Spazmalgon (metamizole, pitophenone) solution for injection ampoules 2 ml. №10

Description

Spazmalgon (metamizole, pitophenone) solution for injection ampoules 2 ml. №10

Composition

active substances: metamizole sodium monohydrate, pitophenone hydrochloride, fenpiverine bromide;

1 ml of solution for injection contains: metamizole sodium monohydrate 500 mg; pitophenone hydrochloride 2 mg; fenpiverine bromide 0.02 mg;

Excipients: water for injections.

Dosage form

Solution for injection.

Basic physical and chemical properties: clear liquid, almost free of particles.

Pharmacotherapeutic group

Antispasmodics in combination with analgesics.
ATX code A03D A02.

Pharmacological properties

Spazmalgon – a combined drug with pronounced antispasmodic and analgesic activity.

Metamizole has a pronounced analgesic and antipyretic effect in combination with weaker anti-inflammatory and antispasmodic activity. The result of his actions is the inhibition of the synthesis of prostaglandins and endogenous algogens, increasing the threshold of excitability in the thalamus, the effect on the hypothalamus and the formation of endogenous pyrogens.

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

Pytophenone hydrochloride has a papaverine-like effect with pronounced antispasmodic activity against smooth muscle.

Indications

The drug Spazmalgon solution for injection 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 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 solution for injection is used intramuscularly. It is recommended to inject Spazmalgon 2-5 milliliters 2-3 times / day.
Before injecting the injection solution, you should warm the ampoule in your hand.
The duration of use of the injection solution Spazmalgon should be no more than five days.
The maximum dose of this agent is no more than 10 ml / day.
If the therapeutic effect of the use of this drug is not observed, then its use should be discontinued. If there is a good or satisfactory therapeutic effect, you should switch to its oral (oral) use.
The duration of the treatment course with this drug is determined depending on the specific clinical case.
In the case of prolonged use of the drug Spazmalgon, it is required to regularly monitor the blood picture, the state of the renal and hepatic functions.

Overdose

In case of an overdose of the drug Spazmalgon, 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 solution for injection, 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.