Spazmex
Spazmex: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Spasmex
ATX code: G04BD09
Active ingredient: trospium chloride (Trospium chloride)
Producer: Dr. R. Pfleger, chemical factory GmbH (Dr. R. Pfleger Chemische Fabrik, GmbH) (Germany)
Description and photo update: 2019-21-08
Prices in pharmacies: from 339 rubles.
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Spazmex is a drug with an antispasmodic effect, which helps to reduce the tone of the smooth muscles of the bladder.
Release form and composition
Dosage forms of Spazmex:
- tablets: weight - 250 mg; biconvex, round, color - almost white or white (10 pcs. in blisters, in a cardboard box 3 or 5 blisters);
- film-coated tablets: weight - 259.6 mg; round, biconvex, scored, almost white or white; at the break - a white or almost white core and a film shell (10 pcs. in blisters, in a cardboard box 3 or 5 blisters).
Composition of 1 tablet:
- active substance: trospium chloride - 5 mg;
- additional components: colloidal silicon dioxide - 0.5 mg; lactose monohydrate - 170 mg; povidone-25,000 - 1 mg; corn starch - 55.5 mg; stearic acid - 3 mg; sodium carboxymethyl starch - 15 mg.
Composition of 1 film-coated tablet:
- active substance: trospium chloride –15 or 30 mg;
- additional components (15/30 mg of active ingredient, respectively): colloidal silicon dioxide - 3/3 mg; povidone-25,000 - 1/1 mg; corn starch - 44/41 mg; lactose monohydrate - 100/100 mg; microcrystalline cellulose - 75/60 mg; stearic acid - 2/5 mg; sodium carboxymethyl starch - 10/10 mg;
- film shell: titanium dioxide - 1.44 mg; hypromellose - 6.24 mg; microcrystalline cellulose - 0.96 mg; stearic acid - 0.96 mg.
Pharmacological properties
Pharmacodynamics
Spazmex is one of the agents that reduce the tone of the smooth muscles of the urinary tract. The active ingredient is trospium chloride, which is a quaternary ammonium base, an m-anticholinergic antagonist, a competitive acetylcholine antagonist on the receptors of the postsynaptic membranes of smooth muscles. It has a high affinity for M1 and M3 cholinergic receptors. Helps to reduce the increased activity of the detrusor of the bladder.
It has an antispasmodic and slight ganglion blocking effect. It has no central effects.
Pharmacokinetics
After taking Spazmex inside, C max (maximum concentration of the substance) of trospium chloride is achieved in 4–6 hours. With a single dose of 20-60 mg, the concentration of the substance is proportional to the dose taken.
Does not cumulate. Binds to blood plasma proteins at the level of 50-80%.
T 1/2 (half-life) varies in the range of 5-18 hours.
Excretion is carried out in the urine. Most of the dose is excreted unchanged, approximately 10% is excreted in the form of spiroalcohol, a metabolite that is formed during the hydrolysis of ether bonds.
Indications for use
- detrusor-sphincter dyssynergia against the background of intermittent (periodic) catheterization;
- urinary incontinence (mixed forms);
- cystitis occurring with imperative symptoms (in combination with other drugs);
- pollakiuria, nocturia;
- overactive bladder, which proceeds with urinary incontinence, urge to urinate and an increase in urinary frequency (with idiopathic overactive detrusor of non-hormonal / inorganic origin);
- neurogenic spastic disorders of the urinary bladder function (with neurogenic increased detrusor activity occurring against the background of spinal injuries, multiple sclerosis, stroke, congenital / acquired diseases of the spinal cord, parkinsonism);
- enuresis (nocturnal / daytime).
Contraindications
Absolute:
- angle-closure glaucoma;
- tachyarrhythmia;
- retention of urine;
- myasthenia gravis;
- glucose-galactose malabsorption, galactose intolerance, lactase deficiency;
- renal failure, in which dialysis is indicated (creatinine clearance less than 10 ml / min / 1.73 m 2);
- slowing down the evacuation of food from the stomach, including the presence of conditions that predispose to its appearance;
- age up to 14 years;
- hypersensitivity to drug components.
