Iopamidol-Unique (Solution) Instructions for Use
Marketing Authorization Holder
Unique Pharmaceutical Laboratories (India)
ATC Code
V08AB04 (Iopamidol)
Active Substance
Iopamidol (Rec.INN registered by WHO)
Dosage Forms
 |
Iopamidol-Unique | Solution for injection 300 mg iodine/ml: 50 ml or 100 ml fl. |
| Solution for injection 370 mg iodine/ml: 50 ml or 100 ml fl. |
Dosage Form, Packaging, and Composition
Solution for injection from colorless to pale yellow, transparent.
| 1 ml | |
| Iopamidol | 612.4 mg, |
| Equivalent to iodine content | 300 mg |
Excipients : trometamol – 1 mg, sodium calcium edetate dihydrate – 0.33 mg, hydrochloric acid (3.5% solution) – to pH 6.8-7.2, water for injections – to 1 ml.
50 ml – bottles (1) – cardboard packs.
100 ml – bottles (1) – cardboard packs.
Solution for injection from colorless to pale yellow, transparent.
| 1 ml | |
| Iopamidol | 755.3 mg, |
| Equivalent to iodine content | 370 mg |
Excipients : trometamol – 1 mg, sodium calcium edetate dihydrate – 0.41 mg, hydrochloric acid (3.5% solution) – to pH 6.8-7.2, water for injections – to 1 ml.
50 ml – bottles (1) – cardboard packs.
100 ml – bottles (1) – cardboard packs.
Clinical-Pharmacological Group
Radiocontrast non-ionic diagnostic agent for intravascular administration
Pharmacotherapeutic Group
Radiocontrast agent
Pharmacological Action
Radiocontrast non-ionic water-soluble agent.
The solution has low osmotic pressure, which contributes to good local and systemic tolerance.
It is used as a contrast agent for intrathecal, intra-arterial and intravenous administration.
Indications
Neuroradiology: myeloradiculography, cisternography, ventriculography.
Angiography: cerebral angiography, coronary angiography, thoracic aortography, abdominal aortography, angiocardiography, selective visceral arteriography, peripheral arteriography, venography, digital subtraction angiography.
Urography: intravenous urography, computed tomography.
Arthrography: fistulography.
ICD codes
| ICD-10 code | Indication |
| Z03 | Medical observation and evaluation for suspected disease or pathological condition |
| ICD-11 code | Indication |
| QA02 | Medical observation or examination for suspected diseases or conditions that were ruled out |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Neuroradiology: 5-15 ml (200-300 mg iodine/ml).
Angiography: for cerebral angiography – 5-10 ml bolus (300 mg iodine/ml); for coronary angiography, thoracic aortography, abdominal aortography, angiocardiography – 1.0-1.2 ml/kg (370 mg iodine/ml); for selective visceral arteriography – 300-370 mg iodine/ml; for peripheral arteriography, administration of 40-50 ml of solution (300-370 mg iodine/ml) is recommended; for venography, administration of 30-50 ml (300 mg iodine/ml) is recommended; for digital angiography 1-15 ml (200 mg iodine/ml) or 40 ml bolus (300-370 mg iodine/ml).
Urography: recommended doses – 30-50 ml.
For computed tomography – 0.5-2 ml/kg (300-370 mg iodine/ml) IV bolus, drip, or a combination of these 2 methods.
Arthrography: recommended doses – 300 mg iodine/ml.
Adverse Reactions
From the digestive system: nausea, vomiting.
From the CNS: headache, dizziness, agitation, loss of consciousness, convulsions.
If an epileptic seizure develops during the examination – IV diazepam or phenobarbital sodium.
From the cardiovascular system: decreased BP, tachycardia, cyanosis.
Allergic reactions: acute rhinitis or laryngeal edema, rash.
General reactions from the body: skin hyperemia, heat, fever, sweating, asthenia, pallor, shortness of breath.
Contraindications
Waldenstrom’s macroglobulinemia, multiple myeloma, hepatic and/or renal failure, severe thyrotoxicosis, hypersensitivity to the active substance.
Use in Pregnancy and Lactation
During pregnancy, the use of an iodine-containing contrast agent is possible only in case of extreme necessity.
Use in Hepatic Impairment
Contraindicated in hepatic failure.
Use in Renal Impairment
Contraindicated in renal failure.
Pediatric Use
When examining young children, their fluid intake should not be restricted before the administration of a hypertonic contrast solution, and any water and electrolyte imbalance should be controlled.
Special Precautions
Avoid using equipment in which the drug may come into direct contact with a metal surface containing Cu2+.
When examining young children, their fluid intake should not be restricted before the administration of a hypertonic contrast solution, and any water and electrolyte imbalance should be controlled.
In patients with thyrotoxicosis, the use of an iodine-containing contrast agent is possible only in case of extreme necessity.
It should be borne in mind that iodine uptake in the thyroid gland will decrease for several days (and sometimes up to 2 weeks) after the use of an iodine-containing contrast agent.
When performing spinal block, as much of the administered contrast solution as possible should be removed.
Drug Interactions
Antipsychotics, analgesics, antihistamines, antiemetics and sedatives, although they increase the seizure threshold, should be discontinued, if possible, at least 48 hours before the administration of this contrast agent and not resumed earlier than 12 hours after the end of the procedure.
Pharmaceutically incompatible with other medicinal products.
Storage Conditions
Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Rx Only
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
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