iodixanol (Rx)

Brand and Other Names:Visipaque
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 270mg/mL organically bound iodine (ie, iodixanol 550mg/mL)
  • 320mg/mL organically bound iodine (ie, iodixanol 652mg/mL)
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Visipaque 320

Intra-arterial administration (arteriography)

  • Carotid arteries: 10-14 mL
  • Verterbral arteries: 10-12 mL
  • Right coronary artery: 3-8 mL
  • Left coronary artery: 3-10 mL
  • Left ventricle: 20-45 mL
  • Renal arteries: 8-18 mL
  • Aortography: 30-70 mL
  • Major aorta branch: 10-70 mL
  • Peripheral arteries: 15-30 mL
  • Aortofermoral runoffs: 20-90 mL

Intra-arterial administration (IA-DSA)

  • Carotid or vertebral arteries: 5-8 mL
  • Aortography: 10-50 mL
  • Major aorta branch: 2-10 mL
  • Aortofemoral runoffs: 6-15 mL
  • Peripheral arteries: 3-15 mL

IV administration

  • CECT of head or body: 75-150 mL bolus, then 100-150 mL infusion not to exceed 150 mL
  • Excretory urography: 1 mL/kg, not to exceed 100 mL
  • Venography: 50-150 mL per lower extremity

Visipaque 270

Intra-arterial administration (IA-DSA)

  • Renal arteries: 10-25 mL
  • Aortography: 20-50 mL
  • Major aorta branches: 5-30 mL

IV administration

  • CECT of head or body: 75-150 mL bolus, then 100-150 mL infusion; not to exceed 150 mL
  • Excretory urography: 1 mL/kg; not to exceed 100 mL for normal renal function
  • Venography (per lower extremity): 50-150 mL; not to exceed 250 mL

Dosage Forms & Strengths

injectable solution

  • 270mg/mL organically bound iodine (ie, iodixanol 550mg/mL)
  • 320mg/mL organically bound iodine (ie, iodixanol 652mg/mL)
more...

Intra-arterial administration

Visipaque 320

1-12 years

  • Cerebral, cardiac chambers and related major arteries, and visceral studies: 1-2 mL/kg; not to exceed 4 mL/kg

>12 years

  • Carotid arteries: 10-14 mL
  • Verterbral arteries: 10-12 mL
  • Right coronary artery: 3-8 mL
  • Left coronary artery: 3-10 mL
  • Left ventricle: 20-45 mL
  • Renal arteries: 8-18 mL
  • Aortography: 30-70 mL
  • Major aorta branch: 10-70 mL
  • Peripheral arteries: 15-30 mL
  • Aortofermoral runoffs: 20-90 mL

Intra-arterial administration (IA-DSA)

Visipaque 320

>12 years

  • Carotid or vertebral arteries: 5-8 mL
  • Aortography: 10-50 mL
  • Major aorta branch: 2-10 mL
  • Aortofemoral runoffs: 6-15 mL
  • Peripheral arteries: 3-15 mL

IV administration

Visipaque 320

>12 years

  • CECT of head or body: 75-150 mL bolus, then 100-150 mL infusion not to exceed 150 mL
  • Excretory urography: 1 mL/kg, not to exceed 100 mL
  • Venography: 50-150 mL per lower extremity

Intra-arterial administration (IA-DSA)

Visipaque 270

1-12 years

  • CECT or excretory urography: 1-2 mL/kg; not to exceed 2 mL/kg

>12 years

  • Renal arteries: 10-25 mL
  • Aortography: 20-50 mL
  • Major aorta branches: 5-30 mL

IV administration

Visipaque 270

>12 years

  • CECT of head or body: 75-150 mL bolus, then 100-150 mL infusion; not to exceed 150 mL
  • Excretory urography: 1 mL/kg; not to exceed 100 mL for normal renal function
  • Venography (per lower extremity): 50-150 mL; not to exceed 250 mL<
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Adverse Effects

>10%

Discomfort at injection site (<30%)

1-10%

Angina pectorin (<2%)

Chest pain (<2%)

Headache (<3%)

Migraine (<3%)

Vertigo (<2%)

Parethesia (1%)

Pruritus (2%)

Skin rash (<2%)

Erythema (<2%)

Dysguesia (4%)

