ISOVUE-M IOPAMIDOL 612 mg/mL Injection, Solution
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- Iopamidol is a contrast dye — it contains iodine, which absorbs X-rays and makes blood vessels, organs, and other structures show up much more clearly on CT scans, angiograms, and...
- What exactly is iopamidol and why do I need it before my scan?
- Yes, a warm or flushing sensation is one of the most common things people feel right after iopamidol is injected into a vein or artery — it's expected and passes quickly. Nausea is...
- Is it normal to feel warm or nauseous right after the injection?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Iopamidol — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
0.39 mg / 1 mL
UNII 25IH6R4SGF
Edetate calcium disodium is a chelating agent, a chemical that binds to metal ions. It's used in some medications to prevent unwanted metals from interfering with the drug's stability and effectiveness.
-
1 mg / 1 mL
UNII 023C2WHX2V
Tromethamine is a chemical buffer that helps maintain the proper acidity level in liquid medicines. It neutralizes acids and stabilizes the solution so the medication remains effective and safe throughout its shelf life.
2 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · Q9967 | $0.155 / Q9967 unit | — |
Where does this data come from?
🧾 Billing & reimbursement
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| iopamidol 612 mg/mL 70436-0126-34 | Slate | 15 ml | — | AP1 | FDA listed | — |
| Isovue-M 612 mg/mLthis 00270-1412-15 | Bracco | 10 vials | — | AP | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Code | What it grants | Expires |
|---|---|---|
| I-975 | New indication (3-year) | Oct 10, 2028 |
| I-975 | New indication (3-year) | Oct 10, 2028 |
| I-975 | New indication (3-year) | Oct 10, 2028 |
| I-975 | New indication (3-year) | Oct 10, 2028 |
Is there a generic version of ISOVUE-M 300 61% VIAL?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00270-1412-15 You're viewing this | 10 VIAL, SINGLE-DOSE in 1 PACKAGE (0270-1412-15) / 15 mL in 1 VIAL, SINGLE-DOSE | 1985-12-31 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Who lists this product with the FDA?
Do I need a prescription for this product?
Does this product have a billing J-code?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE ISOVUE-M is indicated for: Lumbar and thoracic myelography, and computed tomography (CT) myelography in adults and pediatric patients aged 2 years and older Cervical and total columnar myelography and CT myelography in adults CT cisternography in adults Specific concentrations of ISOVUE-M are recommended for each type of imaging procedure [see Dosage and Administration ( 2.2 , 2.3 )]. ISOVUE-M is a radiographic contrast agent indicated for: Lumbar and thoracic myelography and computed tomography (CT) myelography in adults and pediatric patients aged 2 years and older Cervical and total columnar myelography in adults CT cisternography in adults ( 1 ) Specific concentrations of ISOVUE-M are recommended for each type of imaging procedure.
( 2.2 , 2.3 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Individualize the volume and concentration of ISOVUE-M according to the specific dosing tables based on patient age, body weight, and study to be performed. ( 2.2 , 2.3 ) See full prescribing information for important dosage and administration information. ( 2.1 )
2.1Important Dosage and Administration Information ISOVUE-M is for intrathecal use only. Specific concentrations of ISOVUE-M are recommended for each type of imaging procedure [see Dosage and Administration ( 2.2 , 2.3 )]. Individualize the volume, concentration, and injection rate of ISOVUE-M according to the dosing tables [see Dosage and Administration ( 2.2 , 2.3 )].
Consider factors such as age, body weight, anticipated pathology and degree and extent of opacification required, structure(s) or area to be examined, concomitant medical conditions, and imaging equipment and technique to be employed. Hydrate patients prior to and following ISOVUE-M administration [see Warnings and Precautions ( 5.2) ] . Use aseptic technique for all handling and administration of ISOVUE-M.
ISOVUE-M may be administered at either body temperature (37°C, 98.6°F) or room temperature (20°C to 25°C, 68°F to 77°F). Visually inspect ISOVUE-M for particulate matter and discoloration prior to administration whenever the solution and container permit. Do not administer ISOVUE-M if particulate matter or discoloration are observed.
