Dosing & Uses
Dosage Forms & Strengths
injection solution
- 180mg/mL
- 240mg/mL
- 300mg/mL
intravenous solution
- 140mg/mL
- 350mg/mL
powder for oral solution (Oraltag)
- 9.7g/bottle (equivalent to 4.5g carbon bound iodine)
- The packaging allows for preparation of the iohexol in a single-use bottle
- There are 5 fill lines premolded on the bottle for accurate dilution of the product to a desired concentration
Intrathecal
Omnipaque 180 (180 mgI/mL)
- Lumbar Myelography, via lumbar injection 10-17 mL
- Cervical Myelography, via C1-C2 injection: 7-12.5 mL
Omnipaque 240 (240 mgI/mL)
- Lumbar Myelography, via lumbar injection: 7-12.5 mL
- Thoracic Myelography, via lumber/cervical injection: 6-12.5 mL
- Cervical Myelography, via lumbar injection: 6-12.5 mL; via C1-C2 injection: 6-12.5
- Total Columnar Myelography, via lumbar injection: 6-12.5 mL
Omnipaque 300 (300 mgI/mL)
- Thoracic Myelography, via lumbar/cervical injection: 6-10 mL
- Cervical Myelography, via lumbar injection: 6-10 mL; via C1-C2 injection: 4-10 mL
- Total Columnar Myelography, via lumbar injection: 6-10 mL
Administration
- Rate of injection: Slowly over 1-2 min
- Not to exceed 300 mg/mL or 3060 mg iodine per single myelographic procedure
Intravascular
Omnipaque 140/300/350
Angiocardiography: ventriculography, pulmonary arteriography, venography & studies of collaterol arteries
- Ventriculography: 40 mL, range of 30-60 mL; may be repeated as needed, not to exceed 250 mL
- Selective Coronary Arteriography: 5 mL. range 3-14 mL per injection
- Aortic Root and Arch Study: 50 mL, range 20-75 mL, when used alone
- Pulmonary Angiography: 1 mL/kg
- Combined Angiographic Procedures: Multiple Procedures not to exceed 5 mL/kg or 250 mL
-
Aortography and Selective Arteriography
- Aorta: 50-80 mL
- Major branches incl celiac, mesenteric arteries: 30-60 mL
- Renal arteries: 5-15 mL; not to exceed 291 mL/Omnipaque 300 or 250 mL/Omnipaque 350 when repeat injection indicated
- Cerebral Arteriography: Common Carotid Artery: 6-12 mL
- Internal Carotid Artery: 8-10 mL
- External Carotid Artery: 6-9 mL
- Vertebral Artery: 6-10 mL
CT Scanning of the Body
Head Imaging via injection: 70-150 mL (Omni 300); 80 mL (Omni 350)
Head Imaging via infusion: 120-250 mL (Omni 240)
Body Imaging via injection: 50-200 mL (Omni 300); 60-100 mL (Omni 350)
Digital Subtraction
Omni 350
- Usual amount used for IV digital technique is 30-50 mL
- Administer as bolus at 7.5-30 mL/sec using pressure injector
Omni 140
- Intra-arterial use for head, neck, abdominal, renal, and peripheral vessel
- Administer 1 or more bolus via intra-arterial injection of Omni 140
- Aorta: 20-45 mL at 8-20 mL/sec
- Carotid: 5-10 mL at 3-6 mL/sec
- Femoral: 9-20 mL at 3-6 mL/sec
- Vertebral: 4-10 mL at 2-8 mL/sec
- Renal: 6-12 mL at 3-6 mL/sec
- Other Branches of Aorta: 8-25 mL at 3-10 mL/sec
Excretory Urography
Omnipaque 300/350: 200-350 mgI/kg body weight
Oral
Oraltag
- Indicated for opacification of the GI tract during CT of the abdomen and pelvis
- 1-2 bottles of prepared solution (4.5-9 g iodine) PO 20-60 minutes before image acquisition
Omnipaque 240/300/350
-
GI Tract
- Omni 350 (undiluted): 50-100 mL, dependent on nature of procedure and patient size
-
CECT of abdomen
- Omni 300: Dilute PO dose to 6-9 mg(iodine)/mL and administer in combo with IV dose
- Recommended PO dose: 500-1000 mL
- Recommended IV dose: 100-150 mL
- Administer PO dose 20-40 min prior to IV dose
Intracavity
Usual: 50-150 mL IV OR 100-250 mL IV of (240 mgI/mL)
Hysterosalpingography
- Omnipaque 240: 15-20 mL, but varies with anatomy and/or disease state
- Omnipaque 300: 15-20 mL, but varies with anatomy and/or disease state
Body Imaging
25-75 mL IV OR 50-150 mL IV infusion; not to exceed 150 mL
For 240 mg/mL: 35-100 mL IV OR 70-200 mL IV infusion; not to exceed 250 mL
Dosage Forms & Strengths
injection solution
- 180mg/mL
- 240mg/mL
- 300mg/mL
intravenous solution
- 140mg/mL
- 350mg/mL
powder for oral solution (Oraltag)
- 9.7g/bottle (equivalent to 4.5g carbon bound iodine)
- The packaging allows for preparation of the iohexol in a single-use bottle
- There are 5 fill lines premolded on the bottle for accurate dilution of the product to a desired concentration
Intrathecal
Recommended total doses for lumbar, thoraic, cervical, and/or total columnar myelography
