Description
Release form
Coated tablets.
packaging 56 pcs
Pharmacological action
M-anticholinergic.
Both tolterodine and its 5-hydroxymethyl derivative are highly specific for muscarinic receptors, competitively block m-cholinergic receptors with the highest selectivity for bladder receptors (compared with salivary gland receptors).
The drug reduces the tone of the smooth muscles of the urinary tract, the contractile activity of the detrusor, and also reduces salivation.
In doses exceeding therapeutic, causes incomplete emptying of the bladder and increases the amount of residual urine.
The therapeutic effect of tolterodine is achieved after 4 weeks.
Tolterodine does not inhibit CYP2D6, 2C19, 3A4 or 1A2.
Indications
Hyperreflexia (hyperactivity, instability) of the bladder, manifested by frequent, imperative urges to urinate, increased urination and / or urinary incontinence.
Contraindications
Urinary retention
untreatable angle-closure glaucoma
myasthenia gravis
severe ulcerative colitis
megacolon
up to 18 years of age sensitivity to the drug.
With caution, the drug is prescribed for: severe obstruction of the lower urinary tract due to the risk of urinary retention, an increased risk of decreased gastrointestinal motility, obstructive gastrointestinal diseases (eg, pyloric stenosis), renal or hepatic insufficiency (daily dose should not exceed 2 mg), diaphragm hernia .
Use during pregnancy and lactation
Use of Urotol during pregnancy is possible only if the intended benefit of the therapy for the mother outweighs the potential risk to the fetus.
Since data on the excretion of tolterodine with breast milk are not available, the use of the drug during lactation should be avoided.
Women of childbearing age should use reliable methods of contraception during treatment with Urotol.
Composition
Active ingredient: tolterodine * hydrotartrate 2 mg.
Excipients: microcrystalline cellulose, sodium carboxymethyl starch (type A), colloidal silicon dioxide, sodium stearyl fumarate.
Shell composition: hypromellose 2910/5, macrogol 6000, titanium dioxide, talc.
* is the non-proprietary international name recommended by WHO – tolterodyne.
Dosage and administration
The drug is administered orally at 2 mg 2 times / day, regardless of food intake. The total dose of the drug can be reduced to 2 mg / day, based on the individual tolerance of the drug.
In case of impaired liver and / or kidney function, as well as with simultaneous use with ketoconazole or other strong CYP3A4 inhibitors, a dose reduction of up to 1 mg 2 times / day is recommended.
The effectiveness of therapy should be reevaluated 2-3 months after the start of treatment.
Side effects of
On the part of the immune system: allergic reactions, Quincke’s edema (very rare).
From the nervous system: nervousness, impaired consciousness, hallucinations, dizziness, drowsiness, paresthesia, headache.
On the part of the organs of vision: dry eyes, impaired accommodation.
From the cardiovascular system: tachycardia, palpitations, arrhythmia (rare).
From the digestive system: dry mouth, dyspepsia, constipation, abdominal pain, flatulence, vomiting rarely – gastroesophageal reflux.
Dermatological reactions: dry skin.
Urinary system: urinary retention.
Other: fatigue, chest pain, peripheral edema, bronchitis, weight gain.
Drug Interaction
Avoid concomitant administration of Urotol with strong CYP 3A4 inhibitors such as erythromycin, and anti-fungal risk of drug overdose. M-cholinomimetics reduce the effectiveness of tolterodine. Medications with anticholinergic properties increase the action of Urotol and increase the risk of side effects. Urotol attenuates the action of prokinetics (metoclopramide, cisapride).
The pharmacokinetic interaction of Urotol with drugs metabolised by cytochrome P450 isoenzymes CYP 2D6 or CYP 3A4 (inducers and inhibitors) is possible.
Co-administration with fluoxetine (a potent CYP 2D6 inhibitor that is metabolized to norfluoxetine, a CYP 3A4 inhibitor) leads only to a slight increase in total AUC of tolterodine and its active 5-hydroxymethyl metabolite, which is not significant.
There is no interaction of Urotol with warfarin and combination oral contraceptives (containing ethinyl estradiol / levonorgestrel).
Tolterodine is not a CYP 2D6, 2C19, 3A4, 1A2 inhibitor, therefore, no increase in the level of drugs metabolized by these isoenzymes in blood plasma when co-administered with tolterodine is anticipated.
Overdose
Symptoms: paresis of accommodation, mydriasis, painful urges for urination, hallucinations, severe arousal, convulsions, respiratory failure, tachycardia, QT prolongation, delay.
Treatment: gastric lavage, activated charcoal. At development of hallucinations, strong excitement – physostigmine, at convulsions or the expressed excitement – anxiolytics of benzodiazepine structure, at the developed respiratory insufficiency – IVL, at tachycardia – beta-adrenoblockers, at urinary retention – catheterization of catheterisation or transfer the patient to a dark room.
Storage conditions
Store in a dry place.
Keep out of the reach of children.
The Expiration of
is 3 years.
Deystvuyuschee substances
Tolterodyn
pharmacy terms and conditions for prescription
dosage form
dosage form
tablets
Z ntiva KS, Czech Republic
