Fludeoxyglucose F18 300 mCi/mL
Fludeoxyglucose F18 · INJECTION · MIPS Cyclotron & Radiochemistry Facility
Fludeoxyglucose F18 is a injection containing fludeoxyglucose f18 at 300 mCi/mL, taken intravenous. Manufactured by MIPS Cyclotron & Radiochemistry Facility.
Key Facts
- Brand Name
- Fludeoxyglucose F18
- Generic Name
- Fludeoxyglucose F18
- NDC Code (Product)
69587-001- Manufacturer
- MIPS Cyclotron & Radiochemistry Facility
- Strength
- 300 mCi/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA204472
- Drug Class
- Radioactive Diagnostic Agent [EPC]
- Marketing Start
- 02/28/2015
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Fludeoxyglucose F18 Injection is indicated for positron emission tomography (PET) imaging in the following settings: Fludeoxyglucose F18 Injection is indicated for positron emission tomography (PET) imaging in the following settings: Oncology: For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer. Cardiology: For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging. Neurology: For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures (1) . 1.1 Oncology For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer. 1.2 Cardiology For the identification of left ventricular myocardium with…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Fludeoxyglucose F18 Injection emits radiation. Use procedures to minimize radiation exposure. Calculate the final dose from the end of synthesis (EOS) time using proper radioactive decay factors. Assay the final dose in a properly calibrated dose calibrator before administration to the patient [ see Description (11.2) ]. Fludeoxyglucose F18 Injection emits radiation. Use procedures to minimize radiation exposure. Screen for blood glucose abnormalities. In the oncology and neurology settings, instruct patients to fast for 4 – 6 hours prior to the drug’s injection. Consider medical therapy and laboratory testing to assure at least two days of normoglycemia prior to the drug’s administration (5.2) . In the cardiology setting, administration of glucose-containing food or liquids (e.g., 50 – 75 grams) prior to the drug’s injection facilitates localization of cardiac ischemia (2.3) . Aseptically withdraw Fludeoxyglucose F18 Injection from its container and administer by intravenous injection (2). The recommended dose: for adults is 5 – 10 mCi (185 – 370 MBq), in all indicated clinical settings (2.1) . for pediatric patients is 2.6 mCi in the neurology setting …
Contraindications
4 CONTRAINDICATIONS None None
Drug Interactions
7 DRUG INTERACTIONS The possibility of interactions of Fludeoxyglucose F 18 Injection with other drugs taken by patients undergoing PET imaging has not been studied.
Adverse Reactions
6 ADVERSE REACTIONS Hypersensitivity reactions with pruritus, edema and rash have been reported in the post-marketing setting. Have emergency resuscitation equipment and personnel immediately available. Hypersensitivity reactions have occurred; have emergency resuscitation equipment and personnel immediately available (6) . To report SUSPECTED ADVERSE REACTIONS, MIPS Cyclotron & Radiochemistry Facility at 650-725-4182 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Fludeoxyglucose F18 used for?
Fludeoxyglucose F18 contains Fludeoxyglucose F18. It is a injection taken intravenous. Consult your doctor for specific uses.
Is Fludeoxyglucose F18 a controlled substance?
Fludeoxyglucose F18 is not classified as a controlled substance by the DEA.
What is the generic name for Fludeoxyglucose F18?
The generic name for Fludeoxyglucose F18 is Fludeoxyglucose F18. There are no other listed brand versions of Fludeoxyglucose F18.
What is the NDC code for Fludeoxyglucose F18 300 mCi/mL?
The NDC (National Drug Code) for Fludeoxyglucose F18 300 mCi/mL is 69587-001, listed by MIPS Cyclotron & Radiochemistry Facility.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)