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Iohexol: Drug information

Iohexol: Drug information
(For additional information see "Iohexol: Patient drug information" and see "Iohexol: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Not for intrathecal use:

Iohexol 300 (bulk) and 350 (bulk) are for IV use only and not for intrathecal use. Iohexol 140 and 350 are not for intrathecal use. Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema.

Brand Names: US
  • Omnipaque
Brand Names: Canada
  • Omnipaque;
  • Omnipaque 240;
  • Omnipaque 300
Pharmacologic Category
  • Contrast Agent;
  • Iodinated Contrast Media;
  • Radiological/Contrast Media (Nonionic, High Osmolality);
  • Radiological/Contrast Media (Nonionic, Low Osmolality)
Dosing: Adult

Note: Concentration, volume, and rate may depend on the equipment, condition of injected vessel, size/condition of patient, and imaging technique used. Refer to prescribing information for detailed dosing and administration information.

Intrathecal imaging

Intrathecal imaging: Note: gI = grams of iodine; mgI = mg of iodine. Verify product prior to administration; some products are contraindicated for intrathecal administration.

Myelography: Intrathecal: Iohexol 180, 240, or 300 only:

Lumbar (lumbar injection):

Iohexol 180: 10 to 17 mL (1.8 to 3.06 gI)

Iohexol 240: 7 to 12.5 mL (1.7 to 3 gI)

Thoracic (lumbar or cervical injection) or cervical (lumbar injection):

Iohexol 240: 6 to 12.5 mL (1.4 to 3 gI)

Iohexol 300: 6 to 10 mL (1.8 to 3 gI)

Cervical (c1-2 injection):

Iohexol 180: 7 to 10 mL (1.3 to 1.8 gI)

Iohexol 240: 6 to 12.5 mL (1.4 to 3 gI)

Iohexol 300: 4 to 10 mL (1.2 to 3 gI)

Total columnar (lumbar injection):

Iohexol 240: 6 to 12.5 mL (1.4 to 3 gI)

Iohexol 300: 6 to 10 mL (1.8 to 3 gI)

Single myelographic procedure: Do not exceed a concentration of 300 mgI/mL or total dose of iodine 3,100 mg. If a repeat procedure is required, wait at least 48 hours (5 to 7 days is preferred).

Intravascular imaging

Intravascular imaging: Note: gI = grams of iodine; mgI = mg of iodine.

Ventriculography: Iohexol 350: 40 mL (range 30 to 60 mL) as a single dose; may repeat as necessary; with multiple injections, do not exceed a total volume of 250 mL. May be combined with selective coronary arteriography.

Selective coronary arteriography: Iohexol 350: 5 mL (range 3 to 14 mL) per injection; with multiple injections, do not exceed a total volume of 250 mL.

Aortic root and arch studies: Iohexol 350 (used alone): 50 mL (range: 20 to 75 mL)

Aortography and selective visceral arteriography: Iohexol 300 or 350 (may repeat up to a maximum total of 290 mL [iohexol 300] or 250 mL [iohexol 350]):

Aorta: 50 to 80 mL

Major branches, including celiac and mesenteric arteries: 30 to 60 mL

Renal arteries: 5 to 15 mL

Cerebral arteriography: Iohexol 300:

Common carotid artery: 6 to 12 mL

Internal carotid artery: 8 to 10 mL

External carotid artery: 6 to 9 mL

Vertebral artery: 6 to 10 mL

Contrast enhanced CT:

Head imaging by injection:

Iohexol 300: 70 to 150 mL (21 to 45 gI)

Iohexol 350: 80 mL (28 gI)

Head imaging by infusion: Iohexol 240: 120 to 250 mL (29 to 60 gI)

Body imaging by injection:

Iohexol 300: 50 to 200 mL (15 to 60 gI)

Iohexol 350: 60 to 100 mL (21 to 35 gI)

Digital subtraction angiography:

IV: Iohexol 350: 30 to 50 mL (using a pressure injector; rate: 7.5 to 30 mL/second); 3 or more injections may be required; maximum total dose: 250 mL.

Intra-arterial: Iohexol 140:

Aorta: 20 to 45 mL (rate: 8 to 20 mL/second)

Carotid: 5 to 10 mL (rate: 3 to 6 mL/second)

Femoral: 9 to 20 mL (rate: 3 to 6 mL/second)

Vertebral: 4 to 10 mL (rate: 2 to 8 mL/second)

Renal: 6 to 12 mL (rate: 3 to 6 mL/second)

Other aorta branches (subclavian, axillary, innominate and iliac): 8 to 25 mL (rate: 3 to 10 mL/second)

Peripheral angiography:

Aortofemoral runoffs:

Iohexol 300: 30 to 90 mL

Iohexol 350: 20 to 70 mL

Selective arteriograms (femoral/iliac):

Iohexol 300: 10 to 60 mL

Iohexol 350: 10 to 30 mL

Venography/phlebography (per leg):

Iohexol 240: 20 to 150 mL

Iohexol 300: 40 to 100 mL

Excretory urography: Iohexol 300 or 350: 0.6 to 1.2 mL/kg

Oral/body cavity imaging

Oral/body cavity imaging: Note: gI = grams of iodine; mgI = mg of iodine.

Contrast enhanced abdominal CT:

Oral: Iohexol 240, 300, and 350 diluted to 6 to 12 mgI/mL or iohexol 9 and 12: 500 to 1,000 mL (use smaller volumes for higher concentrations); may administer all at once or over a period of up to 45 minutes

IV (in conjunction with dilute oral iohexol): Iohexol 300: 100 to 150 mL (administered up to 40 minutes after consumption of oral iohexol)

Gastrointestinal tract examination: Oral: Iohexol 350 (undiluted): 50 to 100 mL (depending on patient size and the nature of the exam)

Arthrography: Note: Lower volumes recommended for double-contrast examinations; higher volumes recommended for single-contrast examinations.

