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Generic Name

Iopamidol

Brand Names
Isovue 200, Isovue 250, Isovue 300, Isovue 370, Isovue-M
FDA approval date: December 31, 1985
Classification: Radiographic Contrast Agent
Form: Injection

What is Isovue 200 (Iopamidol)?

ISOVUE is indicated for angiography throughout the cardiovascular system, including cerebral and peripheral arteriography, coronary arteriography and ventriculography, pediatric angiocardiography, selective visceral arteriography and aortography, peripheral venography , and adult and pediatric intravenous excretory urography and intravenous adult and pediatric contrast enhancement of computed tomographic head and body imaging. CECT Head Imaging ISOVUE may be used to refine diagnostic precision in areas of the brain which may not otherwise have been satisfactorily visualized. Tumors ISOVUE may be useful to investigate the presence and extent of certain malignancies such as: gliomas including malignant gliomas, glioblastomas, astrocytomas, oligodendrogliomas and gangliomas, ependymomas, medulloblastomas, meningiomas, neuromas, pinealomas, pituitary adenomas, craniopharyngiomas, germinomas, and metastatic lesions. The usefulness of contrast enhancement for the investigation of the retrobulbar space and in cases of low grade or infiltrative glioma has not been demonstrated. In calcified lesions, there is less likelihood of enhancement. Following therapy, tumors may show decreased or no enhancement. The opacification of the inferior vermis following contrast media administration has resulted in false-positive diagnosis in a number of otherwise normal studies. Nonneoplastic Conditions ISOVUE may be beneficial in the image enhancement of nonneoplastic lesions. Cerebral infarctions of recent onset may be better visualized with contrast enhancement, while some infarctions are obscured if contrast media are used. The use of iodinated contrast media results in contrast enhancement in about 60 percent of cerebral infarctions studied from one to four weeks from the onset of symptoms. Sites of active infection may also be enhanced following contrast media administration. Arteriovenous malformations and aneurysms will show contrast enhancement. For these vascular lesions, the enhancement is probably dependent on the iodine content of the circulating blood pool. Hematomas and intraparenchymal bleeders seldom demonstrate any contrast enhancement. However, in cases of intraparenchymal clot, for which there is no obvious clinical explanation, contrast media administration may be helpful in ruling out the possibility of associated arteriovenous malformation. CECT Body Imaging ISOVUE may be used for enhancement of computed tomographic images for detection and evaluation of lesions in the liver, pancreas, kidneys, aorta, mediastinum, abdominal cavity, pelvis and retroperitoneal space. Enhancement of computed tomography with ISOVUE may be of benefit in establishing diagnoses of certain lesions in these sites with greater assurance than is possible with CT alone, and in supplying additional features of the lesions . In other cases, the contrast agent may allow visualization of lesions not seen with CT alone , or may help to define suspicious lesions seen with unenhanced CT . Contrast enhancement appears to be greatest within 60 to 90 seconds after bolus administration of contrast agent. Therefore, utilization of a continuous scanning technique may improve enhancement and diagnostic assessment of tumor and other lesions such as an abscess, occasionally revealing unsuspected or more extensive disease. For example, a cyst may be distinguished from a vascularized solid lesion when precontrast and enhanced scans are compared; the nonperfused mass shows unchanged x-ray absorption . A vascularized lesion is characterized by an increase in CT number in the few minutes after a bolus of intravascular contrast agent; it may be malignant, benign, or normal tissue, but would probably not be a cyst, hematoma, or other nonvascular lesion. Because unenhanced scanning may provide adequate diagnostic information in the individual patient, the decision to employ contrast enhancement, which may be associated with risk and increased radiation exposure, should be based upon a careful evaluation of clinical, other radiological, and unenhanced CT findings.

