Cystografin

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.

• If you have an allergy to diatrizoate meglumine or any other part of Cystografin (diatrizoate meglumine).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Blood in the urine.
• Bladder irritation.
• Not able to pass urine or change in how much urine is passed.
• Seizures.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Cystografin is indicated for retrograde cystourethrography.

Severe sensitivity reactions are more likely to occur in patients with a personal or family history of bronchial asthma, significant allergies, or previous reactions to contrast agents.

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

Applies to diatrizoate: intravenous solution

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

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes Comments: The effects in the nursing infant are unknown.

Substance Name

Diatrizoate

CAS Registry Number

117-96-4

Drug Class

Contrast Agents

Diagnostic Agents