Spazmex (trospium chloride) coated tablets 15 mg. №30

Description

Spazmex (trospium chloride) coated tablets 15 mg. №30

Composition

healing substance: trospium chloride;

1 film-coated tablet contains 15 mg of trospium chloride;

Excipients: lactose monohydrate, microcrystalline cellulose, corn starch, sodium starch glycolate (type A), colloidal anhydrous silica, stearic acid, povidone;

shell composition: hypromellose, microcrystalline cellulose, titanium dioxide (E 171), stearic acid.

Dosage form

Film-coated tablets.

Main physical and chemical properties: almost white, odorless film-coated tablets, round, biconvex, with a SNAP-TAB break line on one side and an O embossing on the other side, about 9 mm in diameter. The tablet can be divided into two equal parts.

Pharmacotherapeutic group

Means used in urology. Antispasmodics acting on the urinary tract. Trospium.
ATX code G04B D09.

Pharmacological properties

Trospium chloride is a Quaternary ammonium base, a derivative of nortropanol and belongs to the group of parasympatholytics or anticholinergics. Depending on the concentration of the drug competes with endogenous transmitters of acetylcholine at the postsynaptic level. It is a competitive antagonist of acetylcholine at smooth muscle receptor postsynaptic membranes, has high similarity to M1 and M3 receptors, lower similarity to M2 receptors, and binds to nicotine receptors at slightly low levels. M-cholinolytic acts on peripheral M-cholinoreceptors. The mechanism of action is the competitive inhibition of acetylcholine at the receptors of postsynaptic membranes of smooth muscles of the gastrointestinal tract and genitourinary system. The drug reduces the tone of smooth muscles of the urinary tract and weakens the detrusor of the bladder due to the anticholinergic effect and due to direct antispastic action.

Indications

Symptomatic treatment of idiopathic detrusor overactivity or detrusor neurological activity accompanied by symptoms of polakiuria, bladder dysfunctions such as urinary incontinence or urge to urinate.
It is used to treat diseases of the urinary system such as urinary incontinence, and is also effective in treating diseases such as stroke, parkinsonism, neurogenic hyperactivity (hyperreflexia) of the detrusor against the background of multiple sclerosis, back injuries, as well as congenital or acquired diseases of the spinal cord. It is used in the treatment of cystitis, which is accompanied by pollakiuria, nocturia. Effective for the treatment of bedwetting, in addition, with mixed forms of urinary incontinence.

Contraindications

Do not use Spazmex if you are hypersensitive to any of the components of the drug. In addition, Spazmex is contraindicated in urinary retention, urinary tract infections, renal failure, which requires dialysis.
It is also forbidden to prescribe Spazmex treatment for myasthenia gravis, tachyarrhythmias, ulcerative colitis and Crohn’s disease, impaired liver function, heart function, pancreatic hyperplasia, angle-closure glaucoma. You should also exclude the presence of malignant tumors, including the urinary system. It is forbidden to appoint children under the age of 1 years.

Application during pregnancy and lactation

Not applicable

Method of administration and dosage

It is taken on an empty stomach, swallowed without chewing. Drink with plenty of water. The dosage is prescribed by the doctor on an individual basis, depending on the physical condition of the patient and the severity of the clinical picture of the disease.
In the treatment of idiopathic detrusor overactivity, it is usually prescribed from 10 to 15 mg three times a day (that is, 2-3 tablets 2-3 times a day).
In the treatment of neuralgic overactive detrusor – 20 mg of Spazmex 2 times a day, morning and evening, but not more than 40-45 mg per day. It is necessary to observe equal intervals before using the drug.
For patients with renal insufficiency, the daily dose of Spazmex should not exceed 20 mg.
The course of treatment is from 2 to 3 months. After the negative symptoms have disappeared, preventive treatment is recommended for 2 to 4 weeks. Longer courses of treatment can be prescribed by a doctor on an individual basis, approximately once every 3-6 months.
Patients suffering from disorders of the detrusor need to use a catheter to ensure the fullest possible excretion of urine from the bladder.

Overdose

Tachycardia, skin hyperemia, dry mouth. In this case, treatment should be interrupted, gastric lavage and sorbent intake should be prescribed.

Side effects

Spazmex and its main active ingredient, trospia chloride, is a selective agent, at the same time, side effects were observed during treatment with this drug:

• On the part of the gastrointestinal tract, symptoms of dyspepsia, impaired stool, vomiting, epigastric pain, and increased gas production were observed.
• From the side of the immune system – anaphylactic reactions, angioedema.
• From the side of the nervous system – violation of accommodation, dizziness, headaches, weakness.
• Skin manifestations such as a rash are also possible.