Sodium Iothalamate I-125 Injection

Generic Name: sodium iothalamate i-125 injection

Over-the-Counter (OTC)

Brand Names:

Glofil-125

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 µCi/mL as of the calibration date. Sodium bicarbonate and hydrochloric acid are present for pH adjustment.

Overview

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 µCi/mL as of the calibration date. Sodium bicarbonate and hydrochloric acid are present for pH adjustment.

Uses

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

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.

Side Effects

ADVERSE REACTIONS None Reported

Warnings

WARNINGS None known CONTRAINDICATIONS GLOFIL-125 should not be administered via a central venous line.

Storage

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

Frequently Asked Questions

What is Sodium Iothalamate I-125 Injection 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.

What are the side effects of Sodium Iothalamate I-125 Injection?

ADVERSE REACTIONS None Reported

What are the important warnings for Sodium Iothalamate I-125 Injection?

WARNINGS None known CONTRAINDICATIONS GLOFIL-125 should not be administered via a central venous line.

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.