Componentes:
Método de ação:
Opção de tratamento:
Medicamente revisado por Fedorchenko Olga Valeryevna, Farmácia Última atualização em 10.04.2022
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20 principais medicamentos com os mesmos componentes:
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A injeção de Ioprometo Fuji Yakuhin® é um agente de contraste iodado indicado para:
Procedimentos intra-arteriais *
- 150 mg I / mL para angiografia por subtração digital intra-arterial (IA-DSA)
- 300 mg I / mL para arteriografia cerebral e arteriografia periférica
- 370 mg I / mL para arteriografia coronariana e ventriculografia esquerda, angiografia visceral e aortografia
Procedimentos intravenosos *
- 240 mg I / mL para venografia periférica
- 300 mg I / mL para urografia excretora
- 300 mg I / mL e 370 mg I / mL para contraste Tomografia computadorizada (TC) da cabeça e do corpo (regiões intratorácicas, intra-abdominais e retroperitoneais) para avaliação de lesões neoplásicas e não neoplásicas. A utilidade do aprimoramento do contraste para a investigação do espaço retrobulbar e do glioma de baixo grau ou infiltrativo não foi demonstrada.
* Para informações sobre as concentrações e doses da população pediátrica.
A injeção ULTRAVIST® é um agente de contraste iodado indicado para:
Procedimentos intra-arteriais *
- 150 mg I / mL para angiografia por subtração digital intra-arterial (IA-DSA)
- 300 mg I / mL para arteriografia cerebral e arteriografia periférica
- 370 mg I / mL para arteriografia coronariana e ventriculografia esquerda, angiografia visceral e aortografia
Procedimentos intravenosos *
- 240 mg I / mL para venografia periférica
- 300 mg I / mL para urografia excretora
- 300 mg I / mL e 370 mg I / mL para contraste Tomografia computadorizada (TC) da cabeça e do corpo (regiões intratorácicas, intra-abdominais e retroperitoneais) para avaliação de lesões neoplásicas e não neoplásicas. A utilidade do aprimoramento do contraste para a investigação do espaço retrobulbar e do glioma de baixo grau ou infiltrativo não foi demonstrada.
* Para informações sobre as concentrações e doses da população pediátrica.
- Inspecione visualmente o Ioprometo Fuji Yakuhin quanto a partículas e / ou descoloração, sempre que a solução e o recipiente permitirem. Não administre Ioprometo Fuji Yakuhin se for observado material particulado e / ou descoloração.
- Determine o volume e a concentração de Injeção de Ioprometo Fuji Yakuhin a serem usados levando em consideração fatores como a idade, peso corporal, tamanho do vaso e taxa de fluxo sanguíneo dentro do vaso; considere também a extensão da opacificação necessária, estrutura(s) ou área a ser examinada, processos de doença que afetam o paciente, e equipamento e técnica a serem empregados. Ajustes específicos da dose para idade, sexo, peso e função renal não foram estudados para a injeção de Ioprometo Fuji Yakuhin. Como em todos os agentes de contraste iodados, doses mais baixas podem ter menos risco. A eficácia da injeção de Ioprometo Fuji Yakuhin abaixo das doses recomendadas não foi estabelecida.
- A dose total máxima recomendada de iodo em adultos é de 86 gramas; não foi estabelecida uma dose total máxima recomendada de iodo para pacientes pediátricos.
- Hidratar os pacientes adequadamente antes e após a administração de Ioprometo Fuji Yakuhin.
- O aquecimento do ioprometo Fuji Yakuhin até a temperatura corporal pouco antes da administração pode ajudar a melhorar a tolerabilidade e a facilidade da injeção.
Procedimentos intra-arteriais
O volume e a taxa de injeção do agente de contraste variam de acordo com o local da injeção e a área que está sendo examinada. Injete contraste a taxas aproximadamente iguais à vazão no vaso que está sendo injetado.
- Arteriografia Cerebral (300 mg I / mL), Arteriografia Coronariana e Ventriculografia Esquerda (370 mg I / mL), Arteriografia Periférica (300 mg I / mL), Angiografia Intra-Terial de Subtração Digital (IA-DSA) (150 mg I / mL): veja a tabela 1.
- Aortografia e angiografia visceral (370 mg I / mL) :
Use uma injeção de volume e taxa de contraste proporcional ao fluxo sanguíneo e relacionada às características vasculares e patológicas dos vasos específicos que estão sendo estudados. Não exceda 225 mL como dose total para o procedimento.
Tabela 1: Doses sugeridas de injeção única para procedimentos intra-arteriais para adultos
IA-DSA * (150 mg I / mL) | Arteriografia cerebral (300 mg I / mL) | Arteriografia Periférica (300 mg I / mL) | Arteriografia Coronária e Ventriculografia Esquerda (370 mg I / mL) | ||
Locais de injeção intra-arterial | Artérias carotídeos | 6-10 mL | 3-12 mL | - | - |
Artérias vertebrais | 4-8 mL | 4-12 mL | - | - | |
Injeção de arco da aorta (estudo de 4 vasos) | - | 20-50 mL | - | - | |
Artéria Coronária Direita | - | - | - | 3-14 mL | |
Artéria Coronária Esquerda | - | - | - | 3-14 mL | |
Ventrículo esquerdo | - | - | - | 30-60 mL | |
Aorta | 20-50 mL | - | - | - | |
Grandes ramos da Aorta Abdominal | 2-20 mL | - | - | - | |
Artéria subclávia ou femoral | - | - | 5-40 mL | - | |
Bifurcação aórtica (escoamento distal) | - | - | 25-50 mL | - | |
Dose total máxima | 250 mL | 150 mL | 250 mL | 225 mL | |
* IA-DSA = Angiografia de subtração digital intra-arterial |
Procedimentos intravenosos
- Venografia Periférica (240 mg I / mL) :
Injete o volume mínimo necessário para visualizar satisfatoriamente as estruturas em exame. Não exceda 250 mL como dose total para o procedimento.
