Trospium chloride

Brand Dr. Pfleger

In stock 535 Items

Available since: 2019-09-19

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15 mg, 30 pcs
30 mg, 30 pcs
5 mg, 30 pcs

$37.19

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Clinical Pharmacology

Pharmacodynamics

Trospium chloride is a quaternary ammonium base, belongs to the group of m-holinoblokatorov. It is a competitive acetylcholine antagonist at smooth muscle postsynaptic membrane receptor receptors. It has a high affinity for m 1 - and m 3 - cholinergic receptors. Reduces the increased activity of the bladder detrusor. It has antispasmodic and some ganglion blocker effect. It does not have central effects.

Pharmacokinetics

Suction and distribution

The maximum concentration of trospium chloride in plasma (C _max ) is achieved in 4-6 hours after oral administration of trospia chloride; half-life (T _1/2 ) averages 5-18 hours, not cumulated. Binding to plasma proteins is 50-80%. The concentration of trospium chloride in the blood plasma after a single ingestion of 20-60 mg is proportional to the dose taken.

Metabolism and excretion

The predominant amount of trospium chloride is excreted by the kidneys in unchanged form, a smaller part (about 10%) - in the form of spiro-alcohol metabolite, formed during the hydrolysis of ester bonds.

Indications

Overactive bladder, accompanied by urinary incontinence, imperative urination to urinate and increase the frequency of urination (with idiopathic hyperactivity of the detrusor of non-hormonal and inorganic etiology);
mixed urinary incontinence;
spastic neurogenic dysfunction of the bladder: with neurogenic hyperactivity (hyperreflexia) of the detrusor (multiple sclerosis, spinal injuries, congenital and acquired diseases of the spinal cord, strokes, parkinsonis);
detrusor-sphincter-dyssynergy on the background of intermittent catheterism;
pollakiuria;
nocturia;
night and daytime enuresis;
in the treatment of cystitis, accompanied by imperative symptoms.

Composition

1 coated tablet contains:

Active substance: Trospium Chloride - 30 mg.

Excipients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, corn starch, stearic acid, Povidone K25, colloidal silicon dioxide, hypromellose, titanium dioxide.

Shell composition: hypromellose, titanium dioxide, microcrystalline cellulose, stearic acid.

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Dosage and Administration

Orally, before meals, without chewing and drinking plenty of water.

Adults and children from 14 years of age are prescribed the drug individually, depending on the clinical picture and the severity of the disease.

The drug is taken 1/2 tablet 3 times a day or 1 tablet in the morning and 1/2 tablet in the evening (45 mg).

In patients with renal failure

In patients with renal insufficiency (creatinine clearance 10-30 ml / min / 1.73 m²a) 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.

Adverse reactions

Incidence of side effects (number of cases: number of observations):

often - more than 1: 100;
Infrequently - 1: 100-1000;
rarely less than 1: 1000.

Since the cardiovascular system: infrequently - tachycardia; rarely - chest pain, fainting tachyarrhythmia, hypertensive crisis.

From the gastrointestinal tract: often - dry mouth, dyspepsia, constipation, nausea, abdominal pain; infrequently - diarrhea, bloating; rarely - gastritis.

On the part of the respiratory system: infrequently - shortness of breath.

From the nervous system: rarely - confusion, hallucinations.

From the musculoskeletal system: rarely, acute skeletal muscle necrosis.

On the part of the organ of vision: infrequently - accommodation disturbance.

From the urinary system: infrequently - a violation of the emptying of the bladder; rarely - urinary retention.

From the hepatobiliary system: rarely, a slight or moderate increase in transaminase activity.

On the part of the immune system: infrequently - skin rash; rarely - anaphylactic reactions, Stevens-Johnson syndrome.

Contraindications

Carefully: cardiovascular diseases in which an increase in heart rate may be undesirable (atrial fibrillation, tachycardia, chronic heart failure (CHF), coronary heart disease, mitral stenosis, arterial hypertension, acute bleeding); thyrotoxicosis (possibly increased tachycardia); increased body temperature (may even increase due to the suppression of the activity of the sweat glands); reflux esophagitis; hernia of the esophageal orifice of the diaphragm, combined with reflux esophagitis (reduced motility of the esophagus and stomach and relaxation of the lower esophageal sphincter may help slow gastric emptying and increase gastroesophageal reflux through the sphincter with impaired function); diseases of the gastrointestinal tract (GIT), accompanied by obstruction (achalasia, pyloric stenosis (possible decrease in motility and tone, leading to obstruction and delay the contents of the stomach)); intestinal atony in elderly patients or debilitated patients (possible obstruction); paralytic intestinal obstruction (possible development of obstruction); diseases with elevated intraocular pressure (open-angle glaucoma (mydriatic effect may cause some increase in intraocular pressure; correction of therapy may be required), age over 40 years (danger of undiagnosed glaucoma)); ulcerative colitis; high doses may inhibit intestinal peristalsis, increasing the likelihood of paralytic ileus; the manifestation or aggravation of such a severe complication as toxic megacolon is possible; dry mouth (prolonged use may further increase the intensity of xerostomia); renal failure (risk of side effects due to decreased elimination); chronic lung diseases, especially in children and debilitated patients (reduction of bronchial secretion may lead to thickening of the secret and the formation of traffic jams in the bronchi); myasthenia (condition may worsen due to inhibition of the action of acetylcholine); autonomic (autonomous) neuropathy (urinary retention and accommodation paralysis may increase); prostatic hyperplasia without urinary tract obstruction; urinary retention or predisposition to it, or disease, accompanied by obstruction of the urinary tract (includingbladder neck due to prostatic hypertrophy); preeclampsia (possibly increased arterial hypertension); diseases of the brain in children (effects from the central nervous system may increase); Down's disease (perhaps an unusual dilation of the pupils and an increase in heart rate); central paralysis in children (the reaction to anticholinergic drugs may be most pronounced); liver failure.

Drug interactions

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 affects 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, Kolestiramin and colestipol, it is possible to reduce the absorption of trospium chloride.

No interaction was found between trospium chloride and cytochrome P450 isoenzymes (CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, ZA4), since trospia chloride is metabolized by them only in a small amount, and hydrolysis of esters is the main pathway of its metabolism.

Pregnancy and Lactation

In pregnancy and during breastfeeding, the drug should be used if the intended benefit to the mother outweighs the potential risk to the fetus or child.

Special instructions

Before starting treatment, organic causes of pollakiuria and urinary incontinence, such as cardiac or renal failure, polydipsia, urinary tract tumors, should be excluded.

When prescribing the drug to patients with impaired bladder detrusor function, it must be possible to completely release the bladder (including catheterization).

Application for violations of the liver

Precautions should be prescribed the drug for liver failure.

Application for violations of renal function

In patients with renal insufficiency (creatinine clearance 10-30 ml / min / 1.73 m²) daily dose is 20 mg.

Influence on ability to drive motor transport and control mechanisms

During the period of treatment, one should refrain from driving vehicles and practicing potentially hazardous activities that require increased concentration and psychomotor speed.

Overdosage

Symptoms: Signs of overdose are increased anticholinergic symptoms, such as: visual disturbance, tachycardia, dry mouth, and redness of the skin.

Treatment: gastric lavage and absorption of adsorbents (Activated charcoal, etc.), instillation of pilocarpine 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, beta-adrenoblockers are administered intravenously under the control of an ECG and blood pressure.