Ultravist 300 mg/mL
iopromide · INJECTION · Bayer HealthCare Pharmaceuticals Inc.
Ultravist is a injection containing iopromide at 300 mg/mL, taken intra-arterial. Manufactured by Bayer HealthCare Pharmaceuticals Inc..
Key Facts
- Brand Name
- Ultravist
- Generic Name
- iopromide
- NDC Code (Product)
50419-344- Manufacturer
- Bayer HealthCare Pharmaceuticals Inc.
- Strength
- 300 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRA-ARTERIAL, INTRAVENOUS
- Marketing Status
- Application #
- NDA020220
- Drug Class
- Radiographic Contrast Agent [EPC]
- Marketing Start
- 12/30/2009
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ULTRAVIST ® Injection is an iodinated contrast agent indicated for: ULTRAVIST is a radiographic contrast agent indicated for: Intra-Arterial Procedures † • Cerebral arteriography and peripheral arteriography in adults ( 1.1 ) • Coronary arteriography and left ventriculography, visceral angiography, and aortography in adults ( 1.1 ) • Radiographic evaluation of cardiac chambers and related arteries in pediatric patients aged 2 years and older ( 1.1 ) Intravenous Procedures † • Excretory urography in adults and pediatric patients aged 2 years and older ( 1.2 ) • Contrast computed tomography (CT) of head and body in adults and pediatric patients aged 2 years and older ( 1.2 ) • Contrast mammography in adults as an adjunct following mammography and/or ultrasound ( 1.2 ) † Specific concentrations and presentations are recommended for each type of imaging procedure. ( 2.2 , 2.3 , 2.4 ) 1.1 Intra-Arterial Procedures* ULTRAVIST is indicated for: • Cerebral arteriography and peripheral arteriography in adults • Coronary arteriography and left ventriculography, visceral angiography, and aortography in adults • Radiographic evaluation of cardiac chambers and related ar…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Individualize the volume and concentration according to the specific dosing tables accounting for factors such as age, body weight, size of the vessel, and the rate of blood flow within the vessel. ( 2.2 , 2.3 , 2.4 ) • For contrast mammography, use ULTRAVIST with a device that is cleared for dual-energy full field digital mammography. ( 2.5 ) • See full prescribing information for important dosage and administration instructions and directions for use of pharmacy bulk packages and imaging bulk packages. ( 2.1 , 2.6 , 2.7 ) 2.1 Important Dosage and Administration Information • ULTRAVIST is for intra-arterial or intravenous use only and must not be administered intrathecally [see Warnings and Precautions ( 5.1 )] . • Specific concentrations and presentations of ULTRAVIST are recommended for each type of imaging procedure [see Dosage and Administrations ( 2.2 , 2.3 , 2.4 )] . • Hydrate patients, as appropriate, prior to and following the administration of ULTRAVIST [see Warnings and Precautions ( 5.3 )] . • Individualize the volume, concentration, and injection rate of ULTRAVIST according to the specific dosing tables [see Dosage and Administration ( 2.2…
Contraindications
4 CONTRAINDICATIONS None None
Drug Interactions
7 DRUG INTERACTIONS 7.1 Drug-Drug Interactions Metformin In patients with renal impairment, biguanides can cause lactic acidosis. Iodinated contrast agents appear to increase the risk of metformin-induced lactic acidosis, possibly as a result of worsening renal function. Stop metformin at the time of, or prior to, ULTRAVIST administration in patients with an eGFR between 30 and 60 mL/min/1.73 m2; in patients with a history of hepatic impairment, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast agents. Re-evaluate eGFR 48 hours after the imaging procedure and reinstitute only after renal function is stable. Radioactive Iodine ULTRAVIST may interfere with thyroid uptake of radioactive iodine (I-131 and I-123) and decrease therapeutic and diagnostic efficacy. Avoid thyroid therapy or testing for up to 6 weeks post ULTRAVIST. 7.2 Drug-Laboratory Test Interactions Protein-Bound Iodine Test Iodinated contrast agents, including ULTRAVIST, will temporarily increase protein-bound iodine in blood. Do not perform protein-bound iodine test for at least 16 days following administration of ULTRAVIST. However, thyroid function tests which do …
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: • Risks Associated with Intrathecal Use [see Warnings and Precautions ( 5.1 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 )] • Acute Kidney Injury [see Warnings and Precautions ( 5.3 )] • Cardiovascular Adverse Reactions [see Warnings and Precautions ( 5.4 )] • Thromboembolic Events [see Warnings and Precautions ( 5.5 )] • Extravasation and Injection Site Reactions [see Warnings and Precautions ( 5.6 )] • Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age [see Warnings and Precautions ( 5.8 )] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.11 )] Common adverse reactions (>1%) are headache, nausea, injection site and infusion site reactions, vasodilatation, vomiting, back pain, urinary urgency, chest pain, pain, dysgeusia, and abnormal vision. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in t…
Frequently Asked Questions
What is Ultravist used for?
Ultravist contains iopromide. It is a injection taken intra-arterial. Consult your doctor for specific uses.
Is Ultravist a controlled substance?
Ultravist is not classified as a controlled substance by the DEA.
What is the generic name for Ultravist?
The generic name for Ultravist is iopromide. There are no other listed brand versions of iopromide.
What is the NDC code for Ultravist 300 mg/mL?
The NDC (National Drug Code) for Ultravist 300 mg/mL is 50419-344, listed by Bayer HealthCare Pharmaceuticals Inc..
Other Ultravist Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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