Omnipaque 180 (180 mgI/mL)
- 0 to <3 months: 2-4 mL
- 3 to <36 months: 4-8 mL
- 3 to <7 years: 5-10 mL
- 7 to <13 years: 5-12 mL
- 13-18 years: 6-15 mL
Administration
- Rate of injection: Slowly over 1-2 min
- Not to exceed 180 mg/mL or 2700 iodine per single myelographic procedure
Intravascular
Omnipaque 240/300/350
Angiocardiography: ventriculography, pulmonary arteriography, venography & studies of collaterol arteries
- Ventriculography: Omnipaque 350: 1.25 mL/kg, range 1-1.5 mL/kg; not to exceed 5 mL/kg or 250 mL, when multiple injections given
- Omnipaque 300: 1.75 mL/kg, range 1.5-2 mL/kg; not to exceed 6 mL/kg or 291 mL, when multiple injections given
- Pulmonary Angiography: 1 mL/kg
-
Combined Angiographic Procedures - Multiple Procedures
- Omnipaque 350: Not to exceed 5 mL/kg or 250 mL
- Omnipaque 300: Not to exceed 6 mL/kg or 291 mL
- Aortography and selective arteriography: 1 mL/kg single inj dose; not to exceed 5 mL/kg or 250 mL
CT Scanning of the Body
Head imaging: 1-2 mL/kg; not to exceed 28 gI (Omni 240) or 35 gI Omni 300
Head imaging via infusion: 120-250 mL (Omni 240)
Body imaging via injection: 50-200 mL (Omni 300); 60-100 mL (Omni 350)
Excretory Urography
Omnipaque 300: 0.5-3 mL/kg of body weight
Infants/children: According to age and body weight
Usual dose: 1-1.5 mL/kg; not to exceed 3 mL/kg
Oral
Oraltag
- Indicated for opacification of the GI tract during CT of the abdomen and pelvis
-
<3 years
- Up to 4.5 g of iodine PO 20-60 minutes before image acquisition
- From portion of 1 bottle of prepared solution; 120-300 mL, depending on size of patient
-
3-18 years
- Up to 9 g of iodine PO 20-60 minutes before image acquisition
- From <1 bottle up to 2 bottles of prepared solution; 280-750 mL, depending on size of patient
Omnipaque 180/240/300 mg(iodine)/mL
-
GI tract
- For oral pass through, dependent on nature of procedure and patient size
- <3 months: Omnipaque 180: 5-30 mL
- 3 months to 3 years: Omnipaque 180/240/300: up to 60 mL
- 4-10 years: Omnipaque 180/240/300: up to 80 mL
- >10 years: Omnipaque 180/240/300: up to 100 mL
- When given rectally, larger volumes may be used
-
CECT of abdomen
- Omni 300: dilute PO dose to conc of 9-21 mgI/mL (180-750 mL) and administer in combo with IV dose
- <3 years: Not to exceed 5 gI
- 3-18 years: Not to exceed 10 gI
- Give total oral dose all at once or over 30-45 min, if there is difficulty consuming
-
Recommended IV dose, given in conjunction with dilute PO dose, of Omni 240/300
- Recommended PO dose: 180-750 mL
- Recommended IV dose: 2 mL/kg; range 1-2 mL/kg; not to exceed 3 mL/kg
- Administer PO dose 30-60 min prior to IV dose
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy
Adverse Effects
Frequency Not Defined
Headache
Mild to moderate pain including backache, neckache and stiffness
Nausea, and vomiting
Neuralgia
Rash
Erythema
Pruritus
Urticaria
Skin discoloration
Stevens-Johnson syndrome
Toxic epidermal necrolysis (SJS/TEN)
Acute generalized exanthematous pustulosis (AGEP)
Drug reaction with eosinophilia and systemic symptoms (DRESS)
Postmarketing Reports
Immune system disorders: Hypersensitivity reactions, anaphylactic or anaphylactoid reactions, anaphylactic or anaphylactoid shock including life-threatening or fatal anaphylaxis
General disorders and administration site conditions: Pyrexia, chills, pain and discomfort, asthenia, administration site conditions including extravasation
Hyperthyroidism, hypothyroidism
Intrathecal administration
- Nervous system disorders: Meningism, aseptic meningitis, seizures or status epilepticus, disorientation, coma, depressed or loss of consciousness, transient contrast-induced toxic encephalopathy (including amnesia, hallucination, paralysis, paresis, speech disorder, aphasia, dysarthria), restlessness, tremors, hypoesthesia
- Musculoskeletal and connective tissue disorders: Pain, muscle spasms or spasticity
- Psychiatric disorders: Confusional state, agitation, anxiety
- Eye disorders: Transient visual impairment including cortical blindness
- Renal reactions: Acute kidney injury
Intravascular administration
- Cardiovascular disorders: Severe cardiac complications (including cardiac arrest, cardiopulmonary arrest), shock, peripheral vasodilatation, palpitations, vasospasm including spasm of coronary arteries, myocardial infarction, syncope, cyanosis, pallor, flushing, chest pain
