Iothalamate meglumine

What Iothalamate meglumine is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Cysto-Conray II is indicated for use in retrograde cystography and cystourethrography.

— FDA label: Cysto-Conray II, Liebel-Flarsheim Company LLC, effective December 31, 2020. Read the full label on DailyMed →

Label quoted: the one for the most common form (injection, ureteral), Cysto-Conray II, Liebel-Flarsheim Company LLC; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

This label has a boxed warning. Read it on the full label →

Iothalamate meglumine boxed warning: what the label says

Quoted from the boxed warning of the FDA-approved label.

NOT FOR INTRAVASCULAR ADMINISTRATION NOT FOR INTRATHECAL USE

— FDA label: Cysto-Conray II, Liebel-Flarsheim Company LLC, effective December 31, 2020. Read the full label on DailyMed →

Iothalamate meglumine side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

Irritation of the bladder or ureter, common to some degree to all contrast media administered for retrograde urographic procedures, may occasionally occur. As with all contrast media, intravasation may lead to hypersensitivity reactions such as a sense of warmth, flushing, sneezing, sweating, chills, fever, urticaria, laryngeal edema, bronchospasm, hypertension, hypotension, cardiac arrhythmias and cardiac arrest.

Read more of this section

Adverse reactions associated with procedural technique include injury to the urethra, bladder, ureter, and introduction of infection. In the event of serious or anaphylactoid reactions, it should be kept in mind that the reactions known to occur with intravenous administration of radiopaque contrast materials are possible.

— FDA label: Cysto-Conray II, Liebel-Flarsheim Company LLC, effective December 31, 2020. Read the full label on DailyMed →

Iothalamate meglumine dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

Patient Preparation Unless contraindicated, an appropriate laxative is given the night before the examination. Radiographic Technique The radiographic procedure normally employed for cystography and cystourethrography should be employed. A preliminary radiograph is recommended before the contrast agent is administered. Administration Sterile catherization is essential. Cysto-Conray II may be introduced by gravity flow using an appropriate venoclysis set or by syringe.

Read more of this section

Excessive pressure should be avoided with any method of administration. Usual Dosage Cystography and Cystourethrography – Either Conray 43 supplied at 43% w/v or Cysto-Conray II supplied at a 17.2% w/v concentration may be used for these procedures. The desired concentration will vary depending upon the patient’s size and age and also with the technique and equipment used. (SEE CONRAY 43 PACKAGE INSERT FOR SPECIFIC INFORMATION ABOUT THE USE OF THIS PRODUCT.) Sufficient volume of contrast medium is administered to adequately fill the urinary bladder. The volume of solution required will vary depending upon the individual patient. Adults usually require a volume in the range of 200 to 400 mL. Children require a volume in proportion to their body size. The usual dose ranges from 30 to 300 mL.

— FDA label: Cysto-Conray II, Liebel-Flarsheim Company LLC, effective December 31, 2020. Read the full label on DailyMed →

Iothalamate meglumine in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

Category C. Animal reproduction studies have not been conducted with Cysto-Conray II. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cysto-Conray II should be used in pregnant women only if clearly needed.

— FDA label: Cysto-Conray II, Liebel-Flarsheim Company LLC, effective December 31, 2020. Read the full label on DailyMed →

Iothalamate meglumine and breastfeeding

Quoted from the nursing mothers / lactation part of the FDA-approved label.

Iothalamate salts are excreted unchanged in human milk. Although it has not been established that serious adverse reactions occur in nursing infants, because of the potential for adverse reactions, caution should be exercised when Cysto-Conray II is administered to a nursing woman.

— FDA label: Cysto-Conray II, Liebel-Flarsheim Company LLC, effective December 31, 2020. Read the full label on DailyMed →

When Iothalamate meglumine should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

See WARNINGS concerning inadvertant intrathecal administration.

— FDA label: Cysto-Conray II, Liebel-Flarsheim Company LLC, effective December 31, 2020. Read the full label on DailyMed →

Forms and how it is given

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• Liebel-Flarsheim Company LLC1 product

FDA approval history

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

Next steps

• Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
• Latest FDA drug recallsAll medicines, newest first
• Liebel-Flarsheim Company LLCMaker or distributor
• All prescription drugs A to ZSearch by generic, brand or Spanish name

Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Cysto-Conray II, Liebel-Flarsheim Company LLC, effective December 31, 2020; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

Report an error → · Information for medicine makers