- Tomografia computadorizada de contraste (TC) (300 mg I / mL e 370 mg I / mL) e Urografia excretora (300 mg I / mL): ver Tabela 2.
Tabela 2: Dosagem sugerida por injeção de ioprometo de Fuji Yakuhin para administração de contraste intravenoso adulto
Urografia excretora (300 mg I / mL) | Tomografia computadorizada de contraste (300 mg I / mL) | Tomografia computadorizada de contraste (370 mg I / mL) | |
Urografia excretora | Aproximadamente 300 mg I / kg de corpo em peso. (Adultos com função renal normal) | - | - |
Cabeça | - | 50-200 mL | 41-162 mL |
Corpo | |||
Injeção de Bolus | 50-200 mL | 41-162 mL | |
Infusão rápida | 100-200 mL | 81-162 mL | |
Dose total máxima | 100 mL (30 g de iodo) | 200 mL (60 g de iodo) | 162 mL (60 g de iodo) |
Dosagem pediátrica
A dose recomendada em crianças com mais de 2 anos de idade para as seguintes avaliações é:
- Intra-arterial :
Câmaras cardíacas e artérias relacionadas (370 mg I / mL)
Injete 1 a 2 mililitros por quilograma (mL / kg). Não exceda 4 mL / kg como dose total.
- Intravenoso:
Tomografia computadorizada de contraste ou utrografia excretória (300 mg I / mL)
Injete 1 a 2 mL / kg. Não exceda 3 mL / kg como dose total.
As relações de segurança e eficácia de outras doses, concentrações ou procedimentos não foram estabelecidas.
- Inspecione visualmente o ULTRAVIST quanto a partículas e / ou descoloração, sempre que a solução e o recipiente permitirem. Não administre ULTRAVIST se for observado material particulado e / ou descoloração.
- Determine o volume e a concentração da injeção de ULTRAVIST a ser usada levando em consideração fatores como a idade, peso corporal, tamanho do vaso e taxa de fluxo sanguíneo dentro do vaso; considere também a extensão da opacificação necessária, estrutura(s) ou área a ser examinada, processos de doença que afetam o paciente, e equipamento e técnica a serem empregados. Ajustes específicos da dose para idade, sexo, peso e função renal não foram estudados para a injeção de ULTRAVIST. Como em todos os agentes de contraste iodados, doses mais baixas podem ter menos risco. A eficácia da injeção de ULTRAVIST abaixo das doses recomendadas não foi estabelecida.
- A dose total máxima recomendada de iodo em adultos é de 86 gramas; não foi estabelecida uma dose total máxima recomendada de iodo para pacientes pediátricos.
- Hidratar pacientes adequadamente antes e após a administração de ULTRAVIST
- O aquecimento ultravista à temperatura corporal pouco antes da administração pode ajudar a melhorar a tolerabilidade e a facilidade da injeção.
Procedimentos intra-arteriais
O volume e a taxa de injeção do agente de contraste variam de acordo com o local da injeção e a área que está sendo examinada. Injete contraste a taxas aproximadamente iguais à vazão no vaso que está sendo injetado.
- Arteriografia Cerebral (300 mg I / mL), Arteriografia Coronariana e Ventriculografia Esquerda (370 mg I / mL), Arteriografia Periférica (300 mg I / mL), Angiografia Intra-Terial de Subtração Digital (IA-DSA) (150 mg I / mL): veja a tabela 1.
- Aortografia e angiografia visceral (370 mg I / mL) :
Use uma injeção de volume e taxa de contraste proporcional ao fluxo sanguíneo e relacionada às características vasculares e patológicas dos vasos específicos que estão sendo estudados. Não exceda 225 mL como dose total para o procedimento.
Tabela 1: Doses sugeridas de injeção única para procedimentos intra-arteriais para adultos
IA-DSA * (150 mg I / mL) | Arteriografia cerebral (300 mg I / mL) | Arteriografia Periférica (300 mg I / mL) | Arteriografia Coronária e Ventriculografia Esquerda (370 mg I / mL) | ||
Locais de injeção intra-arterial | Artérias carotídeos | 6-10 mL | 3-12 mL | - | - |
Artérias vertebrais | 4-8 mL | 4-12 mL | - | - | |
Injeção de arco da aorta (estudo de 4 vasos) | - | 20-50 mL | - | - | |
Artéria Coronária Direita | - | - | - | 3-14 mL | |
Artéria Coronária Esquerda | - | - | - | 3-14 mL | |
Ventrículo esquerdo | - | - | - | 30-60 mL | |
Aorta | 20-50 mL | - | - | - | |
Grandes ramos da Aorta Abdominal | 2-20 mL | - | - | - | |
Artéria subclávia ou femoral | - | - | 5-40 mL | - | |
Bifurcação aórtica (escoamento distal) | - | - | 25-50 mL | - | |
Dose total máxima | 250 mL | 150 mL | 250 mL | 225 mL | |
* IA-DSA = Angiografia de subtração digital intra-arterial |
Procedimentos intravenosos
- Venografia Periférica (240 mg I / mL) :
Injete o volume mínimo necessário para visualizar satisfatoriamente as estruturas em exame. Não exceda 250 mL como dose total para o procedimento.