- Hemodynamic reactions: Vasospasm and thrombophlebitis following intravenous injection
- Blood and lymphatic system disorders: Neutropenia
- Nervous system disorders: Disorientation, coma, depressed or loss of consciousness, transient contrast-induced toxic encephalopathy (including amnesia, hallucination, paralysis, paresis, speech disorder, aphasia, dysarthria), restlessness, tremors, hypoesthesia
- Psychiatric disorders: Confusional state, agitation
- Eye disorders: Eye irritation or itchiness, periorbital edema, ocular or conjunctival hyperemia, lacrimation
- Renal reactions: Acute kidney injury, nephropathy toxic (CIN), transient proteinuria, oliguria or anuria, increased serum creatinine
- Gastrointestinal disorders: Abdominal pain, pancreatitis aggravated, salivary gland enlargement
Injection for hysterosalpingography
- Immediate, transient pain
- Nervous system: Pain (49%), somnolence and fever each with an individual incidence of 3%
- Gastrointestinal system: Nausea (3%)
Warnings
Contraindications
For procedural contraindications see package insert
Intrathecal administration of OMNIPAQUE 140 and OMNIPAQUE 350
Parenteral administration of OMNIPAQUE oral solution 9 and 12
Significant bacterial infection
OMNIPAQUE body cavity 240 and 300 for hysterosalpingography
- During pregnancy or suspected pregnancy
- Menstruation or when menstruation imminent
- Within 6 months after termination of pregnancy
- Within 30 days after conization or curettage
- When signs of infection are present in any portion of genital tract including external genitalia
- When reproductive tract neoplasia is known or suspected
Cautions
DO NOT immediately repeat myelography because of technical problem (see Dosing)
Inhibits blood coagulation
Caution in combined renal/hepatic disease, severe multiple myeloma, anuria, CHF, severe arterial/venous disease
Hypertensive crisis has occurred after use of iodinated contrast agents in patient with pheochromocytoma; monitor patients when administering intravascularly if pheochromocytoma or catecholamine-secreting paragangliomas are suspected; inject minimum amount of contrast necessary, assess blood pressure throughout procedure, and have measures for treatment of a hypertensive crisis readily available
Iodinated contrast agents when administered intravascularly may promote sickling in individuals who are homozygous for sickle cell disease; hydrate patients prior to and following administration and administer only if the necessary imaging information cannot be obtained with alternative imaging modalities
Focal and generalized motor seizures reported patients with history of epilepsy when higher than recommended doses used
If immediate, transient pain occurs during hysterosalpingography, monitor injection pressure and volume instilled to minimize pain and to avoid disruptive distention of uterus and fallopian tubes; fluoroscopic monitoring recommended
Acute renal failure reported in diabetic patients with diabetic nephropathy and in susceptible nondiabetic patients (often elderly with preexisting renal disease) following excretory urography; careful consideration of potential risks should be given before performing radiographic procedures in these patients
Extravasation during intravascular injection may cause tissue necrosis and/or compartment syndrome, particularly in patients with severe arterial or venous disease; ensure intravascular placement of catheters prior to injection; monitor patients for extravasation and advise patients to seek medical care for progression of symptoms
Oraltag not a sterile product and not suitable for a parenteral route of administration; serious adverse reactions such as sepsis can occur if administered parenterally; do not administer solution parenterally
Thyroid storm has occurred after intravascular use of iodinated contrast agents in patients with hyperthyroidism, or with autonomously functioning thyroid nodule; evaluate risk in such patients before use
Iodinated contrast agents may alter results of thyroid function tests which depend on iodine estimation, eg, radioactive iodine uptake test; therefore, such testing, if indicated, should be performed prior to administration of this preparation