Relative (Spazmex is prescribed with caution in the presence of the following diseases / conditions):
- reflux esophagitis or hiatal hernia, occurring with reflux esophagitis (due to the likelihood of slowing gastric emptying with increased gastroesophageal reflux);
- intestinal atony in debilitated patients or elderly patients, paralytic intestinal obstruction (due to the likelihood of obstruction);
- thyrotoxicosis (due to the likelihood of increased tachycardia);
- diseases of the cardiovascular system, in which an increase in heart rate is undesirable, including ischemic heart disease, mitral stenosis, tachycardia, atrial fibrillation, chronic heart failure, acute bleeding, arterial hypertension;
- diseases of the gastrointestinal tract, proceeding with obstruction, including pyloric stenosis and achalasia (due to the likelihood of a decrease in tone and motility, which can lead to a delay in stomach contents and obstruction);
- increased body temperature (due to the likelihood that this symptom indicates suppression of the activity of the sweat glands);
- diseases occurring with increased intraocular pressure, including open-angle glaucoma (dose adjustment may be required), age over 40 years (due to an increased likelihood of undiagnosed glaucoma);
- ulcerative colitis (the use of Spazmex in high doses can lead to an increase in the likelihood of paralytic intestinal obstruction, inhibition of intestinal motility, and toxic megacolon can also manifest / worsen);
- xerostomia (long-term therapy can lead to a further increase in the severity of symptoms);
- myasthenia gravis (due to the likelihood of deterioration of the condition, which is associated with inhibition of the action of acetylcholine);
- renal failure (due to an increased risk of adverse reactions associated with a decrease in the excretion of the active substance);
- liver failure;
- central paralysis in children (due to the likelihood of the most pronounced reaction to anticholinergic drugs);
- chronic lung diseases, especially in debilitated patients and children (due to a decrease in bronchial secretion, the formation of plugs in the bronchi and thickening of the secretion is possible);
- prostatic hyperplasia without urinary tract obstruction, autonomic (autonomic) neuropathy (due to the likelihood of increased urinary retention and accommodation paralysis), urinary retention (presence / predisposition to it), as well as diseases occurring with urinary tract obstruction;
- Down's disease (due to the likelihood of an increase in heart rate and unusual pupil dilation);
- brain diseases in children (due to the likelihood of increasing the effects of the central nervous system);
- gestosis (due to the likelihood of increased arterial hypertension);
- pregnancy and lactation (Spazmex is prescribed only after assessing the ratio of benefits to risks).
Instructions for the use of Spazmex: method and dosage
Spazmex is taken orally with a sufficient amount of water, preferably before meals. Do not chew the tablets.
The duration of the course, the single dose and the frequency of use, the doctor determines on an individual basis, based on the severity of the condition and the clinical picture.
Usually Spazmex is prescribed at 30–45 mg per day with a frequency of reception 3 times a day (intervals between doses - 8 hours). At a daily dose of 45 mg, it is possible to take it 2 times a day - 30 mg in the morning and 15 mg in the evening.
The daily dose for renal failure (in patients with creatinine clearance of 10-30 ml / min / 1.73 m 2) is not more than 15 mg.
The average course duration is from 2 to 3 months. With a longer use of Spazmex, the question of the appropriateness of further treatment is decided every 3-6 months by the doctor on an individual basis.
Side effects
- allergic reactions: infrequently - skin rash; rarely - Stevens-Johnson syndrome, anaphylactic reactions;
- urinary system: infrequently - impaired emptying of the bladder; rarely - urinary retention;
- respiratory system: infrequently - dyspnea;
- musculoskeletal system: rarely - acute skeletal muscle necrosis;
- cardiovascular system: infrequently - tachycardia; rarely - hypertensive crisis, fainting, chest pain, tachyarrhythmia;
- digestive system: often - xerostomia, dyspeptic symptoms, nausea, constipation, abdominal pain; infrequently - bloating, diarrhea; rarely - gastritis, moderate / slight increase in transaminase activity;
- nervous system: rarely - confusion, hallucinations;
- organ of vision: infrequently - accommodative disorders.
