Reno-Dip

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

This section provides information on the proper use of a number of products that contain diatrizoate. It may not be specific to Reno-Dip. Please read with care.

A doctor or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

Your doctor may give you a laxative the night before the test, and may recommend a low residue diet the day before the procedure.

Diagnostic procedures which involve the use of radiopaque contrast agents should be carried out under the direction of personnel with the prerequisite training and with a thorough knowledge of the particular procedure to be performed (see ADVERSE REACTIONS).

Severe, life-threatening reactions suggest hypersensitivity to the radiopaque agent, which has prompted the use of several pretesting methods, none of which can be relied upon to predict severe reactions. Many authorities question the value of any pretest. A history of bronchial asthma or allergy, a family history of allergy, or a previous reaction to a contrast agent warrant special attention. Such a history, by suggesting histamine sensitivity and a consequent proneness to reactions, may be more accurate than pretesting in predicting the likelihood of a reaction, although not necessarily the severity or type of reaction in the individual case.

The sensitivity test most often performed is the slow injection of 0.5 to 1 mL of the radiopaque medium, administered intravenously, prior to injection of the full diagnostic dose. It should be noted that the absence of a reaction to the test dose does not preclude the possibility of a reaction to the full diagnostic dose. If the test dose causes an untoward response of any kind, the necessity for continuing with the examination should be carefully reevaluated and, if it is deemed essential, the examination should be conducted with all possible caution. In rare instances reactions to the test dose itself may be extremely severe; therefore, close observation of the patient, and facilities for emergency treatment appear indicated.

The recommended rate of infusion should not be exceeded.

Renal toxicity has been reported in a few patients with liver dysfunction who were given oral cholecystographic agents followed by urographic agents. Diagnostic infusion studies should therefore be postponed in any patient with a known or suspected hepatic or biliary disorder who has recently taken a cholecystographic contrast agent.

The diuretic effect of the drip infusion procedure may hinder an assessment of residual urine in the bladder.

Consideration must be given to the functional ability of the kidneys before injecting diatrizoate meglumine. Adequate visualization may be difficult or impossible to attain in uremic patients or others with severely impaired renal function.

Acute renal failure has been reported with the use of contrast agents in patients with diabetic nephropathy and susceptible nondiabetic patients (often elderly with preexisting renal disease).

Contrast agents may interfere with some chemical determinations made on urine specimens; therefore, urine should be collected before administration of the contrast media or two or more days afterwards.

Caution should be exercised during lower extremity venography when thrombosis, phlebitis, total venous system obstruction, severe ischemia, or local infection is suspected. Extreme caution during injection of the agent is needed to avoid extravasation and fluoroscopy is recommended, particularly in patients with severe arterial or venous disease.

Usage In Pregnancy

The safety of diatrizoate meglumine for use during pregnancy has not been established; therefore, it should be used in pregnant patients only when, in the judgement of the physician, its use is deemed essential to the welfare of the patient.

Reno-Dip (Diatrizoate Meglumine Injection USP 30%) is available in packages of 10 single dose 300 mL bottles (NDC 0270-0809-75). An excess volume (1 mL) is available in each container for sensitivity testing.

Storage

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

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

Printed in USA
Rev September 2003

Applies to diatrizoate: intravenous solution

Along with its needed effects, diatrizoate (the active ingredient contained in Reno-Dip) 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 while taking diatrizoate:

• 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

Applies to diatrizoate: injectable powder for injection, injectable solution, oral powder for reconstitution, oral and rectal solution

General

The most frequently reported adverse reactions were vomiting, nausea, diarrhea, erythema, a sensation of pain, and a general feelings of warmth on intravascular administration.[Ref]

Cardiovascular

Common (1% to 10%) Transient disturbance in heart rate, blood pressure, disturbance in cardiac rhythm or function, cardiac arrest
Uncommon (0.1% to 1%): Thrombophlebitis, venous thrombosis
Rare (0.01% to 0.1%): Thromboembolic events, myocardial infarction
Very rare (less than 0.01%): Severe hypotension and collapse; circulatory failure; ventricular fibrillation
Frequency not reported: Tachycardia, shock, hypotension, hypertension, reflex tachycardia, cyanosis[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomit, diarrhea
Frequency not reported: Diarrhea (ceases as soon as the intestine has been emptied); existing enteritis or colitis may be temporarily exacerbated; in case of obstruction, the prolonged contact with bowel mucosa can lead to erosions and to bowel necrosis; intestinal perforation; abdominal pain; oral mucosal blistering[Ref]

Hypersensitivity

Common (1% to 10%): Anaphylactoid reactions (mild angioedema, conjunctivitis, coughing pruritus, rhinitis, sneezing, urticarial)[Ref]

Respiratory

Common (1% to 10%): Transient disturbances in respiratory rate, dyspnea, respiratory distress, cough
Rare (less than 0.1%): Respiratory arrest, pulmonary edema
Frequency not reported: Bronchospasm, medication aspiration, pulmonary edema following aspiration, aspiration pneumonia, sneezing, laryngeal spasm[Ref]

Endocrine

Uncommon (0.1% to 1%): Thyroid function tests indicative of hypothyroidism or transient thyroid suppression in adults and pediatric patients (including infants)
Frequency not reported: Hyperthyroidism[Ref]

Dermatologic

Rare (less than 0.1%): Toxic epidermal necrolysis, urticaria, rash, pruritus, erythema, face edema, mucocutaneous syndrome (e.g. Stevens-Johnson's or Lyell syndrome)
Frequency not reported: Sweating, mild angioedema[Ref]

Nervous system

Very rare (less than 0.01%): Convulsions, cerebral symptoms
Frequency not reported: Disturbances in consciousness, dizziness, headache, tremor, somnolence, transient paresis (vision or facial muscle paresis and epileptic fits), amnesia, photophobia, temporary states of agitation or confusion[Ref]

Genitourinary

Frequency not reported: Perforation of the urethra, genitourinary tract infections, oliguria, hematuria, anuria[Ref]

Local

Frequency not reported: Local pain, edema[Ref]

Metabolic

Frequency not reported: Fluid and electrolyte imbalance[Ref]

Ocular

Frequency not reported: Lacrimation, temporary blindness[Ref]

Other

Frequency not reported: Pyrexia, sweating, chills, blanching, weakness, gagging and feeling suffocated, gasping, edema, cramp, malaise[Ref]

Renal

Frequency not reported: Temporary renal failure[Ref]

Some side effects of Reno-Dip may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.