Optiray

Optiray

Manufacturer:

Guerbet

Distributor:

Biogenetech
Concise Prescribing Info
Contents
Per 300 mg Ioversol 636 mg/mL (iodine 300 mg/mL). Per 320 mg Ioversol 678 mg/mL (iodine 320 mg/mL). Per 350 mg Ioversol 741 mg/mL (iodine 350 mg/mL)
Indications/Uses
350 mgI/mL: Coronary arteriography & ventriculography, peripheral & visceral arteriography, IV contrast enhancement in computed tomography (CT) of the head & body, excretory urography, IV digital subtraction angiography & venography in adults. Angiocardiography in childn. 320 mgI/mL: Angiography throughout the CV system (cerebral, coronary, peripheral, visceral & renal arteriography, aortography & left ventriculography) in adults. Contrast enhanced CT imaging of the head & body & in excretory urography in adults & childn ≥1 yr. 300 mgI/mL: Cerebral angiography, aortography, peripheral & visceral arteriography, IV contrast enhancement of CT of the brain & body, excretory urography, IV digital subtraction angiography & venography in adults. IV excretory urography & intra-arterial digital subtraction angiography in childn ≥1 yr.
Dosage/Direction for Use
Use the lowest dose necessary to obtain adequate visualization. Cerebral angiography Optiray 300 mgI/mL or 320 mgI/mL may be used. Adult Usual dose: Common carotid arteriography: 5-10 mL. Vertebral arteriography: 4-8 mL. Aortic arch inj: 15-25 mL of Optiray 320 mgI/mL. Inj should be made at rates approx equal to flow rate of vessel being inj. Max total procedural dose: 200 mL. Intra-arterial digital subtraction arteriography Optiray 300 mgI/mL is suitable. Childn ≥1 yr 1-3 mL/kg of Optiray 300 mgI/mL depending on the area to be examined. Peripheral arteriography Arteriograms of the lower extremities: Optiray 300 mgI/mL, 320 mgI/mL, or 350 mgI/mL. Adult Aorto-iliac run-off studies: 20-50 mL. Iliac & femoral arteries: 10-30 mL. Dose may be repeated. Max total procedural dose: 250 mL. Selective coronary arteriography w/ or w/o left ventriculography Optiray 320 mgI/mL or 350 mgI/mL is recommended. Adult Left coronary arteriography: 2-10 mL. Right coronary arteriography: 2-6 mL. Left ventriculography: 30-40 mL. Dose may be repeated. Max total procedural dose: 250 mL. Childn ≥1 yr 1.25 mL/kg as usual single inj dose w/ a range of 1-1.5 mL/kg. Total dose: 5 mL/kg up to a total vol of 250 mL. Aortography & visceral arteriography Optiray 300 mgI/mL, 320 mgI/mL, or 350 mgI/mL is recommended. Adult Usual individual inj vol: Abdominal aorta: 20-50 mL. Superior mesenteric artery: 20-40 mL. Renal artery: 4-10 mL. Total procedure dose: 250 mL. CT of the head neoplastic conditions & non-neoplastic conditions Optiray 300 mgI/mL, 320 mgI/mL, or 350 mgI/mL may be used. Adult 50-100 mL. Max dose: 150 mL of Optiray 320 mgI/mL or 350 mgI/mL. Childn ≥1 yr 1-3 mL/kg of Optiray 320 mgI/mL. Body CT Optiray 300 mgI/mL, 320 mgI/mL, or 350 mgI/mL. Adult 30-100 mL as bolus inj, rapid infusion or combination of both. Prolonged enhancement: 25-50 mL as rapid bolus & the remainder as infusion. Total dose: 150 mL. Childn ≥1 yr 1-3 mL/kg of Optiray 320 mgI/mL w/ a usual dose of 2 mL/kg. Venography Optiray 300 mgI/mL or 350 mgI/mL. Adult 20-100 mL for the lower extremity. Max dose: 250 mL. Excretory urography Optiray 300 mgI/mL, 320 mgI/mL, or 350 mgI/mL may be used. Adult 50 mL. High dose urography may be preferred using Optiray 320 mgI/mL at a dose of 1.5-2 mL/kg IV usually within 1-3 min. Max dose: 150 mL of Optiray 300 mgI/mL or 320 mgI/mL & 140 mL of Optiray 350 mgI/mL. Childn ≥1 yr 0.5-3 mL/kg of Optiray 300 mgI/mL & 320 mgI/mL has produced diagnostic opacification of the urinary tract. Usual dose: 1 mL/kg. Max total dose: 3 mL/kg.
Contraindications
