ioversol (Rx)

Brand and Other Names:Optiray
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 160mg/mL (34%)
  • 240mg/mL (51%)
  • 300mg/mL (64%)
  • 320mg/mL (68%)
  • 350mg/mL (74%)
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Radiographic Body Imaging

Usual: 50-150 mL IV OR 100-250 mL IV of (240 mg/mL)

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

Cerebral Arteriography

2-12 mL of 51%, 64%, 68%; may repeat as necessary; not to exceed 200 mL/procedure

20-50 mL aortic arch injection of 51%, 64%, 68% for a simultaneous 4-vessel study; not to exceed 200 mL/procedure

Aortography

45 mL (10-80 mL range) of 68%; may repeat as necessary; not to exceed 250 mL/procedure

Computed Tomography

25-75 mL IV bolus followed by 50-150 mL infusion of 74%; not to exceed 150 mL

25-75 mL IV bolus followed by 50-150 mL infusion of 68%; not to exceed 150 mL

25-75 mL IV bolus followed by 50-150 mL infusion of 64%; not to exceed 150 mL

35-100 mL IV bolus followed by 70-200 mL infusion of 51%; not to exceed 150 mL

Head Imaging

50-150 mL IV of 68% or 64% OR

100-250 mL IV of 51%

Perform scanning immediately following IV administration

Coronary Arteriography

8 mL (2-10 mL) left coronary; 6 mL (1-10 mL) right coronary; may repeat as necessary; not to exceed 250 mL/procedure

IV-DSA

160 mg/mL (34%) recommended

30-50 mL IV, repeat PRN; not to exceed 250 mL/procedure

Administration

  • Carotid arteries: 6-10 mL
  • Subclavian or brachial arteries: 2-10 mL
  • Aorta: 25-50 mL
  • Vertebral arteries: 4-8 mL
  • Major branches of the abdominal aorta

IV Urography

50-75 mL IV of 74%, 68%, or 64% OR

75-100 mL IV of 51%

Higher dosages may be indicated

  • 1.4 mL/kg IV of 350 mg/mL; not to exceed 140 mL, OR
  • 1.5-2 mL/kg IV of 320 mg/mL; not to exceed 150 mL, OR
  • 1.5 mL/kg IV of 300 mg/mL; not to exceed 150 mL, OR
  • 2 mL/kg IV of 240 mg/mL; not to exceed 200 mL

Preparatory dehydration may contribute to ARF

Dosage Forms & Strengths

injectable solution

  • 160mg/mL (34%)
  • 240mg/mL (51%)
  • 300mg/mL (64%)
  • 320mg/mL (68%)
  • 350mg/mL (74%)
more...

Angiocardiography

< 1 month

  • Safety & efficacy not established

> 1 month

  • 1.25 mL/kg (1-1.5 mL/kg) of 68% or 74% as single ventricular injection; not to exceed 5 mL/kg or 250 mL total volume

IV Urography

< 1 month

  • Safety & efficacy not established

> 1 month

  • 0.5-3 mL/kg IV (1-1.5 mL/kg usual); not to exceed 3 mL/kg

Computed Tomography

< 1 month

  • Safety & efficacy not established

> 1 month

  • Body imaging: 2 mL/kg (1-3 mL/kg) of 68%
  • Head imaging: 1-3 mL/kg of 68%
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Interactions

Interaction Checker

and ioversol

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            <1%

            Cardiac disorders: Myocardial infarction, arrhythmia, atrioventricular block complete, atrioventricular block, nodal rhythm, bradycardia, angina pectoris, palpitations

            Ear and labyrinth disorders: Vertigo, tinnitus

            Eye disorders: Vision blurred, periorbital edema, conjunctivitis

            Gastrointestinal disorders: Vomiting, abdominal pain, dysphagia, dry mouth

            General disorders and administration site conditions: Chest pain, pain, hematoma, extravasation, pyrexia, swelling, asthenia, malaise, fatigue, chills, injection site pain, injection site hematoma, extravasation, pyrexia, swelling, asthenia, malaise, fatigue chills

            Infections and infestations: Rhinitis

            Injury, poisoning, and procedural complications: Heart injury, vascular pseudoaneurism

            Metabolism and nutrition disorders: Acidosis

            Musculoskeletal and connective tissue disorders: Muscular weakness, muscle spasms, back pain

            Nervous system disorders: Cerebral infarction, aphasia, tremor, dizziness, presyncope, headache, paraesthesia, dysgeusia

            Psychiatric disorders: Hallucination, visual hallucination, disorientation, anxiety

            Renal and urinary disorders: Urinary retention, renal pain, polyuria

            Respiratory, thoracic, and mediastinal disorders: Laryngeal edema, hypoxia, pulmonary edema, dyspnea, hyperventilation, cough, sneezing, nasal congestion

            Skin and subcutaneous tissue disorders: Urticaria, rash, pruritus, swelling face, hyperhidrosis, erythema

            Vascular disorders: Hypertension, hypotension, arterial spasm, vasospasm, vasodilation, flushing

            Postmarketing Reports

            Endocrine disorders: Transient hypothyroidism neonatal

            Eye disorders and administrative site conditions: Injection site reactions (nerve injury, extravasation, pruritus, induration, bruising, rash, erythema)

