GLOFIL®-125 (Sodium Iothalamate I-125 Injection) is indicated for evaluation of glomerular filtration in the diagnosis or monitoring of patients with renal disease.
* Dosing Information
:* Dosage
====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
=====Condition2=====
Sigman (1) method
* Dosing Information
I. Preparation:
:* Dosage
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.
It is not necessary to withhold breakfast or admit the patient the night before.
II. Procedure:
=====Condition3=====
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 Ringer’s (Hartmann’s) 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 Ringer’s 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:
* Dosing Information
Aliquots (1 mL each) of plasma and urine from each collection period are counted in a standard gamma-ray scintillation well detector.
All counts are corrected for background activity.
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
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/m2).
Unilateral glomerular filtration rates can be determined by the same technique by utilizing ureteral catheterization.
Single intravenous injection
:* Dosage
Cohen (2) method:
=====Condition4=====
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.
* Dosing Information
I. Preparation:
:* Dosage
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.
<!--Off-Label Use and Dosage (Adult)-->
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.
<!--Guideline-Supported Use (Adult)-->
Empty the bladder and label the urine Urine control.
|offLabelAdultGuideSupport======Condition1=====
Inject 10-30 μCi GLOFIL®-125 intravenously; wait 30 to 60 minutes.
Collect the entire urine and label Urine discard.
Draw 4 to 5 mL of blood into a heparinized syringe. Label Plasma #1.
After another 30 to 60 minutes, collect the entire urine and label Urine #1.
Immediately draw another blood specimen. Label Plasma #2.
After final 30 to 60 minute wait, collect the urine. Label Urine #2.
Draw the last blood specimen immediately. Label Plasma #3.
III. Clearance Calculations:
* Developed by:
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 = UV/P + 1.73/SA where
* Class of Recommendation:
C = glomerular filtration rate in mL/min/1.73 m2
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 m2
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%.
* Strength of Evidence:
[[File:Iothalamate dosage.png|none|400px]]
* Dosing Information
Visual Inspection
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
:* Dosage
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
=====Condition2=====
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Non–Guideline-Supported Use (Adult)-->
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Pediatric Indications and Dosage-->
<!--Pediatric Indications and Dosage-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
|fdaLIADPed=* Safety and efficacy not established in pediatrics patients.
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
<!--Off-Label Use and Dosage (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
* Developed by:
* Class of Recommendation:
* Strength of Evidence:
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Non–Guideline-Supported Use (Pediatric)-->
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
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Overview
Iothalamate Sodium I 125 is a Diagnostic Agent that is FDA approved for the diagnosis of renal disease by evaluation of glomerular filtration. Common adverse reactions include Hyperpyrexia.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
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.
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 Ringer’s (Hartmann’s) 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 Ringer’s 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:
Aliquots (1 mL each) of plasma and urine from each collection period are counted in a standard gamma-ray scintillation well detector.
All counts are corrected for background activity.
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
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/m2).
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:
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.
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.
Empty the bladder and label the urine Urine control.
Inject 10-30 μCi GLOFIL®-125 intravenously; wait 30 to 60 minutes.
Collect the entire urine and label Urine discard.
Draw 4 to 5 mL of blood into a heparinized syringe. Label Plasma #1.
After another 30 to 60 minutes, collect the entire urine and label Urine #1.
Immediately draw another blood specimen. Label Plasma #2.
After final 30 to 60 minute wait, collect the urine. Label Urine #2.
Draw the last blood specimen immediately. Label Plasma #3.
III. Clearance Calculations:
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 = UV/P + 1.73/SA where
C = glomerular filtration rate in mL/min/1.73 m2
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 m2
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%.
Visual Inspection
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Iothalamate Sodium I 125 in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Iothalamate Sodium I 125 in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Safety and efficacy not established in pediatrics patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Iothalamate Sodium I 125 in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Iothalamate Sodium I 125 in pediatric patients.
Contraindications
Condition1
Warnings
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Iothalamate Sodium I 125 in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Iothalamate Sodium I 125 in the drug label.
