Brand Name
Ultravist
Generic Name
Iopromide
View Brand Information FDA approval date: December 30, 2009
Classification: Radiographic Contrast Agent
Form: Injection
What is Ultravist (Iopromide)?
ULTRAVIST ® injection is an iodinated contrast agent indicated In Adults For Computed Tomography of the head and body for the evaluation of neoplastic and non-neoplastic lesions in adults., The usefulness of contrast enhancement for the investigation of the retrobulbar space and of low grade or infiltrative glioma has not been demonstrated. Pediatric Patients, For Computed Tomography of the head and body For use only with an automated contrast injection system, contrast management system, or contrast media transfer set approved or cleared for use with this contrast agent in this Imaging Bulk Package. ULTRAVIST Imaging Bulk Package is a radiographic contrast agent indicated for contrast computed tomography imaging of head and body For use only with an automated contrast injection system, contrast management system, or contrast media transfer set approved or cleared for use with this contrast agent in this Imaging Bulk Package.
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Brand Information
Ultravist (iopromide)
WARNING: NOT FOR INTRATHECAL USE
Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.
1INDICATIONS AND USAGE
ULTRAVIST
Adults
- For Computed Tomography (CT) of the head and body (intrathoracic, intra-abdominal and retroperitoneal regions) for the evaluation of neoplastic and non-neoplastic lesions in adults.
- The usefulness of contrast enhancement for the investigation of the retrobulbar space and of low grade or infiltrative glioma has not been demonstrated.
Pediatric Patients
- For Computed Tomography (CT) of the head and body
For use only with an automated contrast injection system, contrast management system, or contrast media transfer set approved or cleared for use with this contrast agent in this Imaging Bulk Package.
2DOSAGE FORMS AND STRENGTHS
ULTRAVIST injection is a nonionic, sterile, clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution of iopromide available as an Imaging Bulk Package in two strengths:
300 mg Iodine per mL provides 623.4 mg/mL iopromide
370 mg Iodine per mL provides 768.86 mg/mL iopromide
3CONTRAINDICATIONS
- Do not administer ULTRAVIST injection intrathecally. Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.
- Preparatory dehydration (for example, prolonged fasting and the administration of a laxative) before ULTRAVIST injection is contraindicated in pediatric patients because of risk of acute renal failure.
4ADVERSE REACTIONS
The most important adverse drug reactions in patients receiving ULTRAVIST are anaphylactoid shock, contrast induced acute kidney injury, coma, cerebral infarction, stroke, brain edema, convulsion, arrhythmia, cardiac arrest, myocardial ischemia, myocardial infarction, cardiac failure, bradycardia, cyanosis, hypotension, shock, dyspnea, pulmonary edema, respiratory insufficiency and aspiration.
4.1Clinical 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 or predict the rates observed in practice.
The following table of incidence of reactions is based upon controlled clinical trials in which ULTRAVIST injection was administered to 1142 patients. This listing includes all reported adverse reactions regardless of attribution.
Adverse reactions are listed by System Organ Class and in decreasing order of occurrence for rates greater than 1% in the ULTRAVIST injection group: see
One or more adverse reactions were recorded in 273 of 1142 (24%) patients during the clinical trials, coincident with the administration of ULTRAVIST injection or within the defined duration of the study follow-up period (24–72 hours). ULTRAVIST injection is often associated with sensations of warmth and/or pain.
Serious, life-threatening and fatal reactions have been associated with the administration of iodine-containing contrast media, including ULTRAVIST injection. In clinical trials 7/1142 patients given ULTRAVIST injection died 5 days or later after drug administration. Also, 10/1142 patients given ULTRAVIST injection had serious adverse events.
