Description
General Glofil-125 (Sodium Iothalamate I-125 Injection) is a sterile, nonpyrogenic aqueous injection containing approximately 1 mg sodium iothalamate per mL, and 0.9 percent benzyl alcohol as a preservative. The radioactive concentration of the material is 250-300 uCi/mL as of the calibration date. Sodium bicarbonate and hydrochloric acid are present for pH adjustment. Physical Characteristics Iodine-125 decays by electron capture with a physical half-life of 60.14 days.
Clinical Pharmacology
The renal clearance of sodium iothalamate in man closely approximates that of inulin. The cmpd is cleared by glomerular filtration w/out tobular secretion or reabsorption. Following infusion administration of I-125 iothalamate, the effective half-life is about 0.07 days.
Indications and usage
GLOFIL-125 (Sodium Iothalamate I-125 Injection) is indicated for evaluation of glomerular filtration in the diagnosis or monitoring of patients with renal disease.
Contraindications
None known.
Warnings
None known.
Precautions
General
As in the use of any radioactive material, care should be taken to minimize radiation exposure to the patient, consistent with proper patient management, and to insure minimum radiation exposure to occupational workers. Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides. Rapid or bolus-like injections should be avoided.
Carcinogenesis, Mutagenisis, Impairment of Fertility
No long-term animal studies have been performed to evaluate carcinogenic potential, mutagenic potential, or whether this drug affects fertility in males or females.
Pregnancy Category C
Animal reproduction studies have not been conducted with GLOFIL-125. It is also not known whether GLOFIL-125 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. GLOFIL-125 should be given to a pregnant woman only if clearly needed.
Nursing Mothers
Radioiodine is excreted in human milk during lactation. It is not known whether GLOFIL-125 is excreted in human milk. Therefore, formula feedings should be substituted for breast feedings.
Pediatric Use
Safety and effectiveness in children have not been established.
Adverse Reactions
None reported.
Visual Inspection
Parental drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.