Loading…
NIOPAM is a brand name for Iopamidol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: This medicinal product is for diagnostic use only. X-ray contrast medium f or use in lumbar and thoraco-cervical myelography, cerebral angiography, peripheral angiography, venography, computer tomography enhancement, urography and arthrography.
Verbatim from this product's MHRA label. Tap a section to expand.
Route of administration:
Intra-ventricular Intra-arterial Intra-venous Intra-articular Intra-thecal Intra-cisternal Posology NIOPAM 300: DOSAGE SCHEDULE Procedure Dosage Lumbar Myelography Adults 5 - 10 ml Thoraco-Cervical Myelography Adults 5 - 10 ml Cerebral Angiography Adults 5 - 10 ml * Children ** Peripheral Arteriography Venography Adults 20 - 50 ml * Children ** Adults 20 - 50 ml * Children ** Do not exceed 250 ml Computer Tomography Enhancement Adults: Brain scanning 50 - 100ml Whole body scanning 40-100ml Intravenous Urography Adults 40 - 80 ml In severe renal failure the usual high dose methods should be employed.
5 ml/kg or ** Arthrography Adults 1 - 10 ml according to the joint being examined. * repeat as necessary; ** according to body size and age; The dosage must be adapted to the examination, the age, body weight, cardiac output, renal function, general condition of the patient and the technique used.
Usually the same iodine concentration and volume are used with other iodinated x-ray contrast in current use. As with all contrast media, the lowest dose necessary to obtain adequate visualisation should be used. Method of administration Non-ionic contrast media have less anti-coagulant activity in-vitro than ionic media.
Meticulous attention should therefore be paid to angiographic technique. Non-ionic media should not be allowed to remain in contact with blood in the syringe and intravascular catheters should be flushed frequently, to minimise the risk of clotting, which rarely has led to serious thromboembolic complications after procedures.
Factors such as length of procedure, catheter and syringe material, underlying disease state, and concomitant medications may contribute to the development of thromboembolic events. As experience shows that warmed contrast media are better tolerated, the contrast medium should be warmed up to body temperature before administration.
No other drugs or contrast media should be mixed with the iopamidol solution for injection. Lumbar myelography A slow sub-arachnoid injection is made through a fine lumbar puncture needle into one of the lower lumbar interspinous spaces (L3-L4 or L4-L5).
Optimum contrast appears immediately after injections and films should be obtained promptly. Thoraco-cervical myelography Following a slow sub-arachnoid injection the patient should be turned on his side and tilted 10°-20° head down under fluoroscopic control.
The use of iodinated contrast media may cause untoward side effects. They are usually mild to moderate and transient in nature. However, severe and life threatening reactions sometimes leading to death have been reported. Anaphylaxis (anaphylactoid reactions/hypersensitivity) may manifest with: mild localized or more diffuse angioneurotic oedema, tongue oedema, laryngospasm or laryngeal oedema, dysphagia, pharyngitis and throat tightness, pharyngolaryngeal pain, cough, conjunctivitis, rhinitis, sneezing, feeling hot, sweating increased, asthenia, dizziness, pallor, dyspnoea, wheezing, bronchospasm, and moderate hypotension.
Skin reactions may occur in the form of various types of rash, diffuse erythema, diffuse blisters, urticaria, and pruritus. These reactions, which occur irrespective of the dose administered and the route of administration, may represent the first signs of incipient state of shock.
Administration of the contrast medium must be discontinued immediately and – if necessary – specific treatment initiated via a venous access. Following intravascular administration, in most cases reactions occur within minutes of dosage.
However, delayed reactions, usually involving skin, may occur, mostly within 2-3 days, more rarely within 7 days, after the administration of the contrast medium. After intrathecal administration, most side effects occur with a delay of some hours due to the slow absorption from the site of administration and distribution to the whole body.
Reactions usually occur within 24 hours after injection. More severe reactions involving the cardiovascular system such as vasodilatation with pronounced hypotension, tachycardia, dyspnoea, agitation, cyanosis and loss of consciousness progressing to respiratory and/or cardiac arrest may result in death.
These events can occur rapidly and require full and aggressive cardio-pulmonary resuscitation. Primary circulatory collapse can occur as the only and/or initial presentation without respiratory symptoms or without other signs or symptoms outlined above.
Diagnostic procedures which involve the use of any radiopaque medium should be carried out under the direction of personnel with the prerequisite training and with a thorough knowledge of the particular procedure to be performed. Appropriate facilities should be available for coping with any complication of the procedure, as well as for emergency treatment of severe reaction to the contrast medium itself.
