Trinalgin - instructions for use, doses, side effects, contraindications

Trinalgin - a combined drug, which includes: non-narcotic analgesic metamizol sodium, myotropic antispasmodic pitophenone and m-cholin-blocking agent fenpiverinia bromide.

Metamizol sodium has analgesic, antipyretic and weak anti-inflammatory effect. Pitophenone, like papaverine, has a direct myotropic effect on the smooth muscles of the internal organs and causes it to relax. Fentipierinium bromide due to m-holinoblokiruyuschego action has an additional antispasmodic effect on smooth muscle.

The combination of the three components of the drug leads to a mutual enhancement of their pharmacological action.

Pharmacokinetics:

Absorbed quickly; after intramuscular injection is largely absorbed from the injection site.

Connection with blood plasma proteins - 50-60%. In therapeutic doses is excreted in breast milk.

Metamizole sodium is subjected to intensive biotransformation in the liver. Only after intravenous administration, a small concentration of unchanged metamizole sodium is detected in the plasma. The main metabolites are 4-methylaminoantipyrine, 4-formylaminoantipyrine, 4-amino-antipyrine and 4-acetylaminoantipyrine. Approximately 20 additional metabolites, including glucuronic acid derivatives, have been identified.The main four metabolites are found in the cerebrospinal fluid. It is excreted mainly by the kidneys.

Pitophenone and fenpiverinia bromide are characterized by incomplete resorption, and they are completely ionized. They have poorly solubility. Do not pass through the blood-brain barrier.

Metabolised in the liver by oxidative reactions.

Pitophenone is excreted by the kidneys. The maximum concentration in the plasma is reached within 30-60 minutes. The elimination half-life is 1.8 hours.

Fenpiverinia bromide is excreted by the kidneys 32,4-40,4 % in an unchanged form, 2.5-5.3% of the substance is excreted with bile.

Indications:

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

For short-term treatment: arthralgia, myalgia, neuralgia, ischialgia.

As an auxiliary: pain syndrome after surgical interventions and diagnostic procedures.

Contraindications:

Hypersensitivity to the drug components (including pyrazolone derivatives), inhibition of bone marrow hematopoiesis, granulocytopenia, severe liver or kidney dysfunction, glucose-6-phosphate dehydrogenase deficiency, tachyarrhythmia, severe angina pectoris, decompensated chronic heart failure, acute "intermittent" porphyria, closed-angle glaucoma, prostatic hyperplasia, intestinal obstruction, megacolon, collapse, pregnancy, breast-feeding period, for intravenous injection eniya - infancy to 1 year or less body weight of 9 kg, intramuscular administration - infancy to 3 months, or less body weight 5 kg, increased individual sensitivity to non-steroidal antiinflammatory agent or non-narcotic analgesics.

Carefully:

With caution and under the supervision of a doctor, the drug should be administered to patients with impaired liver or kidney function, with a tendency to arterial hypotension, bronchial asthma, intolerance to acetylsalicylic acid, polyps of the nose.

Pregnancy and lactation:

The drug during pregnancy is contraindicated.If you need to use the drug during lactation for the period of treatment, breastfeeding should be discontinued.

Dosing and Administration:

Before the introduction of the drug, it should be warmed in the hand. The solution is incompatible in one syringe with other drugs.

Adults and teenagers over 15 years of age.

Intravenously slow In acute severe colic 2 ml of the drug (1 ml per 1 minute) is administered; if necessary, re-introduced after 6-8 hours.

The drug in a dose of more than 1 g should be administered intravenously in conditions that provide anti-shock therapy.

Intramuscularly 2 ml of solution are administered 2 times a day.

Side effects:not described

Overdose:not described

Interaction:

With simultaneous application cyclosporine the concentration of the latter in the blood decreases.

Metamizole sodium, displacing from the bond with the protein oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids and indomethacin, can increase the severity of their action.

Thiamazole and cytostatics increase the risk of developing leukopenia.

Enhance the effect codeine, blockers H2-gistaminovyh receptors and propranolol (slows the inactivation of metamizole and sodium).

If it is necessary to simultaneously use Trinalgin with these and other medicinal products, you should consult your doctor.

All of the above interactions with other drugs are indicated for metamizole sodium, for pituopenone and fenpiverinia bromide there is no data.

Special instructions:

Parenteral administration should be used only in those cases when ingestion is impossible or impaired absorption from the gastrointestinal tract.

Special care is required when introducing more than 2 ml of solution (the risk of a sharp drop in blood pressure).

Intravenous injection should be done slowly, in the "lying" position and under the control of blood pressure, the number of heartbeats and the frequency of breathing.

When treating children under 5 years and patients receiving cytotoxic drugs, metamizole sodium intake should be done only under the supervision of a doctor. For intramuscular injection, a long needle should be used.

During treatment with the drug is not recommended to take ethanol. If suspected of agranulocytosis or in the presence of thrombocytopenia should stop taking the drug. It is not allowed to use acute pains in the abdomen for relief (until the cause is clarified). Intolerance is very rare, but the threat of developing an anaphylactic shock after intravenous administration of the drug is relatively higher than after taking the drug in tablet form inside. Patients with atopic bronchial asthma and pollinosis have an increased risk of developing allergic reactions.

Effect on the ability to drive transp. cf. and fur:

During the period of treatment, one should refrain from driving vehicles and practicing other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Solution for intravenous and intramuscular injection.

By 2 ml or 5 ml in ampoules from the light-protective glass.

10 ampoules of 2 ml each are placed in a cardboard box.

5 ampoules of 2 ml or 5 ml each are placed in a contoured cell pack of a polyvinyl chloride film. 1, 2 contour mesh packages are placed in a pack of cardboard.

In each pack, the box is enclosed with instruction for use, ampoule knife or scarifier (when packing ampoules with a break ring, a point or an incision, the ampoule knife or scarifier does not insert).

Packaging:The ampoule from the light-protective glass (10) / 10 ampoules is placed in carton boxes with corrugated paper partitions. The instructions for use are enclosed in the box, the ampoule knife or ampoule scapper (when packing ampoules with a ring of fracture, a point and an incision the ampoule knife or scarifier do not insert) ./- a box of cardboard
The ampoule from the light-protective glass (10) / 5 ampoules is placed in the contour cell box. 2 contour mesh packages are placed in a pack of cardboard. In the package insert instructions for use, a knife ampoule or scarifier ampoule (when you pack the ampoules with a break ring, a point and an incision, an ampoule knife or a scarifier do not put it) ./- A pack of cardboard
The ampoule from the light-protective glass (5) / 5 ampoules is placed in the contour cell pack. 1 contour mesh package is placed in a pack of cardboard. In the package insert instructions for use, a knife ampoule or scarifier ampoule (when you pack the ampoules with a break ring, a point and an incision, an ampoule knife or a scarifier do not put it) ./- A pack of cardboard

Storage conditions:

In dry, dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-001826

Date of registration:10.09.2012

The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia

Manufacturer: & nbsp

BIOSINTEZ, PAO Russia

Information update date: & nbsp10.09.2012

Illustrated instructions

Instructions

Trinalgin (Trianalgin)