- Tomografia computadorizada de contraste (TC) (300 mg I / mL e 370 mg I / mL) e Urografia excretora (300 mg I / mL): ver Tabela 2.
Tabela 2: Dosagem sugerida de injeção de ULTRAVIST para administração de contraste intravenoso de adultos
Urografia excretora (300 mg I / mL) | Tomografia computadorizada de contraste (300 mg I / mL) | Tomografia computadorizada de contraste (370 mg I / mL) | |
Urografia excretora | Aproximadamente 300 mg I / kg de corpo em peso. (Adultos com função renal normal) | - | - |
Cabeça | - | 50-200 mL | 41-162 mL |
Corpo | |||
Injeção de Bolus | 50-200 mL | 41-162 mL | |
Infusão rápida | 100-200 mL | 81-162 mL | |
Dose total máxima | 100 mL (30 g de iodo) | 200 mL (60 g de iodo) | 162 mL (60 g de iodo) |
Dosagem pediátrica
A dose recomendada em crianças com mais de 2 anos de idade para as seguintes avaliações é:
- Intra-arterial :
Câmaras cardíacas e artérias relacionadas (370 mg I / mL)
Injete 1 a 2 mililitros por quilograma (mL / kg). Não exceda 4 mL / kg como dose total.
- Intravenoso:
Tomografia computadorizada de contraste ou utrografia excretória (300 mg I / mL)
Injete 1 a 2 mL / kg. Não exceda 3 mL / kg como dose total.
As relações de segurança e eficácia de outras doses, concentrações ou procedimentos não foram estabelecidas.
- Não administre a injeção de Ioprometo Fuji Yakuhin por via intratecal. A administração intratecal inadvertida pode causar morte, convulsões, hemorragia cerebral, coma, paralisia, aracnoidite, insuficiência renal aguda, parada cardíaca, convulsões, rabdomiólise, hipertermia e edema cerebral.
- Desidratação preparatória (por exemplo, jejum prolongado e administração de um laxante) antes da injeção de Ioprometo Fuji Yakuhin é contra-indicada em pacientes pediátricos devido ao risco de insuficiência renal aguda.
- Não administre Injeção ULTRAVIST intratecalmente. A administração intratecal inadvertida pode causar morte, convulsões, hemorragia cerebral, coma, paralisia, aracnoidite, insuficiência renal aguda, parada cardíaca, convulsões, rabdomiólise, hipertermia e edema cerebral.
- Desidratação preparatória (por exemplo, jejum prolongado e administração de um laxante) antes da injeção de ULTRAVIST ser contra-indicada em pacientes pediátricos devido ao risco de insuficiência renal aguda.
WARNINGS
Included as part of the PRECAUTIONS section.
PRECAUTIONS
Anaphylactoid Reactions
Life-threatening or fatal, anaphylactoid reactions, may occur during or after Iopromide Fuji Yakuhin administration. Manifestations include respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock. Increased risk is associated with a history of previous reaction to a contrast agent (3-fold), a known sensitivity to iodine and known allergic disorders (that is, bronchial asthma, hay fever and food allergies) or other hypersensitivities (2-fold). Exercise extreme caution when considering the use of iodinated contrast agents in patients with these histories or disorders.
Emergency facilities and personnel trained in the treatment of anaphylactoid reactions should be available for at least 30 to 60 minutes after Iopromide Fuji Yakuhin administration.
Contrast Induced Acute Kidney Injury
Acute kidney injury, including renal failure,may occur after intravascular administration of Iopromide Fuji Yakuhin. 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 / paraproteinemia, repetitive and/or large doses of Iopromide Fuji Yakuhin.
Use the lowest necessary dose of Iopromide Fuji Yakuhin in patients with renal impairment. Adequately hydrate patients prior to and following Iopromide Fuji Yakuhin administration.
Cardiovascular Reactions
Iopromide Fuji Yakuhin increases 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, combined renal and cardiac disease, particularly when repetitive and/or large doses are administered.
Among patients who have had cardiovascular reactions, most deaths occurred from the start of injection to 10 minutes later; the main feature was cardiac arrest with cardiovascular disease as the main underlying factor. Isolated reports of hypotensive collapse and shock have been published.
The administration of Iopromide Fuji Yakuhin may cause pulmonary edema in patients with heart failure. Based upon published reports, deaths from the administration of iodinated contrast agents range from 6.6 per 1 million (0.00066 percent) to 1 in 10,000 patients (0.01 percent). Observe patients with preexisting cardiovascular disease for several hours following Iopromide Fuji Yakuhin administration.
