• Ultravist 300mg indications
• Uses of Ultravist 300mg in details
• Ultravist 300mg description
• Ultravist 300mg dosage
• Ultravist 300mg interactions
• Ultravist 300mg side effects
• Ultravist 300mg contraindications

What is Ultravist 300mg?

Ultravist 300mg injection is used to help diagnose or find problems in the brain, heart, head, blood vessels, and other parts of the body. It is an iodinated contrast agent. Contrast agents are used to create a clear picture of the different parts of the body during certain medical procedures such as CT scans and angiography.

Ultravist 300mg is to be used only by or under the direct supervision of a doctor.

Ultravist 300mg indications

Ultravist 300mg® Injection is an iodinated contrast agent indicated for:

Intra-Arterial Procedures*

• 150 mg I/mL for intra-arterial digital subtraction angiography (IA-DSA)
• 300 mg I/mL for cerebral arteriography and peripheral arteriography
• 370 mg I/mL for coronary arteriography and left ventriculography, visceral angiography, and aortography

Intravenous Procedures*

• 240 mg I/mL for peripheral venography
• 300 mg I/mL for excretory urography
• 300 mg I/mL and 370 mg I/mL for contrast Computed Tomography (CT) of the head and body (intrathoracic, intraabdominal and retroperitoneal regions) for the evaluation of neoplastic and non-neoplastic lesions. The usefulness of contrast enhancement for the investigation of the retrobulbar space and of low grade or infiltrative glioma has not been demonstrated.

*For information on the concentrations and doses for the Pediatric Population.

Uses of Ultravist 300mg in details

Ultravist 300mg is used in diagnostic procedures such as computed tomography (CT) scans and X-ray imaging to improve the visibility of different organs in the body and thus helps in the diagnosis of any find problems in different body regions.

Ultravist 300mg description

Ultravist 300mg is a low osmolar, non-ionic X-ray contrast agent for intravascular administration. It functions as a contrast agent by opacifying blood vessels in the path of flow of the contrast agent, permitting radiographic visualization of the internal structures until significant hemodilution occurs. Available as the FDA-approved product Ultravist 300mg, Ultravist 300mg is used in radiographic studies such as intra-arterial digital subtraction angiography (IA-DSA), cerebral and peripheral arteriography, peripheral venography, excretory urography, brain computer tomography (CT), coronary arteriography, left ventriculography, visceral angiography, and aortography.

Ultravist 300mg dosage

Ultravist 300mg Dosage

Applies to the following strengths: 150 mg/mL; 240 mg/mL; 300 mg/mL; 370 mg/mL

Usual Adult Dose for:

• Intra-arterial Digital Subtraction Angiography
• Cerebral Arteriography
• Peripheral Arteriography
• Coronary Arteriography
• Left Ventriculography
• Venography
• Computed Tomography
• Urography

Usual Pediatric Dose for:

• Computed Tomography
• Urography
• Coronary Arteriography

Additional dosage information:

• Renal Dose Adjustments
• Liver Dose Adjustments
• Dose Adjustments
• Precautions
• Dialysis
• Other Comments

Usual Adult Dose for Intra-arterial Digital Subtraction Angiography

Ultravist 300mg 150 mg I/mL: Carotid Arteries: 6 to 10 mL; Vertebral Arteries 4 to 8 mL; Aorta: 20 to 50 mL; Abdominal Aorta 2 to 20 mL. The maximum total recommended dose is 250 mL.

Usual Adult Dose for Cerebral Arteriography

Ultravist 300mg 300 mg I/mL: Carotid Arteries: 3 to 12 mL; Vertebral Arteries 4 to 12 mL; Aortic Arch Injection (4 vessel study): 20 to 50 mL. The maximum total recommended dose is 150 mL.

Usual Adult Dose for Peripheral Arteriography

Ultravist 300mg 300 mg I/mL: Subclavian or Femoral Artery: 5 to 40 mL; Aortic Bifurcation (distal runoff): 25 to 50 mL. The maximum total recommended dose is 250 mL.

