Hypaque Meglumine

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

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.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

No information is available on the relationship of age to the effects of diatrizoate meglumine injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of diatrizoate meglumine injection in geriatric patients.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Propranolol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to iodine or other contrast agents, or history of or
• Asthma, or history of—Use with caution. May increase risk for more serious side effects.

• Urinary tract infection—Use with caution. May make this condition worse.

This section provides information on the proper use of a number of products that contain diatrizoate. It may not be specific to Hypaque Meglumine. 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.

Applies to diatrizoate: intravenous solution

Along with its needed effects, diatrizoate (the active ingredient contained in Hypaque Meglumine) 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 Hypaque Meglumine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.