Thromboembolic Complications
- Angiography may be associated with local and distal organ damage, ischemia, thromboembolism and organ failure including stroke, brachial plexus palsy, chest pain, myocardial infarction, sinus arrest, hepato-renal function abnormalities. For these reasons, meticulous angiographic techniques are recommended, including close attention to guide wire and catheter manipulation, use of manifold systems and/or three-way stopcocks, frequent catheter flushing with heparinized saline solutions and minimizing the length of the procedure. In angiographic procedures, consider the possibility of dislodging plaques or damaging or perforating the vessel wall with resultant pseudoaneurysms, hemorrhage at puncture site, dissection of coronary artery during catheter manipulations and contrast agent injection. The physicochemical properties of the contrast agent, the dose and the speed of injection can influence the reactions. Test injections to ensure proper catheter placement are suggested. Increased thrombosis and activation of the complement system has also occurred. Specialized personnel, and adequate equipment and facilities for immediate resuscitation and cardioversion are necessary. Monitor electrocardiograms and vital signs throughout the procedure.
- Exercise care when performing venography in patients with suspected thrombosis, phlebitis, severe ischemic disease, local infection, venous thrombosis or a totally obstructed venous system.
- Clotting may occur when blood remains in contact with syringes containing iodinated contrast agents.
- Avoid angiography whenever possible in patients with homocystinuria because of the risk of inducing thrombosis and embolism.
Reactions in Patients with Hyperthyroidism, Pheochromocytoma, or Sickle Cell Disease
Thyroid storm in patients with hyperthyroidism
Thyroid storm has occurred after the intravascular 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 any iodinated contrast agent.
Hypertensive crises in patients with pheochromocytoma
Administer iodinated contrast agents with extreme caution in patients with known or suspected pheochromocytoma. Inject the minimum amount of contrast necessary. Assess the blood pressure throughout the procedure, and have measures for treatment of a hypertensive crisis readily available.
Sickle cell disease
Contrast agents may promote sickling in individuals who are homozygous for sickle cell disease when administered intravascularly.
Extravasation
Extravasation of Iopromide Fuji Yakuhin Injection may cause tissue necrosis and/or compartment syndrome, particularly in patients with severe arterial or venous disease.
Increased Radiation Exposure
The decision to use contrast enhancement is associated with risk and increased radiation exposure. Use contrast after a careful evaluation of clinical, other radiologic data, and the results of non-contrast CT findings, taking into account the increased radiation dose and other risks.
Interference with Image Interpretation
As with other iodinated contrast agents, the use of Iopromide Fuji Yakuhin Injection may obscure some lesions which were seen on non-contrast CT scans. Calcified lesions are less likely to enhance. The enhancement of tumors after therapy may decrease. The opacification of the inferior vermis following contrast agent administration has resulted in false-positive diagnosis. Cerebral infarctions of recent onset may be better visualized with contrast enhancement. However, older infarctions may be obscured by the contrast agent.
In patients with normal blood-brain barriers and renal failure, iodinated contrast agents have been associated with bloodbrain barrier disruption and accumulation of contrast in the brain. Accumulation of contrast in the brain also occurs in patients where the blood-brain barrier is known or suspected to be disrupted.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies have not been performed with iopromide to evaluate carcinogenic potential or effects on fertility. Iopromide was not genotoxic in a series of studies including the Ames test, an in vitro human lymphocytes analysis of chromosomal aberrations, an in vivo mouse micro-nucleus assay, and in an in vivo mouse dominant lethal assay.
Use In Specific Populations
Pregnancy
Pregnancy Category B
Reproduction studies performed with iopromide in rats and rabbits at doses up to 3.7 g I/kg (2.2 times the maximum recommended dose for a 50 kg human, or approximately 0.7 times the human dose following normalization of the data to body surface area estimates) have revealed no evidence of direct harm to the fetus. Embryolethality was observed in rabbits that received 3.7 g I/kg, but this was considered to have been secondary to maternal toxicity. Adequate and wellcontrolled studies in pregnant women have not been conducted. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers
It is not known whether Iopromide Fuji Yakuhin Injection is excreted in human milk. However, many injectable contrast agents are excreted unchanged in human milk. Although it has not been established that serious adverse reactions occur in nursing infants, caution should be exercised when intravascular contrast agents are administered to nursing women because of potential adverse reaction, and consideration should be given to temporarily discontinuing nursing.
Pediatric Use
The safety and efficacy of Iopromide Fuji Yakuhin Injection have been established in the pediatric population over 2 years of age. Use of Iopromide Fuji Yakuhin Injection in these age groups is supported by evidence from adequate and well controlled studies of Iopromide Fuji Yakuhin Injection in adults and additional safety data obtained in literature and other reports in a total of 274 pediatric patients. Of these, there were 131 children (2–12 years), 57 adolescents, and 86 children of unreported or other ages. There were 148 females, 94 males and 32 in whom gender was not reported. The racial distribution was: Caucasian 93 (33.9%), Black 1 (0.4%), Asian 6 (2.2%), and unknown 174 (63.5%). These patients were evaluated in intra-arterial coronary angiographic (n=60), intravenous contrast computerized tomography (CT) (n=87), excretory urography (n=99) and 28 other procedures.
