CYSTOGRAFIN- diatrizoate meglumine injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

diatrizoate meglumine (UNII: 3X9MR4N98U) (diatrizoic acid - UNII:5UVC90J1LK)

Available from:

BRACCO DIAGNOSTICS INC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

This preparation is contraindicated in patients with a hypersensitivity to salts of diatrizoic acid.

Product summary:

Cystografin (Diatrizoate Meglumine Injection USP 30%) is available in 200 mL and 400 mL bottles containing 100 mL and 300 mL of Cystografin respectively with sufficient capacity for dilution up to 167 mL and 350 mL respectively. Store at 20-25°C (68-77°F) [See USP]. Protect from light. Cystografin Dilute (Diatrizoate Meglumine Injection USP 18%) is also available, as a 300 mL fill in a 400 mL bottle.

Authorization status:

New Drug Application

Summary of Product characteristics

CYSTOGRAFIN- DIATRIZOATE MEGLUMINE INJECTION, SOLUTION
BRACCO DIAGNOSTICS INC
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CYSTOGRAFIN
DIATRIZOATE MEGLUMINE
INJECTION USP 30%
FOR RETROGRADE CYSTOURETHROGRAPHY
NOT INTENDED FOR INTRAVASCULAR INJECTION
DESCRIPTION
Cystografin is a radiopaque contrast agent supplied as a sterile,
clear, colorless to pale yellow, mobile
or slightly viscous solution. Each mL provides 300 mg diatrizoate
meglumine with 0.4 mg edetate
disodium as a sequestering agent. Each mL of solution also contains
approximately 141 mg organically
bound iodine. At the time of manufacture, the air in the container is
replaced by nitrogen. The
preparation should be protected from strong light.
INDICATION
Cystografin is indicated for retrograde cystourethrography.
CONTRAINDICATIONS
This preparation is contraindicated in patients with a
hypersensitivity to salts of diatrizoic acid.
WARNINGS
Severe sensitivity reactions are more likely to occur in patients with
a personal or family history of
bronchial asthma, significant allergies, or previous reactions to
contrast agents.
A history of sensitivity to iodine _per se_ or to other contrast
agents is not an absolute contraindication to
the use of diatrizoate meglumine, but calls for extreme caution in
administration.
PRECAUTIONS
Safe and effective use of this preparation depends upon proper dosage,
correct technique, adequate
precautions, and readiness for emergencies.
Retrograde cystourethrography should be performed with caution in
patients with a known active
infectious process of the urinary tract.
Sterile technique should be employed in administration. During
administration, care should be taken to
avoid excessive pressure, rapid or acute distention of the bladder,
and trauma.
Contrast agents may interfere with some chemical determinations made
on urine specimens; therefore,
urine should be collected before administration of the contrast medium
or two or more days afterwards.
PREGNANCY—TERATOGENIC EFFECTS:
Animal reproduction studies have not been conducted with diatrizoate
meglumine in