Knee joint:

Iohexol 240 or 300: 5 to 15 mL

Iohexol 350: 5 to 10 mL

Shoulder joint:

Iohexol 240: 3 mL

Iohexol 300: 10 mL

Temporomandibular joint: Iohexol 300: 0.5 to 1 mL

Endoscopic retrograde pancreatography, cholangiopancreatography: Iohexol 240: 10 to 50 mL

Hysterosalpingography: Iohexol 240 or 300: 15 to 20 mL

Herniography: Iohexol 240: 50 mL

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. Use with caution and use the lowest dose necessary.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Pediatric

(For additional information see "Iohexol: Pediatric drug information")

Note: Concentration, volume, and rate may depend on the equipment, condition of injected vessel, size/condition of patient, and imaging technique used. Refer to prescribing information for detailed dosing and administration information.

Intrathecal imaging

Intrathecal imaging:

Myelography (lumbar, thoracic, cervical, and total columnar): Intrathecal: Iohexol 180 mgI/mL (Omnipaque 180):

0 to <3 months: 2 to 4 mL (0.36 to 0.72 gI).

3 months to <3 years: 4 to 8 mL (0.72 to 1.44 gI).

3 to <7 years: 5 to 10 mL (0.9 to 1.8 gI).

7 to <13 years: 5 to 12 mL (0.9 to 2.16 gI).

13 to 18 years: 6 to 15 mL (1.08 to 2.7 gI).

For a single myelographic procedure: Do not exceed a concentration of 180 mgI/mL or total dose of iodine 2,700 mg. If a repeat procedure is required, wait at least 48 hours (5 to 7 days is preferred).

Intravascular imaging

Intravascular imaging: Note: Method of administration variable determined by imaging technique.

Ventriculography: Infants, Children, and Adolescents:

Iohexol 300 mgI/mL (Omnipaque 300): Injection: 1.75 mL/kg; range: 1.5 to 2 mL/kg; if multiple injections are used, then maximum total dose: 5 mL/kg not to exceed a total volume of 291 mL.

Iohexol 350 mgI/mL (Omnipaque 350): Injection: 1.25 mL/kg; range: 1 to 1.5 mL/kg; if multiple injections are used, then maximum total dose: 5 mL/kg not to exceed a total volume of 250 mL.

Pulmonary angiography: Infants, Children, and Adolescents: Iohexol 350 mgI/mL (Omnipaque 350): Injection: 1 mL/kg.

Combined angiocardiographic procedures: Infants, Children, and Adolescents: Maximum total dose for all procedures:

Iohexol 300 mgI/mL (Omnipaque 300): Total volume of doses: 6 mL/kg not to exceed a volume of 291 mL.

Iohexol 350 mgI/mL (Omnipaque 350): Total volume of doses: 5 mL/kg not to exceed a volume of 250 mL.

Aortography (aortic root, aortic arch, ascending and descending aorta): Infants, Children, and Adolescents: Iohexol 350 mgI/mL (Omnipaque 350): Injection: Usual dose: 1 mL/kg; maximum total dose: 5 mL/kg not to exceed a total volume of 250 mL.

Contrast enhanced CT head imaging: Infants, Children, and Adolescents: Iohexol 240 mgI/mL (Omnipaque 240) or iohexol 300 mgI/mL (Omnipaque 300): Injection: 1 to 2 mL/kg; maximum dose, product dependent: Omnipaque 240: 28 gI/dose or Omnipaque 300: 35 gI/dose.

Excretory urography: Infants, Children, and Adolescents: Iohexol 300 mgI/mL (Omnipaque 300): Injection: Usual dose: 1 to 1.5 mL/kg; range: 0.5 to 3 mL/kg; maximum total dose: 3 mL/kg total.

Oral/body cavity imaging

Oral/body cavity imaging:

Pass-through gastrointestinal examination: Note: When administered rectally, larger volumes may be used.

<3 months: Iohexol 180 mgI/mL (Omnipaque 180), undiluted: Oral, Rectal: 5 to 30 mL.

3 months to 3 years: Iohexol 180 mgI/mL, 240 mgI/mL, or 300 mgI/mL (Omnipaque 180, 240, or 300), undiluted: Oral, Rectal: Up to 60 mL.

4 to 10 years: Iohexol 180 mgI/mL, 240 mgI/mL, or 300 mgI/mL (Omnipaque 180, 240, or 300), undiluted: Oral, Rectal: Up to 80 mL.

>10 years and Adolescents: Iohexol 180 mgI/mL, 240 mgI/mL, or 300 mgI/mL (Omnipaque 180, 240, or 300), undiluted: Oral, Rectal: Up to 100 mL.

Contrast enhanced abdomen CT:

Omnipaque: Infants, Children, and Adolescents:

Diluted Iohexol 9 to 21 mgI/mL (Omnipaque): Oral: 180 to 750 mL; use smaller volumes for higher concentrations; may administer all at once or over 30 to 45 minutes; maximum total iodine dose is age dependent: <3 years: 5 gI total; 3 to 18 years: 10 gI total.

Diluted Iohexol 240 or 300 mgI/mL (Omnipaque 240 or 300): IV: 2 mL/kg; range: 1 to 2 mL/kg; maximum total IV dose: 3 mL/kg total; use in combination with oral diluted iohexol and administer ~30 to 60 minutes after oral diluted iohexol dose.

Voiding cystourethrography (VCU): Infants, Children, and Adolescents: Iohexol diluted to 50 to 100 mgI/mL (Omnipaque): Intraurethral: Use a volume sufficient to fill the bladder; dependent on patient age and size; usual volume ranges from 50 to 300 mL at a concentration of 100 mgI/mL or 50 to 600 mL at a concentration of 50 mgI/mL.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling. Use caution in severe impairment and in setting of combined renal and hepatic disease.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling. Use caution in patients with combined hepatic and renal disease.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Children generally have a lower frequency of reactions than adults.

