The following Structured Product Label (SPL) was submitted to the FDA by Interpharma Praha, A.s. for the product Oraltag (NDC 54702-501). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 1 indications and usage, 2 dosage and administration, 2.1 recommended dosing, 2.2 preparation and administration instructions, 3 dosage forms and strengths, 4 contraindications, 5 warnings and precautions, 5.1 risks associated with inadvertent parenteral administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Oraltag is indicated for use in computed tomography of the abdomen and pelvis to opacify bowel loops and delineate between normal loops and adjacent organs or areas of suspected pathology.
Limitations of Use
Oraltag is not indicated for diagnostic examination of the gastrointestinal tract.
For oral use only[see Warnings and Precautions (5.1)]
Refer to Table 1 for dosing information.
Table 1 Dosing Guidelines for Oraltag
Patient Age | Recommended Dose Total volume of Oraltag administered will vary depending on the size of the patient | Volume of Prepared | Maximum |
Adults | Administer 4.5 g to 9 g of iodine (1 to 2 bottles of prepared solution), orally | 500 mL to 1000 mL | 9 grams |
3 to 18 years of age | Administer up to 9 g of iodine (from less than 1 bottle up to 2 bottles of prepared solution), orally | 280 mL to 750 mL, | 9 grams |
Less than 3 years of age | Administer up to 4.5 g of iodine (portion of 1 bottle of prepared solution), orally | 120 mL to 300 mL, | 4.5 grams |
The variables of patient age, weight, or medical condition, may require adjustment of the concentration and/or volume of solution to be prepared for administration. If it is anticipated that the patient will have difficulty in consuming the required volume, a higher concentration of solution (up to 21 mgI per mL) can be prepared and a smaller volume administered (see Table 2).
Table 2 Preparation of Higher Concentrations of Oraltag at Lower Volumes
For Final Concentration | Add Water or a Beverage Examples include infant formula, milk, juice, carbonated beverage or a sports drink (mL) |
9 | 500 |
12 | 375 |
15 | 300 |
18 | 250 |
21 | 214 |
For oral solution: Oraltag is provided as a white to off-white powder of 9.7 g iohexol, (equivalent to 4.5 g of carbon bound iodine) in a single-use bottle.
Oraltag is contraindicated in patients with a known hypersensitivity to iodinated contrast agents, including iohexol [see Warnings and Precautions (5.2)].
Oraltag is not a sterile product and is not suitable for a parenteral route of administration. Serious adverse reactions such as sepsis can occur if administered parenterally. Do not administer Oraltag parenterally.
Administration of Oraltag can cause life-threatening hypersensitivity reactions including anaphylaxis [see Contraindications (4)]. Patients at increased risk include those with a previous reaction to an iodinated contrast agent and allergic disorders (i.e., bronchial asthma, allergic rhinitis, and food allergies). Emergency resuscitation equipment and trained personnel should be available.
Iodinated contrast agents may alter the results of thyroid function tests which depend on iodine estimation, e.g., radioactive iodine uptake test. Therefore, such testing, if indicated, should be performed prior to the administration of this preparation.
The following adverse reactions are described in greater detail in other sections:
In studies involving 44 adult and 69 pediatric patients who received oral and intravenous iohexol for CT examinations of the abdomen, two reports of vomiting (2%) were noted.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following adverse reactions have been reported following oral administration of the dilute, hypotonic solutions of iohexol (9 mgI/mL to 21 mgI/mL):
Risk Summary
There are no human data on risks associated with the use of Oraltag during pregnancy. The background risk in the U.S. general population of major birth defects is 2% to 4% and risk of miscarriage is 15% to 20% of clinically recognized pregnancies. In animal reproduction studies, no evidence of fetal harm was observed with intravenous administration of iohexol to rats and rabbits at doses up to 100 times the maximum recommended human intravenous dose.
Risk Summary
Iohexol administered intravenously is present in human milk at concentrations approximately 0.5% of the maternal dose; however, it is not known to what extent iohexol administered orally is present in human milk. Iodinated contrast is poorly excreted into human milk and is poorly absorbed by 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 Oraltag and any potential adverse effects on the breastfed infant from Oraltag.
Clinical Considerations
Interruption of breastfeeding after exposure to iodinated contrast media 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 Oraltag administration in order to minimize potential drug exposure to a breastfed infant.