In these pediatric patients, a concentration of 300 mg I/mL was employed for intravenous contrast CT or excretory urography. A concentration of 370 mg I/mL was employed for intra-arterial and intracardiac administration in the radiographic evaluation of the heart cavities and major arteries. Most pediatric patients received initial volumes of 1–2 mL/kg.
Optimal doses of Iopromide Fuji Yakuhin Injection have not been established because different injection volumes, concentrations and injection rates were not studied. The relationship of the volume of injection with respect to the size of the target vascular bed has not been established. The potential need for dose adjustment on the basis of immature renal function has not been established. In the pediatric population, the pharmacokinetic parameters have not been established.
Pediatric patients at higher risk of experiencing an adverse reaction during and after administration of any contrast agent include those with asthma, a sensitivity to medication and/or allergens, cyanotic and acyanotic heart disease, congestive heart failure, or a serum creatinine greater than 1.5 mg/dL. The injection rates in small vascular beds, and the relationship of the dose by volume or concentration in small pediatric patients have not been established. Exercise caution in selecting the dose.
Safety and effectiveness in pediatric patients below the age of two have not been established.
Geriatric Use
Middle-aged and elderly patients, without significantly impaired renal function, who received Iopromide Fuji Yakuhin Injection in doses corresponding to 9–30 g iodine, had mean steady-state volumes of distribution that ranged between 30–40 L. Mean total and renal clearances were between 81–125 mL/min and 70–115 mL/min respectively in these patients, and were similar to the values found in the young volunteers. The distribution phase half-life in this patient population was 0.1 hour, the main elimination phase half-life was 2.3 hours, and the terminal elimination phase half-life was 40 hours. The urinary excretion (97% of the dose) and fecal excretion (2%) was comparable to that observed in young healthy volunteers, suggesting that, compared to the renal route, biliary and/or gastrointestinal excretion is not significant for iopromide.
Renal Impairment
In patients with renal impairment, opacification of the calyces and pelves by iopromide may be delayed due to slower renal excretion of iopromide.
A pharmacokinetic study in patients with mild (n=2), moderate (n=6), and severe (n=3) renal impairment was conducted. The total clearance of iopromide was decreased proportionately to the baseline decrease in creatinine clearance. The plasma AUC increased about 2-fold in patients with moderate renal impairment and 6-fold in patients with severe renal impairment compared to subjects with normal renal function. The terminal half-life increased from 2.2 hrs for subjects with normal renal function to 11.6 hrs in patients with severe renal impairment. The peak plasma concentration of iopromide was not influenced by the extent of renal impairment. Exercise caution and use the lowest necessary dose of Iopromide Fuji Yakuhin in patients with renal dysfunction.
WARNINGS
Included as part of the PRECAUTIONS section.
PRECAUTIONS
Anaphylactoid Reactions
Life-threatening or fatal, anaphylactoid reactions, may occur during or after ULTRAVIST administration. Manifestations include respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock. Increased risk is associated with a history of previous reaction to a contrast agent (3-fold), a known sensitivity to iodine and known allergic disorders (that is, bronchial asthma, hay fever and food allergies) or other hypersensitivities (2-fold). Exercise extreme caution when considering the use of iodinated contrast agents in patients with these histories or disorders.
Emergency facilities and personnel trained in the treatment of anaphylactoid reactions should be available for at least 30 to 60 minutes after ULTRAVIST administration.
Contrast Induced Acute Kidney Injury
Acute kidney injury, including renal failure,may occur after intravascular administration of ULTRAVIST. 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 / paraproteinemia, repetitive and/or large doses of ULTRAVIST.
Use the lowest necessary dose of ULTRAVIST in patients with renal impairment. Adequately hydrate patients prior to and following ULTRAVIST administration.
Cardiovascular Reactions
ULTRAVIST increases 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, combined renal and cardiac disease, particularly when repetitive and/or large doses are administered.
Among patients who have had cardiovascular reactions, most deaths occurred from the start of injection to 10 minutes later; the main feature was cardiac arrest with cardiovascular disease as the main underlying factor. Isolated reports of hypotensive collapse and shock have been published.
The administration of ULTRAVIST may cause pulmonary edema in patients with heart failure. Based upon published reports, deaths from the administration of iodinated contrast agents range from 6.6 per 1 million (0.00066 percent) to 1 in 10,000 patients (0.01 percent). Observe patients with preexisting cardiovascular disease for several hours following ULTRAVIST administration.
Thromboembolic Complications
- Angiography may be associated with local and distal organ damage, ischemia, thromboembolism and organ failure including stroke, brachial plexus palsy, chest pain, myocardial infarction, sinus arrest, hepato-renal function abnormalities. For these reasons, meticulous angiographic techniques are recommended, including close attention to guide wire and catheter manipulation, use of manifold systems and/or three-way stopcocks, frequent catheter flushing with heparinized saline solutions and minimizing the length of the procedure. In angiographic procedures, consider the possibility of dislodging plaques or damaging or perforating the vessel wall with resultant pseudoaneurysms, hemorrhage at puncture site, dissection of coronary artery during catheter manipulations and contrast agent injection. The physicochemical properties of the contrast agent, the dose and the speed of injection can influence the reactions. Test injections to ensure proper catheter placement are suggested. Increased thrombosis and activation of the complement system has also occurred. Specialized personnel, and adequate equipment and facilities for immediate resuscitation and cardioversion are necessary. Monitor electrocardiograms and vital signs throughout the procedure.
