Urotol 2mg 56 tablets — Made in Czech — Free Delivery
(Urotol )
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Description Urotol 2mg 56 tablets — Made in Czech — Free Delivery
Product description
Urotol is indicated for the symptomatic treatment of overactive bladder with frequent urge to urinate and/or urinary incontinence.
Compound
active ingredient: tolterodine;
1 tablet contains tolterodine hydrogen tartrate 2 mg, equivalent to 1.37 mg of tolterodine;
Excipients: microcrystalline cellulose, sodium starch (type A), colloidal silicon dioxide, sodium stearyl fumarate, hypromellose, macrogol 6000, titanium dioxide (E 171), talc.
Tolterodine is a specific competitive muscarinic receptor antagonist with selective action (the action 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 an accelerated (intense) metabolism, this metabolite significantly enhances the therapeutic effect of tolterodine (see Section "Pharmacokinetics").
Contraindications
The preparation is contraindicated in patients with:
- hypersensitivity to tolterodine or to excipients of the preparation
- urinary retention
- uncontrolled angle-closure glaucoma;
- myasthenia gravis;
- severe ulcerative colitis;
- toxic megacolon.
Dosage and administration
The recommended dose for adults and elderly patients is 2 mg 2 times a day.
In the event of unwanted side reactions, the dose can be reduced to 2 mg / day (1 mg 2 times a day, it is possible to use tolterodine preparations in the appropriate dosage).
In patients with impaired liver and kidney function [glomerular filtration rate (inulin withdrawal) ≤ 30 ml / min] the recommended daily dose is 2 mg / day (1 mg 2 times a day, it is possible to use tolterodine preparations at the appropriate dosage).
Use simultaneously with CYP3A4 inhibitors The recommended daily dose is 2 mg (1 mg 2 times a day) for patients who use ketoconazole or other potent inhibitors of CYP3A4.
The effect of treatment should be evaluated after 2-3 months.
Application features
Use during pregnancy or lactation
Pregnancy.
There are no data on the use of tolterodine in pregnant women. Reproductive toxicity has been observed in animal studies. The potential risk to humans is unknown, therefore it is not recommended for use during pregnancy.
Breastfeeding.
There are no data on the penetration of tolterodine into breast milk. The use of tolterodine should be avoided during lactation.
Children
The effectiveness of the preparation in children has not been established, therefore it is not recommended for use in children.
The ability to influence the reaction rate when driving vehicles or operating other mechanisms
Since the preparation can lead to accommodation disorders and affect the reaction rate, the likely negative impact of the use of tolterodine on the ability to drive vehicles or work with other mechanisms.
Overdose
The highest dose administered to healthy volunteers was 12.8 mg of tolterodine L-tartrate as a single dose. Painful side reactions were recorded, there were disturbances of accommodation and difficulty urinating.
In case of an overdose of tolterodine, gastric lavage should be performed and activated charcoal administered. In the treatment of overdose symptoms, the following measures should be taken:
- with the development of severe anticholinergic manifestations of central origin (hallucinations, significant arousal), use physostigmine;
- with the development of severe trials or severe arousal - use benzodiazepine preparations;
- with the development of respiratory failure - apply artificial ventilation of the lungs;
- with the development of tachycardia - use blockers of β-adrenergic receptors;
- with the development of urinary retention - apply bladder catheterization
- with the development of mydriasis - apply pilocarpine eye drops and / or keep the patient in a dark room.
An increase in the duration of the QT interval was observed with the use of a daily dose of 8 mg of immediate release tolterodine (which is twice the recommended daily dose of the immediate release preparation and three times the maximum exposure of the preparation with extended release in the form of capsules), which was used for more than 4 days. In the event of an overdose of tolterodine, standard maintenance measures should be taken to control QT prolongation.
Adverse reactions
Through the pharmacological effects of tolterodine, the development of antimuscarinic effects, such as dryness of the oral mucosa, digestive disorders and dryness of the mucous membrane of the eye, is possible.
The following data were obtained during clinical trials and in the post-marketing period. Among the adverse reactions, dryness of the mucous membranes of the mouth was most often recorded - in 35% of patients receiving tolterodine tablets, and in 10% of patients receiving placebo. Headache was also very common, in 10.1% of patients treated with tolterodine tablets and in 7.4% of patients treated with placebo.
Infections and invasions: often - bronchitis.
From the side of the immune system - infrequently, hypersensitivity reactions in the absence of other verification; unknown - anaphylactoid reactions.
Mental disorders: infrequently - nervousness; unknown - confusion, hallucinations, disorientation.
Neurological disorders: very often - headache; often - dizziness, drowsiness, paresthesia infrequently - memory impairment.
On the part of the organ of vision: often - dryness of the mucous membranes of the eye, impaired function of vision, including impaired accommodation.
On the part of the hearing and vestibular apparatus: often - vertigo.
From the side of the heart: often - palpitations; infrequently - tachycardia, heart failure, cardiac arrhythmias.
From the side of the vessels: unknown - hot flashes.
From the gastrointestinal tract: very often - dryness of the mucous membranes of the mouth; often - digestive disorders, constipation, abdominal pain, bloating, nausea, diarrhea; infrequently - gastroesophageal reflux.
From the side of the skin and subcutaneous tissue: often - dry skin; unknown - angioedema.
From the urinary system: often - dysuria, urinary retention.
General disorders: often - increased fatigue, chest pain, peripheral edema
Study: often - weight gain
With the use of tolterodine, cases of exacerbation of symptoms of dementia (confusion, disorientation, misconceptions) have been reported in patients taking cholinesterase inhibitors for the treatment of dementia.
Interaction with other medicinal products and other forms of interaction
The concomitant use of systemically active preparations with strong CYP3A4 inhibition, such as macrolides (erythromycin, clarithromycin), antifungals (ketoconazole and itraconazole) and antiproteases, is not recommended due to an increase in the serum concentration of tolterodine with a reduced level of metabolism of CYP2D6 and the subsequent risk of overdose ( see the Application Features section).
The simultaneous use of other preparations with antimuscarinic properties can lead to an increase in the therapeutic effect and manifestations of adverse reactions. Conversely, the therapeutic effect of tolterodine can be reduced with the simultaneous use of cholinergic muscarinic receptor agonists.
Tolterodine may reduce the therapeutic effects of prokinetics (metoclopramide and cisapride).
The simultaneous use of fluoxetine (a potent inhibitor of CYP2D6) does not lead to a clinically significant interaction, since tolterodine and its CYP2D6-dependent metabolite, 5-hydroxymethyl tolterodine, are equipotent.
No interactions have been found in preparation interaction studies with warfarin or combined oral contraceptives (ethinylestradiol/levonorgestrel).
The results of clinical studies indicate that tolterodine is not a metabolic inhibitor of CYP2D6, 2C19, 2C9, 3A4 or 1A2. Thus, an increase in plasma concentrations of preparations metabolized by these isoenzymes is not expected in case of their combined use with tolterodine.
Storage conditions
Does not require special storage conditions. Keep out of the reach of children.
Shelf life - 2 years.
Tags: Urotol
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