Usual Adult Dose for Coronary Arteriography

Ultravist 300mg 370 mg I/mL: Right or Left Coronary Artery: 3 to 14 mL; Left Ventricle: 30 to 60 mL. The maximum total recommended dose is 225 mL.

Usual Adult Dose for Left Ventriculography

Ultravist 300mg 370 mg I/mL: Right or Left Coronary Artery: 3 to 14 mL; Left Ventricle: 30 to 60 mL. The maximum total recommended dose is 225 mL.

Usual Adult Dose for Venography

Peripheral Venography:

Ultravist 300mg 240 mg I/mL: Inject the minimum volume necessary to visualize satisfactorily the structures under examination. Do not exceed 250 mL as total dose for the procedure.

Usual Adult Dose for Computed Tomography

Contrast Computed Tomography:

Ultravist 300mg 300 mg I/mL: Head: 50 to 200 mL; Body, bolus injection: 50-200 mL; Body, rapid infusion: 100-200 mL. The maximum total recommended dose is 200 mL.

Ultravist 300mg 370 mg I/mL: Head: 41 to 162 mL; Body, bolus injection: 41-162 mL; Body, rapid infusion: 81-162 mL. The maximum total recommended dose is 162 mL.

Usual Adult Dose for Urography

Excretory urography: Ultravist 300mg 300 mg I/mL: 300 mg I/kg body weight. The maximum total recommended dose is 100 mL.

Usual Pediatric Dose for Computed Tomography

Contrast Computerized Tomography or Excretory Urography (300 mg I/mL): Inject 1 to 2 mL/kg intravenously. Do not exceed 3 mL/kg as total dose.

Usual Pediatric Dose for Urography

Contrast Computerized Tomography or Excretory Urography (300 mg I/mL): Inject 1 to 2 mL/kg intravenously. Do not exceed 3 mL/kg as total dose.

Usual Pediatric Dose for Coronary Arteriography

Cardiac chambers and related arteries (370 mg I/mL): Inject 1 to 2 milliliters per kilogram (mL/kg) intra-arterially. Do not exceed 4 mL/kg as total dose.

Renal Dose Adjustments

Renal dysfunction: Use with caution. The lowest necessary dose should be used.

Liver Dose Adjustments

Data not available

Dose Adjustments

Carefully individualize the volume and concentration of Ultravist 300mg to be used for a vascular procedure, according to the specific dosing guidelines. Adjust the dose accounting for factors such as age, body weight, size of the vessel and the rate of blood flow within the vessel. Also consider the extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed.

Ultravist 300mg should be used at the lowest effective dose in order to minimize adverse effects. The efficacy of Ultravist 300mg at doses below those recommended has not been established.

The maximum recommended total dose of iodine in adults is 86 grams; a maximum recommended total dose of iodine has not been established for pediatric patients.

Precautions

US BOXED 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.

Safety and efficacy have not been established in patients younger than 2 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Hydrate patients adequately prior to and following the administration of Ultravist 300mg.

Warming Ultravist 300mg to body temperature shortly before administration may help improve tolerability and ease of injection.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

More about Ultravist 300mg

• Ultravist 300mg Side Effects
• During Pregnancy or Breastfeeding
• Drug Interactions
• Drug class: non-ionic iodinated contrast media

Consumer resources

• Ultravist 300mg
• Ultravist 300mg Injection (Advanced Reading)

Other brands: Ultravist 300mg

Professional resources

• Ultravist 300mg (Wolters Kluwer)

Related treatment guides

• Cerebral Arteriography
• Computed Tomography
• Coronary Arteriography
• Intra-arterial Digital Subtraction Angiography
• ... +4 more

Ultravist 300mg interactions

Drug-Drug Interactions

In patients with renal impairment, biguanides can cause lactic acidosis. Ultravist 300mg appears to increase the risk of biguanide induced lactic acidosis, possibly as a result of worsening renal function.

Patients on beta-blockers may be unresponsive to the usual doses of epinephrine used to treat allergic reactions. Because of the risk of hypersensitivity reactions, use caution when administering iodinated contrast agents to patients taking betablockers.

