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Active ingredients
Trospium chloride
Release form
Pills
Composition
Each tablet contains 5 mg of trospium chloride. Auxiliary substances - lactose monohydrate, sodium starch glycolate, corn starch, stearic acid, povidone (K 25), colloidal silicon dioxide.
Pharmacological effect
Trospium chloride, a quaternary ammonium base, belongs to the group of anticholinergics. It is a competitive acetylcholine antagonist on smooth muscle postsynaptic membrane receptor receptors. It has a high affinity for M1 - and M3 - cholinergic receptors. Reduces the increased activity of the bladder detrusor. Trospia chloride has some ganglioblokiruyuschee action, as well as myotropic action, like papaverine. It does not have central effects.
Pharmacokinetics
The maximum concentration in blood plasma (Сmax) is reached in 4-6 after oral administration of trospia chloride. The half-life of T1 / 2 after oral administration is on average 5-18 hours, does not accumulate. Binding to plasma proteins is 50-80%. The concentration of trospium chloride in a single dose of 20 to 60 mg is proportional to the dose taken. Excreted by the kidneys, the majority - in unchanged form, about 10% - in the form of spiroalkol, a metabolite formed during the hydrolysis of ester bonds.
Indications
urinary incontinence and urge to urinate (with idiopathic hyperactivity of the detrusor; with neurogenic hyperactivity (hyperreflexia) of the detrusor - multiple sclerosis, spinal injuries, congenital and acquired diseases of the spinal cord, strokes, parkinsonism, etc.); catheterism; in the treatment of cystitis, accompanied by imperative symptoms; pollakiuria, nocturia; night and day enuresis; mixed forms of urinary incontinence.
Contraindications
hypersensitivity to the drug, drug components; urinary retention; narrow-angle glaucoma; tachyarrhythmia; myasthenia; age up to 14 years (no adequate, strictly controlled studies of the use of trospium chloride in children have been conducted).
Precautionary measures
With care: diseases of the cardiovascular system in which an increase in heart rate may be undesirable: tachycardia, chronic heart failure,coronary heart disease; thyrotoxicosis, elevated body temperature; reflux esophagitis, hernia of the esophageal opening of the diaphragm, combined with reflux esophagitis; diseases of the gastrointestinal tract, accompanied by obstructive conditions: achalasia and pyloric stenosis; intestinal atony in elderly or debilitated patients, paralytic ileus; diseases with increased intraocular pressure: angle-closure and open-angle glaucoma; chronic inflammatory bowel diseases (Crohn's disease, ulcerative colitis); dry mouth; renal failure; chronic lung diseases, especially in debilitated patients; autonomic (autonomous) neuropathy; pregnancy toxicosis; cerebral palsy; Down's disease.
Use during pregnancy and lactation
The use of trospia chloride during pregnancy and lactation is possible only when the expected benefit to the mother outweighs the potential risk for the fetus and child (there are no adequate, well-controlled studies of the use of trospia chloride in pregnant women and during breastfeeding).
Dosage and administration
Tablets are taken before meals, without chewing and drinking plenty of water. For adults and children from 14 years of age, trospia chloride is prescribed individually, depending on the clinical picture and the severity of the disease. Is taken orally on 10 mg 3 times a day (30 mg / day) or 15 mg 2-3 times a day (30-45 mg / day). With a daily dose of 45 mg, it is also permissible to take 30 mg in the morning and 15 mg in the evening. When neurogenic hyperactivity of the detrusor trospia chloride is prescribed, 15-20 mg 2 times a day in the morning and evening (30-40 mg / day). On average, the duration of treatment is 2-3 months. After symptoms disappear, anti-relapse treatment is recommended for 2-4 weeks. If you need a longer treatment, the question of continuing treatment is reviewed by a doctor every 3-6 months. In patients with renal insufficiency (creatinine clearance 10-30 ml / min / 1.73 m2), the daily dose of trospium chloride should not exceed 20 mg.
Side effects
The frequency of occurrence of side effects (number of cases: number of observations) - frequent: more than 1: 100; infrequent: 1: 100-1000; rare: less than 1: 1000. From the cardiovascular system: rare - tachycardia. From the gastrointestinal tract: frequent - dry mouth, dyspepsia, constipation,Nausea. From the side of the central nervous system: infrequent - accommodation paresis. From the urinary system: infrequent - violation of the emptying of the bladder. Allergic reactions: infrequent - skin rash.
Overdose
Signs of overdose are increased anticholinergic symptoms, such as blurred vision, tachycardia, dry mouth and skin hyperemia. Treatment: gastric lavage and taking of adsorbents (activated carbon, etc.), local administration of pilocarpine in patients with glaucoma, catheterization during urinary retention. In severe cases, the appointment of cholinomimetics (for example, neostigmine). With insufficient effect, severe tachycardia and / or instability of blood circulation - the introduction of beta-blockers (for example, 1 mg of propranolol intravenously under the control of an ECG and blood pressure).
Interaction with other drugs
Enhances the action of amantadine, tricyclic antidepressants, quinidine, antihistamine drugs, disopyramide, beta-adrenostimulyatorov.
special instructions
Before starting treatment, it is necessary to eliminate the organic causes of pollakiuria and urinary incontinence, such as cardiac or renal failure, polydipsia, urinary tract tumors. and activities of potentially hazardous activities that require increased concentration and psychomotor speed. No mutual Action trospium chloride with cytochrome P450 enzymes (P450) involved in cleavage of drugs in the metabolic process (P450 1A2, 2A6, ZS9, 2C19, 2D6, 2E1, ZA4). Therefore, interactions with other drugs affecting the cytochrome system are not expected.