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Iotrolan (BAN, USAN, Rinn) Description

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Iotrolan (BAN, USAN, Rinn) Description 1486 Contrast Media Iotrolan (BAN, USAN, rINN) Description. Meglumine iotroxate contains about 47.4% of I. Ioxaglic Acid (BAN, USAN, rINN) Iotrol; Iotrolán; Iotrolane; Iotrolanum; Iotrolum; Jotrolaani; Jotro- Adverse Effects, Treatment, and Precautions Acide ioxaglique; Ácido_ ioxáglico; Acidum ioxaglicum; Joksagliini- lan; ZK-39482. N,N′,N′′,N′′′-Tetrakis(2,3-dihydroxy-1-hydroxy- See under the amidotrizoates, p.1475. happo; Joksagliko rugštis; Joxaglinsav; Joxaglinsyra; Kyselina joxa- methylpropyl)-2,2′,4,4′,6,6′-hexaiodo-5,5′-(N,N′-dimethylmalo- glová; P-286. N-(2-Hydroxyethyl)-2,4,6-tri-iodo-5-[2′,4′,6′-tri- nyldi-imino)di-isophthalamide. Pharmacokinetics iodo-3′-(N-methylacetamido)-5′-methylcarbamoylhippuramido]- After intravenous injection, iotroxic acid binds to plasma pro- isophthalamic acid. Йотролан teins and is taken up by the liver; plasma-protein binding is about Йоксагловая Кислота C37H48I6N6O18 = 1626.2. 60 to 90%. It is excreted primarily unchanged in the bile; a small CAS — 79770-24-4. amount is metabolised and excreted in the urine. C24H21I6N5O8 = 1268.9. ATC — V08AB06. CAS — 59017-64-0. ATC Vet — QV08AB06. Uses and Administration ATC — V08AB03. Iotroxic acid is an ionic dimeric iodinated radiographic contrast ATC Vet — QV08AB03. medium (see p.1474); it is taken up by the liver and excreted in OH OH bile, and is used in cholecystography and cholangiography. IO OH OH OH Iotroxic acid is given intravenously as a solution containing HO 10.5% of the meglumine salt. The usual dose is 10.5 g of meglu- HO N O HN OH HN mine iotroxate (equivalent to about 5 g of iodine), given by infu- H I O I O sion over at least 15 minutes. Alternatively, a solution containing CH3 III O HN OH O HC 22.8% of meglumine iotroxate may be used. HN I N I Preparations N O NH HO H Proprietary Preparations (details are given in Part 3) O HO IIN O NH I I OH HC O O Austral.: Biliscopin; Austria: Biliscopin; Ger.: Biliscopin; Gr.: Biliscopin; NZ: Biliscopin; Spain: Bilisegrol†; Swed.: Biliscopin†; Switz.: Biliscopin; UK: Bi- N CH OH 3 liscopin. H3C OH O Description. Iotrolan contains about 46.8% of I. Description. Ioxaglic acid contains about 60% of I. Ioversol (BAN, USAN, rINN) Pharmacopoeias. In Eur. (see p.vii). Pharmacopoeias. In Eur. (see p.vii) and US. Ph. Eur. 6.2 (Iotrolan). A white or yellowish-white, hygroscopic Ioversolum; Joversol; Joversoli; MP-328. N,N′-Bis(2,3-dihydroxy- Ph. Eur. 6.2 (Ioxaglic Acid). A white or almost white hygroscop- powder. Very soluble in water; practically insoluble in alcohol; propyl)-5-[N-(2-hydroxyethyl)glycolamido]-2,4,6-tri-iodoisoph- ic powder. Very slightly soluble in water and in dichloromethane; freely soluble in dimethyl sulfoxide. Store in airtight containers. thalamide. slightly soluble in alcohol. It dissolves in dilute solutions of alkali Protect from light. hydroxides. Store in airtight containers. Protect from light. Йоверсол Adverse Effects, Treatment, and Precautions USP 31 (Ioxaglic Acid). Store at a temperature of 25°, excursions As for the amidotrizoates, p.1475. For the adverse effects relat- C18H24I3N3O9 = 807.1. permitted between 15° and 30°. ing to the use of nonionic contrast media such as iotrolan for my- CAS — 87771-40-2. elography, see under Iohexol, p.1483. ATC — V08AB07. Meglumine Ioxaglate (BANM, rINNM) Pharmacokinetics ATC Vet — QV08AB07. Ioxaglate de Méglumine; Ioxaglate Meglumine (USAN); Ioxaglato Iotrolan is excreted unchanged in the urine. After intrathecal in- de meglumina; Meglumini Ioxaglas; MP-302 (meglumine jection, about 80% is excreted in the urine within 24 hours. ioxaglate with sodium ioxaglate). The N-methylglucamine salt of Uses and Administration OH ioxaglic acid. Iotrolan is a nonionic dimeric iodinated radiographic contrast Меглумина Йоксаглат medium (p.1474). It is given intrathecally for myelography and C24H21I6N5O8,C7H17NO5 = 1464.1. for contrast enhancement in computed tomography, and by in- HO CAS — 59018-13-2. stillation into body ducts or cavities for procedures including HN ATC — V08AB03. lymphography, arthrography, hysterosalpingography, cholangio- ATC Vet — QV08AB03. I O pancreatography, and for visualisation of the mammary ducts. It Description. Meglumine ioxaglate contains about 52% of I. may also be given orally for imaging of the gastrointestinal tract. Iotrolan is usually available as solutions containing 51.3% or HO N I Sodium Ioxaglate (BANM, rINNM) 64.1% of iotrolan (equivalent to 240 or 300 mg/mL of iodine, Ioxaglate de Sodium; Ioxaglate Sodium (USAN); Ioxaglato sódico; respectively) and the dose and strength used vary according to