Do not mix ISOVUE-M with other drugs. ISOVUE-M is packaged in a single-dose vial and intended for one procedure only. Discard any unused portion.
2.2Recommended Dosage for Intrathecal Procedures in Adults The recommended doses in adults are shown in Table 1 . Administer over 1 minute to 2 minutes. Allow at least 48 hours before repeat administration to avoid overdose; however, whenever possible, 5 days to 7 days is recommended.
If CT myelography is performed, delay imaging by at least 4 hours to reduce the degree of contrast. Table 1: Recommended Concentrations and Volumes of ISOVUE-M for Intrathecal Procedures in Adults Imaging Procedure Concentration (mg Iodine/mL) Volume to Administer Injection Type Lumbar and thoracic myelography 200 10 mL to 15 mL Lumbar Cervical myelography 200 10 mL to 15 mL Lumbar 10 mL Lateral cervical 300 10 mL Lumbar Total columnar myelography 300 10 mL Lumbar CT cisternography 200 4 mL to 6 mL Lumbar
2.3Recommended Dosage for Intrathecal Procedures in Pediatric Patients Aged 2 Years and Older The recommended doses based on age for pediatric patients aged 2 years and older are shown in Table 2. Administer over 1 minute to 2 minutes. Allow at least 48 hours before repeat administration to avoid overdose; however, whenever possible, 5 days to 7 days is recommended.
If CT myelography is performed, delay imaging by at least 4 hours to reduce the degree of contrast. Table 2: Recommended Concentrations and Volumes of ISOVUE-M Based on Age for Intrathecal Procedures in Pediatric Patients Aged 2 Years and Older Imaging Procedure Age Concentration (mg Iodine/mL) Volume to Administer Injection Type Lumbar and thoracic myelography 2 years to 7 years 200 7 mL to 9 mL Lumbar 8 years to 12 years 8 mL to 11 mL Lumbar 13 years and older 10 mL to 12 mL Lumbar
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: clear, colorless to pale yellow solution available in two concentrations of iodine: Concentration (mg of Iodine/mL) Package Size Package Type 200 10 mL Single-Dose Vial 300 15 mL Single-Dose Vial Injection: 200 mg Iodine/mL and 300 mg Iodine/mL in single-dose vials ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Life-threatening or fatal reactions can occur. Always have emergency resuscitation equipment and trained personnel available. ( 5.1 ) Acute Kidney Injury: Acute injury including renal failure can occur.
Use the lowest dose and maintain adequate hydration to minimize risk. ( 5.2 ) Cardiovascular Adverse Reactions: Hemodynamic disturbances including shock and cardiac arrest may occur during or after ISOVUE-M administration. ( 5.4 ) Thyroid Dysfunction in Pediatric Patients 0 Years to 3 Years of Age: Individualize thyroid function monitoring based on risk factors such as prematurity.
( 5.6 )
5.1Hypersensitivity Reactions ISOVUE-M can cause life-threatening or fatal hypersensitivity reactions including anaphylaxis. Manifestations include respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock [see Adverse Reactions ( 6.2 )] . Most severe reactions develop shortly after the start of injection (e.g., within 1 to 3 minutes), but delayed reactions can also occur.
There is increased risk of hypersensitivity reactions in patients with a history of previous reactions to contrast agents, and known allergic disorders (i.e., bronchial asthma, allergic rhinitis, and food allergies) or other hypersensitivities. Premedication with antihistamines or corticosteroids does not prevent serious life-threatening reactions, but may reduce their incidence and severity. Obtain a history of allergy or hypersensitivity reactions to iodinated contrast agents and always have emergency resuscitation equipment and trained personnel available prior to ISOVUE-M administration.
Monitor all patients for hypersensitivity reactions.
5.2Acute Kidney Injury Acute kidney injury, including renal failure, may occur after administration of iodinated contrast agents. Risk factors include pre-existing renal insufficiency, dehydration, diabetes mellitus, congestive heart failure, advanced vascular disease, elderly age, concomitant use of nephrotoxic or diuretic medications, multiple myeloma or other paraproteinemias, and repetitive or large doses of iodinated contrast agents. Use the lowest dose of ISOVUE-M, especially in patients with risk factors for acute kidney injury.
