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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 for injection, particularly in digital subtraction angiography.
Verbatim from this product's MHRA label. Tap a section to expand.
5ml/kg or ** Arthrography Adults: 1 - 10ml according to the joint being examined * repeat as necessary; ** according to body size and age; Do not exceed 250 ml. Single injection volume depends on the vascular area to be examined. 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. Method of administration As with all contrast media, the lowest dose necessary to obtain adequate visualisation should be used.
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. Therefore, meticulous angiographic techniques are recommended including close attention to guide wire and catheter manipulation, use of manifold systems and/or three-way stopcocks, frequent catheter flushing with heparinized saline solutions, and minimizing the length of the procedure.
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.
Peripheral arteriography and phlebography (enography) Percutaneous injection into the appropriate blood vessel is used for visualisation of peripheral arteries and veins. Angiocardiography, left ventriculography, selective coronary arteriography Niopam may be administered by rapid injection through a catheter into a suitable peripheral artery or vein.
It can also be introduced under pressure through a cardiac catheter into any of the heart chambers, or injected into large vessels for immediate visualisation. The contrast medium may also be administered during selective catheterisation of the coronary arteries.
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. 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.
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 of consciousness or loss of consciousness, Convulsion, Hemiplegia 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 or 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, Apnoe 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 Face oedema, muco-cutaneous syndromes*, Acute generalised exanthematous pustulosis (AGEP) Musculoskeletal and connective tissue disorders Back pain Muscle spasms Musculoskeletal pain, Muscular weakness Renal and urinary disorders Acute renal failure General disorders and administration site conditions Feeling hot Chest pain, Injection site pain***, Pyrexia, Feeling cold Rigors, Pain, Malaise Investigations Blood creatinine increased Electrocardiogram change including ST segment depression * Cardiac reactions may occur as consequences of the coronary catheterization procedural hazard: these complications include coronary artery thrombosis and coronary artery embolism.
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. Local tissue irritation can occur as an event of perivascular infiltration of the contrast media. 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 phenolbarbital. Iopamidol injection should be used with caution in patients with hypercalcaemia and cerebral vascular disease.
The risk associated with a particular investigation may be increased by conditions such as advanced arteriosclerosis and hypertension. 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.
Hypersensitivity to the active ingredient iopamidol or to any of the excipients.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Aortography The contrast medium may be introduced directly by intra-arterial injection (retro- grade method) for visualisation of the aorta and its main branches. Arthrography Visualisation of joint cavities and articular surfaces can be achieved by either single or double contrast examination.
Selective visceral angiography Visualisation can be achieved by selective catheterisation and injection into the hepatic, coeliac or mesenteric arteries. Digital subtraction angiography For cardiac imaging the contrast medium may be administered intra-arterially by selective catheterisation to provide subtracted images.
Niopam 340 and 370 injected intravenously either centrally or peripherally is also recommended for use in this modality. 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.
v. injection. v. administration as a bolus, as a drip infusion or by a combination of the two methods.
** As with other iodinated contrast media, very rare cases of muco-cutaneous syndromes, including Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome) and erythema multiforme, have been reported following the administration of Iopamidol *** Injection site pain and swelling may occur.
In the majority of cases it is due to extravasation of contrast medium. These reactions are usually transient and result in recovery without sequelae. However, inflammation and even skin necrosis have been seen on very rare occasions.
In isolated reports extravasation led to the development of compartment syndrome Intravascular administration – Pediatric Population Frequency type and severity of adverse reactions in children are similar to those in adults. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
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. The risk of bronchospasm-inducing reactions in asthmatic patients is higher after contrast media administration, especially in patients taking beta-blockers.
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.
Patients with severe hepatic, renal or combined hepato-renal insufficiency should not be examined unless absolutely indicated. Re- examination should be delayed for 5-7 days. Care should be taken in renal impairment and diabetes. In these patients it is important to maintain hydration in order to minimise deterioration in renal function.
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). Patients must be sufficiently hydrated before and after radiographic procedures.
Patients with severe functional impairment of the liver or myocardium, myelomatosis, diabetes, polyuria or oliguria, hyperuricemia, infants, elderly patients and patients with severe systemic disease should not be exposed to dehydration.
Fluid intake should not be limited and any abnormalities of fluid or electrolyte balance should be corrected prior to use of this hypertonic solution. Patients with paraproteinaemia of Waldenström, with multiple myeloma or severely compromised hepatic and renal impairment are also more at risk: in these cases adequate hydration is recommended after contrast medium administration.
Contrast media may promote sickling in individuals who are homozygous for sickle cell disease when injected intravenously and intra-arterially. To prevent crises in patients with sickle cell disease adequate hydration should be assured and a minimal volume of low concentration should be used.
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.. In patients undergoing angiocardiographic procedures special attention should be paid to the status of the right heart and pulmonary circulation.
Right heart insufficiency and pulmonary hypertension may precipitate bradycardia and systemic hypotension, when the organic iodine solution is […]