Glofil-125

Glofil-125 is an FDA-registered drug product whose active ingredient is SODIUM IOTHALAMATE I-125 INJECTION. It is labelled by Iso-Tex Diagnostics, Inc. taken by intravenous and marketed as a human prescription drug product. Identifiers on file: NDC 50914-7729, application NDA017279, label effective 20191209. 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 SODIUM IOTHALAMATE I-125 INJECTION are most often described in connection with: usage glofil-, sodium iothalamate, injection indicated, evaluation glomerular, diagnosis monitoring, renal disease. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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.

Dosage The suggested dose range employed in the average patient (70 kg) is as follows: Continuous intravenous infusion: 20 to 100 μCi (0.74-3.7 megabecquerels) (Sigman, et al (1) method). Single intravenous injection: 10 to 30 µCi (0.37-1.11 megabecquerels) Cohen, et al (2) method) The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. Technique Continuous intravenous infusion Sigman 1 method I. Preparation: Adequate diuresis (a urine flow exceeding 3 mL/min.) is established, preferably by an oral water load of 1,500 mL two hours prior to the beginning of the clearance study. 2. It is not necessary to withhold breakfast or admit the patient the night before. II. Procedure: After the establishment of adequate diuresis, a number 14 or 16 French Foley catheter is aseptically inserted into the bladder. An intravenous infusion of Lactated Ringers (Hartmanns) solution is started in each arm, one to maintain a site for injection of the GLOFIL-125, the other to serve as a site for serial withdrawal of blood. A two-way stopcock connects the needle and intravenous tubing of each arm. The dose is equally divided into (1) an intravenous priming dose to be injected as is and (2) a sustaining dose to be diluted in 30 to 60 mL of isotonic sodium chloride, depending on how many collection periods are anticipated. The priming dose is slowly injected into one arm. This is immediately followed by infusion of the sustaining solution through the same site, usually at the rate of 0.5 mL/min., by means of an automatic pump. During this infusion, the Lactated Ringers solution in the same arm is discontinued, and 40 to 45 minutes are allowed for equilibration in order to reach a state of constant plasma concentration of radioactivity. After attaining equilibrium, consecutive 15 minute collection periods are started. From the arm opposite the injection site, 5 mL of blood (allowing duplicate plasma counting volumes) is drawn six minutes prior to the midpoint of each collection period, placed in heparinized tubes, mixed, and centrifuged. The blood samples may be obtained through the two-way stopcock after discarding the first 30 mL aspirated into the syringe. This 30 mL contains the contents of the tubing, including infusion fluid, and must be cleared in order to obtain an undiluted blood sample. If desired, this step may be eliminated and blood samples obtained by direct venipuncture. During each collection period, total urine must be accurately collected and the volume accurately measured. Three such consecutive collection periods are sufficient for most clinical studies. III. Clearance Calculations: 1. Aliquots (1 mL each) of plasma and urine from each collection period are counted in a standard gamma-ray scintillation well detector. 2. All counts are corrected for background activity. 3. Glomerular filtration rate is calculated by the formula C=UV/P, in which: C = glomerular filtration rate in mL/min U= urinary concentration of radioactivity in net counts/min/mL V= urinary flow rate in mL/min P = plasma concentration of radioactivity in net counts/min/mL 4. Average glomerular filtration rate (GFR) is calculated from the rates for the individual collection periods. GFR can be expressed in terms of body weight (mL/min/kg) or body surface area (mL/min/m 2 ). 5. Unilateral glomerular filtration rates can be determined by the same technique by utilizing ureteral catheterization. Single intravenous injection Cohen 2 method: The method of Cohen, et al 2 requires little preparation, few and small blood samples, no bladder catheterization, and no constant intravenous infusion. It is simple to perform, rapid, and utilizes equipment which is readily available in most modern laboratories. I. Preparation: 1. Lugol's solution, 3 drops orally, three times a day, is administered for one or two days prior to the test. No diet or water restriction is necessary. 2. Oral water load is begun one hour before starting the test. Start with 20 mL/kg and force any clear liquids (unless contraindicated) until the test is complete. II. Procedure: Record actual times for the collection of the blood and urine samples. 1. Empty the bladder and label the urine Urine control. 2. Inject 10-30 µCi GLOFIL-125 intravenously; wait 30 to 60 minutes. 3. Collect the entire urine and label Urine discard. 4. Draw 4 to 5 mL of blood into a heparinized syringe. Label Plasma #1. 5. After another 30 to 60 minutes, collect the entire urine and label Urine #1. 6. Immediately draw another blood specimen. Label Plasma #2. 7. After final 30 to 60 minute wait, collect the urine. Label Urine #2. 8. Draw the last blood specimen immediately. Label Plasma #3. III. Clearance Calculations: 1. Radioactivity of one mL aliquots of both urine and plasma are determined using a well-scintillation detector with a single channel pulse-height analyzer. Sufficiently reproducible counts are usually obtained with time settings of 2 minutes for urine samples and 20 minutes for the plasma samples. Calculations of the clearance rates are made by using the formula:(1) C = C = UV/P + 1.73/SA where C = glomerular filtration rate in mL/min/1.73 m 2 U = urine radioactivity in counts/min/mL V = urine flow rate in mL/min P= mean plasma radioactivity in counts/min/mL SA= body surface area in m 2 Radiation Dosimetry The estimated absorbed radiation doses to an average (70 kg) patient from an intravenous dose of 100 µCi (3.7 megabecquerels) of GLOFIL-125 are shown in Table 4. Calculations assume that there is 1% free iodide in the preparation and that the thyroid uptake of the iodine is 25%. image description

CONTRAINDICATIONS GLOFIL-125 should not be administered via a central venous line.

WARNINGS None known

ADVERSE REACTIONS None Reported

What is Glofil-125 used for?
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.

Who makes Glofil-125?
Iso-Tex Diagnostics, Inc. is the labeler of record for Glofil-125.

What form does Glofil-125 come in?
administered by intravenous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Glofil-125 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.

Has Glofil-125 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.