Overdose
The main signs: increased anticholinergic symptoms, including visual impairment, tachycardia, flushing of the skin and xerostomia.
Therapy: prescribed gastric lavage and treatment with adsorbents (including activated carbon); with glaucoma - instillation of pilocarpine; with urinary retention - bladder catheterization.
In severe cases, cholinomimetics (neostigmine methyl sulfate) are indicated. If the effect is insufficient, as well as patients with severe tachycardia and / or instability of blood circulation, beta-blockers are administered intravenously under the control of blood pressure and ECG.
special instructions
In the treatment of autonomic disorders of the bladder function, before the appointment of Spazmex, it is necessary to determine the cause of the dysfunction. The following organic causes should also be excluded: heart failure, urinary tract infections, polydipsia, bladder cancer. If they are available, treatment is prescribed to eliminate the cause of the disease (etiotropic therapy).
Reception of Spazmex against the background of impaired function of the detrusor of the bladder or the internal sphincter of the urethra should be carried out with its complete release by catheterization.
Influence on the ability to drive vehicles and complex mechanisms
When driving vehicles and performing work with moving mechanisms, it is necessary to take into account that at the beginning of the course of treatment, in cases of drug replacement, with an increase in the daily dose of Spazmex or combined intake of alcohol, vision may deteriorate.
Application during pregnancy and lactation
According to the instructions, Spazmex during pregnancy / lactation can only be used in cases where the expected benefit is assessed above the possible risks.
Pediatric use
Spazmex therapy is contraindicated in patients under 14 years of age.
With impaired renal function
Renal failure is a relative contraindication to Spazmex therapy. With a creatinine clearance of 10-30 ml / min / 1.73 m 2, the recommended dose is 20 mg per day.
For violations of liver function
Liver failure is a relative contraindication to the use of Spazmex.
Drug interactions
Spazmex affects the digestive system and can change the absorption of drugs used in combination with it.
With the combined use of Spazmex with certain drugs / substances, the following effects may develop:
- beta-adrenomimetics: enhancing their positive chronotropic effect;
- amantadine, tricyclic antidepressants, quinidine, disopyramide, antihistamines: enhancing their m-anticholinergic action;
- preparations containing substances such as cholestyramine, guar, colestipol: decreasing the absorption of trospium chloride;
- prokinetics: weakening their action.
Analogs
The analogue of Spazmex is Betmiga, Spazmolit, Driptan, Vesikar, Novitropan, etc.
Terms and conditions of storage
Store in a dark, dry place at a temperature of 15-25 ° C. Keep out of the reach of children.
The shelf life is 5 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Spazmex
According to reviews, Spazmex is an effective drug. It relieves well such symptoms of diseases of the genitourinary system as frequent urination and urinary incontinence, and also reduces pain. In most cases, the drug is well tolerated, but sometimes patients complain of the development of adverse reactions. The cost of Spazmex is most often assessed as high.
Price for Spazmex in pharmacies
The approximate price for Spazmex for 30 tablets per pack depends on the dosage and varies in the range:
- 5 mg: 350-378 rubles;
- 15 mg: 401–473 rubles;
- 30 mg: 606-710 rubles.
Spazmex: prices in online pharmacies
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Drug name Price Pharmacy |
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Spazmex 5 mg tablets 30 pcs. 339 r Buy |
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Spazmex tablets 5mg 30 pcs. 373 r Buy |
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Spazmex 15 mg film-coated tablets 30 pcs. 397 r Buy |
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Spazmex tablets p.p. 15mg 30 pcs. 431 r Buy |
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Spazmex 30 mg film-coated tablets 30 pcs. 623 RUB Buy |
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Spazmex tablets p.p. 30mg 30 pcs. 656 r Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
