MD GASTROVIEW- 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:

Liebel-Flarsheim Company LLC

INN (International Name):

DIATRIZOATE MEGLUMINE

Composition:

DIATRIZOATE MEGLUMINE 600 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

MD-Gastroview (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. MD-Gastroview 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 MD-Gastroview or any of its components.

Product summary:

Available as an aqueous lemon-vanilla flavored solution in bottles of 30 mL in packages of 25 (NDC 0019-4816-04). Protect from light. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]; Avoid excessive heat. If precipitation or solidification has occurred due to storage in the cold, the bottle should be brought to room temperature. Shake intermittently to redissolve any solids. As with all contrast media, containers should be inspected prior to use to ensure that breakage or other damage has not occurred during shipping and handling. All containers should be inspected for closure integrity. Damaged containers should not be used. Manufactured by: Liebel-Flarsheim Company LLC Raleigh, NC 27616 Made in USA GBT 48160817 Rev 08/17

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MD GASTROVIEW- DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM SOLUTION
LIEBEL-FLARSHEIM COMPANY LLC
----------
AUGUST 2017
MD-GASTROVIEW
(DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM SOLUTION USP)
DESCRIPTION
MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution)
is a palatable lemon-vanilla
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. MD-Gastroview does not contain the
wetting agent polysorbate 80.
The inactive ingredients are: Edetate Disodium Dihydrate,
Lemon-Vanilla Flavor, Sodium Citrate,
Sodium Hydroxide, Sodium Saccharin, Water for Injection. Air in the
container is displaced with
nitrogen.
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. The two salts have the following structural formulae:
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 the distal small bowel is generally unsatisfactory,
sin