Hypersensitivity or clinically significant cases of hepatic & renal impairment.
Special Precautions
Patients w/ a history of previous reactions to a contrast medium or iodine sensitivity, allergy, bronchial asthma or other allergic manifestations, combined renal & hepatic disease, elderly, debilitated or severely ill patients, those w/ homocystinuria, endotoxemia, elevated body temp, severe HTN or CHF, other CV disease, hyperthyroidism & recent renal transplant recipients; serum creatinine level >3 mg/dL. Advanced renal disease. Not recommended in patients w/ anuria or severe oliguria. Known or suspected of pheochromocytoma. Assess BP throughout the procedure. Discontinue administration if rash, abdominal pain, vomiting & breathing difficulties occur. Patients who have multiple myeloma & other paraproteinemias. Hydrate patient prior to exam. May promote sickling in individuals who are homozygous for sickle cell disease. Do not inj contrast medium following the administration of vasopressors. Patients w/ hepatic or biliary disorders who have recently taken a cholecystopgraphic agent. Allow at least 48 hr between exam in patients w/ reduced renal reserve. Diabetic nephropathy & susceptible non-diabetic patients w/ preexisting renal disease. Carefully evaluate patients w/ hyperthyroidism or w/ autonomously functioning thyroid nodule prior to treatment. Patients w/ increased intra-cranial pressure, cerebral thrombosis or embolism, primary or metastatic cerebral lesions, subarachnoid hemorrhage, arterial spasm, transient ischemic attacks & in any condition when the blood-brain barrier is breached or the transit time of the contrast agent material through the cerebral vasculature is prolonged. Clinically unstable patients or those in critical condition. Patients w/ CHF should be kept under surveillance for several hr in order to detect delayed hemodynamic disturbances. Patients on adrenergic β-blockers. Avoid large conc bolus into aortic branch. Thromboangiitis obliterans (Buerger's disease). Severe ischemia w/ ascending infection. Patients w/ suspected thrombosis, ischemic disease, local infection or a significantly obstructed vascular system. Patients w/ aorta-iliac or femoral artery bed obstruction, abdominal compression, hypotension, HTN, & following vasopressors inj. Avoid angiography in patients w/ homocystinuria. Pregnancy. Discontinue lactation for at least 48 hr following procedure. Childn <12 mth. Elderly.
Adverse Reactions
Angina pectoris, hypotension, BP fluctuation, arterial spasm, bradycardia, conduction defect, false aneurysm, HTN, transient arrhythmia, vascular trauma; nausea, vomiting; cerebral infarct, headache, blurred vision, vertigo, lightheadedness, vasovagal reaction, disorientation, paresthesia, dysphasia, muscle spasm, syncope, visual hallucination; laryngeal & pulmonary edema, sneezing, nasal congestion, coughing, shortness of breath, hypoxia; periorbital edema, urticaria, facial edema, flush, pruritus; extravasation, hematoma, shaking chills, bad taste, general pain.
Drug Interactions
Drugs that lower seizure threshold especially phenothiazine derivatives eg, antihistaminic or antinauseant properties. Renal toxicity may occur w/ oral cholecystographic agent.
ATC Classification
V08AB07 - ioversol ; Belongs to the class of watersoluble, nephrotropic, low osmolar preparations used as X-ray contrast media.
Presentation/Packing
Form
Optiray inj ioversol 320 mg iodine/mL
Packing/Price
100 mL x 10 × 1's
Form
Optiray inj ioversol 350 mg iodine/mL
Packing/Price
100 mL x 10 × 1's;50 mL x 10 × 1's
Form
Optiray inj ioversol 300 mg iodine/mL
Packing/Price
100 mL x 10 × 1's;50 mL x 10 × 1's
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