Adequately hydrate patients prior to and following ISOVUE-M administration .
5.3Increased Risk of Seizures Focal and generalized motor seizures have been reported after intrathecal use of iodinated contrast agents including ISOVUE-M. In several of the cases, higher than recommended doses were administered. Use of medications that may lower the seizure threshold (phenothiazine derivatives, including those used for their antihistaminic properties; tricyclic antidepressants; MAO inhibitors; CNS stimulants; analeptics; antipsychotic agents) should be carefully evaluated.
Consider discontinuing these agents at least 48 hours before and for at least 24 hours following intrathecal administration of ISOVUE-M.
5.4Cardiovascular Adverse Reactions Iodinated contrast agents increase the circulatory osmotic load and may induce acute or delayed hemodynamic disturbances in patients with congestive heart failure, severely impaired renal function, combined renal and hepatic disease, and combined renal and cardiac disease, particularly when repetitive or large doses are administered. Fatal cardiovascular reactions have occurred mostly within 10 minutes of injection of iodinated contrast agent by an intravascular route; the main feature was cardiac arrest with cardiovascular disease as the main underlying factor.
Hypotensive collapse and shock have occurred. The administration of iodinated contrast agent may cause pulmonary edema in patients with heart failure. Based upon published reports, deaths associated with the administration of iodinated contrast agents range from 6.6 per 1 million (0.00066 percent) to 1 in 10,000 patients (0.01 percent).
Use the lowest necessary dose of ISOVUE-M in patients with congestive heart failure and always have emergenc…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Acute Kidney Injury [see Warnings and Precautions ( 5.2 )] Increased Risk of Seizures [see Warnings and Precautions ( 5.3 )] Cardiovascular Adverse Reactions [see Warnings and Precautions ( 5.4 )] Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age [see Warnings and Precautions ( 5.6 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (incidence > 1%) are headache, nausea, vomiting, back pain, leg pain, neck pain, and hypotension.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc. at 1-800-257-5181 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ISOVUE-M was evaluated in 686 adult patients receiving ISOVUE-M intrathecally in clinical studies. Table 3 shows the common adverse reactions (>1%).
These reactions usually occur 1 to 10 hours after injection, almost all occurring within 24 hours. Table 3: Adverse Reactions Reported in >1% of Patients Receiving Intrathecal Injection of ISOVUE-M in Clinical Studies Adverse Reaction ISOVUE-M (N=686) % Headache
16.4 Nausea
7.3 Vomiting
3.6 Back pain
2.2 Leg Pain
1.4 Neck Pain
1.1 Hypotension
1.1The following additional adverse reactions occurred in ≤ 1% of patients receiving intrathecal injection of ISOVUE-M: Cardiovascular disorder: tachycardia, hypertension, chest pain Gastrointestinal: diarrhea, heartburn General disorders and administration site conditions: pyrexia, muscle weakness, hot flashes, malaise, fatigue, weakness, injection site pain Musculoskeletal: leg cramps, sciatica, cervicobrachial irritation, meningeal irritation, radicular irritation lumbosacral, other musculoskeletal pain, involuntary movement, burning sensation Nervous system: dizziness, paresthesia, confusion, hallucinations, lightheadedness, syncope, numbness, cold extremities, ataxia, irritability Urogenital: urinary retention Respiratory: dyspnea Skin and subcutaneous tissues : rash
6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of ISOVUE-M and other iopamidol products. Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure. Blood and lymphatic system disorders: thrombocytopenia Cardiovascular disorders: cardiopulmonary arrest, cardiac decompensation, arrhythmias, myocardial infarction, shock, electrocardiographic changes (e.g., increased QTc, increased R-R, increased T-wave amplitude), decreased systolic pressure, deep vein thrombosis, arterial spasms, transient ischemic attack, flushing, vasodilation, chest pain, pallor Endocrine disorders: hyperthyroidism, hypothyroidism Eye disorders: lacrimation increased, conjunctivitis, eye pruritus, transient blindness, visual disturbance, photophobia Gastrointestinal disorders: retching, abdominal pain, salivary hypersecretion, salivary gland enlargement General disorders and administration site conditions: chills, malaise Immune system disorders: anaphylaxis characterized by cardiovascular, respiratory, and cutaneous manifestations (e.g., chest tightness, laryngeal edema, periorbital edema, facial edema); delayed hypersensitivity reactions including generalized maculopapular rash, erythema, pruritus, localized blistering, skin peeling Infections and infestations: meningitis aseptic, meningitis bacterial as consequence of the procedural hazard Musculoskeletal disorders: muscle spasm, musculoskeletal pain…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: A lactating woman may pump and discard breast milk for 10 hours after ISOVUE-M administration. ( 8.2 )
8.1Pregnancy Risk Summary Available data from published literature and postmarketing cases from decades of use with iopamidol during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Iopamidol crosses the placenta and reaches fetal tissues in small amounts ( see Data ). In animal reproduction studies, no adverse developmental outcomes were observed with intravenous administration of iopamidol to pregnant rats and rabbits during organogenesis at doses up to 2.7 and 1.4 times, respectively, the maximum recommended human dose ( see Data ).
