NEUROLITE
Generic: BICISATE DIHYDROCHLORIDE
Basic Information
Manufacturer
Lantheus Medical Imaging, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
FDA Set ID
f9adbcd5-1ac1-42d8-b18a-a76c9204014c
Indications & Usage
INDICATIONS Neurolite single photon emission computerized tomography (SPECT) is indicated as an adjunct to conventional CT or MRI imaging in the localization of stroke in patients in whom stroke has already been diagnosed.
Neurolite is not indicated for assessment of functional viability of brain tissue.
Also, Neurolite is not indicated for distinguishing between stroke and other brain lesions.
Neurolite is not indicated for assessment of functional viability of brain tissue.
Also, Neurolite is not indicated for distinguishing between stroke and other brain lesions.
Warnings
WARNINGS None known.
Adverse Reactions
ADVERSE REACTIONS In clinical trials, Neurolite has been administered to 1063 subjects (255 normals, 808 patients).
Of these, 566 (53%) were men and 494 (47%) were women.
The mean age was 58 years (range 17 to 92 years).
In the 808 patients, who had experienced neurologic events, there were 11 (1.4%) deaths, none of which were clearly attributed to Neurolite.
A total of 60 subjects experienced adverse reactions; the adverse reaction rates were comparable in the <65 year, and the >65 year age groups.
The following adverse effects were observed in ≤ 1% of the subjects: headache, dizziness, seizure, agitation/anxiety, malaise/somnolence, parosmia, hallucinations, rash, nausea, syncope, cardiac failure, hypertension, angina, and apnea/cyanosis.
In clinical trials of 197 patients, there were inconsistent changes in the serum calcium and phosphate levels.
The cause of the changes has not been identified and their frequency and magnitude have not been clearly characterized.
None of the changes required medical intervention.
Of these, 566 (53%) were men and 494 (47%) were women.
The mean age was 58 years (range 17 to 92 years).
In the 808 patients, who had experienced neurologic events, there were 11 (1.4%) deaths, none of which were clearly attributed to Neurolite.
A total of 60 subjects experienced adverse reactions; the adverse reaction rates were comparable in the <65 year, and the >65 year age groups.
The following adverse effects were observed in ≤ 1% of the subjects: headache, dizziness, seizure, agitation/anxiety, malaise/somnolence, parosmia, hallucinations, rash, nausea, syncope, cardiac failure, hypertension, angina, and apnea/cyanosis.
In clinical trials of 197 patients, there were inconsistent changes in the serum calcium and phosphate levels.
The cause of the changes has not been identified and their frequency and magnitude have not been clearly characterized.
None of the changes required medical intervention.