hypaque sodium- Diatrizoate Sodium injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Diatrizoate Sodium (UNII: V5403H8VG7) (Diatrizoic acid - UNII:5UVC90J1LK)

Available from:

Amersham Health Inc.

INN (International Name):

Diatrizoate Sodium

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

500 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

HYPAQUE sodium 50 percent is indicated for excretory urography, cerebral and peripheral angiography, aortography, intraosseous venography, direct cholangiography, hysterosalpingography, splenoportography, and contrast enhancement of computed tomographic head imaging. Diatrizoate salts are used in small, medium, and large dose urography (see Dosage and Administration—EXCRETORY UROGRAPHY). Visualization of the urinary tract can be achieved by either direct intravenous bolus injection, intravenous drip infusion, or incidentally following intra-arterial procedures.Visualization of the urinary tract is delayed in infants less than 1 month old, and in patients with urinary tract obstruction (see CLINICAL PHARMACOLOGY). Injectable radiopaque contrast media may be used to refine diagnostic precision in areas of the brain which may not otherwise have been satisfactorily visualized. Radiopaque diagnostic agents may be useful to investigate the presence and extent of certain malignancies such as: gliomas including malig

Product summary:

Vials of 50 mL, rubber stoppered, box of 25 (NDC 0407-0766-04). Protect from light. Store at 15°C to 30°C (59° F to 86°F).

Summary of Product characteristics

HYPAQUE SODIUM- DIATRIZOATE SODIUM INJECTION, SOLUTION
AMERSHAM HEALTH INC.
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HYPAQUE™ SODIUM
(DIATRIZOATE SODIUM INJECTION, USP)
50%
Sterile Aqueous Injection
FOR EXCRETORY UROGRAPHY
CEREBRAL ANGIOGRAPHY
PERIPHERAL ANGIOGRAPHY
AORTOGRAPHY
INTRAOSSEOUS VENOGRAPHY
DIRECT CHOLANGIOGRAPHY
HYS TEROS ALPINGOGRAPHY
SPLENOPORTOGRAPHY
NOT FOR INTRATHECAL USE
RX ONLY
DESCRIPTION
HYPAQUE sodium, brand of diatrizoate sodium, is a radiopaque
diagnostic agent, water-soluble
organic iodide contrast medium. In pure form, it contains 59.87
percent organically bound iodine.
The 50 percent (w/v) solution contains 300 mg iodine per mL and 0.8
mEq (18.1 mg) sodium per mL. It
has an osmolality of 1515 mosm/kg (determined by VPO), and is
hypertonic to blood. As a point of
information only, a 10 percent solution (w/v) is isotonic. The
viscosity (cp) is about 3.25 at 25° C and
2.34 at 37° C. Sodium carbonate and hydrochloric acid have been added
to adjust pH between 6.5 and
7.7.The pKa is 3.4 for diatrizoic acid. If a solution of this medium
is chilled, crystals may form but
readily dissolve if the vial is placed in moderately hot water before
use; cool to body temperature
before injecting.
The sterile aqueous solution is clear and nearly colorless. It is
relatively thermostable and may be
autoclaved without harmful effects, although it should be protected
from strong light. The 50 percent
solution contains edetate calcium disodium 1:10,000 as a sequestering
stabilizing agent.
Diatrizoate sodium is a triiodinated benzoic acid derivative, the
sodium salt of 3,5-diacetamido-2,4,6-
triiodobenzoate with a molecular weight of 635.90, and has the
following structural formula:
CLINICAL PHARMACOLOGY
Intravascular injection of a radiopaque diagnostic agent opacifies
those vessels in the path of the flow
of the contrast medium, permitting radiographic visualization of the
internal structures of the human
body until significant hemodilution occurs.
At physiologic pH, the water-soluble contrast media are completely
dissociated into a r