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Human Data Literature reports show that intravenously administered iopamidol crosses the placenta and is visualized in the digestive tract of exposed infants after birth. Animal Data Iopamidol did not affect fetal development and did not induce teratogenic changes in the offspring in either rats or rabbits at the following dose levels tested: 600 mg, 1,500 mg, or 4,000 mg iodine/kg in rats, administered intravenously once a day during days 6 through 15 of pregnancy; 300 mg, 800 mg, or 2,000 mg iodine/kg in rabbits, administered intravenously once a day during days 6 through 18 of pregnancy.
8.2Lactation Risk Summary There are no data on the presence of iopamidol in human milk, the effects on the breastfed infant, or the effects on milk production. Iodinated contrast agents are present unchanged in human milk in very low amounts, with poor absorption from the gastrointestinal tract of a breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ISOVUE- M and any potential adverse effects on the breastfed infant from ISOVUE-M or from the underlying maternal condition.
Clinical Considerations Interruption of breastfeeding after exposure to iodinated contrast agents is not necessary because the potential exposure of the breastfed infant to iodine is small. However, a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk for 10 hours (approximately 5 half- lives) after ISOVUE-M administration in order to minimize drug exposure to a breastfed infant.
8.4Pediatric Use The safety and effectiveness of ISOVUE-M for lumbar and thoracic myelography and CT myelography have been established in pediatric patients aged 2 years and older. Pediatric patients at higher risk of experiencing adverse reactions during and after any iodinated contrast agent administration may include those having asthma, sensitivity to medication or allergens, cyanotic heart disease, congestive heart failure, or serum creatinine greater than 1.5 mg/dL. Thyroid function tests indicative of thyroid dysfunction, characterized by hypothyroidism or transient thyroid suppression have been reported following iodinated contrast agent administration in pediatric patients, including term and preterm neonates; Some patients were treated for hypothyroidism.
After exposure to iodinated contrast agent, individualize thyroid function monitoring in pediatric patients 0 to 3 years of age based on underlying risk factors, especially in term and preterm neonates [see Warnings and Precautions ( 5.6 ) and Adverse Reactions ( 6.2 )] . The safety and effectiveness of ISOVUE-M for lumbar and thoracic myelography and CT myelography have not been established in pediatric patients younger than 2 years of age. The safety and effectiveness of ISOVUE-M for…
🆘 Overdosage ▾
10 OVERDOSAGE Doses above 3,000 mg iodine in adults and 2,400 mg iodine in pediatric patients aged 2 years and older may result in an increased frequency and severity of adverse reactions including seizures. Treatment of an overdose is directed toward the support of all vital functions and prompt institution of symptomatic therapy. Iopamidol can be removed by dialysis.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Intrathecal administration of iopamidol opacifies the body structures where the contrast agent is present, permitting their radiographic visualization through attenuation of photons.
12.2Pharmacodynamics Following intrathecal injection, iopamidol provides diagnostic contrast for at least 30 minutes for conventional myelography. At about 1 hour, contrast will no longer be sufficient for conventional myelography. However, diagnostic contrast for CT myelography remains at least 6 hours after administration. The exposure-response relationships and time course of pharmacodynamic response of iopamidol have not been fully characterized.