Interleukins are associated with an increased prevalence of delayed hypersensitivity reactions after iodinated contrast agent administration. These reactions include fever, chills, nausea, vomiting, pruritus, rash, diarrhea, hypotension, edema, and oliguria.

Renal toxicity has been reported in a few patients with liver dysfunction who were given an oral cholecystographic agent followed by intravascular contrast agents. Administration of any intravascular contrast agent should therefore be postponed in patients who have recently received a cholecystographic contrast agent.

Do not mix other drugs with Ultravist 300mg.

Drug-Laboratory Test Interactions

Thyroid Function Tests

The results of protein bound iodine and radioactive iodine uptake studies, which depend on iodine estimation, will not accurately reflect thyroid function for at least 16 days following administration of iodinated contrast agents. However, thyroid function tests which do not depend on iodine estimations, for example, T3 resin uptake and total or free thyroxine (T4) assays are not affected.

Laboratory Assay of Coagulation Parameters, Fibrinolysis and Complement System

The effect of Ultravist 300mg on coagulation factors in in vitro assays increased with the administered dose. Coagulation, fibrinolysis and complement activation were evaluated with standard citrated human plasma in the following assays: thrombin time, thrombin coagulase time, calcium thromboplastin time, partial thromboplastin time, plasminogen, thrombin, alpha-2 antiplasmin and factor XIIa activity. Thrombin inhibition was almost complete. Data on reversibility are not available. The thrombin time increased from approximately 20 seconds at an Ultravist 300mg concentration of 10 mg I/mL, up to 100 seconds at an Ultravist 300mg concentration of 70 mg I/mL.

The PTT increased from approximately 50 seconds at an Ultravist 300mg concentration of 10 mg I/mL, up to approximately 100 seconds at an Ultravist 300mg concentration of 70 mg I/mL. A similar increase was noted in the thrombin coagulase time. Lesser effects were noted in the calcium thromboplastin time. Coagulation time increased from 13.5 to 23 seconds at the highest Ultravist 300mg concentration of 70 mg I/mL. The Hageman factor split products decreased by about 20% over the range of 10 to 70 mg I/mL of Ultravist 300mg. Plasminogen was relatively stable. There was no evidence of activation of fibrinolysis. The complement alternate pathway was activated. Factor B conversion increased in a dose dependent manner. The duration of these effects was not studied.

In vitrostudies with human blood showed that Ultravist 300mg had a slight effect on coagulation and fibrinolysis. No Factor XIIa formation could be demonstrated. The complement alternate pathway also can be activated.

Ultravist 300mg side effects

See also:
What are the possible side effects of Ultravist 300mg?

The most important adverse drug reactions in patients receiving Ultravist 300mg 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.

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 or predict the rates observed in practice.

The following table of incidence of reactions is based upon controlled clinical trials in which Ultravist 300mg 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 300mg group: see Table 3.

Table 3: ADVERSE REACTIONS REPORTED IN > 1% OF PATIENTS WHO RECEIVED Ultravist 300mg IN CLINICAL TRIALS

One or more adverse reactions were recorded in 273 of 1142 (24%) patients during the clinical trials, coincident with the administration of Ultravist 300mg or within the defined duration of the study follow-up period (24–72 hours). Ultravist 300mg 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 300mg. In clinical trials 7/1142 patients given Ultravist 300mg died 5 days or later after drug administration. Also, 10/1142 patients given Ultravist 300mg had serious adverse events.

The following adverse reactions were observed in ≤ 1% of the subjects receiving Ultravist 300mg:

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.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Ultravist 300mg. 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 300mg 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: Stevens-Johnson Syndrome, skin discoloration;

Vascular disorders:vasospasm.

Pediatrics

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.

Ultravist 300mg contraindications

•

Do not administer Ultravist 300mg 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 300mg is contraindicated in pediatric patients because of risk of acute renal failure.

Active ingredient matches for Ultravist 300mg:

Iopromide in Switzerland.

References

1. DailyMed. "IOPROMIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. PubChem. "iopromide". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. DrugBank. "Iopromide". http://www.drugbank.ca/drugs/DB09156 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology