hypaque- Diatrizoate Meglumine and Diatrizoate Sodium injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Diatrizoate Meglumine (UNII: 3X9MR4N98U) (Diatrizoate - UNII:), Diatrizoate Sodium (UNII: V5403H8VG7) (Diatrizoate - UNII:)

Available from:

Amersham Health Inc.

INN (International Name):

Diatrizoate Meglumine and Diatrizoate Sodium

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

660 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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)

Summary of Product characteristics

HYPAQUE- DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM INJECTION,
SOLUTION
AMERSHAM HEALTH INC.
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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