>10%:

Cardiovascular: Cardiac arrhythmia (intravascular: 2% to 16%; including atrial premature contractions and ventricular premature contractions)

Gastrointestinal: Diarrhea (body cavity injection, intravascular: ≤3%; oral/rectal: 36% to 42%), nausea (body cavity injection, intrathecal, intravascular: ≤6%; oral/rectal: 5% to 15%), vomiting (body cavity injection, intravascular: ≤2%; intrathecal: 3% to 6%; oral/rectal: 9% to 11%)

Nervous system: Headache (body cavity injection, intravascular, oral: ≤6%; intrathecal: 9% to 18%), localized warm feeling (body cavity injection: ≤13%; intrathecal, intravascular: <1%), pain (body cavity injection: 7% to 49%; intrathecal: 8% [including back pain, neck pain, stiffness, and neuralgia]; intravascular: ≤5%)

Neuromuscular & skeletal: Lower limb cramp (intravascular: 21%)

Ophthalmic: Vision disturbance (intravascular: ≤15%, including photomas)

1% to 10%:

Cardiovascular: Angina pectoris (intravascular: ≤8%), bradycardia (intravascular: ≤1%), cerebral infarction (intravascular: ≤2%), chest pain (intravascular: ≤1%), hypertension (body cavity injection, intrathecal, intravascular: ≤1%), hypotension (intrathecal, intravascular, oral/rectal: ≤3%), syncope (body cavity injection, intravascular: ≤1%), tachycardia (intravascular: ≤1%), transient ischemic attacks (intravascular: ≤2%)

Dermatologic: Urticaria (intrathecal, intravascular, oral/rectal: ≤2%)

Gastrointestinal: Abdominal distress (pressure: body cavity injection: ≤1%), abdominal pain (oral/rectal: 2% to 7%), dysgeusia (intravascular: ≤1%), flatulence (body cavity injection: ≤10%; oral: 2%)

Local: Hematoma at injection site (body cavity injection: ≤1%)

Nervous system: Burning sensation (body cavity injection: ≤1%), dizziness (body cavity injection, intrathecal, intravascular: ≤2%), drowsiness (body cavity injection, intrathecal: ≤3%), malaise (body cavity injection: ≤3%), myasthenia (body cavity injection: ≤1%)

Neuromuscular & skeletal: Tremor (body cavity injection: ≤1%)

Ophthalmic: Blurred vision (intravascular: ≤2%)

Miscellaneous: Fever (≤5%)

<1%:

Cardiovascular: Asystole, cardiac failure, heart block, vasodepressor syncope, ventricular tachycardia

Dermatologic: Diaphoresis, pruritus, skin rash

Endocrine & metabolic: Hypoglycemia

Gastrointestinal: Abdominal cramps, anorexia, dyspepsia, stomach pain, xerostomia

Genitourinary: Difficulty in micturition

Hematologic & oncologic: Anemia, purpuric disease

Infection: Abscess

Nervous system: Anxiety, feeling of heaviness, hemiparesis, hypertonia, motor dysfunction, paresthesia, seizure, shivering, speech disturbance, vertigo, visual hallucination

Neuromuscular & skeletal: Neck stiffness

Ophthalmic: Nystagmus, photophobia

Otic: Tinnitus

Respiratory: Apnea, cough, dyspnea, laryngitis, respiratory congestion, rhinitis

Postmarketing:

Cardiovascular: Acute myocardial infarction, flushing, palpitations, peripheral vasodilation, shock, thrombophlebitis, vasospasm (including coronary artery vasospasm)

Dermatologic: Acute generalized exanthematous pustulosis, bullous dermatitis, erythema of skin, exfoliative dermatitis, hyperhidrosis, pallor, pleomorphic rash, skin blister, skin discoloration, Stevens-Johnson syndrome, toxic epidermal necrolysis

Endocrine & metabolic: Hyperthyroidism, hypothyroidism (premature infants, infants, and children ≤3 years with underlying medical conditions may be more vulnerable; FDA Safety Alert March 30, 2022)

Gastrointestinal: Dysphagia, enlargement of the salivary glands, pancreatitis (including aggravation)

Genitourinary: Anuria, oliguria, proteinuria, toxic nephrosis

Hematologic & oncologic: Neutropenia

Hypersensitivity: Anaphylactoid shock, anaphylaxis, angioedema, fixed drug eruption, hypersensitivity reaction, nonimmune anaphylaxis

Immunologic: Drug reaction with eosinophilia and systemic symptoms

Local: Injection site reactions, localized edema

Nervous system: Agitation, aseptic meningitis, chills, coma, confusion, disorientation, encephalopathy (transient contrast-induced toxic encephalopathy), hypoesthesia, impaired consciousness, loss of consciousness, meningism, restlessness, status epilepticus, tightness in chest or throat

Neuromuscular & skeletal: Arthritis, asthenia, laryngospasm, muscle spasm, muscle spasticity

Ophthalmic: Conjunctival hyperemia, eye irritation, eye pruritus, eyelid edema, lacrimation, ocular hyperemia, periorbital edema, visual impairment (including cortical blindness)

Renal: Acute kidney injury, increased serum creatinine

Respiratory: Bronchospasm, cyanosis, exacerbation of asthma, laryngeal edema, pharyngeal edema, pleuritic chest pain, pulmonary edema, respiratory distress, respiratory failure, sneezing, status asthmaticus, throat irritation, wheezing

Contraindications

Hysterosalpingography: Iohexol body cavity 240 and 300 for hysterosalpingography are contraindicated during pregnancy (known or suspected), menstruation or when menstruation is imminent, within 6 months after pregnancy termination, within 30 days after conization or curettage, when signs of infection are present in any portion of the genital tract including external genitalia, and with reproductive tract neoplasia (known or suspected).