During the examination an intravenous route for emergency treatment in the event of a reaction is required. After the administration of the contrast medium, competent personnel, drugs and equipment for emergency resuscitation must be available for at least 30 minutes.
Caution during injection of contrast media is necessary to avoid extravasation. In patients who are known epileptics or have a history of epilepsy, anticonvulsant therapy should be maintained before and following myelographic procedures.
In some instances, anticonvulsant therapy may be increased for 48 hours before the examination. If during the procedure a convulsive crisis occurs, it is recommended to administer intravenously diazepam or phenobarbital. Iopamidol injection should be used with caution in patients with hypercalcaemia and cerebral vascular disease.
The administration of iodinated contrast media may aggravate the symptoms of myasthenia gravis. General anaesthesia may be indicated in selected patients. However, a higher incidence of adverse reactions has been reported in these patients, probably due to the hypotensive effect of the anaesthetic.
As with all other contrast media this product may provoke anaphylaxis or other manifestations of allergy with nausea, vomiting, dyspnoea, erythema, urticaria and hypotension. Occasional severe reactions with fatal outcome have been reported.
A positive history of allergy, asthma or untoward reaction during previous similar investigations indicates a need for extra caution; the benefit should clearly outweigh the risk in such patients. Pre-treatment with antihistamines or corticosteroids to prevent or minimise possible allergic reactions in such patients may be considered.
1). Intrathecal administration Because of overdosage considerations, immediate repeat myelography in the event of technical failure is contraindicated.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Iopamidol in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
In this manner it is possible to control movement of the contrast medium column into the dorsal region. If the cervical region is to be examined, the contrast medium should be run into the cervical region first, before the examination of the dorsal areas where it is progressively diluted.
Niopam may also be injected sub-occipitally or by lateral cervical puncture technique. Care should be taken to ensure that the contrast medium does not move intracranially. After completion of direct cervical or lumbo-cervical procedures: - Raise head of table steeply (45° angle) for about two minutes so that the contrast medium flows towards the caudal end.
- Avoid excessive and particularly active patient movement or straining, maintain the patient under close observation, quiet and in a head up position especially in the first few hours. - Patients suspected of having a low seizure threshold should be observed during this period.
- The patient should remain supine and at bed rest during this period. - Encourage the patient, if able, to take in fluids orally and eat. Cerebral angiography Any of the current techniques is suitable for radiological visualisation of the cerebral vasculature with Niopam 300.
Carotid and vertebral angiography, performed by catheterisation or percutaneous injection techniques, require rapid injection, which, if necessary may be repeated. Peripheral arteriography and phlebography (venography) Percutaneous injection into the appropriate blood vessel is used for visualisation of peripheral arteries and veins.
v. injection. v. administration as a bolus, as a drip infusion or by a combination of the two methods. Urography The contrast medium is injected intravenously and rapidly eliminated through the kidneys. In patients with severe renal failure, high dose urography should be used.
Arthrography Visualisation of joint cavities and articular surfaces can be achieved by either single or double contrast examination.
4). Intravascular administration –Adults The adverse reactions are classified by System Organ Class and frequency, using the following convention: Very common (≥1/10), Common (≥1/100 to < 1 /10), Uncommon (≥1/1,000 to < 1/100), Rare (≥1/10,000 to < 1/1,000), Very rare (< 1/10,000), not known (cannot be estimated from the available data) Adverse Reactions Clinical Trials Post-marketing Surveillance System Organ Class Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Frequency unknown Blood and lymphatic system disorders Thrombocytopenia Immune system disorders Anaphylaxis, Anaphylactoid reaction Psychiatric disorders Confusional state Nervous system disorders Headache Dizziness, Taste alteration Paraesthesia Coma, Transient ischaemic attack, Syncope, Depressed level consciousness or loss of consciousness, Convulsion, Hemiplegia, Contrast induced encephalopathy** Eye disorders Transient blindness Visual disturbance Conjunctivitis, Photophobia Cardiac disorders Cardiac dysrhythmias such as extrasystoles, atrial fibrillation, ventricular tachycardia and ventricular fibrillation* Bradycardia Myocardial ischaemia infarction, Cardiac failure, Cardio-respiratory arrest, Tachycardia, Kounis syndrome Vascular disorders Hypotension, Hypertension, Flushing Circulatory collapse or shock Respiratory, thoracic and mediastinal disorders Pulmonary oedema, Asthma, Bronchospasm Respiratory arrest Respiratory failure Acute respiratory distress syndrome, Respiratory distress Apnoea, Laryngeal oedema Dyspnoea Gastrointestinal disorders Nausea Vomiting, Diarrhea, Abdominal pain, Dry mouth Salivary hypersecretion, Salivary gland enlargement Skin and subcutaneous tissue disorders Rash, Urticaria, Pruritus, Erythema, Sweating increased Stevens-Johnson syndrome, Toxic epidermal necrolysis, Erythema multiforme Skin necrosis*** ,Face oedema, muco- cutaneous syndrome **, Acute generalised exanthematous Musculoskeletal and connective tissue disorders Back pain Muscle spasms Compartment syndrome*** Musculoskeletal pain, Muscular weaknessRenal and urinary disorders Acute renal failure General disorders and administration site conditions Feeling hot Chest pain, Injection site pain***, Pyrexia, Feeling cold Injection site swelling Rigors, Pain, Malaise, Injection site inflammation Investigations Blood creatinine increased Electrocardiogram change including ST Segment depression * Cardiac reactions may occur consequences of the coronary catheterization procedural hazard: these complications include coronary artery thrombosis and coronary artery embolism.
