Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/4039
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OMNIPAQUE (Injection)
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| dailymed-instance:dosage |
The individual dose or volume is determined by the size of the structure to be visualized, the anticipated degree of hemodilution, and valvular competence. Weight is a minor consideration in adults, but must be considered in infants and young children. The volume of each individual injection is a more important consideration than the total dosage used. When large individual volumes are administered, as in ventriculography and aortography, it has been suggested that several minutes be permitted to elapse between each injection to allow for subsidence of possible hemodynamic disturbances. The recommended single injection volume of OMNIPAQUE 350 for angiocardiographic procedures in adults and the recommended single injection volumes of OMNIPAQUE 350 and OMNIPAQUE 300 for angiographic procedures in children are as follows:
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| dailymed-instance:descripti... |
Iohexol,N,N��- Bis(2,3-dihydroxypropyl)-5-[N-(2,3-dihydroxypropyl)-acetamido]-2,4,6-triiodo-isophthalamide, is a nonionic, water-soluble radiographic contrast medium with a molecular weight of 821.14 (iodine content 46.36%). In aqueous solution each triiodinated molecule remains undissociated. The chemical structure is: OMNIPAQUE is provided as a sterile, pyrogen-free, colorless to pale-yellow solution, in the following iodine concentrations: 140, 180, 240, 300, and 350 mgI/mL. OMNIPAQUE 140 contains 302 mg of iohexol equivalent to 140 mg of organic iodine per mL; OMNIPAQUE 180 contains 388 mg of iohexol equivalent to 180 mg of organic iodine per mL; OMNIPAQUE 240 contains 518 mg of iohexol equivalent to240 mg of organic iodine per mL; OMNIPAQUE 300 contains 647 mg of iohexol equivalent to 300 mg of organic iodine per mL; and OMNIPAQUE 350 contains 755 mg of iohexol equivalent to 350 mg of organic iodine per mL. Each milliliter of iohexol solution contains 1.21 mg tromethamine and 0.1 mg edetate calcium disodium with the pH adjusted between 6.8 and 7.7 with hydrochloric acid or sodium hydroxide. All solutions are sterilized by autoclaving and contain no preservatives. Unused portions must be discarded. Iohexol solution is sensitive to light and therefore should be protected from exposure. The available concentrations have the following physical properties: OMNIPAQUE 140, OMNIPAQUE 180, OMNIPAQUE 240, OMNIPAQUE 300, and OMNIPAQUE 350 have osmolalities from approximately 1.1 to 3.0 times that of plasma (285 mOsm/kg water) or cerebrospinal fluid (301 mOsm/kg water) as shown in the above table and are hypertonic under conditions of use.
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| dailymed-instance:contraind... |
OMNIPAQUE should not be administered to patients with a known hypersensitivity to iohexol.
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| dailymed-instance:supply |
OMNIPAQUE 180 Vials of 10 mL, 180 mgI/mL, boxes of 10 (NDC 0407-1411-10) Vials of 20 mL, 180 mgI/mL, boxes of 10 (NDC 0407-1411-20) OMNIPAQUE 240 Vials of 10 mL, 240 mgI/mL, boxes of 10 (NDC 0407-1412-10) Vials of 20 mL, 240 mgI/mL, boxes of 10 (NDC 0407-1412-20) OMNIPAQUE 300 Vials of 10 mL, 300 mgI/mL, boxes of 10 (NDC 0407-1413-10) Storage: Protect vials of OMNIPAQUE from strong daylight and direct exposure to sunlight. Do not freeze. Omnipaque should be stored at controlled room temperature, 20��-25��C (68��-77��F); excursions permitted to 15��-30��C (59��-86��F) [see USP Controlled Room Temperature].
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| dailymed-instance:activeMoi... | |
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| dailymed-instance:precautio... |
During administration of large doses of OMNIPAQUE 350, continuous monitoring of vital signs is desirable. Caution is advised in the administration of large volumes to patients with incipient heart failure because of the possibility of aggravating the preexisting condition. Hypotension should be corrected promptly since it may induce serious arrhythmias. Special care regarding dosage should be observed in patients with right ventricular failure, pulmonary hypertension, or stenotic pulmonary vascular beds because of the hemodynamic changes which may occur after injection into the right heart outflow tract. 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, congestive heart failure, a serum creatinine greater than 1.5 mg/dL or those less than 12 months of age.
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| dailymed-instance:overdosag... |
Clinical consequences of overdosage with OMNIPAQUE have not been reported. However, based on experience with other nonionic myelographic media, physicians should be alert to a potential increase in frequency and severity of CNS-mediated reactions. Even use of a recommended dose can produce effects tantamount to overdosage, if incorrect management of the patient during or immediately following the procedure permits inadvertent early intracranial entry of a large portion of the medium. The intracisternal LDvalue of OMNIPAQUE (in grams of iodine per kilogram body weight) is greater than 2.0 in mice.
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| dailymed-instance:genericMe... |
Iohexol
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| dailymed-instance:fullName |
OMNIPAQUE (Injection)
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| dailymed-instance:adverseRe... |
Cardiovascular system reactions in angiocardiography included angina (8%), hypotension (2.5%), bradycardia (1.0%), and tachycardia (1.0%).
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| dailymed-instance:name |
OMNIPAQUE
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