Uses
GLOFIL-125 (Sodium Iothalamate I-125 Injection) is indicated for evaluation of glomerular filtration in the diagnosis or monitoring of patients with renal disease.
Source: US FDA prescribing information
Molecule
Iothalamate sodium i-125
Radioactive Diagnostic Agent
Available on requestCold chain
- Presentations
- 1
- Brands
- 1
- Manufacturers
- 1
- Available from stock
- 0
Iothalamate sodium i-125 is a radioactive diagnostic agent indicated for evaluation of glomerular filtration in the diagnosis or monitoring of patients with renal disease. It is available as injection for intravenous use. MedsAcross supplies Iothalamate sodium i-125 for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- Pharmacological class
- Radioactive Diagnostic Agent, Radiopharmaceutical Activity
- US FDA first approval
- 12 February 1974
- EU status
- Not recorded
- Orphan designation
- Not recorded
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Intravenous
- Dosage forms
- Injection
- Identifiers
- UNII 31J5U3Q9ZNCAS 17692-74-9Q81976750
Clinical information
From the regulator-approved product information. Each section names its source.
Dosing overview
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.
Source: US FDA prescribing information
Contraindications
GLOFIL-125 should not be administered via a central venous line.
Source: US FDA prescribing information
Warnings and precautions
None known
Source: US FDA prescribing information
Side effects
None Reported
Source: US FDA prescribing information
Storage
Refrigerate the product upon receipt at 2°C to 8°C.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
1 presentations of Iothalamate sodium i-125, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Glofil-125 0.275 mCi/mL injectionIntravenous Cold chain | Iso-Tex Diagnostics | US FDA | Available on request |
Brands by market
1 brand names across 1 markets.
United States
Manufacturers
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 12 February 1974 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Questions and answers
Is Iothalamate sodium i-125 available for export from India?
Yes, on request. MedsAcross lists 1 presentations of Iothalamate sodium i-125 and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Iothalamate sodium i-125 have?
The catalogue lists 1 brand names for Iothalamate sodium i-125, including Glofil-125.
Is Iothalamate sodium i-125 approved by the US FDA?
Yes. The US FDA first approved Iothalamate sodium i-125 on 12 February 1974, according to Drugs@FDA.
Does Iothalamate sodium i-125 need cold chain shipping?
At least one listed presentation of Iothalamate sodium i-125 must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
References
- Glofil-125 prescribing information (Iso-Tex Diagnostics). U.S. National Library of Medicine, DailyMed. Retrieved 9 December 2019
Request Iothalamate sodium i-125 for export supply
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