The safety and effectiveness of oral iohexol have been established in pediatric patients.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Oraltag (iohexol) is a radiographic contrast agent for oral solution. Oraltag is provided as a nonsterile white to off-white powder with 9.7 g iohexol (equivalent to 4.5 g of carbon bound iodine) in a 20-ounce beverage bottle. Each bottle is individually sealed in a foil laminated pouch. Oraltag consists of 100 percent iohexol and contains no excipients.
Iohexol is designated chemically as N,N´-bis(2,3-dihydroxypropyl)-5-[N-(2,3-dihydroxypropyl)acetamido]-2,4,6-triiodoisophthalamide. It is a nonionic, water-soluble iodinated contrast medium with a molecular weight of 821.14 (carbon bound iodine content 46.36%). In aqueous solution each triiodinated molecule remains undissociated.
The chemical structure is:
Chemical Structure (Iohexol Structure)
Oraltag, when prepared at a concentration of 9 mgI/mL in water, has an osmolality of 30 mOsmol/kg water. The calculated osmolality of 21 mgI/mL in water is 55 mOsmol/kg water. The prepared solutions are hypotonic.
Iohexol enhances imaging due to its high iodine content attenuating the beam of X-rays during CT examinations. Different tissues within the body attenuate X-rays to different degrees, and oral administration of iohexol allows for enhanced visualization due to the iodine present in bowel loops.
Orally administered iohexol is very poorly absorbed from the normal gastrointestinal tract. Only 0.1 to 0.5% of the oral dose is excreted by the kidneys. This amount may increase in the presence of bowel perforation, bowel obstruction, or severe inflammatory bowel disease.
Iohexol displays a low affinity for serum or plasma proteins and is poorly bound to serum albumin. No significant metabolism, deiodination or biotransformation occurs.
No long-term animal studies have been performed to evaluate carcinogenic potential or mutagenesis.
In animal reproduction studies, no evidence of impaired fertility was observed with intravenous administration of iohexol to rats and rabbits at doses up to 100 times the maximum recommended human intravenous dose.
How Supplied
Oraltag is supplied as a nonsterile white to off-white powder for oral solution in a single-use 20-ounce polyethylene terephthalate beverage bottle closed with a lined polypropylene cap. Each bottle is packaged in a sealed foil pouch.
Twelve (12) bottles per pack (NDC 54702-501-52).
Twenty-five (25) bottles per pack (NDC 54702-501-62).
Storage
Store at controlled room temperature, 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Protect prepared solutions of Oraltag from strong daylight and direct exposure to sunlight.
Do not use if tamper-evident foil pouch has been opened.
Hypersensitivity Reactions
Advise patients about the risk of hypersensitivity reactions to Oraltag and the need to notify their healthcare provider if signs or symptoms of hypersensitivity reaction occur [see Warnings and Precautions (5.2)].
NDC 54702-501-21
Oraltag™
(iohexol) for oral solution
9.7 g of iohexol powder
(equivalent to 4.5 g of carbon bound iodine)
Single Use Bottle - Discard Unused Portion
Prepared solution is 9-21 mgI/mL
For Oral Use Only
Nonsterile
For indications and dosage, see prescribing information.
Store at 20-25˚C (68-77˚F); excursions permitted to 15-30˚C (59-86˚F) [see USP]
Protect prepared solutions of Oraltag from strong daylight and direct exposure to sunlight.
Rx Only
Manufactured for Interpharma Praha, a.s.
Prague, Czech Republic
by Ultra Seal Corporation
New Paltz, New York
Principal Display Panel (Bottle Label)
NDC 54702-501-51
Oraltag™
(iohexol) for oral solution
Contains a single-use bottle with 9.7 g of iohexol powder
(equivalent to 4.5 g of carbon bound iodine)
For Oral Use Only
Nonsterile
Store at 20-25˚C (68-77˚F); excursions permitted to 15-30˚C (59-86˚F) [see USP]
Rx Only
Manufactured for Interpharma Praha, a.s.
Prague, Czech Republic
by Ultra Seal Corporation
New Paltz, New York
Instructions for Use:
1. Add water or beverage up to the fill line on the bottle as prescribed for the patient. Prepare one or two bottles as directed.
2. Replace cap and shake until all the powder has dissolved.
3. The dose is ready to be consumed by the patient.
4. Discard any unused portion.
Principal Display Panel (Pouch Label Front)
Principal Display Panel (Pouch Label Back)
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