Postmarketing Reports

Cardiovascular Disorders: Cardiac arrest, palpitations, spasms of coronary arteries, hypertension, and flushing

Endocrine Disorders: Thyroid function tests indicative of hypothyroidism or transient thyroid suppression have been uncommonly reported following iodinated contrast media administration to adult and pediatric patients, including infants; some patients were treated for hypothyroidism; hypoglycemia, hyperthyroidism

Eye Disorders: Transient visual impairment including cortical blindness, diplopia, and blurred vision

Gastrointestinal Disorders: Abdominal pain, pancreatitis, salivary gland enlargement

General Disorders and Administration Site Conditions: Chills, pyrexia, pain and discomfort, administration site reactions including extravasation

Immune System Disorders: Hypersensitivity reactions, anaphylactic shock including, life-threatening or fatal anaphylaxis

Nervous System Disorders: Tremor (transient), coma, disturbance in consciousness, transient contrast-induced encephalopathy caused by extravasation of contrast media (including amnesia, hallucination, paralysis, paresis, transient speech disorder, aphasia, dysarthria)

Psychiatric Disorders: Anxiety, agitation

Respiratory, Thoracic, and Mediastinal Disorders: Cough, sneezing, throat irritation or tightness, laryngeal edema, pharyngeal edema, bronchospasm

Skin and subcutaneous tissue disorders: Reactions range from mild (e.g. rash, erythema, pruritus, urticaria, and skin discoloration) to severe: [e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS)]

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Warnings

Black Box Warnings

Not for intrathecal (IT) use

Inadvertent IT administration of iodinated contrast media ha resulted in serious adverse reactions including death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema

Contraindications

Hypersensitivity to product or components

Intrathecal use

In children, prolonged fasting and use of laxative before administration is contraindicated

Product label has additional procedure-specific contraindications

Cautions

Maintain adequate hydration

Use caution in renal/hepatic impairment, cardiovascular disease, multiple myeloma, pheochromocytoma, sickle cell disease, elderly patients, and thyroid dysfunction

Increased risk of adverse effects including heart disease, asthma patients, and sensitivity to allergens or medications

Renal failure may occur in patients with diabetes during preparatory dehydration; maintain normal hydration in these patients

Patients with homocystinuria may be at risk for thrombosis and embolism; avoid angiography in these patients

Avoid extravasation, especially in patients with severe arterial or venous disease

Thromboembolic events causing myocaridal infarction and stroke reported; use meticulous intravascular administration techniques, especially during angiographic procedures

Severe cutaneous adverse reactions(SCAR), including Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS), may develop from 1 hr to several weeks after intravascular contrast agent administration; 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 product to patients with history of severe cutaneous adverse reaction to product

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Pregnancy & Lactation

Pregnancy

There are no data with iodixanol use in pregnant women to inform any drug-associated risks; in animal reproduction studies, no developmental toxicity occurred with intravenous iodixanol administration to rats and rabbits at doses up to 0.24 (rat) or 0.48 (rabbit) times the maximum recommended human intravenous dose

Lactation

There are no data on presence of iodixanol in human milk, the effects on breastfed infant or effects on milk production. Iodinated contrast agents are poorly excreted into human milk and are poorly absorbed by gastrointestinal tract of a breastfed infant; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for iodixanol and any potential adverse effects on breastfed infant from iodixanol or from underlying maternal condition

Interruption of breastfeeding after exposure to iodinated contrast agents is not necessary because the 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 hr (approximately 5 elimination half-lives) after iodixanol administration in order to minimize drug exposure to a breast fed 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.

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Pharmacology

Mechanism of Action

Dimeric, isosmolar, nonionic, water-soluble, iodinated x-ray contrast agent for intravascular administration; opacifies vessels within path of flow, thereby permitting radiographic visualization of internal structures until significant dilution and elimination occurs

Pharmacokinetics

Vd: 0.26 L/kg

Excretion: 97% excreted unchanged in urine within 24 hr

Half-life: 2-4 hr (children); 2 hr (adults)

Peak plasma time: Immediate; 15-120 sec (peak enhancement); 5-15 min (optimum renal contrast); up to 1 hr (brain contrast)

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Formulary

FormularyPatient Discounts

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  • View the formulary and any restrictions for each plan.
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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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