Intrathecal: Iohexol 140 and 350 are contraindicated for intrathecal use.

Oral solution: Iohexol 9 and 12 are contraindicated for parenteral administration.

Canadian labeling: Additional contraindications (not in the US labeling): Clinically significant impairment of both hepatic and renal function

Warnings/Precautions

Concerns related to adverse effects:

• Cardiovascular events: Life-threatening or fatal cardiovascular reactions (eg, hypotension, shock, cardiac arrest) have occurred with parenteral iohexol administration; fatal events, while rare, typically occurred during or 5 to 10 minutes after administration. Cardiovascular disease is the predominant aggravating factor. Cardiac decompensation, serious arrhythmias, myocardial ischemia, or MI may occur during coronary arteriography and ventriculography. Use the lowest necessary dose in patients with heart failure; emergency resuscitation equipment and trained personnel should be available during administration. Monitor all patients for severe cardiovascular reactions.

• Dermatological effects: Severe cutaneous adverse reactions (including Stevens-Johnson syndrome [SJS], toxic epidermal necrolysis [TEN], acute generalized exanthematous pustulosis [AGEP], drug reaction with eosinophilia and systemic symptoms [DRESS]) have occurred 1 hour to several weeks after administration; reaction severity may increase and time to onset may decrease with repeat administration. Avoid use in patients with a history of a severe cutaneous adverse reaction to iohexol.

• Extravasation: May be a vesicant (higher osmolar contrast and/or higher volumes are associated with a higher risk); ensure proper needle/catheter/line placement prior to and during administration. Monitor infusion site. Avoid infiltration. Iohexol 140, 180, 240, 300, and 350 have osmolalities of 1.1 to 3 times that of plasma. Extravasation may result in tissue necrosis and/or compartment syndrome, particularly in patients with severe arterial or venous disease.

• Hypersensitivity: Iohexol may cause life-threatening or fatal hypersensitivity reactions, including anaphylaxis. Manifestations have included respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock. Most severe reactions develop shortly after the start of the injection (within 3 minutes), although reactions may be delayed until hours later. The risk for hypersensitivity is increased in patients with a prior history of reaction to contrast agents, known allergies (eg, bronchial asthma, medication, food allergies), and/or other hypersensitivities. Premedication with antihistamines or corticosteroids does not prevent serious life-threatening reactions, although it may reduce the incidence and severity of reactions. Obtain allergy and hypersensitivity history prior to administration. Emergency resuscitation equipment and trained personnel should be available prior to iohexol administration. Monitor all patients for hypersensitivity reactions.

• Nephrotoxicity: Acute kidney injury, including renal failure, may occur after parenteral iohexol administration. Risk factors for nephrotoxicity include preexisting renal impairment, dehydration, diabetes mellitus, congestive heart failure, advanced vascular disease, older age, concomitant use of nephrotoxic or diuretic medications, multiple myeloma (or paraproteinaceous diseases), and repeated and/or large iodinated contrast agent doses. Use the lowest necessary dose in patients with renal impairment. Adequately hydrate patients prior to and following parenteral iohexol administration. Avoid laxatives, diuretics, or preparatory dehydration prior to iohexol administration.

• Thromboembolic events: Serious, rarely fatal, thromboembolic events causing MI and stroke have been reported with both ionic and nonionic contrast media. Ionic iodinated contrast media may inhibit blood coagulation (more than nonionic contrast media). Use meticulous intravascular administration techniques during angiographic procedures and minimize the length of the procedure to minimize the risk. Clotting has been reported when in vitro blood remains in contact with syringes containing nonionic contrast media; use of plastic syringes in place of glass syringes has been reported to decrease, but not eliminate, the likelihood of in vitro clotting. Due to the risk of thrombosis/embolism, avoid angiocardiography in patients with homocystinuria.

Disease-related concerns:

• Hyperthyroidism: Thyroid storm following intravascular administration of iodinated contrast media have occurred in patients with hyperthyroidism or with an autonomously functioning thyroid nodule; evaluate risk.

• Myasthenia gravis: Use may worsen myasthenia gravis (MG); use with caution and monitor for worsening MG (AAN [Narayanaswami 2021]).

• Pheochromocytoma: Hypertensive crisis has occurred after the use of iodinated contrast agents in patient with pheochromocytoma. Use with extreme caution in patients with pheochromocytoma (known or suspected). Minimize the amount of contrast agent used (for intravascular administration) and monitor blood pressure closely throughout procedure. Therapy to manage hypertensive crisis should be readily available.

• Seizures: Use with caution in patients with history of epilepsy. Antiseizure therapy should be maintained. Prophylactic antiseizure therapy should be considered in patients with a seizure history but not currently on antiseizure therapy, and in those with evidence of inadvertent intracranial entry of a concentrated or large bolus of contrast media. CNS-acting agents, primarily those which lower seizure threshold (eg, phenothiazines, MAO inhibitors, tricyclic antidepressants, SSRIs), should be discontinued 24 to 72 hours prior to intrathecal use and not resumed for 24 hours post procedure (ACR 2008). Major motor seizures with nonionic myelographic media are generally associated with one or more of the following situations (avoid situation): Deviations from recommended procedures or in myelographic management; use in patients with history of epilepsy; overdosage; intracranial entry of bolus or premature diffusion of a high medium concentration; medication with neuroleptic drugs or phenothiazine agents for antinausea; failure to maintain head elevation during and following the procedure; and excessive and active patient movement/straining.

• Sickle cell disease: Use with caution in sickle cell disease; iodinated contrast agents may promote sickling in patients homozygous for sickle cell disease. Hydrate patients prior to and following iohexol administration; use iohexol only if the imaging information needed cannot be obtained with alternative imaging measures.

