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IOMERON is a brand name for Iomeprol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: X-ray contrast medium used for: venography cerebral arteriography digital subtraction angiography computed tomography enhancement urography cavernosography myelography
Verbatim from this product's MHRA label. Tap a section to expand.
5ml/kg or * cavernosography adults 40 - 250ml myelography adults 12 - 18ml by lumbar injection * Repeat as necessary * * According to body size and age In elderly patients the lowest effective dose should be used. Unless otherwise instructed by the doctor, a normal diet may be maintained on the day of the examination.
In myelography, lower doses may be used for lumbar or thoracic studies and higher doses for cervical or total columnar studies. Regardless of the nature of the myelographic study, Iomeron should be injected slowly over 1-2 minutes. The X ray can be taken up to 60 minutes following injection.
Post myelographic CT of the spinal column should be delayed for approximately four hours to allow dilution and clearance of excessive contrast.
General 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. In most cases, reactions occur within minutes of dosing but at times reactions may occur at later time.
Anaphylaxis (anaphylactoid/hypersensitivity reactions) may manifest with various symptoms, and rarely does any one patient develop all the symptoms. Typically, in 1 to 15 min (but rarely after as long as 2 h), the patient complains of feeling abnormal, agitation, flushing, feeling hot, sweating increased, dizziness, increased lacrimation, rhinitis, palpitations, paresthesia, pruritus, sore throat and throat tightness, dysphagia, cough, sneezing, urticaria, erythema, mild localised oedema, angioneurotic oedema and dyspnoea due to glottic/laryngeal/pharyngeal oedema and/or spasm manifesting with wheezing, and bronchospasm.
Nausea, vomiting, abdominal pain, and diarrhoea are also reported. These reactions, which can occur independently of the dose administered or the route of administration, may represent the first signs of circulatory collapse. Administration of the contrast medium must be discontinued immediately and, if needed, appropriate specific treatment urgently initiated via venous access.
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.
The adverse reactions reported in clinical trials among 4,903 adult patients and from post- marketing surveillance are represented in the tables below by frequency and classified by MedDRA system organ class. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
4 Special warnings and special precautions for use In consideration of possible complications, the patient should be kept under observation for at least 30 minutes after the examination. Extreme caution during injection of contrast media is necessary to avoid extravasation.
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 diabetes mellitus, polyuria, oligouria, hyperuricaemia, infants, small children, and elderly patients, should not be exposed to dehydration.
Also patients with severely compromised hepatic and renal impairment are more at risk. Caution should be exercised in hydrating patients with underlying conditions that may be worsened by fluid overload, including congestive heart failure.
Rehydration prior to use of iomeprol is recommended in patients with sickle cell disease. Special population Hypersensitivity to iodinated contrast media, allergic predisposition A positive history of allergy, asthma or untoward reaction during previous similar investigations indicates a need for extra caution since, as with other contrast media, this product may provoke anaphylaxis or other manifestations of allergy with nausea, vomiting, dyspnoea, erythema, urticaria and hypotension.
The benefits should clearly outweigh the risks in such patients and appropriate resuscitative measures should be immediately available. ; Williams and Wilkins; Baltimore 1992; Chapter 2 p 23 The risk of bronchospasm-inducing reactions in asthmatic patients is higher after contrast media administration, especially in patients taking beta-blockers.
Hypersensitivity testing In patients with suspected or known hypersensitivity to contrast media, sensitivity test doses are not recommended, as severe or fatal reactions to contrast media are not predictable from sensitivity test. Myelomatosis or paraproteinaemias are conditions predisposing to renal impairment following CM administration.
