Vesicare instructions for use
Vesicare - a drug that helps reduce the tone of the smooth muscles of the urinary tract. Refers to the group of antispasmodics. It is used for the treatment of urological diseases.
Form of issue and composition
Vesicare is released in the form of film-coated tablets in dosages of 5 mg and 10 mg. Tablets in blisters with instructions are placed in cardboard packaging (10 and 30 tablets per pack).
The main active ingredient is solifenacin succinate.
Auxiliary components: lactose monohydrate, corn starch, hypromellose, magnesium stearate.
Ingredients of the shell: macrogol, hypromellose, talc, titanium dioxide, dyes - iron oxide red (tablets of 10 mg) or yellow (5 mg tablets).
Pharmacodynamics. Solifenacin has a pronounced antispasmodic effect. It is a specific competitive inhibitor of muscarinic choloretseptors (predominantly M 3 subtype). The active substance does not show or has a low affinity for other receptors and ion channels.
The therapeutic effect of the drug is noted already in the first week of treatment, stabilized in the next 12 weeks of Vesicare. The maximum therapeutic effect is achieved on average after 4 weeks of treatment. The effectiveness of the therapy persists for up to a year.
Pharmacokinetics. The maximum concentration of solifenacin in the blood plasma is reached in 3-8 hours after taking the tablets. At the same time, the maximum concentration index increases in proportion to the increase in the dose from 5 mg to 40 mg. Absolute bioavailability of solifenacin is 90%. About 98% of the active substance binds to blood proteins. The speed and degree of absorption are not affected by the time of ingestion.
Solifenacin is split in the liver to active and three inactive metabolites. The half-life of the active substance is from 45 to 68 hours. It is excreted by the kidneys and through the intestines.
Indications for use
Vesicare is used in the symptomatic treatment of patients with the syndrome of a hyperactive bladder, accompanied by:
- imperative (urgent) urinary incontinence;
- imperative (urgent) urge to urinate;
- frequent urination.
Contraindications to the use of Vesicare are:
- retention of urination;
- severe renal insufficiency;
- angle-closure glaucoma;
- severe diseases of the digestive tract (including toxic megacolon);
- myasthenia gravis;
- severe hepatic insufficiency or moderate hepatic insufficiency with simultaneous treatment with ketoconazole, itraconazole;
- conducting hemodialysis;
- hereditary intolerance to galactose, lactase deficiency, glucose-galactose malabsorption;
- individual intolerance or hypersensitivity to the main or one of the auxiliary components of the drug;
Dosing and Administration
The recommended dosage of the drug for adults (over 18 years) and the elderly is 5 mg per day. If necessary, the dose rises to 10 mg per day. Tablets are taken orally, whole, daily (at the same time), regardless of the time of eating. Wash down with a sufficient amount of liquid.
When taking Vesicare in some cases, unwanted side effects may develop:
- from the side of the nervous system - mild headache, mild dizziness, mild dry mouth, drowsiness, very rarely - delirium, confusion, hallucinations;
- from the side of the eye - a violation of accommodation (fuzzy visual perception), dry eye mucosa, glaucoma;
- on the part of the digestive system - nausea and dyspepsia (heartburn, bloating), abdominal pain, constipation, gastroesophageal reflux disease and intestinal obstruction, coprostasis, impaired appetite, vomiting;
- on the part of the liver - a violation of liver function, a change in laboratory parameters of liver tests;
- from the excretory system - difficulty urinating, infectious inflammation of the urinary tract, cystitis , acute retention of urination, renal failure (very rare);
- on the part of the respiratory system - dryness of the nasal mucosa;
- from other organs and systems - swelling of the lower extremities, increased fatigue;
- dermatological and allergic reactions - dry skin, itching and rash, hives , erythema multiforme, exfoliative dermatitis.
In case of side effects, a dose reduction or drug withdrawal, sorbent intake, gastric lavage (should be performed within 1 hour after poisoning, it is not possible to induce vomiting) is required. If necessary, symptomatic therapy is prescribed.
When an overdose of solifenacin develop severe disorders that require immediate treatment. Can develop:
- anticholinergic effects of central action (pronounced excitability, hallucinations) - applied carbachol, physostigmine;
- convulsions and severe excitability - are prescribed benzodiazepines;
- respiratory failure - artificial respiration;
- acute urinary retention - catheterization is performed;
- tachycardia - β-blockers are prescribed;
- mydriasis (dilated pupil) - eyes are buried with pilocarpine, the patient moves to a dark room.
With caution, Vesicare is prescribed to patients with certain concomitant pathologies, among which:
- obstruction of the bladder outlet;
- obstructive diseases of the digestive tract (including stagnation of food in the stomach);
- Slow motility of the digestive tract;
- hernia of the esophageal opening of the diaphragm;
- gastroesophageal reflux;
- autonomic neuropathy;
During treatment with Vesicar, the following points should be taken into account:
- Before starting treatment it is important to make sure there are no other causes that cause involuntary urination (kidney disease, heart failure);
- when an infection of the urogenital tract is detected, antibacterial therapy is required;
- there is no need for dosage adjustment for elderly patients;
- pharmacokinetics and pharmacodynamics of the active substance in children and adolescents have not been studied, therefore the drug is not prescribed for patients under 18 years of age;
- after treatment with solifenacin, a one-week break should be done before using M-holinoblockers;
- Vesicare can cause visual impairment to clearly distinguish between subjects, drowsiness, fatigue, so care must be taken when treating patients whose activities require high concentration and reaction speed (including when driving and managing other mechanisms).
- with simultaneous admission with M-cholinomimetics, the therapeutic effect of solifenacin is reduced;
- with the simultaneous use of Vesicare with M-cholinoblockers, the therapeutic effect and side effects of solifenacin are enhanced;
- with simultaneous use of solifenacin reduces the therapeutic effect of drugs that stimulate the motility of the digestive tract (cisapride, metoclopramide and others);
- ketoconazole, itraconazole, ritonavir, nelfinavir increase the bioavailability of solifenacin; therefore, with the simultaneous use of these drugs, the maximum dose of Vesicare should not exceed 5 mg; and patients with severe renal and moderate hepatic insufficiency simultaneously can not take these drugs;
- the combination of solifenacin with verapamil, diltiazem, rifampicin, carbamazepine, phenytoin is not recommended.
Pregnancy and lactemia
Clinical data on the safety and efficacy of Vesicare in pregnant women are not available, so caution should be given during pregnancy.
There is no data on the penetration of solifenacin into breast milk. The drug is not recommended for use during breastfeeding.
A complete structural analogue of Vesicare, which includes solifenacin, is Zevesin.
To similar on therapeutic action, but having other structure preparations concern: Novitropane, Driptan, Detrusitol, Dryman-Apo, Urotol, Sibutin.
Terms and conditions of storage
The drug is stored in a place protected from moisture and sunlight, inaccessible to children, at a temperature of no higher than 25 ° C. Shelf life is 3 years. Do not take the pill after the expiry date indicated on the package.
Vesicare tablets 5 mg - 780-1330 rub. (depending on the number of tablets)