Spasmex, pills 5mg, 30pcs

Composition

Active ingredient:

trospium chloride – 5 mg.

Auxiliary substances:

lactose monohydrate,

microcrystalline cellulose,

sodium starch glycolate

, corn starch,

stearic acid,

povidone K 25,

colloidal silicon dioxide,

hypromellose,

titanium dioxide.

Shell composition:

hypromellose, titanium dioxide, microcrystalline cellulose, stearic acid.

Pharmacological action

Pharmacodynamics

Trospium chloride is a quaternary ammonium base, belongs to the group of m-holinoblockers. It is a competitive antagonist of acetylcholine at the receptors of postsynaptic smooth muscle membranes. It has a high affinity for m1-and m3-cholinergic receptors. Reduces the increased activity of the bladder detrusor. It has an antispasmodic and some ganglioblocking effect. It doesn’t have any central effects.

Pharmacokinetics

Suction and distribution

The maximum concentration of trospium chloride in blood plasma (cmax ) is reached 4-6 hours after oral use of trospium chloride; the half-life (T 1/2 ) averages 5-18 hours, does not accumulate. Binding to plasma proteins is 50-80%. The concentration of trospium chloride in blood plasma with a single oral dose of 20-60 mg is proportional to the dose taken.

Metabolism and elimination

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

Indications

• Urinary incontinence, imperative urge to urinate (with idiopathic detrusor hyperreactivity; with neurogenic detrusor hyperactivity (hyperreflexia) on the background of multiple sclerosis, spinal injuries, congenital and acquired spinal cord diseases, strokes, Parkinsonism).
• Detrusor-sphincter-dyssynergy on the background of intermittent catheterism.
• In the complex therapy of cystitis, accompanied by imperative symptoms.
• Pollakiuria, nocturia.
• Nocturnal and daytime enuresis.
• Mixed forms of urinary incontinence.

Use during pregnancy and lactation

During pregnancy and lactation, the drug should be used if the intended benefit to the mother exceeds the potential risk to the fetus or child.

Contraindicated in children under 14 years of age.

Contraindications

• urinary retention,
• glaucoma,
• delayed evacuation of food from the stomach and conditions predisposing to their development;
• renal failure requiring dialysis (creatinine clearance < 10 ml / min/1.73 m2);
• galactose intolerance;
• hypersensitivity to Spasmex.

Side effects

From the cardiovascular system: infrequently-tachycardia; rarely – pain behind the sternum, syncope tachyarrhythmia, hypertensive crisis.

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

From the respiratory system: infrequently-shortness of breath.

Nervous system disorders: rarely-confusion, hallucinations.

Musculoskeletal disorders: rare-acute skeletal muscle necrosis.

From the side of the organ of vision: infrequently-violation of accommodation.

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

From the side of the hepatobiliary system: rarely-a slight or moderate increase in transaminase activity.

Immune system disorders: infrequently-skin rash; rarely-anaphylactic reactions, Stevens-Johnson syndrome.

Interaction

No interaction is expected with drugs that affect the cytochrome P 450 isoenzyme system, since no interaction of trospium chloride with the isoenzymes CYP1A2, CYP2A6, CYP3C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4 involved in the breakdown of drugs during metabolism was found.

When used concomitantly, trospium chloride enhances the anticholinergic effect of amantadine, tricyclic antidepressants, quinidine, antihistamines, disopyramide, beta-adrenostimulants.

How to take, course of use and dosage

The dosage regimen and duration of treatment are set individually, depending on the clinical picture and severity of the disease.

Tablets should be taken before meals, without chewing, with a sufficient amount of water.

Adults and adolescents 14 years and older are prescribed inside 10 mg 3 times/day (daily dose of 30 mg) or 15 mg 2-3 times/day (daily dose of 30-45 mg).

At a daily dose of 45 mg, it is possible to use 30 mg in the morning and 15 mg in the evening.

With neurogenic detrusor hyperactivity

With neurogenic hyperactivity, detrusor is prescribed 15-20 mg 2 times a day in the morning and evening (a daily dose of 30-40 mg).

The average duration of treatment is 2-3 months.

After symptoms disappear, anti-relapse treatment is recommended for 2-4 weeks.

If longer treatment is necessary, the question of continuing therapy should be reviewed every 3-6 months.

Use in patients with impaired renal function

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

Overdose

Symptoms: signs of overdose are increased anticholinergic symptoms, such as: visual disturbances, tachycardia, dry mouth and flushing of the skin.

Treatment: gastric lavage and use of adsorbents (activated charcoal, etc. ), pilocarpine instillation in patients with glaucoma, bladder catheterization in cases of urinary retention.

In severe cases, cholinomimetics (neostigmine methylsulfate) are prescribed. In case of insufficient effect, pronounced tachycardia and/or circulatory instability, beta-blockers are administered intravenously under the control of ECG and blood pressure.

Special instructions

Taking the drug in case of violation of the function of the internal sphincter of the urethra or detrusor of the bladder should be accompanied by its complete release by catheterization.

In case of vegetative disorders of the bladder, the cause of dysfunction should be determined before starting 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, as they require the appointment of etiotropic therapy.

Influence on the ability to drive vehicles and other mechanisms that require increased concentration of attention

At the beginning of treatment, when increasing the dose of the drug, replacing the drug, as well as when interacting with alcohol, vision loss may occur, which should be taken into account when driving vehicles and working with moving mechanisms.

Form of production

Coated tablets.

Storage conditions

Store in a dry place, protected from light, at a temperature of 15-25 °C

Shelf life

5 years

Active ingredient

Trospium chloride

Conditions of release from pharmacies

By prescription

Dosage form

Tablets