The following adverse reactions were observed in ≤1% of the subjects receiving ULTRAVIST injection:
Cardiac disorders: atrioventricular block (complete), bradycardia, ventricular extrasystole
Gastrointestinal disorders: abdominal discomfort, abdominal pain, abdominal pain upper, constipation, diarrhea, dry mouth, dyspepsia, gastrointestinal disorder, gastrointestinal pain, salivation increased, stomach discomfort, rectal tenesmus
General disorders and administration site conditions: asthenia, chest discomfort, chills, excessive thirst, extravasation, feeling hot, hyperhidrosis, malaise, edema peripheral, pyrexia
Immune system disorders: asthma, face edema
Investigations: blood lactate dehydrogenase increased, blood urea increased, hemoglobin increased, white blood cell count increased
Musculoskeletal and connective tissue disorders: arthralgia, musculoskeletal pain, myasthenia, neck pain, pain in extremity
Nervous system disorders: agitation, confusion, convulsion, dizziness, hypertonia, hypesthesia, incoordination, neuropathy, somnolence, speech disorder, tremor, paresthesia, visual field defect
Psychiatric disorders: anxiety
Renal and urinary disorders: dysuria, renal pain, urinary retention
Respiratory, thoracic and mediastinal disorders: apnea, cough increased, dyspnea, hypoxia, pharyngeal edema, pharyngitis, pleural effusion, pulmonary hypertension, respiratory disorder, sore throat
Skin and subcutaneous tissue disorders: erythema, pruritus, rash, urticaria
Vascular disorders: coronary artery thrombosis, flushing, hypertension, hypotension, peripheral vascular disorder, syncope, vascular anomaly
4.2Postmarketing Experience
The following adverse reactions have been identified during post approval use of ULTRAVIST injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Adverse reactions reported in foreign postmarketing surveillance and other trials with the use of ULTRAVIST injection include:
Cardiac disorders: cardiac arrest, ventricular fibrillation, atrial fibrillation,tachycardia, palpitations, congestive heart failure, myocardial infarction, angina pectoris
Ear and labyrinth disorders: vertigo, tinnitus
Endocrine disorders: hyperthyroidism, thyrotoxic crisis, hypothyroidism
Eye disorders: mydriasis, lacrimation disorder
Gastrointestinal disorders: dysphagia, swelling of salivary glands
Immune system disorders: anaphylactoid reaction (including fatal cases), respiratory arrest, anaphylactoid shock, angioedema, laryngeal edema, laryngospasm, bronchospasm, hypersensitivity
Musculoskeletal and connective tissue disorders: compartment syndrome in case of extravasation
Nervous system disorders: cerebral ischemia/infarction, paralysis, paresis, transient cortical blindness, aphasia, coma, unconsciousness, amnesia, hypotonia, aggravation of myasthenia gravis symptoms
Renal and urinary disorders: renal failure, hematuria
Respiratory, thoracic and mediastinal disorders: pulmonary edema, acute respiratory distress syndrome, asthma
Skin and subcutaneous tissue disorders: Reactions range from mild (e.g. rash, erythema, pruritus, urticaria and skin discoloration) to severe [e.g. Stevens-Johnson Syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS)].
Vascular disorders: vasospasm
4.3Pediatrics
The overall character, quality, and severity of adverse reactions in pediatric patients are generally similar to those reported in adult patients. Additional adverse reactions reported in pediatric patients from foreign marketing surveillance or other information are: epistaxis, angioedema, migraine, joint disorder (effusion), muscle cramps, mucous membrane disorder (mucosal swelling), conjunctivitis, hypoxia, fixed eruptions, vertigo, diabetes insipidus, and brain edema
5OVERDOSAGE
The adverse effects of overdosage are life-threatening and affect mainly the pulmonary and cardiovascular systems. Treatment of an overdosage is directed toward the support of all vital functions, and prompt institution of symptomatic therapy.
Iopromide binds negligibly to plasma or serum protein and can, therefore, be dialyzed.
6DESCRIPTION
ULTRAVIST
Iopromide has the following structural formula:
ULTRAVIST injection is a nonionic sterile, clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution of iopromide, containing 2.42 mg/mL tromethamine buffer and 0.1 mg/mL edetate calcium disodium stabilizer.
