Cholografin Meglumine

• It is used before an x-ray or an alike test.

• If you have an allergy to iodipamide meglumine or any other part of Cholografin Meglumine (iodipamide 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.
• If you have any of these health problems: Kidney disease or liver disease.
• If you are dehydrated, have been eating poorly, or have used a laxative or water pill before this medicine.
• If you have had a skin reaction to Cholografin Meglumine or another drug like it in the past.
• If you are taking metformin, talk with doctor.

This is not a list of all drugs or health problems that interact with this medicine.

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 Cholografin Meglumine 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.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Shortness of breath.
• Very bad dizziness or passing out.
• Chest pain or pressure or a fast heartbeat.
• A heartbeat that does not feel normal.
• Blue or gray skin color.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• This medicine may cause tissue damage if the drug leaks from the vein. Tell your nurse if you have any redness, burning, pain, swelling, blisters, skin sores, or leaking of fluid where the drug is going into your body.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

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.

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

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.

Since iodine-containing contrast agents may alter the results of thyroid function tests, 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 agents is not an absolute contraindication to the use of iodipamide meglumine, but calls for extreme caution in administration.

Diagnostic procedures which involve the use of radiopaque contrast agents should be carried out under the direction of personnel with the prerequisite training and with a thorough knowledge of the particular procedure to be performed. Appropriate facilities should be available for coping with situations which may arise as a result of the procedure, as well as for emergency treatment of severe reactions to the contrast agent itself.

After intravascular administration of a radiopaque agent, competent personnel and emergency facilities should be available for at least 30 to 60 minutes, since severe delayed reactions have been known to occur.

These severe, life-threatening reactions suggest hypersensitivity to the radiopaque agent, which has prompted the use of several pretesting methods, none of which can be relied upon to predict severe reactions. Many authorities question the value of any pretest. A history of bronchial asthma or allergy, a family history of allergy, or a previous reaction to a contrast agent warrant special attention. Such a history, by suggesting histamine sensitivity and a consequent proneness to reactions, may be more accurate than pretesting in predicting the likelihood of a reaction, although not necessarily the severity or type of reaction in the individual case.

The sensitivity test most often performed is the slow injection of 0.5 to 1.0 mL of the radiopaque medium, administered intravenously, prior to injection of the full diagnostic dose. It should be noted that the absence of a reaction to the test dose does not preclude the possibility of a reaction to the full diagnostic dose. If the test dose causes an untoward response of any kind, the necessity for continuing with the examination should be carefully reevaluated and, if it is deemed essential, the examination should be conducted with all possible caution. In rare instances reactions to the test dose itself may be extremely severe; therefore, close observation of the patient, and facilities for emergency treatment, appear indicated.

Caution should be exercised with the use of radiopaque media in severely debilitated patients and in those with marked hypertension. The possibility of thrombosis should be borne in mind when intravenous techniques are employed.

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

Some clinicians feel it may be advisable to have a continuous intravenous infusion running prior to and during administration of the drug.

The admixture of Benadryl® (Diphenhydramine Hydrochloride Injection) with Cholografin Meglumine (lodipamide Meglumine Injection USP 52%) may cause a precipitate which may form in the syringe or tubing. If antihistamines are administered concomitantly, they should not be mixed with the contrast agent but administered at another site.

Usage in Pregnancy

The safety of iodipamide meglumine for use during pregnancy has not been established; therefore, it should be used in pregnant patients, only when, in the judgment of the physician, its use is deemed essential to the welfare of the patient.

Local reactions at the site of injection are not observed, unless excessive amounts are extravasated during injection. After too rapid administration, mild transient symptoms such as restlessness, sensations of warmth, sneezing, perspiration, salivation, flushing, pressure in the upper abdomen, dizziness, nausea, vomiting, chills, fever, headache, pallor and tremors may occur. These symptoms disappear when the injection has been completed. Rarely, swollen eyelids, laryngospasm, respiratory difficulties, hypotension, cardiac reactions and cyanosis have been reported. Hypersensitivity reactions may occur. In rare instances, despite the most careful sensitivity testing, anaphylactoid reactions may occur.

Renal function tests may be altered and renal failure may occur.

LactMed Record Number

559

Last Revision Date

20160226

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Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.