Special populations:

• Older adult: Select doses cautiously, usually starting at the low end of the dosing range, due to a higher frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in older adult patients.

• Pediatric: Pediatric patients at higher risk of experiencing any adverse events during contrast medium administration may include those having asthma, sensitivity to medication or allergens, heart failure, serum creatinine >1.5 mg/dL, or pediatric patients <12 months of age. Thyroid dysfunction, including transient thyroid suppression or hypothyroidism, has been reported in pediatric patients 0 to 3 years of age following single exposure and multiple exposures to iodinated contrast media; risk increases with younger age, very low birth weight, prematurity, underlying medical conditions affecting thyroid function, neonatal or pediatric intensive care admission, and congenital cardiac conditions (may be greatest risk due to requiring higher doses during invasive cardiac procedures).

Other warnings/precautions:

• Appropriate use: Intrathecal administration: Only iohexol 180, 240, and 300 (not bulk) are indicated for intrathecal administration. If repeat procedure is required, a sufficient time in between should be used to allow for clearance (≥48 hours; 5 to 7 days is recommended).

• Appropriate use: Oral administration (Iohexol 9 and 12): Do not administer oral contrast solutions parenterally; serious adverse reactions such as sepsis and hemolysis may occur. Nausea, vomiting, and diarrhea commonly occur with oral administration.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Combination:

Omnipaque: Iodine 300 mg/mL (125 mL [DSC]); Iodine 350 mg/mL (125 mL [DSC]) [contains edetate (edta) calcium disodium]

Solution, Injection:

Omnipaque: Iodine 180 mg/mL (10 mL, 20 mL [DSC]); Iodine 240 mg/mL (50 mL [DSC]); Iodine 300 mg/mL (10 mL, 30 mL, 50 mL, 75 mL [DSC], 100 mL, 125 mL [DSC], 150 mL, 200 mL [DSC], 500 mL) [contains edetate (edta) calcium disodium]

Solution, Injection [preservative free]:

Omnipaque: Iodine 240 mg/mL (10 mL, 20 mL, 50 mL, 100 mL, 150 mL [DSC], 200 mL [DSC]) [pyrogen free; contains edetate (edta) calcium disodium]

Solution, Intravenous:

Omnipaque: Iodine 140 mg/mL (50 mL)

Omnipaque: Iodine 350 mg/mL (50 mL, 75 mL, 100 mL, 125 mL [DSC], 150 mL, 200 mL, 500 mL) [contains edetate (edta) calcium disodium]

Solution, Oral [preservative free]:

Omnipaque: Iodine 9 mg/mL (500 mL); Iodine 12 mg/mL (500 mL) [contains edetate (edta) calcium disodium]

Generic Equivalent Available: US

No

Pricing: US

Solution (Omnipaque Injection)

180 mg/mL (per mL): $4.81

240 mg/mL (per mL): $2.76

300 mg/mL (per mL): $1.67

Solution (Omnipaque Intravenous)

140 mg/mL (per mL): $0.80

350 mg/mL (per mL): $1.21

Solution (Omnipaque Oral)

9 mg/mL (per mL): $0.02

12 mg/mL (per mL): $0.03

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Injection:

Omnipaque: 350 mg/mL (50 mL, 100 mL, 150 mL, 200 mL)

Omnipaque 240: Iodine 240 mg/mL (15 mL, 20 mL, 50 mL, 100 mL, 200 mL)

Omnipaque 300: Iodine 300 mg/mL (10 mL, 20 mL, 50 mL, 100 mL, 150 mL)

Omnipaque: Iodine 180 mg/mL ([DSC]) [contains edetate (edta) calcium disodium]

Administration: Adult

Hydrate well prior to and following administration.

CT of head and body: May be used with an automated contrast injection system approved for use with contrast media; iohexol 300 and 350 (in 150 mL bottles) may also be used with a contrast management system approved for use with iohexol 300 and 350 (in 150 mL bottles); also refer to device instructions. When using contrast media management system, use for one procedure, do not remove bottle from work area once punctured, and do not use for longer than 4 hours from initial puncture; discard any unused portion.

Intravascular: Draw into syringe immediately prior to administration. Intravenous doses should be at body temperature or room temperature prior to administration. In angiography, use meticulous intravascular administration technique to minimize thrombotic events including use of plastic syringes, frequent catheter flushing, and close attention to catheter and guide wire manipulation. When large individual volumes are administered (ie, for ventriculography or aortography), wait several minutes between each injection to allow possible hemodynamic disturbances to subside. Do not mix with other medications; do not administer in the same line containing other medications or parenteral nutrition. Iohexol 300 and 350 (bulk) may be administered simultaneously with saline when utilizing an automated contrast injection system.

May be a vesicant (higher osmolar contrast and/or higher volumes are associated with a higher risk); ensure proper needle or catheter placement prior to and during infusion; avoid extravasation.

Extravasation management: If extravasation occurs, stop infusion immediately and disconnect; remove needle/cannula; elevate extremity. Aspiration of extravasated contrast media is not recommended (Ref). Information conflicts regarding the use of hyaluronidase; the American College of Radiology (ACR) Manual on Contrast Media does not recommend hyaluronidase in the management of contrast media extravasation (Ref); other sources suggest its utility in extravasation management for inoperable cases with compartment syndrome (Stefanos 2023).

If using hyaluronidase: Intradermal or SUBQ: Dose varies based on the size of infiltration; inject a total of 5 to 250 units (~100 mL contrast reabsorbed per 15 units of hyaluronidase) around the site of extravasation (Ref).

