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.
Top Global Experts
Save this treatment for later
Not sure about your diagnosis?
Related Clinical Trials
Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy: A Prospective, Randomized, Non-Inferiority Trial
Summary: This phase II trial compares the effect of rectus sheath block with liposomal bupivacaine to thoracic epidural analgesia (TEA) on pain control in patients following surgical removal of all or part of the pancreas and duodenectomy (pancreatoduodenectomy). Administering long acting local anesthetics, such as liposomal bupivacaine, in between the muscle layers of the abdomen (rectus sheath block) may...
Related Latest Advances
Brand Information
ISOVUE (IOPAMIDOL)
WARNING: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION
Intrathecal administration,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 areconducted under widely varying conditions, adverse reaction ratesobserved in the clinical trials of a drug cannot be directly comparedto rates in the clinical trials of another drug and may not reflectthe rates observed in practice.
Adverse Reactions in Adults
The safety of ISOVUEwas evaluated in 2,246 adult patients receiving ISOVUE by intra-arterialor intravenous route in clinical studies. Table 4 shows the commonadverse reactions (>1%).
The following adversereactions occurred in ≤ 1% of patients receiving intra-arterial orintravenous injection of ISOVUE:
Cardiovascular disorders: tachycardia, hypotension, hypertension, myocardial ischemia, circulatorycollapse, S-T segment depression, bigeminy, extrasystoles, ventricularfibrillation, 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, pulmonaryedema
Skinand subcutaneous tissues: rash, urticaria, pruritus, flushing
Special senses: taste alterations, nasal congestion, visual disturbances
Adverse Reactions inPediatric Patients
In a clinical trial with 76 pediatric patientsundergoing angiocardiography, two adverse reactions (2.6%) were reported:worsening cyanosis and worsening peripheral perfusion.
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) injectionis a radiographic contrast agent for intra-arterial or intravenoususe.
Iopamidol isdesignated 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 empiricalformula of C17H22I3N3O8, and the following structural formula:
ISOVUE is a sterile, clear, colorless topale 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 inactiveingredients: 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 inactiveingredients: 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 inactiveingredients: 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 inactiveingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg(0.002 mEq) sodium) and 1 mg tromethamine.
The pH of ISOVUE hasbeen adjusted to 6.5 to 7.5 with hydrochloric acid and/or sodium hydroxide.
Physicochemical characteristicsare shown in Table 5. ISOVUE is hypertonic as compared to plasma andcerebrospinal fluid (approximately 285 and 301 mOsm/kg water, respectively).
6HOW 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.
7PATIENT COUNSELING INFORMATION
Hypersensitivity Reactions
Advise the patientconcerning the risk of hypersensitivity reactions that can occur bothduring and after ISOVUE administration. Advise the patient to reportany signs or symptoms of hypersensitivity reactions during the procedureand to seek immediate medical attention for any signs or symptomsexperienced after discharge
Advise patients to inform their physicianif they develop a rash after receiving ISOVUE
AcuteKidney Injury
Advise the patient concerning appropriate hydration to decrease therisk of contrast induced kidney injury
Extravasation
If extravasation occurs duringinjection, advise patients to seek medical care for progression ofsymptoms
Thyroid Dysfunction
Advise parents/caregivers about the risk ofdeveloping thyroid dysfunction after ISOVUE administration. Adviseparents/caregivers about when to seek medical care for their childto monitor for thyroid function
Lactation
Advise a lactating woman thatinterruption of breastfeeding is not necessary, however, to minimizeexposure to a breastfed infant, a lactating woman may consider pumpingand discarding breast milk for 10 hours after ISOVUE administration
Manufactured for:
RevisedDecember 2024