Country: United States
Language: English
Source: NLM (National Library of Medicine)
Diatrizoate Meglumine (UNII: 3X9MR4N98U) (Diatrizoate - UNII:), Diatrizoate Sodium (UNII: V5403H8VG7) (Diatrizoate - UNII:)
Amersham Health Inc.
Diatrizoate Meglumine and Diatrizoate Sodium
INJECTION, SOLUTION
660 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
HYPAQUE-76 is indicated for excretory urography, aortography, angiocardiography (ventriculography, pulmonary angiography, selective coronary arteriography), peripheral angiography (peripheral arteriography and peripheral venography), intravenous digital arteriography, contrast enhancement of computed tomographic head imaging, contrast enhancement of computed tomographic body imaging, selective renal arteriography, selective visceral arteriography, central venography, and renal venography. In addition to the following generalCONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS, there are additional listings in these categories under the particular procedures. HYPAQUE-76 has no absolute contraindications in its recommended uses (see general WARNINGS and PRECAUTIONS). Do not use HYPAQUE-76 for myelography or for examination of dorsal cysts or sinuses which might communicate with the subarachnoid space. Even a small amount in the subarachnoid space may produce convulsions and result in fatality. (See
Vials of 50 mL, rubber stoppered, box of 25 (NDC 0407-0776-04) Calibrated bottles of 200 mL, rubber stoppered, with hangers, box of 10 (NDC 0407-0778-02)
HYPAQUE- DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM INJECTION, SOLUTION AMERSHAM HEALTH INC. ---------- HYPAQUE -76 (DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM INJECTION, USP) 76% Sterile Aqueous Injection FOR EXCRETORY UROGRAPHY AORTOGRAPHY ANGIOCARDIOGRAPHY (VENTRICULOGRAPHY, PULMONARY ANGIOGRAPHY, SELECTIVE CORONARY ARTERIOGRAPHY) PERIPHERAL ANGIOGRAPHY (PERIPHERAL ARTERIOGRAPHY AND PERIPHERAL VENOGRAPHY) INTRAVENOUS DIGITAL ARTERIOGRAPHY CONTRAST ENHANCEMENT OF COMPUTED TOMOGRAPHIC HEAD IMAGING CONTRAST ENHANCEMENT OF COMPUTED TOMOGRAPHIC BODY IMAGING SELECTIVE RENAL ARTERIOGRAPHY SELECTIVE VISCERAL ARTERIOGRAPHY CENTRAL VENOGRAPHY RENAL VENOGRAPHY NOT FOR INTRATHECAL USE DESCRIPTION HYPAQUE-76, brand of diatrizoate meglumine and diatrizoate sodium, is a water-soluble, radiopaque diagnostic medium. It is supplied as a 76 percent sterile aqueous solution providing 66 percent (w/v) diatrizoate meglumine and 10 percent (w/v) diatrizoate sodium. It is a triiodinated benzoic acid derivative containing 37 percent (w/v) organically bound iodine. Each mL contains 370 mg iodine and 3.68 mg (0.16 mEq) sodium. It is constituted as a radiopaque iodinated anion, diatrizoate, and the radiolucent cations meglumine and sodium. It is the organically bound iodine of the anion which opacifies internal structures for x-ray visualization and fluoroscopy. The solution is hypertonic to blood with an osmolality of 2016 mosm/kg (determined by VPO). The viscosity is 9 cp at 37° C. The pH is adjusted between 6.0 and 7.7 using Na CO with HCl or NaOH. The pKa is 3.4 for diatrizoic acid. Edetate calcium disodium 0.01 percent has been added as a sequestering stabilizing agent. The solution is clear, colorless to pale yellow. Diatrizoate meglumine is 1-deoxy-1-(methylamino)-D-glucitol 3, 5-diacetamido-2,4,6-triiodobenzoate (salt) and has the following structural formula: ™ 2 3 Diatrizoate sodium is monosodium, 3, 5-diacetamido-2,4,6-triiodobenzoate and has the following structural formula: CLINICAL PHARMACOLOGY Intravascular injectio Read the complete document