Hypaque Sodium (Page 3 of 7)

Information for Patients

Patients receiving injectable radiopaque diagnostic agents should be instructed to:

  1. Inform the physician if they are pregnant (see CLINICAL PHARMACOLOGY).
  2. Inform the physician if they are diabetic or if they have multiple myeloma, pheochromocytoma, homozygous sickle cell disease or known thyroid disorder (see WARNINGS—General).
  3. Inform the physician if they are allergic to any drugs, food, or if they have had any reactions to previous injections of dyes used for x-ray procedures (see PRECAUTIONS—General).
  4. Inform the physician about any other medications they are currently taking, including nonprescription drugs, before they are administered this drug.

Drug Interactions

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

Addition of an inotropic agent to contrast agents may produce a paradoxical depressant response which can be deleterious to the ischemic myocardium.

Diphenhydramine hydrochloride may cause precipitation when mixed in the same syringe with HYPAQUE meglumine 60%.

Under certain circumstances (pH, temperature, concentrations, time), diatrizoate solutions are incompatible with promethazine hydrochloride, diphenhydramine hydrochloride, brompheniramine maleate, or papaverine hydrochloride solutions.

Do not prefill plastic syringes with HYPAQUE meglumine 60% for prolonged periods (ie, for several hours or longer) before use.

Drug/Laboratory Test Interactions

If any of these studies, which might be affected by contrast media are indicated, it is recommended that they be performed prior to administration of the contrast medium or two or more days afterwards.

Diatrizoate salts interfere with several laboratory urine and blood tests.

Blood Tests

Coagulation: Diatrizoate salts significantly inhibit all stages of coagulation. The fibrinogen concentration, Factors V, VII, and VIII are decreased. Prothrombin time and thromboplastin time are increased.

Platelet aggregation: High levels of plasma diatrizoates inhibit platelet aggregation.

Serum calcium: Diatrizoate salts may decrease serum calcium levels. However, this depletion of serum calcium may also be the result of the addition of chelating agents (edetate disodium) in the preparation of certain contrast media.

Red cell counts: Transitory decreases in red cell counts. Technetium-99m—RBC labeling interference.

Leukocyte counts: Decrease.

Urea nitrogen (BUN): Transitory increase (see CLINICAL PHARMACOLOGY).

Serum creatinine: Transitory increase.

Urine Test

Contrast media which are excreted in the urine, may interfere with some laboratory determinations eg, proteinuria, specific gravity, osmolality, or bacterial cultures.

Thyroid Function Test

Protein-bound iodine (PBI) and total serum organic iodine: Transient increase of both tests following urography have been noticed. The results of PBI and radioactive iodine uptake studies which depend on iodine estimations will not accurately reflect thyroid function for up to 16 days following administration of iodinated urographic media. However, thyroid function tests not depending on iodine estimations, eg, T3 resin uptake or free thyroxine assays are not affected.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed in order to evaluate carcinogenic potential, mutagenesis, or whether HYPAQUE meglumine 60 percent can affect fertility in males or females.

Pregnancy Category C

Animal reproduction studies have not been conducted with HYPAQUE meglumine 60 percent. It is also not known whether HYPAQUE meglumine 60 percent can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HYPAQUE meglumine 60 percent should be given to a pregnant woman only if clearly needed. Doses up to 2500 mg/kg in rats, given IV daily, administered during gestation days 6 to 15 revealed no teratogenic abnormalities.

Labor and Delivery

It is not known whether use of these contrast agents during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor or increases the likelihood that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary.

Nursing Mothers

Diatrizoate salts are excreted unchanged in human milk. Because of the potential adverse reactions, although it has not been established that serious adverse reactions occur in nursing infants, caution should be exercised when these intravascular contrast media are administered to a nursing woman.

Pediatric Use

Infants and small children should not have any fluid restriction prior to excretory urography or any other procedures (see PRECAUTIONS—General). Guidelines for pediatric dosages are presented in DOSAGE AND ADMINISTRATION–General.

