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-M is indicated for intrathecal administration in adult neuroradiology including myelography , and for contrast enhancement of computed tomographic cisternography and ventriculography. ISOVUE-M 200 is indicated for thoraco-lumbar myelography in children over the age of two years.
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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, colorlessto pale yellow solution available in the following concentrationsof iodine:
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following adverse reactions are describedin greater detail in other sections:
- 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 ofAge
- 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 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 4 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 reactionshave been identified during post approval use of ISOVUE. Because thereactions are reported voluntarily from a population of uncertainsize, it is not always possible to reliably estimate their frequencyor to establish a causal relationship to drug exposure.
Blood and lymphatic systemdisorders: thrombocytopenia
Cardiovascular disorders: cardiopulmonary arrest, cardiac decompensation, arrhythmias, myocardialinfarction, 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: lacrimationincreased, conjunctivitis, eye pruritus, transient blindness, visualdisturbance, photophobia
Gastrointestinal disorders: retching, abdominalpain, salivary hypersecretion, salivary gland enlargement
General disorders andadministration site conditions: injection site pain, malaise
Immune system disorders: anaphylaxis characterized by cardiovascular, respiratory, and cutaneousmanifestations (e.g., chest tightness, laryngeal edema, periorbitaledema, facial edema); delayed hypersensitivity reactions includinggeneralized maculopapular rash, erythema, pruritus, localized blistering,skin peeling
Musculoskeletal disorders: compartment syndrome followingextravasation, muscle spasm, musculoskeletal pain, muscular weakness
Nervous system disorders: coma, seizure, tremors, syncope, depressed level of consciousnessor loss of consciousness, encephalopathy
Psychiatric disorders: confusionalstate
Respiratorysystem disorders: respiratory arrest, respiratory failure,acute respiratory distress syndrome, respiratory distress, apnea,asthma, sneezing, choking, laryngeal edema, bronchospasm, rhinitis
Skin and subcutaneoustissue disorders: Stevens-Johnson syndrome and toxic epidermalnecrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP),erythema multiforme and drug reaction with eosinophilia and systemicsymptoms (DRESS), skin necrosis, 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 or intravenous 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:
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 organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg (0.001 mEq) sodium) and 1 mg tromethamine.
- ISOVUE 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg organically bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg (0.002 mEq) sodium) and 1 mg tromethamine.
- ISOVUE 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg (0.002 mEq) sodium) and 1 mg tromethamine.
- ISOVUE 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg organically bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg (0.002 mEq) 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 5. 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.
Revised October 2025