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Brand Information

    ISOVUE (IOPAMIDOL)
    WARNING: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION
    Intrathecal administration of ISOVUE, even if inadvertent, can cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema
    1DOSAGE FORMS AND STRENGTHS
    Injection: Clear, colorless to pale yellow solution available in the following concentrations of iodine:
    2CONTRAINDICATIONS
    None.
    3ADVERSE REACTIONS
    The following adverse reactions are described in greater detail elsewhere in the labeling:
    • Risks Associated with Intrathecal Administration
    • Hypersensitivity Reactions
    • Acute Kidney Injury
    • Cardiovascular Adverse Reactions
    • Thromboembolic Events
    • Extravasation and Injection Site Reactions
    • Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age
    • Severe Cutaneous Adverse Reactions
    3.1Clinical 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 the rates observed in practice.
    Adverse Reactions from Intra-arterial or Intravenous Use in Adults
    The safety of ISOVUE was evaluated in 2,246 adult patients receiving ISOVUE by intra-arterial or intravenous route in clinical studies. Table 6 shows the common adverse reactions (>1%).
    The following adverse reactions occurred in ≤ 1% of patients receiving intra-arterial or intravenous injection of ISOVUE:
    Cardiovascular disorders: tachycardia, hypotension, hypertension, myocardial ischemia, circulatory collapse, S-T segment depression, bigeminy, extrasystoles, ventricular fibrillation, angina pectoris, bradycardia, transient ischemic attack, thrombophlebitis
    Gastrointestinal disorders: vomiting, anorexia
    General disorders: headache, fever, chills, excessive sweating, back spasm
    Nervous system disorders: vasovagal reaction, tingling in arms, grimace, faintness
    Renal and urinary disorders: urinary retention
    Respiratory: throat constriction, dyspnea, pulmonary edema
    Skin and subcutaneous tissues: rash, urticaria, pruritus, flushing
    Special senses: taste alterations, nasal congestion, visual disturbances
    Adverse Reactions from Intra-arterial Use in Pediatric Patients
    In a clinical trial with 76 pediatric patients undergoing angiocardiography, two adverse reactions (2.6%) were reported: worsening cyanosis and worsening peripheral perfusion.
    Adverse Reactions from Oral Use in Adult and Pediatric Patients
    There were no new adverse reactions from oral use of ISOVUE in adult and pediatric patients
    3.2Postmarketing Experience
    The following adverse reactions have been identified during post approval use of ISOVUE or other iopamidol-containing products by intra-arterial, intravenous, or oral administration. Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure.
    Blood and lymphatic system disorders: thrombocytopenia
    Cardiovascular disorders: cardiopulmonary arrest, cardiac decompensation, arrhythmias, myocardial infarction, shock, electrocardiographic changes (e.g., increased QTc, increased R-R, increased T-wave amplitude), decreased systolic pressure, deep vein thrombosis, arterial spasms, vasodilation, chest pain, pallor
    Endocrine disorders: hyperthyroidism, hypothyroidism
    Eye disorders: lacrimation increased, conjunctivitis, eye pruritus, transient blindness, visual disturbance, photophobia, eyelid edema
    Gastrointestinal disorders: nausea, vomiting, diarrhea, retching, esophageal pain, abdominal pain, salivary hypersecretion, salivary gland enlargement, oral paresthesia, lip swelling
    General disorders and administration site conditions: injection site pain, malaise
    Immune system disorders: anaphylaxis characterized by cardiovascular, respiratory, and cutaneous manifestations (e.g., chest tightness, laryngeal edema, periorbital edema, facial edema); delayed hypersensitivity reactions including generalized maculopapular rash, erythema, pruritus, localized blistering, skin peeling
    Musculoskeletal disorders: compartment syndrome following extravasation, muscle spasm, musculoskeletal pain, muscular weakness
    Nervous system disorders: coma, seizure, tremors, syncope, depressed level of consciousness or loss of consciousness, encephalopathy
    Psychiatric disorders: confusional state
    Respiratory system disorders: respiratory arrest, respiratory failure, acute respiratory distress syndrome, respiratory distress, apnea, asthma, sneezing, choking, laryngeal edema, bronchospasm, rhinitis
    Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP), erythema multiforme and drug reaction with eosinophilia and systemic symptoms (DRESS), skin necrosis, urticaria, face edema
    4OVERDOSAGE
