Loading…
ISOVUE-M is a brand name for Iopamidol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE ISOVUE-M is indicated for: Lumbar and thoracic myelography, and computed tomography (CT) myelography in adults and pediatric patients aged 2 years and older Cervical and total columnar myelography and CT myelography in adults CT cisternography in adults Specific concentrations of ISOVUE-M are…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION Individualize the volume and concentration of ISOVUE-M according to the specific dosing tables based on patient age, body weight, and study to be performed. 3 ) See full prescribing information for important dosage and administration information.
1 Important Dosage and Administration Information ISOVUE-M is for intrathecal use only. 3 )]. 3 )]. Consider factors such as age, body weight, anticipated pathology and degree and extent of opacification required, structure(s) or area to be examined, concomitant medical conditions, and imaging equipment and technique to be employed.
2) ] . Use aseptic technique for all handling and administration of ISOVUE-M. 6°F) or room temperature (20°C to 25°C, 68°F to 77°F). Visually inspect ISOVUE-M for particulate matter and discoloration prior to administration whenever the solution and container permit.
Do not administer ISOVUE-M if particulate matter or discoloration are observed. Do not mix ISOVUE-M with other drugs. ISOVUE-M is packaged in a single-dose vial and intended for one procedure only. Discard any unused portion. 2 Recommended Dosage for Intrathecal Procedures in Adults The recommended doses in adults are shown in Table 1 .
Administer over 1 minute to 2 minutes. Allow at least 48 hours before repeat administration to avoid overdose; however, whenever possible, 5 days to 7 days is recommended. If CT myelography is performed, delay imaging by at least 4 hours to reduce the degree of contrast.
3 Recommended Dosage for Intrathecal Procedures in Pediatric Patients Aged 2 Years and Older The recommended doses based on age for pediatric patients aged 2 years and older are shown in Table 2. Administer over 1 minute to 2 minutes.
Allow at least 48 hours before repeat administration to avoid overdose; however, whenever possible, 5 days to 7 days is recommended. If CT myelography is performed, delay imaging by at least 4 hours to reduce the degree of contrast.
Table 2:
Recommended Concentrations and Volumes of ISOVUE-M Based on Age for Intrathecal Procedures in Pediatric Patients Aged 2 Years and Older Imaging Procedure Age Concentration (mg Iodine/mL) Volume to Administer Injection Type Lumbar and thoracic myelography 2 years to 7 years 200 7 mL to 9 mL Lumbar 8 years to 12 years 8 mL to 11 mL Lumbar 13 years and older 10 mL to 12 mL Lumbar
9 )] Most common adverse reactions (incidence > 1%) are headache, nausea, vomiting, back pain, leg pain, neck pain, and hypotension. 1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc. gov/medwatch . 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of ISOVUE-M was evaluated in 686 adult patients receiving ISOVUE-M intrathecally in clinical studies. Table 3 shows the common adverse reactions (>1%). These reactions usually occur 1 to 10 hours after injection, almost all occurring within 24 hours.
2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of ISOVUE-M and other iopamidol products. Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure.
, chest tightness, laryngeal edema, periorbital edema, facial edema); delayed hypersensitivity reactions including generalized maculopapular rash, erythema, pruritus, localized blistering, skin peeling Infections and infestations: meningitis aseptic, meningitis bacterial as consequence of the procedural hazard Musculoskeletal disorders: muscle spasm, musculoskeletal pain, muscular weakness Nervous system: coma, seizure, tremors, syncope, cerebral edema, paralysis, depressed level of consciousness or loss of consciousness, meningism, encephalopathy Psychiatric disorders: disorientation, agitation, restlessness, confusional state Respiratory system disorders: respiratory arrest, respiratory failure, acute respiratory distress syndrome, respiratory distress, apnea, asthma, sneezing, choking, laryngeal edema, bronchospasm, rhinitis Skin and subcutaneous tissue disorders : Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP), erythema multiforme and drug reaction with eosinophilia and systemic symptoms (DRESS), skin necrosis, face edema
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Life-threatening or fatal reactions can occur. Always have emergency resuscitation equipment and trained personnel available. 1 ) Acute Kidney Injury: Acute injury including renal failure can occur.
Use the lowest dose and maintain adequate hydration to minimize risk. 2 ) Cardiovascular Adverse Reactions: Hemodynamic disturbances including shock and cardiac arrest may occur during or after ISOVUE-M administration. 4 ) Thyroid Dysfunction in Pediatric Patients 0 Years to 3 Years of Age: Individualize thyroid function monitoring based on risk factors such as prematurity.
1 Hypersensitivity Reactions ISOVUE-M can cause life-threatening or fatal hypersensitivity reactions including anaphylaxis. 2 )] . , within 1 to 3 minutes), but delayed reactions can also occur. , bronchial asthma, allergic rhinitis, and food allergies) or other hypersensitivities.
