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:

Guardian Drug Company

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 is 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 a clear, colorless to pale yellow liquid with citrus aroma and is available in packages of: NDC 53041-690-09               Twenty-four 30 mL single dose bottles NDC 53041-690-03               Twelve 120 mL single dose bottles NDC 53041-688-03               Twelve 120 mL single dose bottles (PET)          Storage Protect from light. Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]; avoid excessive heat. Discard unused portion. Manufactured by: Guardian Drug Company  2 Charles Court, Dayton, New Jersey 08810 Revised: 08/2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM - DIATRIZOATE
MEGLUMINE AND DIATRIZOATE SODIUM SOLUTION
GUARDIAN DRUG COMPANY
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DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM SOLUTION USP
DESCRIPTION
Diatrizoate Meglumine and Diatrizoate Sodium Solution USP is a
palatable lemon-flavored
water-soluble iodinated radiopaque contrast medium for oral or rectal
administration
only. Each mL contains 660 mg diatrizoate meglumine and 100 mg
diatrizoate sodium;
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, flavor, hydrochloric acid,
polysorbate 80, purified
water, saccharin sodium, simethicone, sodium citrate and sodium
hydroxide.
Diatrizoate meglumine is designated chemically as
1-deoxy-1-(methylamino)-D-glucitol
3,5-diacetamido-2,4,6-triiodo-benzoate (salt); diatrizoate sodium is
monosodium 3, 5-
diacetamido-2,4,6-triiodobenzoate. Structural formulas:
Diatrizoate Meglumine
C
H I
N O .C H
NO
MW 809.13
Organically Bound Iodine: 47.1%
CAS – 131-49-7
11
9 3
2
4
7
17
5
Diatrizoate Sodium
C
H I
N NaO
MW 635.90
Organically Bound Iodine: 59.9%
CAS – 737-31-5
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.
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 examination of the colon; however, visualization of th