    The manifestations of overdosage are life-threatening and affectmainly the pulmonary and cardiovascular systems. Treatment of an overdoseis directed toward support of all vital functions and the prompt institutionof symptomatic therapy. Iopamidol can be removed by dialysis.
    5DESCRIPTION
    ISOVUE (iopamidol) injection is a radiographic contrast agent for intra-arterial, intravenous, or oral use.
    Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5- lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C17H22I3N3O8, and the following structural formula:  
    iopamidol-structure
    ISOVUE is a sterile, clear, colorless to pale yellow solution available in four concentrations of iodine:
    • ISOVUE 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg sodium) and 1 mg tromethamine.
    • ISOVUE 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg sodium) and 1 mg tromethamine.
    • ISOVUE 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg sodium) and 1 mg tromethamine.
    • ISOVUE 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg sodium) and 1 mg tromethamine.
    The pH of ISOVUE has been adjusted to 6.5 to 7.5 with hydrochloric acid and/or sodium hydroxide.
    Physicochemical characteristics are shown in Table 7. ISOVUE is hypertonic as compared to plasma and cerebrospinal fluid (approximately 285 and 301 mOsm/kg water, respectively).
    6CLINICAL STUDIES
    Oral Administration for CT of the Abdomen and Pelvis
    The safety and effectiveness of orally administered ISOVUE for CT of the abdomen and pelvis were evaluated in a study in which previously collected images were prospectively re-read from 218 consecutive patients, including 152 adult patients and 66 pediatric patients aged 3 to 16 years, who underwent CT of the abdomen and pelvis after oral ISOVUE administration. Patients who received ISOVUE by enteral tube, who had suspected bowel obstruction, or who had history of surgery altering bowel transit time were excluded. CT images were evaluated by three blinded, independent readers who assessed delineation of each of five segments of the gastrointestinal tract (stomach, duodenum, jejunum, proximal ileum, and distal ileum) using a three-point scale (poor, sufficient, good). Segments rated as sufficient or good were defined as having adequate anatomic delineation. Patients were considered to have adequate delineation if at least three of the five segments were rated as adequate.
    All 218 patients had evaluable CT images. Patient age ranged from 3 years to 97 years, with a mean of 39 years. Patients were 55% female, 75% White, 9% Black or African American, 4% Asian, and <1% Native Hawaiian or Other Pacific Islander, with race not reported or unknown in 12% of patients. ISOVUE was also administered intravenously in 213 (98%) patients.
    The percentage of patients with adequate anatomic delineation of the gastrointestinal tract was 77%, 81%, and 97% for the three readers with lower bounds of the 95% confidence intervals of 71%, 75%, and 94%, respectively.
    7HOW SUPPLIED/STORAGE AND HANDLING
    How Supplied
    ISOVUE (iopamidol) injection is a clear, colorless to pale yellow solution available in the following presentations:
    Storage and Handling
    Store at 20°C to 25°C (68°F to 77°F) [See USP controlled room temperature]. Protect from light.
    8PATIENT COUNSELING INFORMATION
    Hypersensitivity Reactions
    Advise the patient concerning the risk of hypersensitivity reactions that can occur both during and after ISOVUE administration. Advise the patient to report any signs or symptoms of hypersensitivity reactions during the procedure and to seek immediate medical attention for any signs or symptoms experienced after discharge
    Advise patients to inform their physician if they develop a rash after receiving ISOVUE
    Acute Kidney Injury
    Advise the patient concerning appropriate hydration to decrease the risk of contrast induced kidney injury
    Extravasation
    If extravasation occurs during injection, advise patients to seek medical care for progression of symptoms
    Thyroid Dysfunction
    Advise parents/caregivers about the risk of developing thyroid dysfunction after ISOVUE administration. Advise parents/caregivers about when to seek medical care for their child to monitor for thyroid function
    Lactation
    Advise a lactating woman that interruption of breastfeeding is not necessary, however, to minimize exposure to a breastfed infant, a lactating woman may consider pumping and discarding breast milk for 10 hours after ISOVUE administration
    Manufactured for:
    Manufactured by:
    ISOVUE is a registered trademark of Bracco Diagnostics Inc.
    Isovue 200 has been selected.