Iothalamate Sodium I-125 — Active Pharmaceutical Ingredient

Iothalamate Sodium I-125 is an active pharmaceutical ingredient found in 1 FDA-approved drug product. Forms: INJECTABLE. Routes: INJECTION.

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Iothalamate Sodium I-125 (1 brand name, 1 dosage form, 1 route)

Available dosage forms: INJECTABLE.

Routes of administration: INJECTION.

Brand Names

  • GLOFIL-125

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 and Administration

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 Sigman1 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 minut

Contraindications

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

Adverse Reactions

None Reported

⚠ Caution
Medical Disclaimer: This information is for educational purposes only. Always consult a healthcare professional before taking any medication.