- Exercise care when performing venography in patients with suspected thrombosis, phlebitis, severe ischemic disease, local infection, venous thrombosis or a totally obstructed venous system.
- Clotting may occur when blood remains in contact with syringes containing iodinated contrast agents.
- Avoid angiography whenever possible in patients with homocystinuria because of the risk of inducing thrombosis and embolism.
Reactions in Patients with Hyperthyroidism, Pheochromocytoma, or Sickle Cell Disease
Thyroid storm in patients with hyperthyroidism
Thyroid storm has occurred after the intravascular 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 any iodinated contrast agent.
Hypertensive crises in patients with pheochromocytoma
Administer iodinated contrast agents with extreme caution in patients with known or suspected pheochromocytoma. Inject the minimum amount of contrast necessary. Assess the blood pressure throughout the procedure, and have measures for treatment of a hypertensive crisis readily available.
Sickle cell disease
Contrast agents may promote sickling in individuals who are homozygous for sickle cell disease when administered intravascularly.
Extravasation
Extravasation of ULTRAVIST Injection may cause tissue necrosis and/or compartment syndrome, particularly in patients with severe arterial or venous disease.
Increased Radiation Exposure
The decision to use contrast enhancement is associated with risk and increased radiation exposure. Use contrast after a careful evaluation of clinical, other radiologic data, and the results of non-contrast CT findings, taking into account the increased radiation dose and other risks.
Interference with Image Interpretation
As with other iodinated contrast agents, the use of ULTRAVIST Injection may obscure some lesions which were seen on non-contrast CT scans. Calcified lesions are less likely to enhance. The enhancement of tumors after therapy may decrease. The opacification of the inferior vermis following contrast agent administration has resulted in false-positive diagnosis. Cerebral infarctions of recent onset may be better visualized with contrast enhancement. However, older infarctions may be obscured by the contrast agent.
In patients with normal blood-brain barriers and renal failure, iodinated contrast agents have been associated with bloodbrain barrier disruption and accumulation of contrast in the brain. Accumulation of contrast in the brain also occurs in patients where the blood-brain barrier is known or suspected to be disrupted.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies have not been performed with iopromide to evaluate carcinogenic potential or effects on fertility. Iopromide was not genotoxic in a series of studies including the Ames test, an in vitro human lymphocytes analysis of chromosomal aberrations, an in vivo mouse micro-nucleus assay, and in an in vivo mouse dominant lethal assay.
Use In Specific Populations
Pregnancy
Pregnancy Category B
Reproduction studies performed with iopromide in rats and rabbits at doses up to 3.7 g I/kg (2.2 times the maximum recommended dose for a 50 kg human, or approximately 0.7 times the human dose following normalization of the data to body surface area estimates) have revealed no evidence of direct harm to the fetus. Embryolethality was observed in rabbits that received 3.7 g I/kg, but this was considered to have been secondary to maternal toxicity. Adequate and wellcontrolled studies in pregnant women have not been conducted. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers
Pediatric Use
The safety and efficacy of ULTRAVIST Injection have been established in the pediatric population over 2 years of age. Use of ULTRAVIST Injection in these age groups is supported by evidence from adequate and well controlled studies of ULTRAVIST Injection in adults and additional safety data obtained in literature and other reports in a total of 274 pediatric patients. Of these, there were 131 children (2–12 years), 57 adolescents, and 86 children of unreported or other ages. There were 148 females, 94 males and 32 in whom gender was not reported. The racial distribution was: Caucasian 93 (33.9%), Black 1 (0.4%), Asian 6 (2.2%), and unknown 174 (63.5%). These patients were evaluated in intra-arterial coronary angiographic (n=60), intravenous contrast computerized tomography (CT) (n=87), excretory urography (n=99) and 28 other procedures.
In these pediatric patients, a concentration of 300 mg I/mL was employed for intravenous contrast CT or excretory urography. A concentration of 370 mg I/mL was employed for intra-arterial and intracardiac administration in the radiographic evaluation of the heart cavities and major arteries. Most pediatric patients received initial volumes of 1–2 mL/kg.
Optimal doses of ULTRAVIST Injection have not been established because different injection volumes, concentrations and injection rates were not studied. The relationship of the volume of injection with respect to the size of the target vascular bed has not been established. The potential need for dose adjustment on the basis of immature renal function has not been established. In the pediatric population, the pharmacokinetic parameters have not been established.
Pediatric patients at higher risk of experiencing an adverse reaction during and after administration of any contrast agent include those with asthma, a sensitivity to medication and/or allergens, cyanotic and acyanotic heart disease, congestive heart failure, or a serum creatinine greater than 1.5 mg/dL. The injection rates in small vascular beds, and the relationship of the dose by volume or concentration in small pediatric patients have not been established. Exercise caution in selecting the dose.
Safety and effectiveness in pediatric patients below the age of two have not been established.
