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 (123i), the active ingredient in Ioflupane (123i) Rotop, is a radiopharmaceutical presented as a solution for injection for intravenous use. It binds to presynaptic dopamine transporters, allowing single‑photon emission computed tomography (SPECT) imaging to assess dopaminergic neuronal integrity in patients with suspected Parkinsonian syndromes and related movement disorders.

GNH India supplies Ioflupane (123i) Rotop as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals worldwide, providing EU‑approved batches for nuclear medicine departments across global markets.

Manufacturer / TM Owner

Rotop Radiopharmacy Gmbh

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Indications & Clinical Uses

  • Ioflupane (123i) is used in dopamine transporter imaging to evaluate patients with Parkinsonian and other movement disorders.
  • Parkinsonian syndromes: provides visual assessment of dopaminergic neuron loss to aid diagnosis.
  • Movement disorder differential diagnosis: helps distinguish Parkinson's disease from essential tremor and other non‑degenerative tremor conditions.
  • Neurodegenerative disease assessment: quantifies dopamine transporter availability for monitoring disease progression.

How It Works

  • Ioflupane (123i) is a radiolabeled analogue of a dopamine reuptake inhibitor that binds with high affinity to presynaptic dopamine transporters in the striatum. The attached iodine‑123 emits gamma photons, which are captured by SPECT cameras to generate images that reflect the density and functional status of dopaminergic neurons, enabling clinicians to assess neuronal integrity.

Side Effects

Adverse reactions may occur following intravenous administration of Ioflupane (123i).

Common Side Effects

  • Nausea: mild to moderate feeling of stomach upset.
  • Headache: transient headache during or after injection.
  • Injection site pain: brief discomfort at the venipuncture site.
  • Dizziness: temporary light‑headedness.
  • Flushing: brief redness of the skin.
  • Mild hypotension: slight drop in blood pressure.

Serious or Rare Side Effects

  • Anaphylaxis: severe allergic reaction requiring immediate medical attention.
  • Severe hypotension: marked drop in blood pressure causing faintness.
  • Pulmonary edema: fluid accumulation in the lungs.
  • Radiation‑related symptoms: rare excessive radiation exposure effects.
  • Seizures: uncommon neurologic event.
  • Severe skin reactions: such as Stevens‑Johnson syndrome.

Precautions & Warnings

  • Use of Ioflupane (123i) requires careful consideration of patient safety and handling requirements.
  • Pregnancy: avoid unless diagnostic benefit outweighs potential fetal radiation risk.
  • Breastfeeding: contraindicated as the tracer may be secreted in breast milk.
  • Renal impairment: adjust monitoring as reduced clearance may increase exposure.
  • Known iodine‑123 hypersensitivity: do not administer to patients with documented allergy.
  • Radiation safety: ensure administration by qualified nuclear medicine personnel with appropriate shielding.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Ioflupane (123i) may interact with other substances that affect dopamine transporter binding or radiopharmaceutical distribution.

Major Interactions (Avoid)

  • Cocaine or amphetamines: compete for dopamine transporter sites and reduce imaging accuracy.
  • Methylphenidate: similar competition at the transporter level.
  • Bupropion: may alter tracer binding.
  • Nicotine products: can affect dopamine system and imaging results.
  • High‑dose dopamine agonists: may interfere with tracer uptake.

Moderate Interactions (Monitor Closely)

  • Other radiopharmaceuticals administered within 24 hours: cumulative radiation exposure.
  • Iodinated contrast agents: may affect iodine‑123 kinetics.
  • Antihypertensive drugs: monitor blood pressure due to potential additive hypotensive effect.
  • Sedatives or anxiolytics: may mask early adverse reactions.
  • Anticholinergic medications: could influence central nervous system imaging patterns.

Frequently Asked Questions

Ioflupane (123i) Rotop is a diagnostic radiopharmaceutical used in single‑photon emission computed tomography (SPECT) to image dopamine transporters. It helps clinicians identify and differentiate Parkinsonian syndromes and other movement disorders by visualizing the integrity of dopaminergic neurons in the brain.

The molecule binds selectively to presynaptic dopamine transporters in the striatum. The attached iodine‑123 isotope emits gamma photons that are captured by a SPECT camera, producing images that reflect the density and functional status of dopaminergic pathways, thereby indicating neuronal loss or preservation.

The administered activity of Ioflupane (123i) is determined by the prescribing nuclear medicine physician based on patient weight, imaging protocol, and regulatory guidelines. Dosing is individualized and should follow local radiopharmacy standards and the product’s prescribing information.

Safety data are limited. Ioflupane contains iodine‑123, which can cross the placenta and be secreted in breast milk. It is generally avoided in pregnant or nursing women unless the diagnostic benefit clearly outweighs the potential risk, and alternative imaging methods are considered.

Submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain if needed) and the necessary import documentation.

The primary alternative is ^123I‑FP‑CIT (DaTscan). Both agents have comparable affinity for dopamine transporters and provide similar SPECT image quality. Differences may lie in manufacturing source, packaging, regulatory approvals, and pricing, but clinically they serve the same diagnostic purpose.

The solution should be stored at 2‑8 °C, protected from light, and kept in its original container. It must not be frozen or shaken. Handling requires trained nuclear medicine personnel and adherence to radiation safety protocols to prevent contamination and exposure.

Ioflupane is administered as an intravenous injection by a qualified nuclear medicine professional. After injection, a waiting period of typically 3–6 hours allows tracer uptake before the patient undergoes SPECT imaging of the brain.

Rare but serious adverse reactions include severe allergic responses such as anaphylaxis, marked hypotension, pulmonary edema, and radiation‑related effects. Patients should be monitored during and after injection for signs of hypersensitivity, hemodynamic instability, or unexpected neurologic symptoms.

Individuals with known hypersensitivity to iodine‑123 or any component of the formulation, pregnant or breastfeeding women unless the diagnostic benefit outweighs risk, and patients unable to undergo SPECT imaging should not receive the tracer. Contraindications should be confirmed by the prescribing physician.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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