeded-up urination – the signs characteristic to a syndrome of a hyperactive bladder.

Contraindications

Absolute:

• Heavy liver failure;
• Moderate liver failure in need of simultaneous use of CYP3A4 inhibitors (for example, a ketokonazola);
• Serious gastrointestinal illness (including toxic megacolon);
• Urination delay;
• Closed-angle glaucoma;
• Heavy renal failure;
• Carrying out hemodialysis;
• Myasthenia gravis;
• Rare inherited disorders of portability of a galactose, lactose intolerance of falls (Sami), glyukozo-galaktozny malabsorption;
• Age up to 18 years;
• Lactation;
• Hypersensitivity to drug components.

Relative (use of drug is possible, but with extra care since there is a risk of development of complications):

• Clinically significant obstruction of outlet opening of a bladder fraught with development of an ischuria;
• Gastrointestinal obstructive diseases (including stagnation of food in a stomach);
• Risk of decrease in motility of digestive tract;
• Heavy renal (clearance of creatinine of ≤30 ml/minute) and moderate hepatic (7-9 points on a scale of Chayld-Pyyu) insufficiency (for such patients Vezikar's dose should not exceed 5 mg);
• Simultaneous use of powerful inhibitor of an isoenzyme of CYP3A4 (for example, ketokonazola);
• Hernia of an esophageal opening of a diaphragm, gastroesophageal reflux;
• Simultaneous use of drugs which can cause or strengthen an esophagitis (for example, bisfosfonat);
• Autonomous neuropathy;
• Existence of such risk factors as hypopotassemia or syndrome of lengthening of an interval of QT;
• Pregnancy.

Route of administration and dosage

Vezikar it is necessary to accept inside, swallowing of tablets entirely and washing down with enough liquid, regardless of meals.

In an initiation of treatment to adult patients appoint 5 mg of 1 times a day. If necessary the dose is increased to 10 mg of 1 times a day.

Side effects

• Alimentary system: often (> 1/100, <1/10) – dyspepsia, nausea, an abdominal pain, a lock; infrequently (> 1/1000, <1/100) – dryness of a throat, a gastroesophageal reflux disease; seldom (> 1/10 000, <1/1000) – a coprostasis, intestinal impassability; very seldom (<1/10 000, including isolated cases) – a loss of appetite *, vomiting *, increase in level of liver enzymes *, a hyperpotassemia *;
• Urinary system: infrequently – difficulty of an urination, an infection of urinary tract; seldom – an acute ischuria; very seldom – a renal failure *;
• Central nervous system: infrequently – taste disturbance (dysgeusia), drowsiness, is very rare – a headache * and dizziness *;
• Mental disturbances: very seldom – drowsiness *, confusion of consciousness *, delirium *, hallucinations *;
• Organ of sight: often – accommodation disturbance (an illegibility of visual perception); infrequently – a xerophthalmus;
• Respiratory system: infrequently – dryness of a mucous nasal cavity;
• Cardiovascular system: lengthening of an interval of QT *, tachycardias on the pirouette type *;
• Skin and hypodermic cellulose: infrequently – a xeroderma; very seldom – rash *, an itch *, a small tortoiseshell *, exfoliative dermatitis *, a mnogoformny erythema *, a Quincke's disease *;
• Allergic reactions: anaphylactic reactions *;
• Others: infrequently – hypostases of the lower extremities, fatigue.

* – these side effects were observed in the post-registration period of use of drug. Data on them were obtained by method of spontaneous messages therefore determination of frequency and relationship of cause and effect of these reactions with Vezikar's reception difficult.

Special instructions

Before Vezikar's appointment the patient has to undergo full medical examination to define whether there are no other causes of infringement of an urination, such as diseases of kidneys or heart failure. In case of diagnosing of an infection of urinary tract appoint the corresponding antimicrobic therapy.

Solifenatsin, as well as other m-holinoblokatory, can cause an illegibility of visual perception, feeling of fatigue and drowsiness. For this reason during treatment it is necessary to observe extra care at control of motor transport and occupation potentially dangerous types of activity demanding the speed of psychophysical reactions and high concentration of attention.

Medicinal interaction

Vezikar reduces efficiency of the medicines stimulating motility of digestive tract (for example, a tsizaprid and Metoclopramidum).

In case of simultaneous use of a ketokonazol in a daily dose of 200 mg total concentration of a solifenatsin in a blood plasma increases twice, at reception of a ketokonazol in a daily dose of 400 mg – by 3 times. In need of Vezikar's use along with ketokonazoly or other CYP3A4 inhibitors (such as нелфинавир, ритонавир, итраконазол) his dose should not exceed 5 mg/days. The similar combination is contraindicated to patients with a moderate liver failure and a heavy renal failure. Considering that солифенацин CYP3A4 is metabolized, pharmacokinetic interactions and with other CYP3A4 substrates with higher affinity (diltiazem, verapamil), and also with the inductors CYP3A4 (Phenytoinum, rifampicin, carbamazepine) are not excluded.

It must be kept in mind that Vezikar, as well as all drugs with m-holinoblokiruyushchimi properties, can influence effect of any at the same time applied medicines, including expressiveness of their side effects. Before beginning treatment with other m-holinoblokatorom, after reception of a solifenatsin it is necessary to do a week break.

M cholinomimetics can reduce therapeutic effect of Vezikar.

Terms and storage conditions

To store at a temperature up to 25 ºС in the place, unavailable to children.

Period of validity – 3 years.