Iothalamate Sodium I 125: Difference between revisions

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|drugClass=Diagnostic Agent
|drugClass=Diagnostic Agent
|indicationType=diagnosis
|indicationType=diagnosis
|indication=renal disease by evaluation of glomerular filtration  
|indication=renal disease by evaluation of glomerular filtration
|adverseReactions=Hyperpyrexia
|adverseReactions=Hyperpyrexia


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<!--Contraindications-->
<!--Contraindications-->
|contraindications=* Condition1
|contraindications=* GLOFIL®-125 should not be administered via a central venous line.


<!--Warnings-->
<!--Warnings-->
|warnings=* Description
|warnings=* None known


====Precautions====
====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.


* Description
Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides.


<!--Adverse Reactions-->
Rapid or bolus-like injections should be avoided.
 
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.


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<!--Postmarketing Experience-->
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|postmarketing=Hyperpyrexia
 
=====Body as a Whole=====
 
 
 
=====Cardiovascular=====
 
 
 
=====Digestive=====
 
 
 
=====Endocrine=====
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
=====Metabolic and Nutritional=====
 
 
 
=====Musculoskeletal=====
 
 
 
=====Neurologic=====
 
 
 
=====Respiratory=====
 
 
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
=====Special Senses=====
 
 
 
=====Urogenital=====
 
 
 
=====Miscellaneous=====
 
 
 
<!--Drug Interactions-->
|drugInteractions=* Drug
|drugInteractions=* Drug
:* Description
:* Description


<!--Use in Specific Populations-->
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|FDAPregCat=C
|useInPregnancyFDA=* 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.
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''


There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInNursing=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.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInPed=Safety and effectiveness in children have not been established.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
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<!--Administration and Monitoring-->
<!--Administration and Monitoring-->
|administration=* Oral
|administration=* Intravenous
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.


* Intravenous
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.


* Description


<!--IV Compatibility-->
<!--IV Compatibility-->
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<!--Overdosage-->
<!--Overdosage-->
|overdose====Acute Overdose===
|overdose=There is limited information regarding <i>Overdose</i> of {{PAGENAME}} in the drug label.
 
====Signs and Symptoms====
 
* Description
 
====Management====
 
* Description
 
===Chronic Overdose===
 
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.


<!--Pharmacology-->
<!--Pharmacology-->
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<!--Structure-->
<!--Structure-->
|structure=*  
|structure=* 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 μCi/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. Photons that are useful for detection are listed in Table 1.


: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
: [[File:Iothalamate str.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


<!--Pharmacodynamics-->
<!--Pharmacodynamics-->
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<!--Pharmacokinetics-->
<!--Pharmacokinetics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
|PK=The renal clearance of sodium iothalamate in man closely approximates that of inulin. The compound is cleared by glomerular filtration without tubular secretion or reabsorption. Following infusion administration of I-125 iothalamate, the effective half-life is about 0.07 days.


<!--Nonclinical Toxicology-->
<!--Nonclinical Toxicology-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
|nonClinToxic=Carcinogenesis, Mutagenesis, 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.


<!--Clinical Studies-->
<!--Clinical Studies-->
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<!--How Supplied-->
<!--How Supplied-->
|howSupplied=*
|howSupplied=* Identity
|packLabel=<!--Patient Counseling Information-->
No. 1000, GLOFIL®-125 is a clear, colorless, sterile, and nonpyrogenic solution available as a 4 mL vial. It is supplied in a concentration of approximately 1 mg/mL sodium iothalamate (range is 0.5–2.0 mg sodium iothalamate per mL), with a radioactivity concentration of 250 to 300 μCi/mL at the time of calibration. Benzyl alcohol 0.9%, is added as a preservative. Sodium bicarbonate and hydrochloric acid are added for pH adjustment. The calibration and expiration dates are shown on the label.
|storage=* Refrigerate the product upon receipt at 2°C to 8°C.
|packLabel=====INGREDIENTS AND APPEARANCE====
: [[File:Iothalamate I n A.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.


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<!--Brand Names-->
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title =  | url = }}</ref>
|brandNames=* GLOFIL-125®<ref>{{Cite web | title = Iothalamate sodium, i-125 | url = http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2c07ce91-cc83-45e3-bd2b-f923a9c8286c}}</ref>


<!--Look-Alike Drug Names-->
<!--Look-Alike Drug Names-->
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
|lookAlike=There is limited information regarding the look alike drug names.
 
<!--Drug Shortage Status-->
|drugShortage=
|drugShortage=
}}
}}

Revision as of 19:10, 28 April 2015

Iothalamate Sodium I 125
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

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

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

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.

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

Hyperpyrexia

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): 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.


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Iothalamate Sodium I 125 in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Iothalamate Sodium I 125 during labor and delivery.

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.

Geriatic Use

There is no FDA guidance on the use of Iothalamate Sodium I 125 with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Iothalamate Sodium I 125 with respect to specific gender populations.

Race

There is no FDA guidance on the use of Iothalamate Sodium I 125 with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Iothalamate Sodium I 125 in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Iothalamate Sodium I 125 in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Iothalamate Sodium I 125 in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Iothalamate Sodium I 125 in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Intravenous

Monitoring

There is limited information regarding Monitoring of Iothalamate Sodium I 125 in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Iothalamate Sodium I 125 in the drug label.

Overdosage

There is limited information regarding Overdose of Iothalamate Sodium I 125 in the drug label.

Pharmacology

There is limited information regarding Iothalamate Sodium I 125 Pharmacology in the drug label.

Mechanism of Action

Structure

  • 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 μCi/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. Photons that are useful for detection are listed in Table 1.

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Iothalamate Sodium I 125 in the drug label.

Pharmacokinetics

The renal clearance of sodium iothalamate in man closely approximates that of inulin. The compound is cleared by glomerular filtration without tubular secretion or reabsorption. Following infusion administration of I-125 iothalamate, the effective half-life is about 0.07 days.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, 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.

Clinical Studies

There is limited information regarding Clinical Studies of Iothalamate Sodium I 125 in the drug label.

How Supplied

  • Identity

No. 1000, GLOFIL®-125 is a clear, colorless, sterile, and nonpyrogenic solution available as a 4 mL vial. It is supplied in a concentration of approximately 1 mg/mL sodium iothalamate (range is 0.5–2.0 mg sodium iothalamate per mL), with a radioactivity concentration of 250 to 300 μCi/mL at the time of calibration. Benzyl alcohol 0.9%, is added as a preservative. Sodium bicarbonate and hydrochloric acid are added for pH adjustment. The calibration and expiration dates are shown on the label.

Storage

  • Refrigerate the product upon receipt at 2°C to 8°C.

Images

Drug Images

{{#ask: Page Name::Iothalamate Sodium I 125 |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

INGREDIENTS AND APPEARANCE

This image is provided by the National Library of Medicine.

{{#ask: Label Page::Iothalamate Sodium I 125 |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Iothalamate Sodium I 125 in the drug label.

Precautions with Alcohol

  • Alcohol-Iothalamate Sodium I 125 interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • GLOFIL-125®[1]

Look-Alike Drug Names

There is limited information regarding the look alike drug names.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ "Iothalamate sodium, i-125".

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