Spazmalgon (metamizole, pitofenone) tablets №50

Description

Spazmalgon (metamizole, pitofenone) tablets №50

Composition

active substances: metamizole sodium, pitofenone hydrochloride, fenpiverine bromide;

1 tablet contains metamizole sodium 500 mg, pitophenone hydrochloride 5 mg, fenpiverine bromide 0.1 mg;

Excipients: lactose monohydrate, wheat starch, talc, magnesium stearate, gelatin, sodium bicarbonate.

Dosage form

Tablets.

Main physical and chemical properties: round, flat tablets with beveled edges, with a dividing line on one side, diameter 13 mm; color is white or almost white.

Pharmacotherapeutic group

Antispasmodics in combination with analgesics. Synthetic anticholinergics in combination with analgesics. Pitophenone and analgesics.
ATX code A03D A02.

Pharmacological properties

Spazmalgon tablets has analgesic, antispasmodic (papaverine), cholinolytic (atropine) and some anti-inflammatory activity.

Metamizole has a pronounced analgesic and antipyretic effect in combination with less clear anti-inflammatory and antispasmodic activity. Its effects are the result of inhibition of prostaglandin and endogenous allogeneic synthesis, increase of the excitability threshold in the thalamus and conduction of painful extero- and interoceptive impulses in the CNS, and it affects the hypothalamus and the formation of endogenous pyrogens.

Fenpiverine has a moderate ganglioblocking and parasympathetic effect, reduces the tone and motility of the smooth muscles of the stomach, intestines, bile and urinary tract.

Pitophenone has a papaverine-like effect on vascular and extravascular smooth muscles with a pronounced antispasmodic nature.

Indications

The drug Spazmalgon tablets is a combined antispasmodic agent that has the following pharmacological actions: antipyretic (antipyretic), analgesic (analgesic), antispasmodic (eliminates smooth muscle spasm), as well as some anti-inflammatory.
Metamizole sodium has pronounced analgesic and antipyretic effects, and also has less pronounced antispasmodic and anti-inflammatory activities.
Fenpiverinium helps to reduce motility and tone of smooth muscles of the biliary tract, intestines, stomach and urinary tract.
Pitofenone has a pronounced antispasmodic effect, acting on the smooth muscles of the internal organs and blood vessels.
The drug Spazmalgon tablets is used for the symptomatic treatment of moderate and mild pain syndrome against a background of smooth muscle spasm of internal organs. Spazmalgon is indicated for renal colic, spastic dysmenorrhea, inflammatory processes in the urinary tract, which are accompanied by pain and urinary disorders (dysuria), intestinal and stomach cramps, biliary dyskinesia, hepatic colic.

Contraindications

It is forbidden to use the drug Spazmalgon in case of hypersensitivity to any of its components, pyrazolone derivatives, intestinal obstruction, gallbladder atony, megacolone, severe renal and / or liver dysfunction, bladder atony, pathological changes in blood composition (for example, with agranulocytosis, leukopenia) , deficiency of the enzyme glucose-6-phosphate dehydrogenase, blood diseases (anemia of any origin, neutropenia), porphyria, bronchial asthma, tachyarrhythmias, angle-closure glaucoma, collaptoid conditions, prostatic hypertrophy with a tendency to retention (retention) of urine.
This drug is not used if the patient is suspected of having an acute surgical pathology (eg, appendicitis).
It is forbidden to prescribe the drug Spazmalgon to children under fifteen years of age.
The simultaneous use of Spazmalgon with medications that inhibit the work of the brain is prohibited.
Do not drink alcohol while using this drug.
You can not simultaneously take Spazmalgon and other drugs that contain metamizole.
This drug in tablet form is not recommended for use in patients suffering from celiac disease, lactase deficiency, galactose intolerance, and glucose-galactose malabsorption syndrome.
Use caution when using this drug in patients with hyperthyroidism.
Caution is also required by the use of Spazmalgon in patients with a history of allergic hypersensitivity to non-narcotic analgesics, NSAIDs.

Application during pregnancy and lactation

The drug Spazmalgon is prohibited for use in women during these periods.

Method of administration and dosage

Spazmalgon tablets are taken orally after meals with water.
The recommended doses for children over fifteen years of age and adults are 1-2 tablets / day, the maximum dose of this drug is 2 tablets / day.
The duration of the use of Spazmalgon tablets cannot exceed more than three days.

Overdose

In case of an overdose of the drug Spazmalgon tablets №50, impaired hepatic and / or renal function, respiratory paralysis may develop. Most often, gastrointestinal disorders occur, signs of hematopoiesis disorders, toxic-allergic syndrome appear, in severe cases of overdose, symptoms of brain damage may appear.
In case of suspicion of an overdose of this drug, it is necessary to immediately stop its intake into the body and take measures to quickly eliminate it. So, you should induce vomiting and carry out gastric lavage in case of an overdose with the drug in tablet form. It is also recommended to increase urine output (urine output).
In general, in case of an overdose of this drug, symptomatic therapy is carried out. There is no specific antidote.

Side effects

Against the background of the use of Spazmalgon tablets №50, the development of allergic reactions of varying severity is possible. So, urticaria, itching, skin rashes, allergic conjunctivitis, toxic epidermal necrolysis, bronchospasm, angioedema, anaphylactic shock, Stevens-Johnson syndrome can occur.
Also, side effects that may occur with the use of Spazmalgon include dry mouth, abdominal discomfort, constipation, exacerbation of gastritis or gastric / duodenal ulcer, palpitation (abnormal, increased heartbeat), lowering blood pressure, tachycardia and others cardiac arrhythmias, the development of acute renal failure, dizziness, hematopoiesis disorders (for example, granulocytopenia, leukopenia, agranulocytosis, anemia, thrombocytopenia), oliguria (decreased urine production), anuria (no urine excretion), hepatitis, proteinuria (presence of protein in the urine ), interstitial nephritis, visual impairment, decreased sweating.
The metabolic products of the active component of Spazmalgon – metamizole sodium – can change the color of excreted urine to red. This phenomenon has no clinical significance.