NEUROLITE

NEUROLITE is an FDA-registered drug product whose active ingredient is BICISATE DIHYDROCHLORIDE. It is labelled by SHINE SPECT USA, LLC and marketed as a human prescription drug product. Identifiers on file: NDC 87333-006, application NDA020256, label effective 20260910. It is one of 2 FDA drug label records sharing the active ingredient BICISATE DIHYDROCHLORIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing BICISATE DIHYDROCHLORIDE are most often described in connection with: indications neurolite, single photon, emission computerized, tomography spect, indicated adjunct, conventional mri, localization stroke, assessment functional. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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.

DOSAGE AND ADMINISTRATION Before administration, a patient should be well hydrated. After administration, the patient should be encouraged to drink fluids liberally and to void frequently. The recommended dose range for intravenous administration for a 70 kg patient is 370-1110 MBq (10-30mCi). Dose adjustments for age, weight, gender or renal or hepatic impairment have not been studied. The dose for the patient should be measured by a suitable radioactivity calibration system immediately before administration to the patient. Radiochemical purity should be checked before administration to the patient. NEUROLITE ® , like other parenteral drug products, should be inspected visually for particulate matter and discoloration prior to 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 all applicable regulations. Prior to reconstitution, vial A and vial B are stored at 15-25°C. Protect vial A from light. Store at controlled room temperature after preparation. 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.

CONTRAINDICATIONS None known.

WARNINGS None known.

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 toNEUROLITE ® . 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.

FDA lists 2 drug label records with BICISATE DIHYDROCHLORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is NEUROLITE used for?
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 …

Who makes NEUROLITE?
SHINE SPECT USA, LLC is the labeler of record for NEUROLITE. 2 FDA label records share the active ingredient BICISATE DIHYDROCHLORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

Is NEUROLITE prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing BICISATE DIHYDROCHLORIDE?
Yes. 2 FDA drug label records list BICISATE DIHYDROCHLORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has NEUROLITE been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.