Intrathecal: Draw into syringe immediately prior to administration. Intrathecal doses should be administered slowly over 1 to 2 minutes (to avoid excessive mixing with CSF) through a lumbar or cervical needle under fluoroscopic control. Note: Use caution in product selection. Use iohexol 180, 240, or 300 only. Iohexol 140 and 350 are not for intrathecal use.

Discontinue neuroleptic medications (including phenothiazines) at least 48 hours prior to procedure. May maintain a normal diet up to 2 hours before the procedure. Ensure hydration fluids up to the procedure (hydrate well prior to and following administration). During the procedure, when positioning keep the patient's head elevated above the highest level of the spine; do not lower the head of the table more than 15° in moving contrast medium cranially; consider a lateral position (administration and medium movement) in patients with lordosis; to maintain as a bolus, move medium very slowly to distal area; avoid intracranial entry of a bolus; avoid early and high cephalad medium dispersion; avoid abrupt or active patient movement. After the procedure, raise head of stretcher to at least 30° prior to transferring patient on to it; move patient slowly, maintaining a head-up position; before moving patient to a bed, raise head to 30° to 45°; advise patient to remain still in bed, in a sitting or semi-sitting position, at least for the first few hours; observe closely for at least 12 hours; encourage oral fluids/diet as tolerated; if nausea and vomiting occur, do not use phenothiazines for management of nausea/vomiting; utilize prompt fluid replacement in the event of nausea/vomiting to prevent dehydration.

Oral: Large volumes of dilute oral solution may be administered all at once or over up to 45 minutes (if difficult to consume the entire volume).

Administration: Pediatric

Note: Osmolality: Omnipaque 140: 322 mOsm/kg water; Omnipaque 180: 408 mOsm/kg water; Omnipaque 240: 520 mOsm/kg water; Omnipaque 300: 672 mOsm/kg water; Omnipaque 350: 844 mOsm/kg water.

Intrathecal: Draw into syringe immediately prior to administration. Intrathecal doses should be administered slowly over 1 to 2 minutes (to avoid excessive mixing with CSF) through a lumbar or cervical needle under fluoroscopic control. Note: Use caution in product selection. For pediatric administration, only use iohexol 180 mgI/mL (Omnipaque 180); for adults, only use iohexol 180 mgI/mL, 240 mgI/mL, or 300 mgI/mL (Omnipaque 180, 240, or 300). Iohexol 140 and 350 are not for intrathecal use.

Prior to procedure, consider discontinuation of neuroleptic medications (including phenothiazines) at least 48 hours prior to procedure. May maintain a normal diet up to 2 hours before the procedure. Ensure hydration fluids up to the procedure (hydrate well prior to and following administration).

During the procedure, when positioning keep the patient's head elevated above the highest level of the spine; do not lower the head of the table more than 15° in moving contrast medium cranially; consider a lateral position (administration and medium movement) in patients with excessive lordosis; to maintain as a bolus, move medium very slowly to distal area; avoid intracranial entry of a bolus; avoid early and high cephalad medium dispersion; avoid abrupt or active patient movement.

After the procedure, raise head of stretcher to at least 30° prior to transferring patient on to it; move patient slowly, maintaining a head-up position; before moving patient to a bed, raise head to 30° to 45°; advise patient to remain still in bed, in a sitting or semi-sitting position, at least for the first few hours; observe closely for at least 12 hours after myelogram; encourage oral fluids/diet as tolerated; if nausea and vomiting occur, do not use phenothiazines for management of nausea/vomiting; utilize prompt fluid replacement in the event of nausea/vomiting to prevent dehydration.

Intravascular: Patient should be well hydrated prior to and following administration.

Draw into syringe immediately prior to administration. Intravascular doses should be at body temperature prior to administration. In angiography, use meticulous intravascular administration technique to minimize thrombotic events including use of plastic syringes, frequent catheter flushing, and close attention to catheter and guide wire manipulation. When large individual volumes are administered (ie, for ventriculography or aortography), wait several minutes between each injection to allow possible hemodynamic disturbances to subside.

Vesicant; ensure proper needle or catheter placement prior to and during infusion; avoid extravasation.

Extravasation management: If extravasation occurs, stop infusion immediately and disconnect (leave cannula/needle in place); gently aspirate extravasated solution (do NOT flush the line); remove needle/cannula; initiate hyaluronidase antidote; elevate extremity.

Oral: Patient should be well-hydrated prior to and following administration.

Omnipaque: Pediatric patients: Large volumes of dilute oral solution may be administered all at once or over 30 to 45 minutes (if not tolerated all at once).

Use: Labeled Indications

Imaging: Adults:

Intrathecal: Iohexol 180, 240, and 300: Myelography (lumbar, thoracic, cervical, and total columnar), and contrast enhancement for CT (myelography, cisternography, ventriculography).

Intravascular:

Iohexol 140: Intra-arterial digital subtraction angiography of head, neck, abdominal, renal, and peripheral vessels.

Iohexol 240: Contrast enhancement for CT head imaging and peripheral venography (phlebography).

Iohexol 300: Aortography (including studies of aortic arch, abdominal aorta [and branches], contrast enhancement for CT head and body imaging, cerebral arteriography, peripheral venography (phlebography), peripheral arteriography, and excretory urography.

Iohexol 350: Angiocardiography (ventriculography, selective coronary arteriography), aortography (including studies of aortic root, aortic arch, ascending aorta, abdominal aorta [and branches]), contrast enhancement for CT head and body imaging, intravenous digital subtraction angiography of head, neck, abdominal renal and peripheral vessels, peripheral arteriography, and excretory urography.

Iohexol 300 (bulk) and 350 (bulk): Contrast enhancement for CT head and body imaging (for IV administration with an appropriate automated contrast injection system, contrast management system, or contrast media transfer set).

Oral:

Iohexol 350: Oral radiography examination of the gastrointestinal tract.

Oral in conjunction with IV administration:

Iohexol 240, 300, and 350 (diluted; oral) and Iohexol 300 (IV): Contrast enhanced abdomen CT.

