Reno-30

Name: Reno-30

Commonly used brand name(s)

In the U.S.

  • Cystografin
  • Cystografin-Dilute
  • Hypaque-Cysto
  • Hypaque Meglumine
  • Reno-30
  • Reno-60
  • Reno-Dip

Available Dosage Forms:

  • Solution

Therapeutic Class: Radiological Ionic Contrast Media

Uses For Reno-30

Diatrizoate meglumine injection is used to help diagnose or find problems in the urinary bladder. It is a radiopaque contrast agent. Contrast agents are used to create a clear picture of the different parts of the body during certain medical procedures, such as retrograde cystourethrography.

This medicine is to be used only by or under the direct supervision of a doctor.

Reno-30 Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known
  • Blood in the urine
  • convulsions
  • cough
  • decrease in the amount of urine
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • hives, itching, or rash
  • not able to pass urine
  • pain or burning while urinating
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • shortness of breath
  • tightness in the chest
  • unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Contraindications

Reno-30 is contraindicated for use in intrathecal procedures.

Contraindications pertain to the procedure of retrograde pyelography rather than to the administration of the medium per se. Retrograde pyelography should not be performed in those conditions which do not allow for the successful catheterization of the ureters such as extensive urinary tuberculosis, tumors of the bladder, impassable obstructions of the ureters, or marked enlargement of the prostate gland.

Adverse Reactions

The incidence of adverse reactions with diatrizoate meglumine is very low. Costovertebral angle tenderness, elevated temperature and flank pain have been reported in a few patients following use of the preparation for retrograde pyelography, as have nausea, sweating and flushing.

Irritation of the urinary tract mucosa attributable to the contrast agent itself is not likely to occur. However, the technique of retrograde pyelography may be painful and may initiate pelvic, caliceal, or ureteral spasms with consequent renal colic.

Since retrograde pyelography does not involve systemic administration of a contrast agent, the risk of severe reactions, which may occur with intravenous administration, is extremely remote. However, they should be kept in mind whenever a contrast agent is administered. Severe reactions may be manifested by edema of the face and glottis, respiratory distress, convulsions, or shock; such reactions may prove fatal unless promptly controlled by such emergency measures as maintenance of a clear airway and immediate use of oxygen and resuscitative drugs. Like other sensitivity phenomena, severe reactions are more likely to occur in patients with a personal or family history of bronchial asthma, significant allergies, drug reactions, or previous reactions to contrast agents.

How is Reno-30 Supplied

Reno-30 (Diatrizoate Meglumine Injection USP 30%) is available in packages of: Twenty-five 50 mL multiple dose vials (NDC 0270-0804-45).

Storage

The preparation should be protected from strong light and stored at 20–25°C (68–77°F) [See USP]; avoid freezing.

Manufactured for
Bracco Diagnostics Inc.
Princeton, NJ 08543
by SICOR Pharmaceuticals, Inc.
Irvine, CA 92618

Revised September 2003
Printed in USA

Reno-30 
diatrizoate meglumine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0270-0804
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
diatrizoate meglumine (diatrizoic acid) diatrizoic acid 300 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
edetate disodium 0.4 mg  in 1 mL
methylparaben 1 mg  in 1 mL
propylparaben 0.3 mg  in 1 mL
sodium citrate 3.2 mg  in 1 mL
Packaging
# Item Code Package Description
1 NDC:0270-0804-45 25 VIAL (25 VIAL) in 1 PACKAGE
1 50 mL (50 MILLILITER) in 1 VIAL
Labeler - Bracco Diagnostics Inc.
Revised: 03/2007   Bracco Diagnostics Inc.
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