ADVERSE REACTIONS—General

Approximately 95 percent of adverse reactions accompanying the intravascular use of diatrizoate salts are of mild to moderate severity. However, life-threatening reactions and fatalities, mostly of cardiovascular origin, have occurred.

Adverse reactions to injectable contrast media fall into two categories: chemotoxic reactions and idiosyncratic reactions.

Chemotoxic reactions result from the physicochemical properties of the contrast media, the dose, and the speed of injection. All hemodynamic disturbances and injuries to organs or vessels perfused by the contrast medium are included in this category.

Idiosyncratic reactions include all other reactions. They occur more frequently in patients 20 to 40 years old. Idiosyncratic reactions may or may not be dependent on the amount of dose injected, the speed of injection, the mode of injection, and the radiographic procedure. Idiosyncratic reactions are subdivided into minor, intermediate, and severe. The minor reactions are self-limited and of short duration; the severe reactions are life-threatening and treatment is urgent and mandatory.

The reported incidence of adverse reactions to contrast media in patients with a history of allergy are twice that of the general population. Patients with a history of previous reactions to a contrast medium are three times more susceptible than other patients. However, sensitivity to contrast media does not appear to increase with repeated examinations.

Most adverse reactions to injectable contrast media appear within one to three minutes after the start of injection, but delayed reactions may occur.

Adverse reactions are grouped by organ system and listed below by decreasing order of occurrence and with an approximate incidence of occurrence. Significantly more severe reactions are listed before the other reactions regardless of frequency.

Greater Than 1 in 100 Patients

Body as a Whole: Reported incidences of death range from 6.6 per 1 million (0.00066 percent) to 1 in 10,000 patients (0.01 percent). Most deaths occur during injection or 5 to 10 minutes later, the main feature being cardiac arrest with cardiovascular disease as the main aggravating factor.

Isolated reports of hypotensive collapse and shock following urography are found in the literature. The incidence of shock is estimated to occur in 1 out of 20,000 (0.005 percent) patients.

Cardiovascular System: The most frequent adverse reaction to diatrizoate salts is vasodilation (feeling of warmth). The estimated incidence is 49 percent.

Digestive System: Nausea 6 percent, vomiting 3 percent.

Nervous System: Paresthesia 6 percent, dizziness 5 percent.

Respiratory System: Rhinitis 1 percent, increased cough 2 percent.

Skin and Appendages: Urticaria 1 percent.

Pain at the injection site is estimated to occur in about 12 percent of the patients undergoing urography. Pain is usually due to extravasation.

Painful hot erythematous swelling above the venipuncture site was estimated to occur in more than one percent of the patients undergoing phlebography.

Special Senses: Perversion of taste 11 percent.

Urogenital System: Osmotic nephrosis of the proximal tubular cells is estimated to occur in 23 percent of patients following excretory urography.

Less Than 1 in 100 Patients

Other infrequently reported reactions without accompanying incidence rates are listed below, grouped by organ system.

Body as a Whole: Malaria relapse, uremia, high creatinine and BUN (see PRECAUTIONS—General Drug/Laboratory Test Interactions), thrombocytopenia, leukopenia and anemia.

Cardiovascular System: Cerebral hematomas, hemodynamic disturbances, sinus bradycardia, transient electrocardiographic abnormalities, ventricular fibrillation, petechiae, chest pain, cardiac arrest, tachycardia, and cardiorespiratory arrest.

Digestive System: Severe unilateral or bilateral swelling of the parotid and submaxillary glands.

Nervous System: Convulsions, paralysis, coma, speech impairment and severe confusion (see PRECAUTIONS—General).

Respiratory System: Asthma, dyspnea, laryngeal edema, pulmonary edema, bronchospasm, pulmonary embolus and respiratory arrest.

Skin and Appendages: Extravasation necrosis, urticaria with or without pruritus, mucocutaneous edema, and angioneurotic edema.

Special Senses: Bilateral ocular irritation, lacrimation, itching, conjunctival chemosis, infection, conjunctivitis and unilateral blindness.

Urogenital: Renal failure, pain.

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