DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM- diatrizoate meglumine and diatrizoate sodium solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIATRIZOATE MEGLUMINE (UNII: 3X9MR4N98U) (DIATRIZOIC ACID - UNII:5UVC90J1LK), DIATRIZOATE SODIUM (UNII: V5403H8VG7) (DIATRIZOIC ACID - UNII:5UVC90J1LK)

Available from:

Camber Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Diatrizoate meglumine and diatrizoate sodium solution is indicated for radiographic examination of segments of the gastrointestinal tract (esophagus, stomach, proximal small intestine, and colon). The preparation is particularly indicated when a more viscous agent such as barium sulfate, which is not water-soluble, is not feasible or is potentially dangerous. Diatrizoate meglumine and diatrizoate sodium solution may also be used as an adjunct to contrast enhancement in computed tomography of the torso (body imaging); the preparation is indicated, in conjunction with intravenous administration of a radiopaque contrast agent, when unenhanced imaging may not provide sufficient definition in distinguishing normal loops of bowel from adjacent organs or areas of suspected pathology. Do not administer to patients with a known hypersensitivity to diatrizoate meglumine and diatrizoate sodium solution or any of its components.

Product summary:

Diatrizoate Meglumine and Diatrizoate Sodium Solution USP  is available as clear, aqueous, pale yellow color solution, with strawberry flavor in packages of: Twenty-four 30 mL single dose bottles             (NDC 31722-019-31). Twelve 120 mL single dose bottles                   (NDC 31722-019-32). Storage Protect from light. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]; avoid excessive heat. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Annora Pharma Pvt. Ltd. Sangareddy - 502313, Telangana, India. Revised: 04/2024

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM - DIATRIZOATE
MEGLUMINE AND DIATRIZOATE SODIUM SOLUTION
CAMBER PHARMACEUTICALS, INC.
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DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM SOLUTION, USP
DESCRIPTION
Diatrizoate Meglumine and Diatrizoate Sodium Solution, USP is a
palatable strawberry-
flavored water-soluble iodinated radiopaque contrast medium for oral
or rectal
administration only. Each mL contains 660 mg diatrizoate meglumine USP
and 100 mg
diatrizoate sodium USP; pH has been adjusted to 6.0 to 7.6 with sodium
hydroxide. _Each_
_mL contains approximately 4.8 mg (0.21 mEq) sodium_and 367 mg
organically bound
iodine. Inactive ingredients: edetate disodium dihydrate, polysorbate
80, saccharin
sodium, simethicone, sodium hydroxide, strawberry flavor and
tri-sodium citrate
dihydrate.
Diatrizoate meglumine is designated chemically as
1-deoxy-1-(methylamino)-D-glucitol
3,5- diacetamido-2,4,6-triiodobenzoate (salt); diatrizoate sodium is
monosodium 3,5-
diacetamido-2,4,6-triiodobenzoate. Structural formulas:
Diatrizoate meglumine C
H
I
N
O
.C
H
NO
Molecular Weight: 809.13
Organically bound Iodine: 47.1%
Diatrizoate sodium C
H
I
N
NaO
Molecular Weight: 635.90
Organically bound Iodine: 59.9%
CLINICAL PHARMACOLOGY
The most important characteristic of contrast media is the iodine
content. The relatively
high atomic weight of iodine contributes sufficient radiodensity for
radiographic contrast
with surrounding tissues.
11
9 3
2
4
7
17
5
11
8 3
2
4
with surrounding tissues.
Diagnostic enteral radiopaque agents have few known pharmacological
effects.
Diatrizoate meglumine and diatrizoate sodium exert a mild laxative
effect attributable to
their high osmolarity.
Diatrizoate meglumine and diatrizoate sodium are sparingly absorbed
from the intact
gastrointestinal tract, and therefore permit gastrointestinal
opacification and delineation
after oral or rectal administration. Oral administration is used for
radiographic evaluation
of the esophagus, stomach and proximal small intestine. Rectal
administration is used
for