Iothalamate sodium i-125

FDA label, Iso-Tex Diagnostics, Inc., intravenous, effective 2019-12-09. Full label on DailyMed

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Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Preparation and administration

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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 method). Single intravenous injection: 10 to 30 µCi (0.37-1.11 megabecquerels) Cohen, et al 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 an intravenous priming dose to be injected as is and 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.

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.

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.

Contraindications

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

Pregnancy and lactation

Pregnancy

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.

Lactation

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.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

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