            Immune system disorders: Anaphylactoid shock (with multi-organ failure and cardiorespiratory arrest), anaphylactic shock, anaphylactic/hypersensitivity reaction, urticaria

            Renal and urinary disorders: Acute kidney injury

            Skin and subcutaneous tissue disorders: Erythema multiforme, acute generalized exanthematous pustulosis

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            Warnings

            Black Box Warnings

            Administer procedure at facilities where staff is familiar with the recognition and treatment of allergic reactions

            When administering large doses use caution in patients with renal impairment or concurrent renal/hepatic impairment

            Neurologic events including paralysis following cerebral arteriography, arteriography of blood vessels , and spinal arteriography, reported

            Myocardial infarctions and stroke reported with angiographic procedures

            Thyroid storm reported with the use of iodinated contrast media

            Use caution in patients with multiple myeloma and pheochromocytoma

            Serious adverse events reported with inadvertent administration of iodinated contrast media intrathecally

            Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema

            Contraindications

            Not for intrathecal use (may cause death, convulsions, cerebral hemorrhage, coma, paralysis, ARF)

            Symptomatic hyperthyroidism

            Cautions

            Inhibits blood coagulation

            Caution in severe renal impairment, combined renal/hepatic disease, severe thyrotoxicosis, myelomatosis, anuria, pheochromocytoma, sickle cell, CHF, chronic alcoholism, severe arterial/venous disease

            May cause renal failure in patients with advanced vascular disease, diabetes; should be well hydrated before/after procedure; do not use laxatives, diuretics, or preparatory dehydration prior to administering product

            Obtain a history of allergy, hypersensitivity, or prior hypersensitivity reactions to iodinated contrast agents; always have emergency resuscitation equipment and trained personnel available and monitor all patients for hypersensitivity reactions

            Allergies (bronchial asthma, hay fever, food allergies) reported

            Premedication with antihistamines or corticosteroids to avoid or minimize possible allergic reactions should be considered; reports indicate that such pretreatment does not prevent serious life-threatening reactions, but may reduce both their incidence and severity

            General anesthesia may be indicated in the performance of some procedures in selected patients; however, a higher incidence of adverse reactions has been reported in these patients

            In angiographic procedures, the possibility of dislodging plaques or damaging or perforating the vessel wall should be considered during catheter manipulations and contrast medium injection; test injections to ensure proper catheter placement are suggested

            Angiography should be avoided whenever possible in patients with homocystinuria because of risk of inducing thrombosis and embolism

            Patients with congestive heart failure should be observed for several hours following procedure to detect delayed hemodynamic disturbances which may be associated with transitory increase in circulating osmotic load

            Extreme caution during injection of contrast medium is necessary to avoid extravasation; this is especially important in patients with severe arterial or venous disease

            Selective coronary arteriography should be performed only in selected patients and those in whom expected benefits outweigh procedural risk; inherent risks of angiocardiography in patients with chronic pulmonary emphysema must be weighed against necessity for performing this procedure

            Fatal, thromboembolic events causing myocardial infarction and stroke can occur during angiographic procedures; to minimize thromboembolic events use meticulous angiographic technique; avoid blood remaining in contact with syringes containing the product, which increases risk of clotting; avoid angiocardiography in patients with homocystinuria because of risk of inducing thrombosis and embolism

            Contraindicated in patients with symptomatic hyperthyroidism; thyroid storm reported following intravascular use of iodinated radiopaque agents in patients with hyperthyroidism or with autonomously functioning thyroid nodule; evaluate risk in patients before using product

            Hypertensive crisis has occurred after use of iodinated radiopaque contrast agents in patient with pheochromocytoma; closely monitor patients when administering product if pheochromocytoma or catecholamine-secreting paraganglioma is suspected; inject minimum amount of product necessary and have measures for treatment of hypertensive crisis readily available

            Iodinated contrast agents may promote sickling in individuals who are homozygous for sickle cell disease; hydrate patients prior to and following product administration; use product only if necessary imaging information cannot be obtained with alternative imaging modalities, and inject minimum amount necessary

            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

            Postmarketing data with product use in pregnant women are insufficient to determine if there is risk of drug-associated adverse developmental outcomes; literature reports show that product crosses placenta and is visualized in digestive tract of exposed infants after birth; product crosses placenta and reaches fetal tissues in small amounts; in animal reproduction studies, no adverse developmental effects were observed following intravenous administration of ioversol to pregnant rats and rabbits at doses 0.35 and 0.71 times, respectively, the maximum recommended human dose

            Lactation

            There is no information about presence of product in human or animal milk, effects of drug on breastfed infant, or effects of drug on milk production; however, iodinated contrast agents are excreted unchanged in human milk in very low amounts with poor absorption from gastrointestinal tract of breastfed infant; the developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for product and any potential adverse effects on breastfed infant from product 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 8 hours (approximately 5 elimination half-lives) after product administration in order to minimize drug exposure to 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

            Opacifies vessels in the path of flow of the contrast medium, permitting radiographic visualization of the internal structures until significant hemodilution occurs

            Pharmacokinetics

            Half-life: 2 hr

            Excretion: Urine (>95%)

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            Images

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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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