Reno-Dip

Name: Reno-Dip

Uses For Reno-Dip

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-Dip 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-Dip is contraindicated for use in intrathecal procedures.

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

The administration of diatrizoate meglumine is contraindicated in patients with anuria.

Warnings

Severe Adverse Events Inadvertent Intrathecal Administration

Serious adverse reactions have been reported due to the inadvertent intrathecal administration of iodinated contrast media that are not indicated for intrathecal use. These serious adverse reactions include: death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Special attention must be given to insure that this drug product is not inadvertently administered intrathecally.

The possibility exists for inadvertent administration into the intrathecal space during epidural administrations. Therefore, epidural administration procedures, such as pain management catheter placement, should not be performed with use of this product.

General

A definite risk exists in the use of intravascular contrast agents in patients who are known to have multiple myeloma. In such instances there has been anuria resulting in progressive uremia, renal failure and eventually death. Although neither the contrast agent nor dehydration has separately proved to be the cause of anuria in myeloma, it has been speculated that the combination of both may be the causative factor. The risk in myelomatous patients is not a contraindication to the procedures; however, partial dehydration in the preparation of these patients for the examination is not recommended since this may predispose to the precipitation of myeloma protein in the renal tubules. No form of therapy, including dialysis, has been successful in reversing this effect. Myeloma, which occurs most commonly in persons over age 40, should be considered before intravascular administration of a contrast agent.

Administration of radiopaque materials to patients known or suspected to have pheochromocytoma should be performed with extreme caution. If, in the opinion of the physician, the possible benefits of such procedures outweigh the considered risks, the procedures may be performed; however, the amount of radiopaque medium injected should be kept to an absolute minimum. The blood pressure should be assessed throughout the procedure and measures for treatment of a hypertensive crisis should be available.

Contrast media have been shown to promote the phenomenon of sickling in individuals who are homozygous for sickle cell disease when the material is injected intravenously or intra-arterially.

Diatrizoate meglumine should be used with extreme caution in patients with severe concomitant hepatic and renal disease, and those with severe hypertension or congestive heart failure.

Since iodine-containing contrast agents may alter the results of thyroid function tests dependent on iodine estimation, such tests, if indicated, should be performed prior to the administration of this preparation.

A history of sensitivity to iodine per se or to other contrast media is not an absolute contraindication to the use of diatrizoate meglumine, but calls for extreme caution in administration.

In patients with subarachnoid hemorrhage, a rare association between contrast administration and clinical deterioration, including convulsions and death, has been reported; therefore, administration of intravascular iodinated ionic contrast media in these patients should be undertaken with caution.

Adverse Reactions

Adverse reactions accompanying the use of iodine-containing intravascular contrast agents are usually mild and transient although severe and life-threatening reactions, including fatalities, have occurred. Because of the possibility of severe reactions to the procedure and/or the radiopaque medium, appropriate emergency facilities and well-trained personnel should be available to treat both conditions. Emergency facilities and personnel should remain available for 30 to 60 minutes following the procedure since severe delayed reactions have been known to occur.

Nausea, vomiting, flushing, or a generalized feeling of warmth are the reactions most frequently encountered with intravenous administration of contrast agents. Such symptoms as chills, fever, sweating, headache, dizziness, pallor, weakness, severe retching and choking, wheezing, a rise or fall in blood pressure, ventricular fibrillation, cardiac arrest, facial or conjunctival petechiae, urticaria,pruritus, rash, and other eruptions, edema, cramps, tremors, itching, sneezing, lacrimation, etc., may occur. Antihistaminic agents may be of benefit; rarely such reactions may be severe enough to require discontinuation of dosage. Pulmonary edema, spasm, seizures, hemiparesis, syncope, and impairment of vision have also occurred. Neutropenia may also occur.

Severe reactions which may require emergency measures may take the form of a cardiovascular reaction characterized by peripheral vasodilatation with resultant hypotension and reflex tachycardia, apnea, dyspnea, agitation, and confusion and cyanosis progressing to unconsciousness. Or, the histamine-liberating effect of these compounds may induce an allergic-like reaction which may range in severity from rhinitis or angioneurotic edema to laryngeal or bronchial spasm or anaphylactoid shock.

Temporary renal shutdown or other nephropathy may occur.

Although local tissue tolerance to diatrizoate meglumine is usually good, intravenous injection of the medium in a more concentrated formulation has produced a few instances of a burning or stingingsensation or numbness and of venospasm or venous pain, and partial collapse of the injected vein.