Geriatric Use
Middle-aged and elderly patients, without significantly impaired renal function, who received ULTRAVIST Injection in doses corresponding to 9–30 g iodine, had mean steady-state volumes of distribution that ranged between 30–40 L. Mean total and renal clearances were between 81–125 mL/min and 70–115 mL/min respectively in these patients, and were similar to the values found in the young volunteers. The distribution phase half-life in this patient population was 0.1 hour, the main elimination phase half-life was 2.3 hours, and the terminal elimination phase half-life was 40 hours. The urinary excretion (97% of the dose) and fecal excretion (2%) was comparable to that observed in young healthy volunteers, suggesting that, compared to the renal route, biliary and/or gastrointestinal excretion is not significant for iopromide.
Renal Impairment
In patients with renal impairment, opacification of the calyces and pelves by iopromide may be delayed due to slower renal excretion of iopromide.
A pharmacokinetic study in patients with mild (n=2), moderate (n=6), and severe (n=3) renal impairment was conducted. The total clearance of iopromide was decreased proportionately to the baseline decrease in creatinine clearance. The plasma AUC increased about 2-fold in patients with moderate renal impairment and 6-fold in patients with severe renal impairment compared to subjects with normal renal function. The terminal half-life increased from 2.2 hrs for subjects with normal renal function to 11.6 hrs in patients with severe renal impairment. The peak plasma concentration of iopromide was not influenced by the extent of renal impairment. Exercise caution and use the lowest necessary dose of ULTRAVIST in patients with renal dysfunction.
The most important adverse drug reactions in patients receiving Iopromide Fuji Yakuhin 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 Iopromide Fuji Yakuhin 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 Iopromide Fuji Yakuhin group: see Table 3.
Table 3: ADVERSE REACTIONS REPORTED IN > 1% OF PATIENTS WHO RECEIVED Iopromide Fuji Yakuhin INJECTION IN CLINICAL TRIALS
System Organ Class | Adverse Reaction | Iopromide Fuji Yakuhin Injection N=1142 (%) |
Nervous system disorders | Headache | 46 (4) |
Dysgeusia | 15 (1.3) | |
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) |
Vomiting | 22 (1.9) | |
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) |
Pain | 13 (1.4) |
One or more adverse reactions were recorded in 273 of 1142 (24%) patients during the clinical trials, coincident with the administration of Iopromide Fuji Yakuhin Injection or within the defined duration of the study follow-up period (24–72 hours). Iopromide Fuji Yakuhin 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 Iopromide Fuji Yakuhin Injection. In clinical trials 7/1142 patients given Iopromide Fuji Yakuhin Injection died 5 days or later after drug administration. Also, 10/1142 patients given Iopromide Fuji Yakuhin Injection had serious adverse events.
The following adverse reactions were observed in ≤ 1% of the subjects receiving Iopromide Fuji Yakuhin 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.
Postmarketing Experience
The following adverse reactions have been identified during post approval use of Iopromide Fuji Yakuhin 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 Iopromide Fuji Yakuhin 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: 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.
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 N=1142 (%) |
Nervous system disorders | Headache | 46 (4) |
Dysgeusia | 15 (1.3) | |
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) |
Vomiting | 22 (1.9) | |
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) |
Pain | 13 (1.4) |
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.
Postmarketing 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: 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.
Os efeitos adversos da superdosagem são fatais e afetam principalmente os sistemas pulmonar e cardiovascular. O tratamento de uma superdosagem é direcionado para o apoio de todas as funções vitais e para a pronta instituição de terapia sintomática.
A injeção de ioprometo Fuji Yakuhin se liga de maneira insignificante às proteínas plasmáticas ou séricas e, portanto, pode ser dialisada.
Os efeitos adversos da superdosagem são fatais e afetam principalmente os sistemas pulmonar e cardiovascular. O tratamento de uma superdosagem é direcionado para o apoio de todas as funções vitais e para a pronta instituição de terapia sintomática.
A injeção de ULTRAVIST se liga de maneira insignificante ao plasma ou proteína sérica e pode, portanto, ser dialisada.
Após a administração de Ioprometo Fuji Yakuhin, o grau de aprimoramento do contraste está diretamente relacionado ao teor de iodo na dose administrada; os níveis plasmáticos máximos de iodo ocorrem imediatamente após a injeção intravenosa rápida. Os níveis plasmáticos de iodo caem rapidamente em 5 a 10 minutos. Isso pode ser explicado pela diluição nos compartimentos de líquidos vasculares e extravasculares.
Contraste intravascular: O aprimoramento do contraste parece ser maior imediatamente após as injeções em bolus (15 segundos a 120 segundos). Assim, o maior aprimoramento pode ser detectado por uma série de varreduras consecutivas de dois a três segundos, realizadas dentro de 30 a 90 segundos após a injeção (ou seja, imagens tomográficas computadorizadas dinâmicas).
Ioprometo A injeção de Fuji Yakuhin pode ser visualizada no parênquima renal dentro de 30 a 60 segundos após a rápida injeção intravenosa. A opacificação dos cálices e pélvulas em pacientes com função renal normal se torna aparente em 1 a 3 minutos, com contraste ideal ocorrendo em 5 a 15 minutos.
Em contraste, a TC, algumas características de desempenho são diferentes no cérebro e no corpo. Em contraste, a TC do corpo, os agentes de contraste iodados se difundem rapidamente do espaço vascular para o espaço extravascular. Após a administração de agentes de contraste iodados, o aumento da densidade do tecido para raios-x está relacionado ao fluxo sanguíneo, à concentração do agente de contraste e à extração do agente de contraste por vários tecidos intersticiais. O aprimoramento do contraste é, portanto, devido a quaisquer diferenças relativas na difusão extravascular entre os tecidos adjacentes.
