Product image of Ioflupane (123i) Rotop (Ioflupane (123i)) supplied by GNH India

Ioflupane (123i) Rotop

Active Ingredient:
Ioflupane (123i)
Origin:
EU

Ioflupane (123i) Rotop (Ioflupane (123i))

Ioflupane, the active ingredient in Ioflupane (123i) Rotop, is a radiopharmaceutical presented as an injection solution for intravenous use. It is employed to evaluate Parkinsonian syndromes and other movement disorders by visualizing dopaminergic neuron integrity.
GNH India supplies Ioflupane (123i) Rotop as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and clinics worldwide.

Manufacturer / TM Owner

Rotop Radiopharmacy Gmbh

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Indications & Clinical Uses

Ioflupane (123i) Rotop is a radiopharmaceutical used in the assessment of dopaminergic pathways for neurological disorders.

  • Parkinsonian syndromes: enables visualization of presynaptic dopamine transporter loss to support diagnosis.
  • Parkinson's disease differential diagnosis: helps distinguish Parkinson's disease from other movement disorders.
  • Movement disorder assessment: provides quantitative data on dopamine transporter availability for clinical decision‑making.

How It Works

  • Ioflupane binds selectively to presynaptic dopamine transporters (DAT) located on dopaminergic neurons. After intravenous administration, the radiolabelled compound accumulates in regions with intact DAT, allowing single‑photon emission computed tomography (SPECT) to generate images that reflect the density and functional status of dopaminergic pathways in the brain.

Side Effects

Ioflupane is generally well tolerated, but adverse reactions can occur.

Common Side Effects

  • Injection site pain or erythema
  • Nausea or mild vomiting
  • Headache
  • Dizziness or light‑headedness
  • Transient hypotension
  • Flushing

Serious or Rare Side Effects

  • Severe allergic reaction (anaphylaxis)
  • Significant hypotension requiring medical intervention
  • Radiation‑induced skin injury at the injection site
  • Pulmonary edema
  • Cardiac arrhythmias
  • Severe nausea or vomiting leading to dehydration

Precautions & Warnings

Use of Ioflupane requires careful consideration of patient‑specific factors and handling requirements.

  • Pregnancy: safety not established; avoid unless essential.
  • Breastfeeding: unknown excretion; consider discontinuation of nursing.
  • Renal impairment: assess renal function as clearance may be altered.
  • Radiation exposure: limit cumulative dose and follow radiation safety guidelines.
  • Contraindications: known hypersensitivity to Ioflupane or any component of the formulation.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Ioflupane may interact with other agents that affect dopaminergic imaging or iodine handling.

Major Interactions (Avoid)

  • MAO‑B inhibitors: can modify tracer uptake and confound interpretation.
  • D2‑receptor antagonists (typical antipsychotics): may reduce DAT binding visibility.
  • Concurrent radiopharmaceuticals with overlapping emission spectra: can interfere with SPECT image quality.

Moderate Interactions (Monitor Closely)

  • Iodinated contrast agents used in CT/MRI: may affect subsequent Ioflupane imaging.
  • Thyroid hormone therapy: may alter iodine metabolism and tracer distribution.
  • Drugs affecting renal excretion (e.g., loop diuretics): monitor for altered clearance.

Frequently Asked Questions

Ioflupane (123i) Rotop is a radiopharmaceutical used to image presynaptic dopamine transporters in the brain. It helps clinicians evaluate Parkinsonian syndromes, differentiate Parkinson's disease from other movement disorders, and assess overall dopaminergic neuron integrity through SPECT imaging.

After intravenous injection, Ioflupane binds selectively to dopamine transporters on neuronal membranes. The attached radioactive iodine emits gamma photons that are captured by a SPECT scanner, producing images that reflect the density and functional status of dopaminergic pathways.

The administered activity of Ioflupane is determined by the prescribing physician or nuclear medicine specialist. Dosing is individualized based on patient weight, imaging protocol, and regulatory guidelines, and is not standardized across all patients.

Safety data for Ioflupane in pregnant or lactating women are limited. It is classified as having unknown risk, and use is generally avoided unless the diagnostic benefit outweighs potential fetal or infant exposure. Consultation with a specialist is essential.

Enquiries are submitted via the product page on gnhindia.com, where you specify the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain where required), and necessary import documentation.

Ioflupane is chemically identical to the FDA‑approved DaTscan and provides high‑resolution DAT imaging. Compared with non‑specific brain perfusion agents, Ioflupane offers superior specificity for dopaminergic neurons, allowing more accurate differentiation of Parkinsonian syndromes from other movement disorders.

The product must be stored refrigerated at 2‑8 °C, protected from light, and never frozen or shaken. It should be kept in its original container until use, and any unused portion should be discarded according to local radiopharmaceutical waste regulations.

Ioflupane is administered as a single intravenous injection by a qualified nuclear medicine professional. After injection, a waiting period of about 3–6 hours is typical before SPECT imaging to allow optimal tracer uptake and clearance of background activity.

Serious risks include severe allergic reactions such as anaphylaxis, significant hypotension, radiation‑induced skin injury at the injection site, and rare cardiac arrhythmias. Patients should be monitored during and after administration, and any adverse event should be reported promptly.

Ioflupane is contraindicated in individuals with known hypersensitivity to Ioflupane or any excipients in the formulation. It should also be avoided in pregnant women unless absolutely necessary, and used with caution in patients with severe renal impairment or those receiving interfering medications.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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