GASTROGRAFIN- diatrizoate meglumine and diatrizoate sodium liquid

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

diatrizoate meglumine (UNII: 3X9MR4N98U) (DIATRIZOIC ACID - UNII:5UVC90J1LK), diatrizoate sodium (UNII: V5403H8VG7) (DIATRIZOIC ACID - UNII:5UVC90J1LK)

Dostupné s:

Bracco Diagnostics Inc

INN (Mezinárodní Name):

diatrizoate meglumine

Složení:

diatrizoate meglumine 660 mg in 1 mL

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Gastrografin (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. Gastrografin 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 Gastrografin or any of its components.

Přehled produktů:

Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP) is available in packages of: Twenty-four 30 mL single dose bottles (NDC 0270-0445-35). Twelve 120 mL single dose bottles (NDC 0270-0445-40). Protect from light. Store at 20-25°C (68-77°F) [See USP]; avoid excessive heat.

Stav Autorizace:

New Drug Application

Charakteristika produktu

GASTROGRAFIN- DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM LIQUID
BRACCO DIAGNOSTICS INC
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GASTROGRAFIN
DIATRIZOATE MEGLUMINE
AND DIATRIZOATE SODIUM
SOLUTION USP
DESCRIPTION
Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution)
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, polysorbate 80,
purified water, saccharin
sodium, simethicone, and sodium citrate.
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:
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, since the hypertonicity of the medium causes
intraluminal diffusion of
water with subsequent dilution of the medium. Enough absorption from
the
gastrointestinal tract to permit incidental visualizatio