Cystografin Dilute

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

Safe and effective use of this preparation depends upon proper dosage, correct technique, adequate precautions, and readiness for emergencies.

Retrograde cystourethrography should be performed with caution in patients with a known active infectious process of the urinary tract.

Sterile technique should be employed in administration. During administration, care should be taken to avoid excessive pressure, rapid or acute distention of the bladder, and trauma.

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

Pregnancy–Teratogenic Effects:

Pregnancy Category C

Animal reproduction studies have not been conducted with diatrizoate meglumine injection. It is also not known whether diatrizoate meglumine injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cystografin Dilute should be administered to a pregnant woman only if clearly needed.

Retrograde genitourinary procedures may cause such complications as hematuria, perforation of the urethra or bladder, introduction of infection into the genitourinary tract, and oliguria or anuria.

If intravasation of this drug occurs, the reactions which may be associated with intravenous administration may possibly be encountered. Hypersensitivity or anaphylactoid reactions may occur. Severe reactions may be manifested by edema of the face and glottis, respiratory distress, convulsions or shock; such reactions may prove fatal unless promptly controlled by such emergency measures as maintenance of a clear airway and immediate use of oxygen and resuscitative drugs.

Endocrine: Thyroid function tests indicative of hypothyroidism or transient thyroid suppression have been uncommonly reported following iodinated contrast media administration to adult and pediatric patients, including infants. Some patients were treated for hypothyroidism.

Cystografin Dilute (Diatrizoate Meglumine Injection USP 18%) is available in packages of ten 300 mL bottIes (NDC 0270-1410-30).

Storage

Store at 20-25°C (68-77°F) [See USP]; protect from light.

Cystografin Dilute – Carton
NDC 0270-1410-30

• Tell all of your health care providers that you take Cystografin-Dilute. This includes your doctors, nurses, pharmacists, and dentists.
• Thyroid problems have happened after use of this medicine. Some people had to be treated for these thyroid problems. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Cystografin-Dilute.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

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.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Cystografin-Dilute, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Cystografin-Dilute. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Cystografin-Dilute.

Review Date: October 4, 2017

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 diatrizoate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Applies to diatrizoate: intravenous solution

Along with its needed effects, diatrizoate (the active ingredient contained in Cystografin-Dilute) 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