Trianalgin® solution for intravenous and intramuscular administration 5 ml

Trianalgin® solution for intravenous and intramuscular administration 5 ml

International nonproprietary name

Metamizole sodium + Pitofenone + Fenpiverinum bromide

Pharmacological group

Анальгезирующие ненаркотические средства

Composition

Active ingredients:
Metamizole sodium monohydrate (Analgin)- 500 mg
Pitofenone hydochloride - 2.0 mg
Fenpiverinum bromide - 0.02 mg
Excipients:
sodium disulfite (sodium metabisulphite) -1.0 mg
2 М sodium hydroxide solution -sufficient quantity to adjust рН up to 6.0 - 7.5
water for injection - up to 1 ml

Pharmacological action

Trinalgin is a combined drug which includes: non-narcotic analgesic methamizole sodium, myotropic antispasmodic drug of pitofenone and m-cholinoblocking agent of fenpiverinum bromide.
Metamizole sodium has analgesic, antipyretic and weak anti-inflammatory effect.
Pitophenone, like papaverine, has direct myotropic effect on the smooth muscles of the internal organs and relaxes them.
Fenpiverinum bromide due to m-holinoblokiruyuschego effect has additional antispasmodic effect on smooth muscle.
The combination of the three components of the drug increases mutually their pharmacological effect.

Pharmacokinetics

The drug is quickly absorbed; the drug after intramuscular administration is largely absorbed from the injection site. Binding with plasma proteins - 50-60 %.
The drug at therapeutic doses is excreted in breast milk.
Metamizole sodium is biotransformed intensively in the liver. Only after intravenous administration, a small concentration of unchanged metamizole sodium is detected in the plasma. The main metabolites include 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 identified in the cerebrospinal fluid.
The drug is excreted mainly by the kidneys Pitophenone and fenpiverinum bromide are characterized by incomplete resorption, and they are completely ionized. They are poor soluble. They do not cross the blood-brain barrier. They are metabolised in the liver by oxidative reactions. Pitofenone is mainly excreted by the kidneys. The maximum plasma concentration is reached within 30 - 60 minutes. Half-life is 1.8 hours. Fenpiverinum bromide is excreted by the kidneys in the amount of 32.4-40.4% unchanged, 2.5-5.3% of the substance is excreted in the bile.

Indications for Use

Pain syndrome (mild or moderate) with spasms of internal organ smooth muscle: renal colic, spasm of the ureter and bladder; biliary colic, intestinal colic; biliary tract dyskinesia, postcholecystectomy syndrome, chronic colitis; algodismenorrhea, pelvic organ diseases.
For short-term treatment: arthralgia, myalgia, neuralgia, ischialgia.
As an auxiliary agent: 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 administration - infancy under 1 year old or body weight less than 9 kg, intramuscular administration - infancy under 3 months old or body weight less than 5 kg, increased individual sensitivity to non-steroidal antiinflammatory agents or nonnarcotic analgesic drugs.
With care
The drug shall be administered with care and under supervision of a doctor to patients with liver or renal dysfunction, with a tendency to arterial hypotension, bronchial asthma, intolerance to acetylsalicylic acid, polyps of the nose.
Administration during pregnancy and lactation period
The drug is contradicted during pregnancy. If the drug administration is required during lactation breastfeeding shall be discontinued for the period of treatment.

Cautions

Parenteral administration shall be applied only when oral administration is impossible or in case of impaired absorption from the gastrointestinal tract. Special care is required for administration of more than 2 ml of solution (the risk sharp blood pressure drop).
Intravenous administration shall be slow, in the lying position and with blood pressure, hear rate and respiratory rate monitoring.
When treating children and patients receiving cytostatic agents, metamizole sodium shall be administered only under the doctor’s supervision.
A long needle shall be used for intramuscular administration. Ethanol administration is not recommended during the treatment with the drug. In case of suspected agranulocytosis or thrombocytopenia stop administration of the drug.
The drug shall not be used for relief of stomach ache (until the causes are identified). Intolerability is very rare, but the risk of anaphylactic shock after intravenous administration of the drug is relatively higher than after oral administration.
Patients with atopic bronchial asthma and pollinosis have increased risk of allergic reactions.
Effects on ability to drive and use machines
During the treatment avoid driving and performing other potential hazardous activities requiring increased attention focusing and quick psychomotor reactions.

Dosing and Administration

Before administration the drug shall be warmed up in hand.
The solution is incompatible in one syringe with other drugs.
Adults and children at the age from 15 years old.
Slow intravenous administration of 2 ml of the drug for acute severe colic (1 ml per 1 minute); if required, the administration may be repeated after 6 to 8 hours.
The drug at dose more than 1 g shall be administered intravenously under the conditions ensuring anti-shock therapy. Intramuscular administration of 2 ml of solution 2 times per day.
The daily dose shall not exceed 4 ml.
Duration of treatment is maximum 5 days. In children:
3 - 11 months old (5 - 8 kg) - only intramuscular administration - 0.1 - 0.2 ml.
1 - 2 years old (9 - 15 kg) - intravenous administration - 0.1 - 0.2 ml; intramuscular administration 0.2 - 0.3 ml.
3 - 4 years old (16 - 23 kg) - intravenous administration - 0.2 - 0.3 ml; intramuscular administration - 0.3 - 0,4 ml.
5 - 7 years old (24 - 30 kg) - intravenous administration - 0.3 - 0.4 ml; intramuscular administration - 0,4 - 0,5 ml.
8 - 12 years old (31 - 45 kg) - intravenous administration - 0.5 - 0.6 ml; intramuscular administration - 0.6 - 0,7 ml.
12 - 15 years old - intravenous or intramuscular administration - 0.8 - 1 ml.
If required, repeated administration of the drug at the same doses is allowed.

Side effect

Adverse cardiovascular effects: blood pressure drop.
Adverse hematopoietic organ effects: thrombocytopenia, leukopenia, agranulocytosis (symptoms may include unmotivated body temperature rise, chills, sore throat, difficult swallowing, sttomatitis, as well as development of vaginitis or proctitis symptoms).
Adverse urinary system effects: renal disorders, oliguria, anuria, proteinuria, interstitial nephritis, red coloration of urine.
Anticholinergic effects: dry mouth, decreased sweating, paresis of accommodation, tachycardia, difficult urinating.
Allergic reactions: urticaria fever including on the conjunctiva and nasopharynx mucosa, angioneurotic edema; in rare cases - Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), bronchospastic syndrome, anaphylactic shock.
Local reactions: infiltrates at the administration place are possible after intramuscular administration.
Overdose
Symptoms: nausea, vomiting, blood pressure drop, epigastric pain, oliguria, hypothermia, tachycardia, dyspnea, tympanophony, somnolency, confused consciousness, delusion, acute agranulocytosis, hemorrhagic syndrome, liver and kidney dysfunction, convulsions, stethoparalysis. Treatment expectant therapy.

Interaction with other medicines

Because of the high risk of pharmaceutical incompatibility, Trianalgin shall not be mixed with other drugs in the same syringe.
Roentgenocontrast drugs, colliod blood substitutes and penicillin shall not be administered during treatment with the drugs containing metamizole sodium.
Combined administration with H2 histamine antagonists, butyrophenone and phenothiazine derivatives, tricyclic antidepressants, amantadine and quinidine may increase m-cholinoblocking effect.
The drug increases the effect of ethanol.
Simultaneous administration with chlorpromazine or other phenothiazine derivatives may cause severe hyperthermia.
Tricyclic antidepressants, oral contraceptives and allopurinol increase the toxicity of the drug.
Simultaneous administration with phenylbutazone, barbiturates and other hepatoinductors reduces the efficacy of metamizole sodium.
Sedative and anxiolytic drugs (tranquilizers) increase the analgesic effect of metamizole sodium.
Simultaneous administration with cyclosporine reduces the concentration of the latter in the blood.
Metamizole sodium displaces oral hypoglycaemics, indirect anticoagulating agents, glucocorticosteroids and indometacin from the binding with protein and enhances their effect.
Thiamazol and sarcolysine enhance the risk of leukopenia development.
The effect is enhanced with codeine, H2 histamine antagonists, propranalol (slower inactivation of metamizole sodium).
If simultaneous administration of Trinalgin with these and other drugs is required please consult your doctor.
All the above interactions with other drugs are indicated for metamizole sodium, data for pituopenone and fenpiverinum bromide are not available.

Form release

Storage conditions

In a dry and dark place at temperature maximum 25 °С.

Expiration date

2 years