Premedication with antihistamines or corticosteroids does not prevent serious life-threatening reactions, but may reduce their incidence and severity. Obtain a history of allergy or hypersensitivity reactions to iodinated contrast agents and always have emergency resuscitation equipment and trained personnel available prior to ISOVUE-M administration.
Monitor all patients for hypersensitivity reactions. 2 Acute Kidney Injury Acute kidney injury, including renal failure, may occur after administration of iodinated contrast agents. Risk factors include pre-existing renal insufficiency, dehydration, diabetes mellitus, congestive heart failure, advanced vascular disease, elderly age, concomitant use of nephrotoxic or diuretic medications, multiple myeloma or other paraproteinemias, and repetitive or large doses of iodinated contrast agents.
Use the lowest dose of ISOVUE-M, especially in patients with risk factors for acute kidney injury. Adequately hydrate patients prior to and following ISOVUE-M administration . 3 Increased Risk of Seizures Focal and generalized motor seizures have been reported after intrathecal use of iodinated contrast agents including ISOVUE-M.
4 CONTRAINDICATIONS None. None ( 4 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Iopamidol in United States of America.
Know a brand we are missing in United States of America? 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 several of the cases, higher than recommended doses were administered. Use of medications that may lower the seizure threshold (phenothiazine derivatives, including those used for their antihistaminic properties; tricyclic antidepressants; MAO inhibitors; CNS stimulants; analeptics; antipsychotic agents) should be carefully evaluated.
Consider discontinuing these agents at least 48 hours before and for at least 24 hours following intrathecal administration of ISOVUE-M. 4 Cardiovascular Adverse Reactions Iodinated contrast agents increase the circulatory osmotic load and may induce acute or delayed hemodynamic disturbances in patients with congestive heart failure, severely impaired renal function, combined renal and hepatic disease, and combined renal and cardiac disease, particularly when repetitive or large doses are administered.
Fatal cardiovascular reactions have occurred mostly within 10 minutes of injection of iodinated contrast agent by an intravascular route; the main feature was cardiac arrest with cardiovascular disease as the main underlying factor.
Hypotensive collapse and shock have occurred. The administration of iodinated contrast agent may cause pulmonary edema in patients with heart failure. 01 percent). Use the lowest necessary dose of ISOVUE-M in patients with congestive heart failure and always have emergency resuscitation equipment and trained personnel available.
Monitor all patients for severe cardiovascular reactions. 5 Thyroid Storm in Patients with Hyperthyroidism Thyroid storm has occurred after the use of iodinated contrast agents in patients with hyperthyroidism, or with an autonomously functioning thyroid nodule.
Evaluate the risk in such patients before use of ISOVUE-M. 6 Thyroid Dysfunction in Pediatric Patients 0 Years to 3 Years of Age Thyroid dysfunction characterized by hypothyroidism or transient thyroid suppression has been reported after both single exposure and multiple exposures to iodinated contrast agents in pediatric patients 0 years to 3 years of age.
Younger age, very low birth weight, prematurity, underlying medical conditions affecting thyroid function, admission to neonatal or pediatric intensive care units, and congenital cardiac conditions are associated with an increased risk of hypothyroidism after iodinated contrast agent exposure.
Pediatric patients with congenital cardiac conditions may be at greatest risk given that they often require high doses of contrast during invasive cardiac procedures. An underactive thyroid during early life may be harmful for cognitive and neurological development and may require thyroid hormone replacement therapy.
After exposure to iodinated contrast agent, individualize thyroid function monitoring based on underlying risk factors, especially in term and preterm neonates. 4 )] . 7 Hypertensive Crisis in Patients with Pheochromocytoma Hypertensive crisis in patients with pheochromocytoma has occurred with iodinated contrast agents.
Closely monitor patients when administering ISOVUE-M if pheochromocytoma or catecholamine-secreting paragangliomas are suspected. Inject the minimum amount of ISOVUE-M necessary and have measures for treatment of hypertensive crisis readily available.
8 Sickle Cell Crisis in Patients with Sickle Cell Disease Iodinated contrast agents may promote sickling in individuals who are homozygous for sickle cell disease. Hydrate patients prior to and following ISOVUE-M administration and use only if the necessary imaging information cannot be obtained with alternative imaging modalities.
9 Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (SCAR) may develop from 1 hour to several weeks after administration of iodinated contrast agent. These reactions include Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS).
Reaction severity may increase and time to onset may decrease with repeat administration of contrast agent; prophylactic medications may not prevent or mitigate severe cutaneous adverse reactions. Avoid administering ISOVUE-M to patients with a history of a severe cutaneous adverse reaction to ISOVUE-M.
2 )] .