Thyroid dysfunction in pediatric patients
- Thyroid dysfunction characterized by hypothyroidism or transient thyroid suppression reported after both single exposure and multiple exposures to iodinated contrast media; among patients 0- 3 years of age exposed to iodinated contrast media, thyroid dysfunction reported depending on age of patient and dose of the iodinated contrast agent
- Pediatric patients with congenital cardiac conditions may be at greatest risk given that they often require high doses of contrast during invasive cardiac procedures
- An underactive thyroid during early life may be harmful for cognitive and neurological development and may require thyroid hormone replacement therapy
- After exposure to iodinated contrast media, individualize thyroid function monitoring in pediatric patients 0-3 years of age based on underlying risk factors, especially in term and preterm neonates
- Pediatric patients 0-3 years of age warrant closer monitoring because an underactive thyroid during early life may be harmful to motor, hearing, and cognitive development and may require transient T4 replacement therapy
Contrast induce acute kidney injury
- Acute kidney injury, including renal failure, may occur after parenteral administration; risk factors include: preexisting renal impairment, dehydration, diabetes mellitus, congestive heart failure, advanced vascular disease, elderly age, concomitant use of nephrotoxic or diuretic medications, multiple myeloma / paraproteinaceous diseases, repetitive and/or large doses of an iodinated contrast agent
- Use lowest necessary dose in patients with renal impairment; adequately hydrate patients prior to and following parenteral administration; do not use laxatives, diuretics, or preparatory dehydration prior to administration
Cardiovascular adverse reactions
- Life-threatening or fatal cardiovascular reactions including hypotension, shock, cardiac arrest have occurred with parenteral administration; most deaths occur during injection or five to ten minutes later, with cardiovascular disease as the main aggravating factor; cardiac decompensation, serious arrhythmias, and myocardial ischemia or infarction can occur during coronary arteriography and ventriculography
- Based upon clinical literature reported deaths from administration of iodinated contrast agents range from 6.6 per million (0.00066%) to 1 in 10,000 (0.01%); use lowest necessary dose in patients with congestive heart failure and always have emergency resuscitation equipment and trained personnel available; monitor all patients for severe cardiovascular reaction
Thromboembolic events
- Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke can occur during angiocardiography procedures with both ionic and nonionic contrast media; during these procedures, increased thrombosis and activation of the complement system occurs
- Risk factors for thromboembolic events include length of procedure, catheter and syringe material, underlying disease state, and concomitant medications; to minimize thromboembolic events, use meticulous angiographic techniques, and minimize length of the procedure
- Avoid blood remaining in contact with syringes containing iodinated contrast agents, which increases risk of clotting; avoid angiocardiography in patients with homocystinuria because of risk of inducing thrombosis and embolism
Hypersensitivity reactions
- Therapy can cause life-threatening or fatal hypersensitivity reactions including anaphylaxis; manifestations include respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock; most severe reactions develop shortly after start of injection (within3 minutes), but reactions can occur up to hours later
- There is an increased risk in patients with a history of a previous reaction to contrast agent, and known allergies (eg, bronchial asthma, drug, or food allergies) or other hypersensitivities
- Premedication with antihistaminesor corticosteroids does not prevent serious life-threatening reactions, but may reduce both their incidence and severity
- Obtain a history of allergy, hypersensitivity, or hypersensitivity reactions to iodinated contrast agents and always have emergency resuscitation equipment and trained personnel available prior to administration; monitor all patients for hypersensitivity reactions
