Fludeoxyglucose F 18 Injection

Fludeoxyglucose F 18 Injection (fdg) is a positron emitting radiopharmaceutical used for diagnostic purposes in conjunction with Positron Emission Tomography (PET).

It is also used to assist assessment of

• cancer,
• coronary artery disease, or
• epileptic seizures.

Fludeoxyglucose F 18 Injection,USP is indicated in PET (positron emission tomography) for:

Side effects from Fludeoxyglucose F 18 Injection are uncommon. Infrequent side effects of Fludeoxyglucose F 18 Injection include

• allergic reactions,
• itching,
• rash, and
• water retention.

• F 18 (FDG) uptake may be changed by fasting or by blood sugar changes associated with diabetic mellitus.
• Blood glucose levels should be stabilized in non-diabetic patients by fasting before F 18 (FDG) injection.
• Diabetic patients may need stabilization of blood glucose on the day preceding and on the day of the F 18 (FDG) scan.
• The recommended dose of F 18 (FDG) for an adult (70 kg) is within the range 185-370 MBq (5-10 mCi), intravenous injection.
• In children doses as low as 2.6 mCi have been given.
• Optimal dose reductions for children have not been confirmed.
• The optimum rate of administration and upper safe dose for F 18 (FDG) have not been established.
• The time interval between doses of F 18 (FDG) should be long enough to allow substantial decay (physical and biological) of previous administrations.
• It is recommended that PET imaging be initiated within 40 minutes of F 18 (FDG) injection.
• The final dose for the patient should be calculated using proper decay factors from the time of the EOS, and measured by a suitable radioactivity calibration system before administration.
• F 18 (FDG), like other parenteral drug products, should be inspected visually for particulate matter and discoloration before administration, whenever solution and container permit.
• Preparations containing particulate matter or discoloration should not be administered. They should be disposed of in a safe manner, in compliance with applicable regulations.
• F 18 (FDG) should be stored upright in a lead shielded environment at controlled room temperature.
• Aseptic techniques and effective shielding should be employed in withdrawing doses for administration to patients.
• Waterproof gloves and effective shielding should be worn when handling the product.

• It is not known whether F 18 (FDG) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, F 18 (FDG) should not be administered to a pregnant woman unless the potential benefit justifies the potential risk to the fetus.
• It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when F 18 (FDG) is administered to a nursing woman.