Fluoride F-18 is a radioactive diagnostic agent sold in the U.S. under 2 brand and generic names, for osteoporosis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Fluorine F-18 (application NDA017042). Other fluoride f-18 products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Sodium Fluoride F 18 Injection emits radiation and must be handled with appropriate safety measures. ( 2.1 ) • Administer 300-450 MBq (8-12 mCi) as an intravenous injection in adults. ( 2.4 ) • Administer approximately 2.1 MBq/kg in children with a minimum of 19 MBq (0.5 mCi) and a maximum of 148 MBq (4 mCi) as an intravenous injection. ( 2.5 ) • Imaging can begin 1-2 hours after administration; optimally at one hour post administration. ( 2.7 ) • Encourage patients to void immediately prior to imaging the lumbar spine and bony pelvis. ( 2.7 ) 2.1 Radiation Safety - Drug Handling • Wear waterproof gloves and effective shielding when handling Sodium Fluoride F 18 Injection. Use appropriate safety measures, including shielding, consistent with proper patient management to avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel, and other persons. • Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. • Use aseptic technique to maintain sterility during all operations involved in the manipulation and administration of Sodium Fluoride F 18 Injection. • The…
No adverse reactions have been reported for Sodium Fluoride F 18 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. However, the completeness of these sources is not known. No adverse reactions have been reported for Sodium Fluoride F 18 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. To report SUSPECTED ADVERSE REACTIONS, contact BAMF Health at 1-616-272-5777 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
None. None.
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Injectable | — | — | View → | |
| 2 | Not yet rated | Prescription | Injectable | — | — | View → |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
The possibility of interactions of Sodium Fluoride F 18 Injection with other drugs taken by patients undergoing PET imaging has not been studied.