Fluorodopa F18
Generic Name: fluorodopa f18
Brand Names:
Fluorodopa F18
11 DESCRIPTION 11.1 Chemical Characteristics Fluorodopa F 18 Injection is a radioactive diagnostic agent used in PET imaging. The active ingredient 6-[ 18 F] Fluoro-L-3, 4-dihydroxyphenylalanine has the molecular formula of C 9 H 10 FNO 4 with a molecular weight of 214.18, and has the following chemical structure: Fluorodopa F 18 Injection is a sterile, pyrogen-free, clear, colorless solution.
Overview
11 DESCRIPTION 11.1 Chemical Characteristics Fluorodopa F 18 Injection is a radioactive diagnostic agent used in PET imaging. The active ingredient 6-[ 18 F] Fluoro-L-3, 4-dihydroxyphenylalanine has the molecular formula of C 9 H 10 FNO 4 with a molecular weight of 214.18, and has the following chemical structure: Fluorodopa F 18 Injection is a sterile, pyrogen-free, clear, colorless solution.
Uses
1 INDICATIONS AND USAGE Fluorodopa F 18 Injection is indicated for use in positron emission tomography (PET) to visualize dopaminergic nerve terminals in the striatum for the evaluation of adult patients with suspected Parkinsonian syndromes (PS). Fluorodopa F 18 PET is an adjunct to other diagnostic evaluations. Fluorodopa F 18 Injection is a radioactive diagnostic agent indicated for use in positron emission tomography (PET) to visualize dopaminergic nerve terminals in the striatum for the evaluation of adult patients with suspected Parkinsonian syndromes (PS). Fluorodopa F 18 PET is an adjunct to other diagnostic evaluations.
Dosage
2 DOSAGE AND ADMINISTRATION • The recommended adult dose is 185 megabecquerels (MBq) [5 millicuries (mCi)] by intravenous injection infused over 1 minute. ( 2.2 ) • Use aseptic techniques and radiation shielding to maintain sterility during all operations involved in the manipulation and administration of Fluorodopa F 18 Injection. ( 2.1 , 2.2 ) • Instruct patients to void immediately before imaging and start imaging at approximately 80 minutes post administration (with a 9 second CT scan for attenuation correction) followed by 3D PET scan from 80 to 100 minutes post administration. ( 2.5 ) • See full prescribing information for additional preparation, administration, imaging and radiation dosimetry information.
Side Effects
6 ADVERSE REACTIONS Injection site pain occurred with administration based on a review of the published literature. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact The Feinstein Institutes for Medical Research at 516-562-1052 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 the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. No adverse reactions have been reported for Fluorodopa F 18 Injection based on an open-label clinical trial in 68 patients [see Clinical Studies ( 14 ) ] and additional clinical experience in 53 patients.
Interactions
7 DRUG INTERACTIONS Aromatic L-amino acid decarboxylase (AADC) inhibitors Prior to Fluorodopa F 18 Injection administration, use of AADC inhibitors (e.g. carbidopa, benserazide etc.) may increase Fluorodopa F 18 bioavailability to the brain by inhibiting peripheral decarboxylase activity and restricting peripheral Fluorodopa F 18 metabolism [see Dosage and Administration ( 2.3 )] .
Warnings
5 WARNINGS AND PRECAUTIONS Radiation risks: Use smallest dose necessary for imaging and ensure safe handling to protect the patient and healthcare worker from radiation exposure. ( 5.1 ) 5.1 Radiation Risks Fluorodopa F 18 Injection use contributes to a patient’s overall long-term radiation exposure, which is associated with an increased risk of cancer. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker [see Dosage and Administration ( 2.1 , 2.2 )] . 4 CONTRAINDICATIONS None None
Storage
16 HOW SUPPLIED/STORAGE AND DRUG HANDLING Fluorodopa F 18 Injection (NDC 13267-346-57) is supplied as a clear, colorless injection in a septum capped glass vial containing between 37 MBq/mL to 1,480 MBq/mL (1 mCi/mL to 40 mCi/mL), of Fluorodopa F 18 at calibration time, in 28 mL ±1 mL.
Frequently Asked Questions
What is Fluorodopa F18 used for?▼
1 INDICATIONS AND USAGE Fluorodopa F 18 Injection is indicated for use in positron emission tomography (PET) to visualize dopaminergic nerve terminals in the striatum for the evaluation of adult patients with suspected Parkinsonian syndromes (PS). Fluorodopa F 18 PET is an adjunct to other diagnostic evaluations. Fluorodopa F 18 Injection is a radioactive diagnostic agent indicated for use in positron emission tomography (PET) to visualize dopaminergic nerve terminals in the striatum for the evaluation of adult patients with suspected Parkinsonian syndromes (PS). Fluorodopa F 18 PET is an adjunct to other diagnostic evaluations.
What are the side effects of Fluorodopa F18?▼
6 ADVERSE REACTIONS Injection site pain occurred with administration based on a review of the published literature. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact The Feinstein Institutes for Medical Research at 516-562-1052 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 the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. No adverse reactions have been reported for Fluorodopa F 18 Injection based on an open-label clinical trial in 68 patients [see Clinical Studies ( 14 ) ] and additional clinical experience in 53 patients.
What are the important warnings for Fluorodopa F18?▼
5 WARNINGS AND PRECAUTIONS Radiation risks: Use smallest dose necessary for imaging and ensure safe handling to protect the patient and healthcare worker from radiation exposure. ( 5.1 ) 5.1 Radiation Risks Fluorodopa F 18 Injection use contributes to a patient’s overall long-term radiation exposure, which is associated with an increased risk of cancer. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker [see Dosage and Administration ( 2.1 , 2.2 )] . 4 CONTRAINDICATIONS None None
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.