Spasmex pills 30 mg 30 pcs
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Active ingredients
Trospium chloride
Release form
Pills
Composition
1 tab. Trospium Chloride 30 mg. Excipients: lactose monohydrate - 100 mg, microcrystalline cellulose - 60 mg, corn starch - 41 mg, sodium carboxymethyl starch - 10 mg, stearic acid - 5 mg, povidone-25 thousand.
Pharmacological effect
A drug that reduces the tone of the smooth muscles of the urinary tract. Trospium chloride - quaternary ammonium base, m-holinoblokator. 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. It has antispasmodic and some ganglioblokiruyuschee effect. It does not have central effects.
Pharmacokinetics
Absorption: After taking the drug orally, Cmax is reached after 4-6 hours. The concentration of trospium chloride in a single dose of 20-60 mg is proportional to the dose taken. Distribution :: Plasma protein binding is 50-80%. Does not accumulate. Metabolism: Hydrolysis of ester bonds produces a metabolite, spiro-alcohol. Excretion: T1 / 2 varies from 5 to 18 hours. Excreted in the urine, most of it in an unchanged form, about 10% - in the form of a spiroalkogol-metabolite, formed during the hydrolysis of ester bonds.
Indications
- hyperactivity of the bladder, accompanied by urinary incontinence, imperative urination to urinate and an increase in urination frequency (with idiopathic hyperactivity of non-hormonal and non-organic detrusor etiology) - mixed forms of urinary incontinence - spastic neurogenic disorders of bladder function (with neurogenic hyperactivity (urinary incontinence) - spastic neurogenic disorders of the bladder function (with neurogenic hyperactivity (urinary incontinence) - spastic neurogenic disorders of bladder function (with neurogenic hyperactivity (urinary incontinence) - spastic neurogenic disorders of bladder function) (with neurogenic hyperactivity (urinary incontinence) sclerosis, spinal injuries, congenital and acquired diseases of the spinal cord, strokes, parkinsonism) - Detrusor-with phycterdysynergy on the background of intermittent catheterism - pollakiuria, nocturia - night and day enuresis - in the complex therapy of cystitis, accompanied by imperative symptoms.
Contraindications
- angle-closure glaucoma - tachyarrhythmia - myasthenia - urinary retention - slowing down the evacuation of food from the stomach and conditions predisposing to their development - renal failure requiring dialysis (CC less than 10 ml / min / 1.73 m2) - children and adolescents under 14 years old galactose intolerance, lactase deficiency, glucose-galactose malabsorption - hypersensitivity to the drug.With caution: - diseases of the cardiovascular system in which an increase in heart rate may be undesirable: atrial fibrillation, tachycardia, chronic heart failure, ischemic heart disease, mitral stenosis, arterial hypertension, acute bleeding - thyrotoxicosis (possibly increased tachycardia) - elevated body temperature (may still rise due to the suppression of the activity of sweat glands) - reflux esophagitis, hernia of the esophageal opening of the diaphragm, combined with reflux esophagitis (decreased motility of the esophagus and stomach and weakening of the lower esophageal sphincter may help slow gastric emptying and increase gastroesophageal reflux through the sphincter with impaired function) - gastrointestinal diseases with obstruction: achalasia and pyloric stenosis (reduction in motility and tone, leading to obstruction and delayed gastric contents) - atony (possibly reducing motility and tone, leading to obstruction and delayed stomach contents) - atony (possibly reducing motility and tone, leading to obstruction and delayed gastric contents) - atony (possibly reducing motility and tone, leading to obstruction and delayed stomach contents) - atony (possibly reducing motility and tone, leading to obstruction and delayed stomach contents) - atony (possibly reducing motility and tone, leading to obstruction and delayed stomach contents) - atony (possibly reducing motility and tone, leading to obstruction and delayed stomach contents) in patients of elderly or debilitated patients (possible development of obstruction), paralytic ileus of the intestine (possible development of impassable STI) - diseases with increased intraocular pressure: open-angle glaucoma (mydriatic effect may cause some increase in intraocular pressure, therapy may need to be adjusted), age over 40 years (risk of undiagnosed glaucoma) - ulcerative colitis (a high-dose drug can inhibit intestinal motility, increasing the likelihood paralytic intestinal obstruction, in addition, the manifestation or aggravation of such a severe complication, such as toxic megacolon) is possible - dryness during p that (long-term use may cause further increase in the severity of xerostomia) - renal failure (risk of side effects due to decreased excretion) - chronic lung diseases, especially in children and debilitated patients (reduction of bronchial secretion can lead to thickening of the secret and the formation of traffic jams in the bronchi) - myasthenia gravis (the condition may worsen due to the inhibition of the action of acetylcholine) - autonomic (autonomous) neuropathy (urinary retention and accommodation paralysis may increase), hyper laziya prostate without obstruction of the urinary tract, urine retention or predisposition thereto or diseases accompanied by obstruction of the urinary tract (includingbladder neck due to hypertrophy of the prostate gland) - preeclampsia (possibly increased arterial hypertension) - brain diseases in children (effects from the CNS may increase) - Down syndrome (perhaps unusual pupil dilation and increased heart rate) - central paralysis in children (reaction to anticholinergic drugs may be most pronounced) - liver failure.