Hypersensitivity to the active substance or any of the excipients. Intrathecal concomitant administration of corticosteroids with contrast media is contraindicated.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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1 Intravascular administration Adult patients involved in clinical trials with intravascular administration of Iomeprol were 4,739. Adults Adverse Reactions Clinical Trials Post-marketing Surveillance System Organ Class Common (≥1/100 t o <1/10) Uncommon (≥1/1000 to <1/100) Rare (≥1/10,000 to <1/1000) Frequency unknown* Blood and lymphatic system disorders Thrombocytopenia, Haemolytic anaemia Immune system disorders Anaphylactoid reaction Endocrine disorders Hyperthyroidism Psychiatric disorders Anxiety Confusional state Nervous system disorders Headache Dizziness Presyncope Coma Transient ischaemic attack Paralysis Syncope Convulsion Loss of consciousness Dysarthria Paraesthesia Amnesia Adverse Reactions Clinical Trials Post-marketing Surveillance System Organ Class Common (≥1/100 t o <1/10) Uncommon (≥1/1000 to <1/100) Rare (≥1/10,000 to <1/1000) Frequency unknown* Somnolence Taste abnormality Contrast induced encephalopathy*** Eye disorders Blindness transient Visual disturbance Conjunctivitis Lacrimation increased Photopsia Cardiac disorders Bradycardia Tachycardia Extrasystoles Cardiac arrest Myocardial infarction Cardiac failure Angina pectoris Arrhythmia Ventricular or atrial fibrillation Atrioventricular block Palpitations Vascular disorders Hypertension Hypotension Circulatory collapse or shock Hot flush Flushing Pallor Cyanosis Coronary artery thrombosis Coronary artery embolism Vasospasm**** Ischemia**** Respiratory, thoracic and mediastinal disorders Dyspnoea Respiratory arrest Acute respiratory distress syndrome (ARDS) Pulmonary oedema Laryngeal oedema Pharyngeal oedema Bronchospasm Asthma Cough Hyperventilation Pharynx discomfort Laryngeal discomfort Rhinitis Adverse Reactions Clinical Trials Post-marketing Surveillance System Organ Class Common (≥1/100 t o <1/10) Uncommon (≥1/1000 to <1/100) Rare (≥1/10,000 to <1/1000) Frequency unknown* Dysphonia Gastrointestinal disorders Nausea Vomiting Diarrhoea Abdominal pain Salivary hypersecretion Dysphagia Salivary gland enlargement Skin and subcutaneous tissue disorders Erythema Urticaria Pruritus Rash Acute generalized exanthematous pustulosis Angioedema Cold sweat Sweating increased Stevens-Johnson’s syndrome Toxic epidermal necrolysis Erythema multiforme Drug Reaction with Eosinophilia and Systemic Symptoms Musculoskeletal and connective tissue disorder Back pain Arthralgia Renal and urinary disorders Renal failure ***** General disorders and administration site conditions Feeling hot Chest pain Injection site warmth and pain Asthenia Rigors Pyrexia Injection site reaction** Coldness local Fatigue Malaise Thirst Investigations Blood creatinine increased Electrocardiogram ST segment elevation Electrocardiogram abnormal * Since the reactions were not observed during clinical trials with 4,739 patients, best estimate is that their relative occurrence is rare ( ≥1/10,000 to <1/1000).
The most appropriate MedDRA term is used to describe a certain reaction and its symptoms and related conditions. ** Injection site reactions comprise injection site pain and swelling. In the majority of cases they are due to extravasation of contrast medium.
These reactions are usually transient and result in recovery without sequelae. Cases of extravasation with inflammation, skin necrosis and even development of compartment syndrome have been reported. *** Encephalopathy may manifest with symptoms and signs of neurological dysfunction such as headache, visual disturbance, cortical blindness, confusion, seizures, loss of coordination, hemiparesis, aphasia, unconsciousness, coma, brain oedema.
****Vasospasm and consequent ischaemia have been observed during intra- arterial injections of contrast medium, in particular after coronary and cerebral angiography often procedurally related and possibly triggered by the tip of the catheter or […]
The benefits of the use of a contrast-enhanced procedure should be carefully weighted against the possible risk. Adequate hydration and monitoring of renal function are recommended after CM administration. Cardiovascular diseases Care should be taken in severe cardiac disease particularly heart failure and coronary artery disease.
Reactions may include pulmonary oedema, haemodynamic changes, ischaemic ECG changes and arrhythmias. In severe, chronic hypertension the risk of renal damage following administration of a contrast medium is increased. In these cases the risks associated with the catheterization procedure are increased.
Thyroid function and thyroid function tests The small amount of free inorganic iodide that may be present in contrast media might have some effects on thyroid function. These effects appear more evident in patients with latent or overt hyperthyroidism or goitre.
Hyperthyroidism or even thyroid storms have been reported following administration of iodinated contrast media. The administration of iodinated contrast media may aggravate myasthenia signs and symptoms. CNS Disorders Particular care is needed in patients with acute cerebral infarction, acute intracranial haemorrhage and any conditions involving damage to the blood brain barrier, brain oedema or acute demyelination.
Convulsive seizures are more likely in patients with intracranial tumours or metastases or with a history of epilepsy. Neurological symptoms related to cerebrovascular diseases, intracranial tumours/metastases or degenerative or inflammatory pathologies may be exacerbated.
There is an increased risk of transient neurological complications in patients with symptomatic cerebrovascular disease eg stroke, transient ischaemic attacks. Cerebral ischaemic phenomena may be caused by intravascular injection. 8).
Contrast encephalopathy may manifest with symptoms and signs of neurological dysfunction such as headache, visual disturbance, cortical blindness, confusion, seizures, loss of coordination, hemiparesis, aphasia, unconsciousness, coma and cerebral oedema within minutes to hours after administration of iomeprol, and generally resolves within days.
The product should be used with caution in patients with conditions that disrupt the integrity of the blood brain barrier (BBB), potentially leading to increased permeability of contrast media across the BBB and increasing the risk of encephalopathy.
If contrast encephalopathy is suspected, administration of iomeprol should be discontinued and appropriate medical management should be initiated. In acute and chronic alcoholism the increase in blood brain barrier permeability facilitates the passage of the contrast medium into cerebral tissue possibly leading to CNS disorders.
There is a possibility of a reduced seizure threshold in alcoholics. In patients with a drug addiction there is also the possibility of a reduced seizure threshold. Severe cutaneous adverse reactions Severe cutaneous reactions (SCARs) including Steven-Johnson (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be […]