"Pharmacia Italy S.p. A.": Pfizer Group company,
"Pharmacia &Upjohn SpA for Pfizer Inc. Italy / USA / Italy /
Active substance Detruzitol
Tablets coated with 1 mg, 2 mg No. 56
To whom Detruzitol is indicated
Treatment of bladder hyperactivity( instability) manifested by frequent imperative urges to urinate or urinate incontinence.
How to use Detrusitol
Before starting treatment, the organic causes of frequent and imperative urges should be ruled out.
Recommended dose: 2 mg 2 times a day, except for patients with impaired liver and kidney function( glomerular filtration rate less than 30 ml / min.), For which a dose of 1 mg 2 times a day is recommended. In case of side effects, the dose should also be reduced to 1 mg twice a day.
The use of the drug does not depend on the time of eating. After 6 months, the need for long-term therapy should be evaluated. Tolte
Special considerations for use of
Caution should be exercised when using Detrusitol in patients who have risk factors for prolonging the QT interval( hypokalemia, bradycardia, joint use of QT prolonging drugs), and heart disease: coronary heart disease, arrhythmia, chronic heart failure.
Caution should be exercised in the following conditions:
- significant obstruction of urinary tract outflow with risk of retention of urination;
- obstructive lesion of the gastrointestinal tract( stenosis of the pylorus);
- of kidney disease;
- liver disease: dose should not exceed 1 mg 2 times a day;
- risk of deterioration of the motility of the digestive tract.
Pregnancy and lactation .Study of the results of the drug in pregnant women was not conducted. Therefore, pregnant tolterodine should not be prescribed. Since there is no data on the release of tolterodine in human breast milk, the use of tolterodine in natural feeding should be avoided.
Effect on the ability to drive and the mechanisms of the .Since detrusitol can cause disruption to accommodation and alter the reaction time, it can adversely affect the ability to drive and work with machinery.
Side effects of Detruzitol
Toltero-din may cause mild and moderate mild anti- m-cholinergic effects: dry skin and mucous membranes, reduced tearing, dyspepsia.
- Vision - xerophthalmia( dry eyes), impaired vision, including disturbances of accommodation.
- Cardiovascular system: tachycardia.
- Immune system: allergic reactions.
- GASTROINTESTINAL TRACT: a dyspepsia, a constipation, a pain in a stomach, a meteorism, a vomiting. Kidney and urinary system: retention of urination.
- Mental disorders - nervousness, impaired consciousness, hallucinations;CNS - paresthesia, dizziness, drowsiness.
- Common manifestations - fatigue, headache, chest pain, peripheral edema.
Among other side effects, anaphylactic reactions with angioneurotic edema and heart failure were rare. The use of other drugs in this group is sometimes accompanied by palpitation and arrhythmia.
To whom is contraindicated Detruzitol:
- urinary retention;
- closed angle glaucoma, not treatable;Myasthenia gravis gravis
- hypersensitivity to theteltrine or other components of the drug,
- severe ulcerative colitis,
- toxic megacolon,
- pregnancy, lactation,
- childhood( under 18 years).
Interaction of Detruzitol
Admission with inhibitors of CYP3A 4: macrolide antibiotics( erythromycin and clarithromycin);antifungal azole agents( ketoconazole, itraconazole and miconazole), as well as antiproteasics are not recommended, since these drugs can increase the concentration of tolterodine in the blood plasma and provoke a risk of overdose.
Concomitant treatment with other drugs with anticholinergic properties may lead to increased therapeutic effect and undesirable effects. In contrast, with the simultaneous administration of muscarinic cholinergic receptor agonists, the therapeutic effect of tolterodine may decrease.
The action of prokinetics like metoclopramide and cisapride may be impaired by tolterodine.
Pharmacokinetic interactions with other drugs that are metabolized via cytochrome P 450-2D6( CYP2D6) or CYP3A 4 are possible. However, simultaneous treatment with fluoxetine only leads to a slight increase in the total exposure of unbound tolterodine and its equivalent 5-hydroxymethyl metabolite activity. This does not lead to a clinically noticeable interaction. A clinical trial showed no evidence that tolterodine is capable of inhibiting the activity of CYP2D6, 2C 19, 3A 4 or 1A 2.
Clinical trials have shown no interaction with warfarin and combined oral contraceptives( ethinylestradiol / levonorgestrel).
The highest dose received by volunteers was 12.8 mg tolterodine L-tartrate once. The noted expressed undesirable reactions are a violation of accommodation and painful urge to urinate.
In case of an overdose of tolterodine, rinse the stomach and give activated charcoal. Individual symptoms to be treated as follows:
|Strong central anticholinergic effects( e.g., hallucinations, strong stimulation)||Physostigmine|
|Convulsions or pronounced excitation||Benzodiazepines|
|respiratory disorders||Artificial respiration|
|Dilation of pupils||Eye drops with pilocarpine and / or patient transfer to a dark room|