Spazmalgon - instructions for use, dose, side effects, contraindications

Metamizole sodium - a derivative of pyrazolone - has a pronounced analgesic, antipyretic and mild anti-inflammatory effect, the mechanism of which is associated with inhibition of the synthesis of prostaglandins.

Pitofenone hydrochloride - myotropic antispasmodic, has a direct effect on the smooth muscles of the internal organs and causes its relaxation (papaverin-like action).

Fenpiverinia bromide, being an m-holinoblokatorom, has an additional relaxing effect on smooth muscles.

Pharmacokinetics:

From the site of intramuscular injection the drug is absorbed quickly and to a large extent.

Metamizole sodium is subjected to intense biotransformation. The main metabolites are 4-methylaminoantipyrine, 4-formylaminoantipyrine, 4-aminoantipyrine and 4-acetylaminoantipyrine. Approximately 20 additional metabolites, including glucuronic acid derivatives, have been identified. The main four metabolites are found in the cerebrospinal fluid, the connection with proteins is 50-60%. Metabolized in the liver, excreted mainly by the kidneys. In therapeutic doses penetrates into the mother's milk.

Indications:

Pain syndrome (mild or moderately severe) with spasms of smooth muscles of internal organs: renal colic, spasm of ureters and bladder; biliary colic, intestinal colic, biliary dyskinesia,postcholecystectomy syndrome, chronic colitis; algodismenorea, diseases of the pelvic organs.

Contraindications:

Hypersensitivity to the components of the drug and other pyrazolone derivatives, inhibition of bone marrow hematopoiesis, marked hepatic and / or renal insufficiency, deficiency of glucose-6-phosphate dehydrogenase, tachyarrhythmias, severe angina pectoris, decompensated chronic heart failure, angle-closure glaucoma, prostatic hyperplasia (with clinical manifestations), intestinal obstruction, megacolon, collapse, pregnancy (especially in the first trimester and in the last 6 weeks), lactation period, children's age 15 years.

Carefully:

Renal / hepatic impairment; bronchial asthma; bronchial asthma, urticaria or acute rhinitis triggered by the use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, a tendency to arterial hypotension, hypersensitivity to other non-steroidal anti-inflammatory drugs.

Pregnancy and lactation:

Excludes systematic use of the drug in the first and last trimester of pregnancy and during breastfeeding.If you can not avoid the use of the drug, you must stop breastfeeding for this period of time.

Dosing and Administration:

Intramuscularly 2 - 5 ml of injection solution 2-3 times a day. Before the injection of the injection solution, it should be warmed in the hand.

Duration of treatment - no more than 5 days. The maximum daily dose should not exceed 10 ml of the injection solution (correspondingly 5 g of metamizole sodium).

In the absence of a therapeutic effect, the use of the drug ceases, and with a good or satisfactory effect goes to oral or rectal administration.

The duration of the treatment course is determined depending on the clinical symptomatology and etiopathogenesis of the disease.

Side effects:

From the urinary system: a violation of kidney function, oliguria, anuria, proteinuria, interstitial nephritis, urine staining in red.

Allergic reactions: urticaria (including conjunctiva and mucous membranes of the nasopharynx), angioedema, in rare cases - malignant exudative erythema (Stephen-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), bronchospastic syndrome, anaphylactic shock.

On the part of the organs of hematopoiesis: agranulocytosis, leukopenia, thrombocytopenia. Other: lowering blood pressure (BP).

Anticholinergic effects: dry mouth, decreased sweating, paresis of accommodation, tachycardia, difficulty urinating.

Local reactions: with intramuscular injection, infiltrates are possible at the site of administration.

Overdose:

Symptoms: nausea, vomiting, gastralgia, oliguria, hypothermia, lowering blood pressure, tachycardia, dyspnea, tinnitus, drowsiness, delirium, impaired consciousness, acute agranulocytosis, hemorrhagic syndrome, acute renal and / or hepatic insufficiency, seizures, respiratory muscle paralysis.

Treatment: gastric lavage, intake of activated charcoal, use of water-salt solutions, forced diuresis, hemodialysis, with the development of convulsive syndrome - iv diazepam and high-speed barbiturates.

Interaction:

Because of the high likelihood of developing pharmaceutical incompatibility, you should not mix it with other drugs (LS) in one syringe.

Enhances the effects of ethanol. Radiocontrast drugs, colloidal blood substitutes and penicillin should not be used during treatment.With the simultaneous administration of cyclosporine, the concentration of the latter in the blood decreases. Metamizole, displacing from the connection with protein oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids and indomethacin, increases their activity. Phenylbutazone, barbiturates and other hepatoinductors with simultaneous administration decrease the effectiveness of metamizole.

Simultaneous appointment with other non-narcotic analgesics, tricyclic antidepressants, contraceptive hormonal drugs and allopurinol may lead to increased toxicity. Sedative and anxiolytic drugs (tranquilizers) increase the analgesic effect of the drug. Thiamazole and cytostatics increase the risk of developing leukopenia. The effect is enhanced codeine, H2-histamine receptor blockers and propranolol (slows inactivation). Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

When co-appointed with Hi-gistaminoblockers, butyrophenones, phenothiazines, tricyclic antidepressants, amantadine and quinidine, m-cholinoblocking action may be enhanced.Simultaneous use with chlorpromazine or other phenothiazine derivatives can lead to the development of severe hyperthermia.

Special instructions:

If suspected of agranulocytosis, or if there is thrombocytopenia, the drug should be discontinued. It is not allowed to use acute pains in the abdomen for relief (until the cause is clarified). Special care is required when introducing more than 2 ml of solution (the risk of a sharp decrease in blood pressure).

Effect on the ability to drive transp. cf. and fur:Care should be taken during the treatment of drivers of vehicles and persons engaged in potentially hazardous activities requiring quick physical and mental reactions.

Form release / dosage:

Solution for intramuscular injection

introduction.

2 ml or 5 ml in dark ampoules glass with an identification for opening ampoule (color point).

10 ampoules per tray of PVC film.

One pallet together with instructions for use in a cardboard box.

* In case of production necessity, an additional application of the color ring / colored rings is possible for encoding the ampoule.

Packaging:ampoules of dark glass (10) -pallets
ampoules of dark glass (10) -contoured plastic contours (pallets)
ampoules of dark glass (10) -packaging

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C.

Keep out of the reach of children!

Shelf life:

4 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N012670 / 01

Date of registration:25.12.2007

The owner of the registration certificate:Sopharma, AOSopharma, AO Bulgaria

Manufacturer: & nbsp

SOPHARMA, AD Bulgaria

Representation: & nbspSOFARMA SA SOFARMA SA Bulgaria

Information update date: & nbsp13.04.2015

Illustrated instructions

Instructions

Spazmalgon® (Spasmalgon®)