iopamidol (Rx)

Brand and Other Names:Isovue, Scanlux
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Dosing & Uses

AdultPediatric

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
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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

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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

  • 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
  • Thyroid function tests indicative of thyroid dysfunction, characterized by hypothyroidism or transient thyroid suppression uncommonly reported after both single exposure and multiple exposures to iodinated contrast media in pediatric patients, including term and preterm neonates; some patients were treated for hypothyroidism; monitor pediatric patients 0-3 years of age closely, particularly those with one or more potential risk factors, for thyroid dysfunction
  • Pediatric patients with 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)
  • Pediatric patients 0-3 years of age warrant closer monitoring because an underactive thyroid during early life may be harmful for motor, hearing, and cognitive development and may require transient T4 replacement therapy
  • Evaluate thyroid function in all pediatric patients 0-3 years of age within 3 weeks following exposure to iodinated contrast media, especially in term and preterm neonates; if thyroid dysfunction detected, treat and monitor thyroid function as clinically needed
  • 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, a 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
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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.

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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%)

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Isovue-M 200 intrathecal
-
41 % vial
Isovue-M 200 intrathecal
-
41 % vial
Isovue-M 300 intrathecal
-
61 % vial
Isovue-300 intravenous
-
61 % solution
Isovue-300 intravenous
-
61 % vial

Copyright © 2010 First DataBank, Inc.

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Patient Handout

A Patient Handout is not currently available for this monograph.
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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.