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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.
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 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 group: see Table 3.
Table 3: ADVERSE REACTIONS REPORTED IN > 1% OF PATIENTS WHO RECEIVED ULTRAVIST INJECTION IN CLINICAL TRIALS
|System Organ Class||Adverse Reaction||ULTRAVIST Injection
|Nervous system disorders||Headache||46 (4)|
|Eye disorders||Abnormal Vision||12 (1.1)|
|Cardiac disorders||Chest pain||18 (1.6)|
|Vascular disorders||Vasodilatation||30 (2.6)|
|Gastrointestinal disorders||Nausea||42 (3.7)|
|Musculoskeletal and connective tissue disorders||Back pain||22 (1.9)|
|Renal and urinary disorders||Urinary urgency||21 (1.8)|
|General disorders and administration site conditions||Injection site and infusion site reactions (hemorrhage, hematoma, pain, edema, erythema, rash)||41 (3.7)|
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;
Immune system disorders: asthma, face edema;
Psychiatric disorders: anxiety;
Renal and urinary disorders: dysuria, renal pain, urinary retention;
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:
Endocrine disorders: hyperthyroidism, thyrotoxic crisis, hypothyroidism;
Gastrointestinal disorders: dysphagia, swelling of salivary glands;
Musculoskeletal and connective tissue disorders: compartment syndrome in case of extravasation
Renal and urinary disorders:renal failure, hematuria;
Skin and subcutaneous tissue disorders: Stevens-Johnson Syndrome, skin discoloration;
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 [see Use in Specific Populations].
Read the Ultravist (iopromide injection) Side Effects Center for a complete guide to possible side effects
In patients with renal impairment, biguanides can cause lactic acidosis. ULTRAVIST appears to increase the risk of biguanide induced lactic acidosis, possibly as a result of worsening renal function [see WARNINGS AND PRECAUTIONS].
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 Injection [see HOW SUPPLIED/Storage and Handling].
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 iopromide 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 iopromide concentration of 10 mg I/mL, up to 100 seconds at an iopromide concentration of 70 mg I/mL.
The PTT increased from approximately 50 seconds at an iopromide concentration of 10 mg I/mL, up to approximately 100 seconds at an iopromide 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 iopromide 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 iopromide. 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 iopromide had a slight effect on coagulation and fibrinolysis. No Factor XIIa formation could be demonstrated. The complement alternate pathway also can be activated.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/24/2012
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