Triombrast (diatrizoic acid dihydrate) solution for injection 60% 20 ml. vials №5

Description

Triombrast (diatrizoic acid dihydrate) solution for injection 60% 20 ml. vials №5

Composition

active substances:

• 1 ml of 60% solution contains diatrizoic acid dihydrate in terms of 100% anhydrous substance – 471.6 mg, meglumine (N-methylglucamine) in terms of 100% dry matter – 125.7 mg;
• 1 ml of 76% solution contains diatrizoic acid dihydrate in terms of 100% anhydrous substance – 597.3 mg, meglumine (N-methylglucamine) in terms of 100% dry matter – 159 mg.

Excipients: sodium hydroxide, disodium edetate, water for injections.

Dosage form

Solution for injection.

Basic physical and chemical properties: clear colorless or light yellow, slightly viscous liquid.

Pharmacotherapeutic group

Iodine-containing X-ray contrast agents.
ATX code V08A A01.

Pharmacological properties

It is an iodine-containing radiopaque substance. When injected intravascularly, it makes the blood flow opaque to X-ray radiation, which provides radiographic imaging of the circulatory system of the organs.

Indications

Triombrast solution is used:

• for intravenous urography;
• for retrograde urography;
• for angiography;
• for arthrography;
• for intraoperative cholangiography;
• for endoscopic retrograde cholangiopancreatography (ERCP);
• for sialography;
• for fistulography;
• for hysterosalpingography;
• for other studies.

Contraindications

The drug Triombrast solution is not used:

• with increased sensitivity to iodine-containing substances;
• with intolerance to excipients;
• with severe hyperthyroidism;
• with decompensated heart failure;
• with severe renal, hepatic failure;
• with active tuberculosis, emphysema of the lungs;
• with myocardial damage (arrhythmias, ventricular fibrillation);
• with arterial hypertension (severe course);
• with shock, collapse;
• with an acute form of phlebitis;
• with epilepsy;
• with a significant increase in the prothrombin index.

Not applicable for myelography, cisternography, ventriculography due to possible neurotoxic effects.

Application during pregnancy and lactation

Contraindicated.
Although no adverse reactions have been identified, caution should be exercised with intravascular administration to nursing patients. It is recommended to stop feeding for 24 hours.

Method of administration and dosage

Triombrast solution is used intravascularly one or more times during a specific X-ray examination.
Use the smallest dose that provides adequate visualization.
Standard intravascular injection is 20 ml / minute. For patients with heart failure, in whom a dose of 100 ml or more is prescribed, the recommended administration time is at least 20-30 minutes.

Overdose

Overdose can be potentially life-threatening, manifested by cardiovascular and respiratory disorders.
Treatment is symptomatic, hemodialysis is indicated.

Side effects:

• Immune disorders: manifestations of allergies, incl. anaphylactoid reactions, anaphylactic shock.
  Endocrine Disorders: Hyperthyroidism.
• Mental disorders: agitation, confusion, anxiety.
• Neurological disorders: fainting, vertigo, tremor, headache, delirium, paresthesia, taste disturbances, loss of consciousness, speech impairment, paralysis, drowsiness, aphasia, stupor, dysphasia, hypesthesia, dyskinesia, convulsions, amnesia.
• Ophthalmic disorders: blurred vision, allergic conjunctivitis, eye irritation, lacrimation, redness, conjunctival edema, transient blindness.
• Otolaryngological disorders: ringing in the ears.
• Cardiovascular disorders: tachycardia, heart block, ECG changes, bradycardia, arrhythmia, angina pectoris, atrial fibrillation, cardiac arrest, coronary artery spasm, ventricular fibrillation, cyanosis, palpitations, extrasystole, arterial hypotension, circulatory hypertension, hypotension / hypertension, hypotension phlebitis, vasodilation, vasospasm, shock, thrombosis, hemodynamic collapse.
• Respiratory disorders: laryngospasm, edema, airway obstruction, nasal congestion, stridor, shortness of breath, sneezing, cough, sore throat, pulmonary edema, hypoxia, pharyngitis, respiratory arrest, bronchospasm, apnea, asthma, dysphonia.
• Gastrointestinal disorders: dry mouth, nausea, sialadenitis, tongue edema, abdominal pain, dysphagia, diarrhea, hypersalivation.
• Dermatological disorders: urticaria, rash, erythema, pruritus, Quincke’s edema, pallor, hyperhidrosis, toxic epidermal necrolysis.
• Musculoskeletal disorders: muscle cramps.
• Urinary disorders: involuntary urination, renal failure, decreased creatinine clearance, incontinence, hematuria, increased urea levels, dysuria, anuria, oliguria.
• General: fever, facial edema, pharyngeal edema, chills, tremors, changes at the injection site (pain, hemorrhage, erythema, necrosis), asthenic conditions, feeling unwell, chest pain, hyperthermia.