Although not reported as resulting following lower extremity venography with diatrizoate meglumine, conditions such as thrombophlebitis, and the rare possibility of gangrene, should be considered as potential adverse reactions.

Reno-Dip Dosage and Administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Reno-Dip (Diatrizoate Meglumine Injection USP 30%) should be at body temperature when administered and may need to be warmed before use.

Drip Infusion Pyelography

While preparation of the patient is not essential for drip infusion pyelography, it is advocated by some investigators. If desired, adults and older children may be given a laxative the night before the examination and a low residue diet the day before, to clear the gastrointestinal tract. Clinicians who feel that partial dehydration enhances radiographic contrast recommend a low liquid intake for 12 hours prior to the procedure; however, adequate hydration has improved the quality of films for other investigators. Preparatory partial dehydration is not recommended in infants, young children, the elderly, or azotemic patients (especially those with polyuria, oliguria, diabetes, advanced vascular disease, or preexisting dehydration). The undesirable dehydration in these patients may be accentuated by the osmotic diuretic action of the medium.

In uremic patients partial dehydration is not necessary and maintenance of adequate fluid intake is particularly desirable.

Cleansing enemas are not recommended, since they may increase residual gas in the bowel.

The recommended dose is 2 mL per pound of body weight. The preparation is given by continuous intravenous infusion, over a period of 8 minutes or longer (see PRECAUTIONS), through a needle with a large bore, usually a 17- or 18-gauge needle. In older patients and in patients with known or suspected cardiac decompensation, a slower rate of infusion is probably wise.

If nausea or flushing occurs during administration, the infusion should be slowed or briefly interrupted.

Films are taken before the onset of the infusion and at the desired intervals following its completion. When renal function is normal, a nephrogram may be taken as soon as the infusion is completed, and films of the collecting system at 10 and 20 minutes thereafter. Voiding cystourethrograms are usually optimal at 20 minutes after the infusion is completed. In hypertensive patients, early minute sequence films may be taken during the course of infusion, in addition to subsequent pyelograms. In patients with renal dysfunction, optimal visualization is usually delayed, and the late films are taken as indicated.

The nephrogram obtained by the drip infusion procedure may be dense enough to obscure the pelvocalyceal system in some cases. The presence of gas in the bowel may hamper early visualization of the renal collecting system. Tomographic “cuts” may help to overcome such difficulties.

Nephrotomography may begin when the infusion is completed. The sustained contrast achieved by the drip infusion technique eliminates the need for precise timing and teamwork that is necessary with ordinary nephrotomography. Thus, if nephrograms taken after infusion of the medium suggest the need for sectional films, or if preselected tomographic“cuts” are not sufficient, additional tomograms may be obtained at once, and without repetition of dosage.

Computed Tomography

Brain Scanning

The suggested dose is 2 mL per pound of body weight by intravenous drip over a period of eight minutes or longer; scanning may be performed during administration and/or immediately afterwards.

Body Scanning

The usual adult dose is 300 mL administered by intravenous infusion over a period of approximately 20 minutes; 150 mL may be infused immediately prior to scanning, and the balance during scanning. Scanning may also be performed immediately following completion of infusion of the entire dose.

Gastrografin® (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP), an oral radiopaque contrast agent, may be useful as an adjunct to the procedure.

Patient Preparation

No special patient preparation is required for contrast enhancement of CT brain scanning or body scanning. However, it is advisable to insure that patients are well hydrated prior to examination.

Lower Extremity Venography

Appropriate premedication, which may include an analgesic, a barbiturate, or a tranquilizer may be administered prior to the examination.

Prior to the administration of the contrast agent, patients should be well hydrated and a preliminary radiograph taken. The patient should be placed on a tilt table, semi-erect (30° to 60°).

The usual dose per intravenous injection may range from 50 to 100 mL; the usual total dose per extremity ranges from 100 to 300 mL. The dose for children should be reduced in proportion to body weight. The dose may be given as a bolus injection or by steady drip infusion. Radiographs are taken at the start of injection/infusion and periodically thereafter at the discretion of the radiologist.

Following the procedure, the contrast agent may be removed from the venous system by flushing with either Dextrose Injection USP 5% or Sodium Chloride Injection USP 0.9%, or by leg massage and/or leg elevation.

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