12.3Pharmacokinetics Absorption Iopamidol is absorbed into the bloodstream from cerebrospinal fluid (CSF); following intrathecal administration, iopamidol appears in plasma within 1 hour and virtually all of the drug reaches the systemic circulation within 24 hours. Distribution Iopamidol did not bind to serum or plasma proteins at 1 hour after administration. Elimination The plasma half-life is approximately 2 hours; the half-life is not dose dependent .
Metabolism Iopamidol does not undergo significant metabolism, deiodination, or biotransformation. Excretion Iopamidol is excreted mainly through the kidneys following intrathecal administration, and the drug is essentially undetectable in the plasma 48 hours later. In patients with normal renal function, the cumulative urinary excretion for iopamidol, expressed as a percentage of administered intravenous dose is approximately 35% to 40% at 60 minutes, 80% to 90% at 8 hours, and 90% or more in the 72- to 96-hour period after administration.
In patients with normal renal function, approximately 1% or less of the administered dose appears in cumulative 72- to 96-hour fecal specimens.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ISOVUE-M (iopamidol) injection is a clear, colorless to pale yellow solution available in the following presentations: Concentration (mg Iodine/mL) Package Size Package Type Sale Unit NDC 200 10 mL Single-Dose Vial Carton of 10 0270-1411-11 300 15 mL Single-Dose Vial Carton of 10 0270-1412-15 Storage and Handling Store at 20°C to 25°C (68°F to 77°F) [See USP controlled room temperature]. Protect from light.
📋 Description ▾
11 DESCRIPTION ISOVUE-M (iopamidol) injection is a radiographic contrast agent for intrathecal use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6- triiodo-5-lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C 17 H 22 I 3 N 3 O 8, and the following structural formula: ISOVUE-M is a sterile, clear, colorless to pale yellow solution available in two concentrations of iodine: ISOVUE-M 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg sodium) and 1 mg tromethamine.
ISOVUE-M 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg sodium) and 1 mg tromethamine. The pH of ISOVUE-M has been adjusted to 6.5 to 7.5 with hydrochloric acid and/or sodium hydroxide. Physicochemical characteristics are shown in Table 4 .
ISOVUE-M is hypertonic as compared to plasma and cerebrospinal fluid (approximately 285 and 301 mOsm/kg water, respectively). Table 4: Physicochemical Characteristics of ISOVUE-M Concentration (mg Iodine/mL) 200 300 Osmolality @ 37°C (mOsm/kg water) 413 616 Viscosity (cP) @ 37°C 2.0
4.7Viscosity (cP) @ 20°C 3.3
8.8Specific Gravity @ 37°C 1.227 1.339 isovue-m-struct
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Hypersensitivity Reactions Advise the patient concerning the risk of hypersensitivity reactions that can occur both during and after ISOVUE-M administration. Advise the patient to report any signs or symptoms of hypersensitivity reactions during the procedure and to seek immediate medical attention for any signs or symptoms experienced after discharge [see Warnings and Precautions ( 5.1 )]. Advise patients to inform their physician if they develop a rash after receiving ISOVUE-M [see Warnings and Precautions ( 5.9 )].
Acute Kidney Injury Advise the patient concerning appropriate hydration to decrease the risk of contrast induced kidney injury [see Warnings and Precautions ( 5.2 )]. Thyroid Dysfunction Advise parents/caregivers about the risk of developing thyroid dysfunction after ISOVUE-M administration. Advise parents/caregivers about when to seek medical care for their child to monitor for thyroid function [see Warnings and Precautions ( 5.6 )].
Lactation Advise lactating women that interruption of breast feeding is not necessary, however, to avoid any exposure a lactating woman may consider pumping and discarding breast milk for 10 hours after ISOVUE-M administration to minimize drug exposure to a breastfed infant [see Use in Specific Populations ( 8.2 )]. Manufactured for: Bracco Diagnostic Inc. Princeton, NJ 08540 Manufactured by: BIPSO GmbH 78224 Singen (Germany) Revised January 2026 CL63A-07 ISOVUE-M is a registered trademark of Bracco Diagnostics Inc.