Use during pregnancy and lactation
The use of the drug during pregnancy and lactation is possible only in the case when the intended benefit to the mother outweighs the potential risk to the fetus and newborn.
Dosage and administration
The drug is prescribed for adults and children over 14 years. The method of administration and the dose and duration of treatment are determined individually, depending on the clinical picture and the severity of the disease. Tablets should be taken before meals, without chewing, drinking plenty of water. Tablets of 5 mg: appoint 2-3 tab. 3 times / day (30-45 mg) with an interval of 8 hours; with a daily dose of 45 mg, it is permissible to take 30 mg in the morning and 15 mg in the evening. Tablets, film coated, 15 mg: appoint 1 tab. 3 times / day with an interval of 8 hours; daily dose of 45 mg. Tablets, film coated, 30 mg: appoint 1/2 tab. 3 times / day or 1 tab. in the morning and 1/2 tab. in the evening; daily dose of 45 mg. In patients with renal insufficiency (CC 10-30 ml / min / 1.73 m2) the daily dose of the drug should not exceed 15 mg. On average, the duration of treatment is 2-3 months. If you need a longer treatment, the question of continuing treatment is reviewed by a doctor every 3-6 months.
Side effects
The frequency of occurrence of side effects (number of cases: number of observations): often (> 1: 100), infrequently (1: 100-1: 1000), rarely (less than 1: 1000). Since the cardiovascular system: infrequently - tachycardia; rarely - pain behind the sternum, syncope, tachyarrhythmia, hypertensive crisis. On the part of the digestive system: often - dry mouth, dyspepsia, constipation, nausea, abdominal pain; infrequently - diarrhea, bloating; rarely - gastritis, a slight or moderate increase in transaminase activity. On the part of the respiratory system: infrequently - shortness of breath. On the part of the nervous system: rarely - confusion, hallucinations.From the musculoskeletal system: rarely - acute necrosis of skeletal muscles. On the part of the organ of vision: infrequently - violation of accommodation. On the part of the urinary system: infrequently - a violation of the emptying of the bladder; rarely - urinary retention. Allergic reactions: rarely - skin rash; rarely - anaphylactic reactions, Stevens-Johnson syndrome.
Overdose
Symptoms: increased anticholinergic symptoms, such as visual disturbances, tachycardia, dry mouth and skin hyperemia. Treatment: gastric lavage and taking of adsorbents (including activated carbon), pilocarpine instillation in patients with glaucoma, bladder catheterization during urinary retention. In severe cases, cholinomimetics are prescribed (neostigmine methyl sulfate). With insufficient effect, severe tachycardia and / or instability of blood circulation, intravenous beta-blockers are administered under the control of ECG and blood pressure.
Interaction with other drugs
With simultaneous use of trospia, the chloride enhances the m-anticholinergic effect of amantadine, tricyclic antidepressants, quinidine and disopyramide, antihistamine drugs, as well as the positive chronotropic effect of beta adrenergic mimetics. Trospia chloride weakens the effect of prokinetics (metoclopramide and cisapride). It has an effect on the motor and secretory functions of the gastrointestinal tract, changing the absorption of simultaneously used drugs. At the same time taking drugs containing such substances as guar, Kolestiramine and colestipol, it is possible to reduce the absorption of trospium chloride. No interaction was found between trospium chloride and isoenzymes of the cytochrome P450 system (CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, 3A4), since they are only metabolized by trospia chloride, and the hydrolysis of esters is the main pathway of its metabolism.
special instructions
The drug in violation of the function of the internal urethral sphincter or bladder detrusor should be accompanied by its complete release by catheterization. In vegetative disorders of the bladder, the cause of dysfunction should be determined before the start of treatment, organic causes of pollakiuria, nocturia and urinary incontinence, such as heart failure, polydipsia, the possibility of urinary tract infection and bladder cancer, are excluded. they require the appointment of etiotropic therapy.Impact on the ability to drive vehicles and control mechanisms At the beginning of treatment, increasing the dose of the drug, changing the drug, as well as when interacting with alcohol may cause visual impairment, which should be considered when driving and working with moving machinery.