Iohexol (oral solution 9 and 12) and Iohexol 300 (IV): Contrast enhanced abdomen CT.

Intraarticular:

Iohexol 240, 300, and 350: Arthrography.

Body cavity:

Iohexol 240: Endoscopic retrograde pancreatography (ERP) and cholangiopancreatography (ERCP), herniography, and hysterosalpingography.

Iohexol 300: Hysterosalpingography.

Imaging: Pediatrics:

Intrathecal: Iohexol 180: Myelography (lumbar, thoracic, cervical, and total columnar), and contrast enhancement for CT (myelography, cisternography).

Intravascular:

Iohexol 240: Contrast enhancement for CT head and body imaging.

Iohexol 300: Angiocardiography (ventriculography), contrast enhancement for CT head and body imaging, and excretory urography.

Iohexol 350: Angiocardiography (ventriculography, pulmonary arteriography, venography, and studies of collateral arteries); aortography, including aortic root, aortic arch, ascending and descending aorta).

Iohexol 300 (bulk): Contrast enhancement for CT head and body imaging (for IV administration with an appropriate automated contrast injection system, contrast management system, or contrast media transfer set).

Oral or rectal:

Iohexol 180, 240, and 300: Oral and rectal radiographic examination of the GI tract.

Oral in conjunction with IV administration:

Iohexol 240, 300, and 350 (diluted; oral) and Iohexol 240 or 300 (IV): Contrast enhanced abdomen CT.

Iohexol (oral solution 9 and 12) and Iohexol 240 or 300 (IV): Contrast enhanced abdomen CT.

Body cavity:

Iohexol 240, 300, and 350 (diluted): Voiding cystourethrography (VCUG).

Medication Safety Issues
High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication (intrathecal administration) among its list of drugs that have a heightened risk of causing significant patient harm when used in error.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Agents With Seizure Threshold Lowering Potential: May enhance the adverse/toxic effect of Iohexol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iohexol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic antiseizure drugs. Risk D: Consider therapy modification

Aldesleukin: May enhance the potential for allergic or hypersensitivity reactions to Iodinated Contrast Agents. Risk C: Monitor therapy

Loop Diuretics: May enhance the nephrotoxic effect of Iodinated Contrast Agents. Risk C: Monitor therapy

MetFORMIN: Iodinated Contrast Agents may enhance the adverse/toxic effect of MetFORMIN. Renal dysfunction that may be caused by iodinated contrast agents may lead to metformin-associated lactic acidosis. Management: Management advice varies. Refer to the full drug interaction monograph content for details. Risk D: Consider therapy modification

Sodium Iodide I131: Iodinated Contrast Agents may diminish the therapeutic effect of Sodium Iodide I131. Management: Discontinue iodinated contrast agents before sodium iodide I-131 administration, and avoid concurrent use. Stop water soluble agents 2 months before, and stop lipophilic agents 6 months before, sodium iodide I-131 administration. Risk X: Avoid combination

Reproductive Considerations

Use of iohexol body cavity 240 and 300 is contraindicated for hysterosalpingography during menstruation or when menstruation is imminent, and with reproductive tract neoplasia.

Routine pregnancy testing is not required prior to iodinated contrast media use; however, screening may be required based on the procedure (ACR 2021).

Pregnancy Considerations

Iohexol crosses the placenta (Moon 2000).

Due to theoretical concerns that exposure to free iodide may adversely affect the fetus, use should be avoided unless absolutely required to obtain diagnostic information that will influence the care of the mother or fetus during pregnancy (ACOG 2017; ACR 2021).

Use of iohexol body cavity 240 and 300 is contraindicated for hysterosalpingography during pregnancy and within 6 months after pregnancy termination.

Breastfeeding Considerations

Iohexol is present in breast milk (Nielsen 1987).

Information related to the presence of iohexol in breast milk was obtained following maternal administration of a single dose of iohexol 350 mg I/mL IV (0.755 g/kg) to 3 breastfeeding women, 1 week to 4 months postpartum. Breast milk samples were collected over 48 hours. The relative infant dose (RID) of iohexol was reported to be <1% when calculated by the authors of a study using average breast milk concentrations and compared to a weight-adjusted maternal dose of iohexol 0.755 g/kg. The RID of iohexol was calculated by using an average milk concentration of ~0.025 mg/mL, providing an estimated daily infant dose via breast milk of 3.7 mg/kg (iodine: 1.7 mg/kg). Higher concentrations of iohexol were found in the breast milk of a fourth woman administered the same dose 14 months postpartum (average milk concentration: 0.13 mg/mL); in this case, iohexol may have accumulated in breast milk as the mother was weaning her child (Nielsen 1987). In general, breastfeeding is considered acceptable when the RID of a medication is <10% (Anderson 2016; Ito 2000).

Because of the low expected excretion of iodinated contrast agents into breast milk and the low absorption from an infant's GI tract, breastfeeding may be continued without interruption after use (ACOG 2017; ACR 2021). Theoretically, the taste of milk could be altered if it contains contrast media. Patients who prefer to temporarily withhold breastfeeding may express and discard milk from both breasts during a period of 10 to 24 hours after the administration of contrast media. They can pump and store milk prior to the procedure then bottle feed using the stored milk during this time (ACR 2021). According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Monitoring Parameters

Monitor BP if pheochromocytoma or catecholamine-secreting paraganglioma are suspected. Monitor infusion site for extravasation during IV administration; monitor for signs/symptoms of hypersensitivity reactions and cardiovascular reactions.

Pediatric patients 0 to 3 years of age: Individualize thyroid function monitoring based on underlying risk factors, especially in term and preterm neonates.