4 On very rare occasions extravasation of contrast medium led to inflammation (manifested with local erythema, oedema and blisters), skin necrosis and compartment syndrome Intravascular administration – Pediatric Population Frequency type and severity of adverse reactions in children are similar to those in adults.
Cases of transient neonatal hypothyroidism have been reported with Iopamidol in very low birth weight infants. Intrathecal administration – Adults Adverse Reactions Clinical Trials Post-marketing Surveillance System Organ Class Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Frequency unknown Infections and infestations Meningitis aseptic, Meningitis bacterial as consequence of the procedural hazard Immune system disorders Anaphylaxis, Anaphylactoid reaction* Psychiatric disorders Confusional state, Disorientation, Agitation, Restlessness Nervous system disorders Headache Coma, Paralysis, Convulsion, Syncope, Depressed level of consciousness or loss […]
The risk of bronchospasm-inducing reactions in asthmatic patients is higher after contrast media administration. In patients with suspected or known hypersensitivity to contrast media, sensitivity testing is not recommended, as severe or fatal reactions to contrast media are not predictable from sensitivity tests.
The patient should also be informed that allergic reactions may develop up to several days after the procedure; in such case, a physician should be consulted immediately. Particular care should be exercised in patients with moderate to severe impairment of renal function (as reflected by a raised blood urea).
Substantial deterioration in renal function is minimized if the patient is well hydrated. Renal function parameters, especially urinary output should be monitored after the examination in these patients. Pre-existing renal impairment may predispose to acute renal dysfunction following contrast media administration.
In patients with impairment of renal function, the administration of potentially nephrotoxic drugs should be avoided until the contrast medium is completely excreted. In such patients, renal function parameters should be monitored after the procedure.
Further administration of contrast media should be postponed until renal function has returned to its previous level. Patients on dialysis may receive contrast media such as iopamidol, which can be removed without difficulty by dialysis.
. The presence of renal damage in diabetic patients is one of the factors predisposing to renal impairment following contrast media administration. 5 - Interaction with medicaments and other forms of interaction). Hydration Patients must be well hydrated, and any relevant abnormalities of fluid or electrolyte balance should be corrected prior to and following contrast media injection.
Especially patients with severe functional impairment of the kidneys, the liver or myocardium, myelomatosis, or other paraproteinaemias, sickle cell disease, diabetes mellitus, polyuria, oligouria, hyperuricaemia, infants, elderly patients, and patients with severe systemic disease should not be exposed to dehydration.
Caution should be exercised in hydrating patients with underlying conditions that may be worsened by fluid overload, including congestive heart failure. Patients with congestive heart failure should be observed for several hours following the procedure to detect delayed haemodynamic disturbances, which may be associated with a transitory increase in the circulating osmotic load.
Special care should be exercisedwhen X- ray contrast medium is injected in the pulmonary artery in patients with pulmonary hypertension. Right heart insufficiency and pulmonary hypertension may precipitate bradycardia and systemic hypotension, when the organic iodine solution is injected.
Right heart insufficiency and pulmonary hypertension may precipitate bradycardia and systemic hypotension, when the organic iodine solution is injected. Right heart angiography should be carried out only when absolutely indicated. During intracardiac and/or coronary arteriography, ventricular arrhythmias may infrequently occur.
Caution should be exercised in performing iodinated contrast-enhanced examinations in patients with, or with suspicion of, hyperthyroidism or autonomously functioning thyroid nodule(s), as thyroid storms have been reported following administration of iodinated contrast media.
Niopam should be used with caution in patients with hyperthyroidism. It is possible that hyperthyroidism may recur in patients previously treated for Graves' disease. In patients scheduled for thyroid examination […]