O HO the procedure and route. MP-302 (sodium ioxaglate with meglumine ioxaglate); Natrii I NH Ioxaglas; Natriumjoksaglaatti; Natriumjoxaglat. Preparations HO O Натрий Йоксаглат Proprietary Preparations (details are given in Part 3) OH C24H20I6N5NaO8 = 1290.9. Austral.: Isovist†; Austria: Isovist; Canad.: Osmovist†; Cz.: Isovist†; CAS — 67992-58-9. Denm.: Isovist; Fin.: Isovist†; Ger.: Isovist; Hung.: Isovist; Neth.: Isovist; NZ: Isovist; S.Afr.: Isovist; Switz.: Isovist; UK: Isovist. ATC — V08AB03. Description. Ioversol contains about 47.2% of I. ATC Vet — QV08AB03. Pharmacopoeias. In US. Description. Sodium ioxaglate contains about 59% of I. USP 31 (Ioversol). Store at a temperature of 25°, excursions per- Iotroxic Acid (BAN, USAN, rINN) Adverse Effects, Treatment, and Precautions mitted between 15° and 30°. See under the amidotrizoates, p.1475. Acide Iotroxique; Ácido iotróxico; Acidum Iotroxicum; Jotroksi- happo; Jotroxsyra; SH-213AB. 3,3′-(3,6,9-Trioxaundecanedioyl- Adverse Effects, Treatment, and Precautions Pharmacokinetics di-imino)bis(2,4,6-tri-iodobenzoic acid). See under the amidotrizoates, p.1475. On intravascular use, ioxaglates are rapidly distributed through- out the extracellular fluid. Protein binding is reported to be very Йотроксовая Кислота Pharmacokinetics low. They are mainly excreted unchanged in the urine, although C22H18I6N2O9 = 1215.8. When given intravascularly, ioversol is rapidly eliminated biliary excretion may predominate in renal impairment. With CAS — 51022-74-3. unchanged in the urine, with a half-life of about 1.5 hours; more normal renal function, about 90% of a dose is excreted in the ATC — V08AC02. than 95% of a dose is eliminated within 24 hours. Binding to urine within 24 hours; an elimination half-life of about 90 min- ATC Vet — QV08AC02. plasma or serum proteins is very low. utes has been reported. Ioxaglates cross the placenta and are dis- Uses and Administration tributed into breast milk. They are removed by haemodialysis and peritoneal dialysis. O Ioversol is a nonionic monomeric iodinated radiographic con- HO I O I trast medium (p.1474) that is given intra-arterially or intrave- Uses and Administration O nously for angiography and urography. It is also used for contrast Ioxaglic acid is an ionic dimeric iodinated radiographic contrast I NH O I enhancement during computed tomography. It is usually availa- medium (p.1474). It is given intravenously, intra-arterially, intra- O O OH ble as a solution containing 34 to 74% of ioversol (equivalent to articularly, or by instillation into body ducts and cavities and is I NH I 160 to 350 mg/mL of iodine). The dose and strength used vary used in diagnostic procedures including angiography, arthrogra- O according to the procedure and route. phy, hysterosalpingography, and urography. It is also used for contrast enhancement during computed tomography. ◊ References. Description. Iotroxic acid contains about 62.6% of I. Ioxaglic acid is usually available as solutions containing a mix- 1. Floriani I, et al. Clinical profile of ioversol: a metaanalysis of 57 ture of the sodium and meglumine salts. Commonly used solu- Pharmacopoeias. In Int. and Jpn. randomized, double-blind clinical trials. Invest Radiol 1996; 31: tions contain 39.3% of meglumine ioxaglate and 19.6% of sodi- 479–91. um ioxaglate (equivalent to 320 mg/mL of iodine) or 24.6% of Meglumine Iotroxate (BANM, rINNM) Preparations meglumine ioxaglate and 12.3% of sodium ioxaglate (equivalent to 200 mg/mL of iodine). The dose and strength used depend Dimeglumine Iotroxate; Iotroxate de Méglumine; Iotroxate Meg- USP 31: Ioversol Injection. lumine; Iotroxato de meglumina; Meglumine Iotroxinate; Meglu- upon the procedure and route. mini Iotroxas. The di(N-methylglucamine)salt of iotroxic acid. Proprietary Preparations (details are given in Part 3) Preparations Arg.: Optiray; Austral.: Optiray; Austria: Optiray; Belg.: Optiject; Optiray; Меглумина Йотроксат Canad.: Optiray; Cz.: Optiray; Denm.: Optiray; Fin.: Optiray; Fr.: Opti- USP 31: Ioxaglate Meglumine and Ioxaglate Sodium Injection. C22H18I6N2O9,2C7H17NO5 = 1606.2. ject; Optiray; Ger.: Optiray†; Gr.: Optiray; Hung.: Optiray; Israel: Optiray; Proprietary Preparations (details are given in Part 3) CAS — 68890-05-1. Ital.: Optiray; Neth.: Optiray; Norw.: Optiray; Port.: Optiray; Spain: Arg.: Hexabrix; Austral.: Hexabrix; Austria: Hexabrix; Belg.: Hexabrix; Optiray; Swed.: Optiray; Switz.: Optiray; UK: Optiray; USA: Optiray. Braz.: Hexabrix†; Canad.: Hexabrix; Chile: Hexabrix; Cz.: Hexabrix; ATC — V08AC02. Denm.: Hexabrix; Fin.: Hexabrix; Fr.: Hexabrix; Ger.: Hexabrix; Gr.: ATC Vet — QV08AC02. Hexabrix; Hung.: Hexabrix; Israel: Hexabrix; Ital.: Hexabrix; Neth.:.
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