Dosing & Uses
Dosage Forms & Strengths
Content expressed as organic bound iodine/mL
injectable solution
- 200mg/mL (41%)
- 300mg/mL (61%)
intravenous solution
- 200mg/mL (41%)
- 250mg/mL (51%)
- 300mg/mL (61%)
- 370mg/mL (76%)
Angiography
Cerebral Arteriography
- 300 mg/mL: 8-12 mL intra-arterial, may repeat, not to exceed 90 mL
Peripheral Venography
- 200 mg/mL: 25-150 mL IV per lower extremity; total not to exceed 350 mL
Coronary Arteriography
- 370 mg/mL: 2-10 mL IV; monitor EKG; not to exceed 200 mL
Coronary Ventriculography
- 370 mg/mL: 25-50 mL IV; monitor EKG; not to exceed 200 mL
Selective Visceral Arteriography
- 370 mg/mL: Up to 50 mL IV; not to exceed 225 mL
Selective Visceral Aortography
- 370 mg/mL: Up to 50 mL IV; not to exceed 225 mL
Peripheral Venography
- 200 mg/mL: 25-150 mL; not to exceed 350 mL
Computed Tomography
CECT of the Head
- 250 mg/mL: 130-240 mL IV; not to exceed 240 mL
- Alternatively, 300 mg/mL: 100-200 mL IV; not to exceed 200 mL
- Imaging may be done immediately after completing administration
CECT of the Body
- 250 mg/mL: 130-240 mL IV; not to exceed 240 mL
- Alternatively, 300 mg/mL: 100-200 mL IV; not to exceed 200 mL
- Imaging may be done immediately after completing administration
Urography
Excretory Urography
- 250 mg/mL: 50-100 mL IV OR
- 300 mg/mL: 50 mL IV OR
- 370 mg/mL: 40 mL IV
Dosage Forms & Strengths
Content expressed as iodine/mL
injectable solution
- 200mg/mL (41%)
- 300mg/mL (61%)
intravenous solution
- 200mg/mL (41%)
- 250mg/mL (51%)
- 300mg/mL (61%)
- 370mg/mL (76%)
Angiocardiography
For 370 mg/mL:
<2 years: 10-15 mL IV, not to exceed 40 mL total
2-9 years: 15-30 mL IV, not to exceed 50 mL (2-4 years) or 100 mL (5-9 years)
10-18 years: 20-50 mL IV, not to exceed 125 mL
Computed Tomography
CECT of the Head
- 250 mg/mL: 1.2-3.6 mL/kg IV; not to exceed 30 g of iodine
- Alternatively, 300 mg/mL: 1-3 mL/kg IV; not to exceed 30 g of iodine
CECT of the Body
- 250 mg/mL: 1.2-3.6 mL/kg IV; not to exceed 30 g of iodine OR
- 300 mg/mL: 1-3 mL/kg IV; not to exceed 30 g of iodine
Urography
Excretory Urography
- 250 mg/mL: 1.2-3.6 mL/kg IV; not to exceed 30 g of iodine OR
- 300 mg/mL: 1-3 mL/kg IV; not to exceed 30 g of iodine
Adverse Effects
1-10%
Hot flashes (3.4%)
Angina pectoris (3%)
Flushing (1.8%)
Bradycardia (1.3%)
Hypotension (1%)
Hives (1%)
<1%
Cyanotic heart disease
Right ventricular abnormalities
Abnormal pulmonary circulation
Postmarketing Reports
Skin necrosis (e.g. rash, erythema, pruritus, urticaria and skin discoloration, Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS)]
Hyperthyroidism, hypothyroidism
Warnings
Black Box Warnings
Not for intrathecal use
Contraindications
Hypersensitvity to product or components
Intrathecal injection concurrently with intrathecal corticosteroid administration (significant bacterial infection)
Cautions
Before examination patients should be well hydrated to prevent contrast associated nephropathy
Caution in patients with seizures, thromboembolic diseases including IM and stroke, chronic alcoholism, heart failure, hepatorenal insufficiency, hyperthyroidism, multiple myeloma, pheochromocytoma, renal disease, sickle cell disease
Serious adverse events reported from inadvertent intrathecal administration of iodinated contrast that is not indicated for intrathecal use (Isovue and Isovue Miltipack are not for intrathecal administration)
Severe cutaneous adverse reactions (SCAR) may develop from 1 hour to several weeks after intravascular contrast agent administration; these 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 agent; prophylactic medications may not prevent or mitigate severe cutaneous adverse reactions; avoid administering therapy to patients with a history of a severe cutaneous adverse reaction to the drug
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 in pediatric patients 0 to 3 years of age
- Advise parents/caregivers about risk of developing thyroid dysfunction after therapy; advise parents/caregivers when to seek medical care for their child to monitor for thyroid function
- Younger age, very low birth weight, prematurity, underlying medical conditions affecting thyroid function, admission to neonatal or pediatric intensive care units, and congenital cardiac conditions are associated with increased risk of hypothyroidism after ICM exposure
- Pediatric patients with congenital cardiac conditions may be at greatest risk given that they often require high doses of contrast during invasive cardiac procedures, such as catheterization and computed tomography (CT)
- An underactive thyroid during early life may be harmful to 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 at higher risk of experiencing adverse events during contrast medium administration may include those having asthma, a sensitivity to medication and/or allergens, cyanotic heart disease, congestive heart failure, serum creatinine greater than 1.5 mg/dL or <12 months of age
FDA MedWatch
- March 30, 2022: FDA recommended newborns and children aged ≤3 years have follow-up thyroid monitoring within 3 weeks after receiving iodinated contrast media (ICM) for X-rays and other medical imaging procedures
- Published studies found underactive thyroid and temporary decreases in thyroid hormone levels were uncommon; however, if identified and treated early, future complications may be prevented
- Appropriately monitor for signs and symptoms of hypothyroidism and decreased thyroid hormone levels following ICM exposure; consider evaluating thyroid function within 3 weeks, especially in term and preterm neonates and children with some underlying conditions
- If thyroid dysfunction detected, treat and monitor thyroid function as needed to avoid future complications
- Certain pediatric patients are at increased risk, including newborns or have very low birth weight, prematurity, or presence of cardiac or other conditions (eg, requiring care in neonatal or pediatric ICUs)
- Patients with cardiac conditions may be at greatest risk since they often require high doses of contrast during invasive cardiac procedures
Pregnancy & Lactation
Pregnancy Category: B
Lactation: Excretion into breast milk unknown; not recommended
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
Radiographic visualization achieved through the opacification of vessels and anatomical structures in the path of flow of the contrast media
Pharmacokinetics
Half-life: 2 hr; prolonged in renal impairment
Excretion: Urine (80-90%)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Isovue-300 intravenous - | 300 mg iodine /mL (61 %) solution |  | |
| Isovue-300 intravenous - | 300 mg iodine /mL (61 %) vial |  | |
| Isovue-M 200 intrathecal - | 200 mg iodine /mL (41 %) vial |  | |
| Isovue-M 200 intrathecal - | 200 mg iodine /mL (41 %) vial |  | |
| Isovue-M 300 intrathecal - | 300 mg iodine /mL (61 %) vial |  |
Copyright © 2010 First DataBank, Inc.
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