ULTRAVIST is available as an Imaging Bulk Package in two strengths:
300 mg Iodine per mL provides 623.4 mg/mL iopromide
370 mg Iodine per mL provides 768.86 mg/mL iopromide
During the manufacture of ULTRAVIST injection, sodium hydroxide or hydrochloric acid may be added for pH adjustment. ULTRAVIST injection has a pH of 7.4 (6.5–8) at 25± 2°C, is sterilized by autoclaving and contains no preservatives.
The iodine concentrations (mg Iodine per mL) available have the following physicochemical properties:
*Osmolality was measured by vapor-pressure osmometry. Osmolarity was calculated from the measured osmolal concentrations.
Solutions of ULTRAVIST injection 300 mg Iodine per mL and 370 mg Iodine per mL have osmolalities respectively 2.1 and 2.7 times that of plasma (285 mOsmol/kg water).
7CLINICAL STUDIES
ULTRAVIST injection was administered to 708 patients; 1 patient was less than 18 years of age, 347 patients were between 18 and 59 years of age, and 360 patients were equal to or greater than 60 years of age; the mean age was 56.6 years (range 17–88). Of the 708 patients, 446 (63%) were male and 262 (37%) were female. The racial distribution was: Caucasian 463 (65.4%), Black 95 (13.4%), Hispanic 36 (5.1%), Asian 11 (1.6 %), and other or unknown 103 (14.5%). Efficacy assessment was based on the global evaluation of the quality of the radiographs by rating visualization as either excellent, good, poor, or no image, and on the ability to make a diagnosis. Contrast CT of head and body was evaluated in three randomized, double-blind clinical trials of ULTRAVIST injection, 300 mg Iodine per mL, in 95 patients with vascular disorders. Visualization ratings were good or excellent in 99% of the patients; a radiologic diagnosis was made in the majority of the patients. A confirmation of contrast CT findings by other diagnostic methods was not obtained.
ULTRAVIST injection was evaluated in a blinded reader trial for CT of the head and body. Among the 382 patients who were evaluated with ULTRAVIST injection 370 mg Iodine per mL, visualization ratings were good or excellent in approximately 97% of patients.
8HOW SUPPLIED/STORAGE AND HANDLING
ULTRAVIST injection is a sterile, clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution available in two strengths.
ULTRAVIST injection 300 mg Iodine per mL Imaging Bulk Package (Multiple-Dose container)
200 mL fill/250 mL bottles (carton of 10) NDC 50419-344-23
500 mL fill/500 mL bottles (carton of 8) NDC 50419-344-65
ULTRAVIST injection 370 mg Iodine per mL Imaging Bulk Package (Multiple-Dose container)
200 mL fill/250 mL bottles (carton of 10) NDC 50419-346-28
500 mL fill/500 mL bottles (carton of 8) NDC 50419-346-65
STORAGE
Store ULTRAVIST injection Imaging Bulk Package at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) and protected from light
9PATIENT COUNSELING INFORMATION
Instruct patients receiving ULTRAVIST injection to inform their physician or healthcare provider of the following:
- Advise patients to inform their physician if they develop a rash after receiving ULTRAVIST
- Lactation: Advise lactating women that interruption of breast feeding is not necessary, however, a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk for 12 to 24 hours after ULTRAVIST Injection administration to minimize exposure to the breastfed infant (
- Thyroid Dysfunction – Advise parents/caregivers about the risk of developing thyroid dysfunction after ULTRAVIST administration. Advise parents/caregivers about when to seek medical care for their child to monitor thyroid function
- Manufactured for:
© 2018, Bayer HealthCare Pharmaceuticals Inc. All rights reserved.
10Package/Label Principal Display Panel
NDC 50419-344-65 8 x 500 mL
sterile solution
imaging bulk package
not for direct infusion
Ultravist®
(brand of iopromide)
300 mg Iodine per mL
injection
Rx only
11Package/Label Principal Display Panel
NDC 50419-346-65 8 x 500 mL
sterile solution
imaging bulk package
not for direct infusion
Ultravist®
(brand of iopromide)
370 mg Iodine per mL
injection
Rx only
