Trianalgin ampoules 5ml 5 vials, 5ml 10 vials,

Composition 

Active substances: 

Metamizol sodium monohydrate (Analgin) 500 mg;

Pitofenone hydrochloride – 2.0 mg;

Fenpiverinia bromide – 0.02 mg.

Excipients:

sodium disulfite (sodium metabisulfite) – 1.0 mg;

2 M solution of sodium hydroxide sufficient quantity to bring the pH to 6,0 – 7,5;

water for injection to 1 ml.

Pharmacological action

Trinalin is a combined preparation, which comprises: non-narcotic analgesic metamizol sodium, myotropic antispasmodic pitofenon and m-anticholinergic remedy fenpiverinia bromide.

Metamizole sodium possesses analgesic, antipyretic and weak anti-inflammatory action. Pitofenon, similar to papaverine, has a direct myotropic effect on smooth muscles of internal organs and causes its relaxation. Fenpiverinia bromide through m-holinoblokirutego action has an additional spasmolytic effect in relation to smooth muscle.

The combination of the three components of a preparation leads to mutual strengthening of their pharmacological action.

Pharmacokinetics

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

Relationship with blood plasma proteins is 50 – 60 %. At therapeutic doses is excreted in breast milk.

Metamizole sodium under intense biotransformation in the liver. Only after intravenous administration minor concentration of unchanged sodium metamizol detected in plasma. The main metabolites are 4-methylaminopterin, 4-formalininactivated, 4-amino-antipyrine and 4-acetylaminofluorene. Identified about 20 additional compounds including derivatives of glucuronic acid. Four main metabolite detected in cerebrospinal fluid.

Write mainly kidneys.

Pitofenon and fenpiverinia bromide characterized by incomplete resorption, however, they are completely ionizerthe. Have a weak laboratoriesthe. Do not pass through the blood-brain barrier.

Metabolised in the liver by oxidative reactions.

Pitofenon excreted by the kidneys. Maximum plasma concentration is reached within 30 – 60 min elimination half-life is 1.8 hours.

Fenpiverinia bromide excreted by the kidneys of 32.4 – 40.4% of the unchanged, in the bile excreted 2,5 – 5,3% of the substance.

Indications for use

Pain syndrome (weak to moderate) spasms of smooth muscles of internal organs renal colic, spasm of the ureter and bladder biliary colic, intestinal colic; biliary dyskinesia, postcholecystectomical syndrome, chronic colitis; algomenorrhea, diseases of the pelvic organs.

For short-term therapy: arthralgia, myalgia, neuralgia, sciatica.

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

Contraindications

Hypersensitivity to the preparation components (including to pyrazolone derivative), oppression kostnomozgovy blood, granulocytopenia, severe liver or kidney disease, the deficit glukozo-6-fosfatdegidrogenaza, tachyarrhythmia, severe angina, decompensated congestive heart failure, acute “intermittent” porphyria, angle-closure glaucoma, prostatic hyperplasia, intestinal obstruction, megacolon, collapse, pregnancy, breastfeeding, and intravenous infant under 1 year of age or weighing less than 9 kg, intramuscular injection – infant under 3 months or body weight less than 5 kg, increased individual sensitivity to non-steroidal anti-inflammatory drugs or narcotic analgesics.