Mechanism of Action

Opacification of vessels and anatomical structures in the path of flow of the contrast media which allows for radiographic visualization

Pharmacokinetics (Adult Data Unless Noted)

Duration:

CNS: ~30 minutes following intrathecal administration, 60 minutes following intravenous administration.

Serum: 15 to 120 seconds.

Absorption: Oral: Poorly absorbed.

Distribution: Vd: IV: 165 mL/kg (range: 108 to 219 mL/kg); Intrathecal: 559 mL/kg (range: 350 to 849 mL/kg).

Metabolism: Not significantly metabolized.

Protein binding: Minimal.

Excretion: Urine (Intrathecal, Intravascular: ~88% to 90%, as unchanged drug; Oral: <1%).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Omnipaque;
  • (AT) Austria: Accupaque | Omnipaque;
  • (BE) Belgium: Omnipaque;
  • (BG) Bulgaria: Omnipaque;
  • (BR) Brazil: Omnipaque;
  • (CO) Colombia: Nitigraf | Omnipaque;
  • (CZ) Czech Republic: Omnipaque;
  • (DE) Germany: Omnipaque;
  • (ES) Spain: Nitigraf;
  • (GB) United Kingdom: Omnipaque;
  • (HR) Croatia: Omnipaque;
  • (HU) Hungary: Omnipaque;
  • (IE) Ireland: Omnipaque;
  • (IT) Italy: Omnipaque;
  • (JP) Japan: Iopaque | Iosol | Ioverin | Moiopaque | Omnipaque | Omnipaque test;
  • (KE) Kenya: Omnipaque;
  • (KR) Korea, Republic of: Bonorex 350;
  • (LT) Lithuania: Omnipaque;
  • (LV) Latvia: Omnipaque;
  • (MY) Malaysia: Omnipaque;
  • (NO) Norway: Omnipaque;
  • (PL) Poland: Omnipaque;
  • (PR) Puerto Rico: Omnipaque;
  • (PY) Paraguay: Omnipaque;
  • (QA) Qatar: Omnipaque;
  • (RU) Russian Federation: Omnipaque;
  • (SA) Saudi Arabia: Omnipaque;
  • (SI) Slovenia: Omnipaque;
  • (TN) Tunisia: Omnipaque;
  • (TR) Turkey: Biemexol | Iobrix | Omnipaque | Omnipol;
  • (UA) Ukraine: Omnipaque
  1. American College of Obstetricians and Gynecologists (ACOG) Committee on Obstetric Practice. Committee opinion no. 723: guidelines for diagnostic imaging during pregnancy and lactation. Obstet Gynecol. 2017;130(4):e210-e216. Erratum in: Obstet Gynecol. 2018;132(3):786. [PubMed 28937575]
  2. American College of Radiology, “Practice Guideline for the Performance of Myelography and Cisternography,” 2008. Available at https://www.asnr.org/wp-content/uploads/2016/12/Myelography.pdf
  3. American College of Radiology (ACR) Committee on Drugs and Contrast Media. ACR manual on contrast media. Version 2023. https://www.acr.org/-/media/ACR/Files/Clinical-Resources/Contrast_Media.pdf. Published January 2021. Accessed August 12, 2021.
  4. American College of Radiology (ACR) Committee on Drugs and Contrast Media. ACR manual on contrast media. 2023. https://www.acr.org/-/media/ACR/Files/Clinical-Resources/Contrast_Media.pdf. Accessed May 17, 2023.
  5. Anderson PO, Sauberan JB. Modeling drug passage into human milk. Clin Pharmacol Ther. 2016;100(1):42-52. [PubMed 27060684]
  6. FDA Safety Alert. MedWatch. Iodine-containing contrast agents for medical imaging. Food and Drug Administration website. http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm472995.htm. Updated November 17, 2015. Accessed November 18, 2015.
  7. FDA Safety Alert. MedWatch. FDA recommends thyroid monitoring in babies and young children who receive injections of iodine-containing contrast media for medical imaging. Food and Drug Administration website: https://www.fda.gov/drugs/drug-safety-and-availability/fda-recommends-thyroid-monitoring-babies-and-young-children-who-receive-injections-iodine-containing. Updated March 30, 2022. Accessed March 31, 2022.
  8. Ito S. Drug therapy for breast-feeding women. N Engl J Med. 2000;343(2):118-126. [PubMed 10891521]
  9. Moon AJ, Katzberg RW, Sherman MP. Transplacental passage of iohexol. J Pediatr. 2000;136(4):548-549.
  10. Narayanaswami P, Sanders DB, Wolfe G, et al. International consensus guidance for management of myasthenia gravis: 2020 update. Neurology. 2021;96(3):114-122. doi:10.1212/WNL.0000000000011124 [PubMed 33144515]
  11. Nielsen ST, Matheson I, Rasmussen JN, Skinnemoen K, Andrew E, Hafsahl G. Excretion of iohexol and metrizoate in human breast milk. Acta Radiol. 1987;28(5):523-526. [PubMed 2960342]
  12. Omnipaque (iohexol) [prescribing information]. Marlborough, MA: GE Healthcare Inc; received April 2023.
  13. Omnipaque Pharmacy Bulk (iohexol) injection 300 and 350 [prescribing information]. Marlborough, MA: GE Healthcare Inc; received April 2023.
  14. Omnipaque, Omnipaque 180, Omnipaque 240, Omnipaque 300, Omnipaque 350 (iohexol) [product monograph]. Mississauga, Ontario, Canada; GE Healthcare Canada Inc; January 2021.
  15. Stefanos SS, Kiser TH, MacLaren R, Mueller SW, Reynolds PM. Management of noncytotoxic extravasation injuries: a focused update on medications, treatment strategies, and peripheral administration of vasopressors and hypertonic saline. Pharmacotherapy. 2023;43(4):321-337. doi:10.1002/phar.2794 [PubMed 36938775]
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