No cérebro normal com uma barreira hematoencefálica intacta, o contraste é geralmente devido à presença de agente de contraste iodado no espaço intravascular. O aprimoramento radiográfico das lesões vasculares, como malformações arteriovenosas e aneurismas, depende do teor de iodo da poça de sangue circulante.
Nos tecidos com uma ruptura na barreira hematoencefálica, o agente de contraste se acumula no tecido cerebral intersticial. O tempo até o aprimoramento máximo do contraste pode variar desde o momento em que os níveis máximos de iodo no sangue são atingidos até 1 hora após a administração intravenosa do bolus. Esse atraso sugere que o aprimoramento do contraste radiográfico depende pelo menos em parte do acúmulo de iodo contendo meio dentro da lesão e fora da poça de sangue. O mecanismo pelo qual isso ocorre não está claro.
Para informações sobre parâmetros de coagulação, fibrinólise e sistema de complemento.
Após a administração de ULTRAVIST, o grau de aumento do contraste está diretamente relacionado ao teor de iodo na dose administrada; os níveis plasmáticos máximos de iodo ocorrem imediatamente após a rápida injeção intravenosa. Os níveis plasmáticos de iodo caem rapidamente em 5 a 10 minutos. Isso pode ser explicado pela diluição nos compartimentos de líquidos vasculares e extravasculares.
Contraste intravascular: O aprimoramento do contraste parece ser maior imediatamente após as injeções em bolus (15 segundos a 120 segundos). Assim, o maior aprimoramento pode ser detectado por uma série de varreduras consecutivas de dois a três segundos, realizadas dentro de 30 a 90 segundos após a injeção (ou seja, imagens tomográficas computadorizadas dinâmicas).
A injeção de ULTRAVIST pode ser visualizada no parênquima renal dentro de 30 a 60 segundos após a injeção intravenosa rápida. A opacificação dos cálices e pélvulas em pacientes com função renal normal se torna aparente em 1 a 3 minutos, com contraste ideal ocorrendo em 5 a 15 minutos.
Em contraste, a TC, algumas características de desempenho são diferentes no cérebro e no corpo. Em contraste, a TC do corpo, os agentes de contraste iodados se difundem rapidamente do espaço vascular para o espaço extravascular. Após a administração de agentes de contraste iodados, o aumento da densidade do tecido para raios-x está relacionado ao fluxo sanguíneo, à concentração do agente de contraste e à extração do agente de contraste por vários tecidos intersticiais. O aprimoramento do contraste é, portanto, devido a quaisquer diferenças relativas na difusão extravascular entre os tecidos adjacentes.
No cérebro normal com uma barreira hematoencefálica intacta, o contraste é geralmente devido à presença de agente de contraste iodado no espaço intravascular. O aprimoramento radiográfico das lesões vasculares, como malformações arteriovenosas e aneurismas, depende do teor de iodo da poça de sangue circulante.
Nos tecidos com uma ruptura na barreira hematoencefálica, o agente de contraste se acumula no tecido cerebral intersticial. O tempo até o aprimoramento máximo do contraste pode variar desde o momento em que os níveis máximos de iodo no sangue são atingidos até 1 hora após a administração intravenosa do bolus. Esse atraso sugere que o aprimoramento do contraste radiográfico depende pelo menos em parte do acúmulo de iodo contendo meio dentro da lesão e fora da poça de sangue. O mecanismo pelo qual isso ocorre não está claro.
Para informações sobre parâmetros de coagulação, fibrinólise e sistema de complemento.
Distribuição
Após administração intravenosa a jovens voluntários saudáveis, o perfil do tempo de concentração plasmática de ioprômides mostra uma fase inicial de distribuição com meia-vida de 0,24 horas; uma fase principal de eliminação com meia-vida de 2 horas; e uma fase de eliminação terminal com meia-vida de 6,2 horas. O volume total de distribuição no estado estacionário é de cerca de 16 L, sugerindo distribuição no espaço extracelular. A ligação plasmática do ioprometo é de 1%.
Agentes de contraste iodados podem atravessar a barreira hematoencefálica.
Metabolismo
O ioprometo não é metabolizado.
Eliminação
As quantidades excretadas inalteradas na urina representam 97% da dose em indivíduos jovens e saudáveis. Apenas 2% da dose é recuperada nas fezes. Recuperações semelhantes na urina e fezes são observadas em pacientes de meia idade e idosos. Esse achado sugere que, comparado à via renal, a excreção biliar e / ou gastrointestinal não é importante para o ioprometo. Durante a fase terminal mais lenta, apenas 3% da dose é eliminada; 97% da dose é descartada durante as fases anteriores, a maior parte das quais ocorre durante a fase principal de eliminação. A razão entre a depuração renal do ioprometo e a depuração da creatinina é de 0,82, sugerindo que o ioprometo é principalmente excretado pela filtração glomerular. Reabsorção tubular adicional é possível. A farmacocinética do ioprometo em doses intravenosas de até 80 g de iodo é proporcional à dose e de primeira ordem.
As folgas totais e renais médias são 107 mL / min e 104 mL / min, respectivamente.