Urotol (tolterodine) coated tablets 2 mg. №56

Description

Urotol (tolterodine) coated tablets 2 mg. №56

Composition

active substance: tolterodine;

1 tablet contains tolterodine hydrogen tartrate 2 mg, which is equivalent to 1.37 mg of tolterodine;

Excipients: microcrystalline cellulose, sodium starch glycolate (type A), colloidal anhydrous silica, sodium stearyl fumarate, hypromellose, macrogol 6000, titanium dioxide (E 171), talc.

Dosage form

Coated tablets.

Main physical and chemical properties: round biconvex, coated tablets, white.

Pharmacotherapeutic group

Drugs for the treatment of increased frequency of urination and urinary incontinence. ATX code G04B D07.

Pharmacological properties

Tolterodine is a specific competitive antagonist of muscarinic receptors with selective action (the effect on the bladder is more pronounced than on the salivary glands) in vivo. One of the metabolites of tolterodine (5-hydroxymethyl derivative of tolterodine) has a pharmacological profile similar to the parent compound. In patients with accelerated (intensive) metabolism, this metabolite significantly enhances the therapeutic effect of tolterodine.

The therapeutic effect can be expected within 4 weeks.

The effect of tolterodine was evaluated in patients who underwent urodynamic studies before treatment, and depending on the results of urodynamics they were divided into a group with positive urodynamics (motor incontinence) or a group with negative urodynamics (sensory incontinence). Patients were randomized to receive tolterodine or placebo. The study did not provide convincing evidence that tolterodine has an effect on patients with sensory incontinence compared with placebo.

Indications

Urotol is used in the treatment of bladder hyperreflexia, which is manifested by frequent, imperative urge to urinate, as well as increased frequency of urination and urinary incontinence.

Contraindication

Urotol is not prescribed for intolerance to tolterodine hydrotartrate, urinary retention, poorly treatable angle-closure glaucoma, severe ulcerative colitis, myasthenia gravis, megacolone. The drug is not used in patients under 18 years of age.
You should be extremely careful when prescribing the drug to patients with obstruction of the lower urinary tract, an increased risk of deterioration of intestinal motility, obstructive lesions of the digestive system, renal or hepatic failure, hernia of the esophageal opening of the diaphragm and neuropathies.

Application during pregnancy and breastfeeding

The appointment of Urotol to pregnant women is justified only if the benefits of its use significantly exceed the possible risk to the fetus.
Due to the lack of information on the degree of penetration of tolterodine into breast milk when prescribing the drug to women at the stage of lactation, the patient should refuse breastfeeding.

Method of administration and dosage

Urotol tablets are taken orally, regardless of the meal. Adult patients should take 1 tablet or 2 mg of the drug 2 times a day. If necessary, the daily dose of Urotol can be reduced to 2 mg per day, in this case the patient should take 1 tablet of 1 mg twice a day.
In case of impaired liver or kidney function, as well as when taking Urotol together with ketoconazole or other CYP3A4 inhibitors, it is recommended to reduce the dose of the drug to 1 mg twice a day.
It is recommended to evaluate the effectiveness of treatment with Urotol no earlier than 2 or 3 months after the start of therapy.

Overdose

In acute poisoning with Urotol, the patient has paresis of accommodation, painful urge to urinate, mydriasis, hallucinations, convulsions, severe agitation, respiratory failure, increased heart rate, prolongation of the QT interval and urinary retention.
Treatment of poisoning consists in the timely lavage of the stomach, the appointment of activated charcoal to the victim, as well as the appointment of the correct symptomatic treatment.

Side effects

When taking Urotol, patients experience allergic reactions, increased nervousness, impaired consciousness, dizziness, hallucinations, paresthesias, drowsiness, accommodation disorder, arrhythmia, tachycardia, dyspepsia, constipation, abdominal pain, flatulence, gastroesophageal reflux, dry skin and urinary retention.