Severe cutaneous adverse reactions
- Severe cutaneous adverse reactions (SCAR) may develop from 1 hour to several weeks after intravascular contrast agent administration
- These reactions include Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS)
- Reaction severity may increase and time to onset may decrease with repeat administration of contrast agents; prophylactic medications may not prevent or mitigate severe cutaneous adverse reactions
- Avoid administering to patients with a history of a severe cutaneous adverse reaction to this drug
Pregnancy & Lactation
Pregnancy
Postmarketing data with use in pregnant women are insufficient to determine if there is drug-associated risk of adverse developmental outcomes; drug crosses placenta and reaches fetal tissues in small amounts; in animal reproduction studies, no adverse developmental effects were observed following intravenous administration to pregnant rats and rabbits during organogenesis at doses up to 0.4 (rat) and 0.5 (rabbit) times maximum recommended human intravenous dose
Lactation
Literature reports that breast feeding after administration to mother would result in the infant receiving oral dose of approximately 0.7% of maternal intravenous dose; there is no information on effects of drug on milk production; iodinated contrast agents are excreted unchanged in human milk in very low amounts with poor absorption from gastrointestinal tract of a breastfed infant; exposure to to a breastfed infant can be minimized by temporary discontinuation of breastfeeding; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition
Interruption of breastfeeding after exposure to iodinated contrast agents is not necessary because potential exposure of breastfed infant to iodine is small; however, a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk for 10 hours (approximately 5 elimination half-lives) after drug administration to minimize drug exposure to breastfed infant
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Allows for radiographic visualization through the opacification of vessels and anatomical structures in the path of flow of the contrast media
Pharmacokinetics
Protein binding: Minimal
Excretion: Urine (80-90%)
Duration: 30 min following intrathecal administration, 60 min following IV administration; 15-120 seconds in serum
Administration
Oral Preparation (Oraltag)
Reconstitute powder in the single use bottle with water or other beverages (eg, infant formula, milk, juice, carbonated beverage, sports drink) just before use
Use the 5 fill lines premolded and labeled on the bottle to determine the volume for the 5 target concentrations (ie, 9, 12, 15, 18, and 21 mg(iodine)/mL)
Variables of patient age, weight, or medical condition, may require adjustment of the concentration and/or volume of solution to be prepared for administration; if it is anticipated that the patient will have difficulty in consuming the required volume, a higher concentration of solution (up to 21 mg (iodine) per mL) can be prepared and a smaller volume administered
Do not mix with other pharmaceuticals
Once dissolved, the solution can then be directly administered from the bottle
Protect prepared solution from strong daylight and direct exposure to sunlight
Oral Administration
Oraltag: Administer 20-60 minutes before image acquisition
Discard any unused portions
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Omnipaque 180 intrathecal - | 180 mg iodine/mL vial |  | |
| Omnipaque 180 intrathecal - | 180 mg iodine/mL vial |  | |
| Omnipaque 240 intravenous - | 240 mg iodine/mL vial |  | |
| Omnipaque 240 intravenous - | 240 mg iodine/mL solution |  | |
| Omnipaque 240 intravenous - | 240 mg iodine/mL vial |  | |
| Omnipaque 240 intravenous - | 240 mg iodine/mL solution |  | |
| Omnipaque 300 intravenous - | 300 mg iodine/mL solution |  | |
| Omnipaque 300 intravenous - | 300 mg iodine/mL vial |  | |
| Omnipaque 350 intravenous - | 350 mg iodine/mL solution |  | |
| Omnipaque 350 intravenous - | 350 mg iodine/mL solution |  | |
| Omnipaque 350 intravenous - | 350 mg iodine/mL solution |  | |
| Omnipaque 350 intravenous - | 350 mg iodine/mL solution |  |
Copyright © 2010 First DataBank, Inc.
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