Bicisate Dihydrochloride
Generic Name: bicisate dihydrochloride
Brand Names:
Neurolite
DESCRIPTION This kit formulation consists of two nonradioactive vials: Vial A contains bicisate dihydrochloride (N, N'-1,2-ethylenediylbis-L-cysteine diethyl ester dihydrochloride) and a reducing agent as a lyophilized solid and vial B contains a buffer solution. Both vials are sterile and non-pyrogenic.
Overview
DESCRIPTION This kit formulation consists of two nonradioactive vials: Vial A contains bicisate dihydrochloride (N, N'-1,2-ethylenediylbis-L-cysteine diethyl ester dihydrochloride) and a reducing agent as a lyophilized solid and vial B contains a buffer solution. Both vials are sterile and non-pyrogenic.
Uses
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
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.
Side Effects
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 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.
Warnings
WARNINGS None known. CONTRAINDICATIONS None known.
Pregnancy
Pregnancy: Teratogenic Effects Animal reproduction studies have not been conducted with Technetium Tc99m Bicisate. It is also not known whether Technetium Tc99m Bicisate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, Technetium Tc99m Bicisate should not be administered to a pregnant woman unless the potential benefit justifies the potential risk to the fetus.
Storage
HOW SUPPLIED Lantheus Medical Imaging, Inc. Neurolite® Kit for the Preparation of Technetium Tc99m Bicisate for Injection, is supplied in kits of two (2) vials of A and two (2) vials of B (NDC # 11994-006-02); and five (5) vials of A and five (5) vials of B (NDC 11994-006-05). Included in each kit are one (1) package insert and twelve (12) radiation labels.
Frequently Asked Questions
What is Bicisate Dihydrochloride 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 lesions.
What are the side effects of Bicisate Dihydrochloride?▼
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 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.
Can I take Bicisate Dihydrochloride during pregnancy?▼
Pregnancy: Teratogenic Effects Animal reproduction studies have not been conducted with Technetium Tc99m Bicisate. It is also not known whether Technetium Tc99m Bicisate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, Technetium Tc99m Bicisate should not be administered to a pregnant woman unless the potential benefit justifies the potential risk to the fetus.
What are the important warnings for Bicisate Dihydrochloride?▼
WARNINGS None known. CONTRAINDICATIONS None known.
Related Medications
Codeine Phosphate, Dexbrompheniramine Maleate
codeine phosphate, dexbrompheniramine maleate
Antihistamine Antitussive
Aristolochia Clematitis 1x
aristolochia clematitis 1x
Dosage form: LIQUID. Active ingredients: ARISTOLOCHIA CLEMATITIS FLOWERING TOP (1 [hp_X]/L). Category: DRUG FOR FURTHER PROCESSING.
Zinc Oxide 24.08%
zinc oxide 24.08%
Purpose Sunscreen
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.