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 a sterile solution for injection for intravenous use. It is used to image dopamine transporters to help differentiate Parkinsonian syndromes and assess neurodegenerative disorders affecting the dopaminergic system.

GNH India supplies Ioflupane (123i) Rotop as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, clinics and diagnostic centres worldwide.

Manufacturer / TM Owner

Rotop Radiopharmacy Gmbh

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Indications & Clinical Uses

Ioflupane is employed in diagnostic imaging of the dopaminergic system, particularly for conditions where dopamine transporter integrity is relevant.

  • Parkinsonian syndromes: enables differentiation of Parkinson's disease from other movement disorders by visualizing dopamine transporter loss.
  • Dementia with Lewy bodies: assists in confirming diagnosis through characteristic transporter binding patterns.
  • Other neurodegenerative disorders affecting dopaminergic neurons: provides functional assessment of neuronal integrity for research and clinical evaluation.

How It Works

  • Ioflupane binds with high affinity to presynaptic dopamine transporters (DAT) in the striatum. After intravenous administration, the radiolabelled compound is taken up by dopaminergic neurons, allowing single‑photon emission computed tomography (SPECT) to visualize and quantify DAT density, which reflects neuronal integrity and helps distinguish disease states.

Side Effects

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

Common Side Effects

  • Nausea: mild to moderate discomfort after injection.
  • Headache: transient, often resolves without treatment.
  • Injection site pain: mild soreness at the venipuncture site.
  • Dizziness: temporary light‑headedness post‑administration.
  • Dry mouth: reduced salivation lasting a few hours.
  • Fatigue: mild tiredness reported by some patients.

Serious or Rare Side Effects

  • Anaphylactic reaction: severe allergy requiring immediate medical attention.
  • Severe hypotension: marked drop in blood pressure after injection.
  • Pulmonary edema: rare fluid accumulation in lungs.
  • Seizures: infrequent neurologic events.
  • Stevens‑Johnson syndrome: severe skin reaction.
  • Radiation‑induced toxicity: unlikely but possible with repeated exposure.

Precautions & Warnings

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

  • Pregnancy: safety not established; avoid unless benefits outweigh potential risks.
  • Breastfeeding: unknown excretion in milk; consider discontinuation of nursing.
  • Renal impairment: adjust use cautiously as clearance may be reduced.
  • Concomitant dopamine‑affecting drugs: may alter imaging results; assess medication history.
  • Pediatric use: only if diagnostic benefit justifies exposure.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Ioflupane may interact with substances that influence dopamine transporter availability or alter SPECT imaging quality.

Major Interactions (Avoid)

  • Cocaine or amphetamines: compete for DAT binding, leading to false‑negative scans.
  • Methylphenidate: similar competitive inhibition at DAT.
  • Bupropion: can reduce tracer uptake and affect image interpretation.

Moderate Interactions (Monitor Closely)

  • MAO inhibitors: may modestly affect DAT density.
  • Antipsychotics (e.g., haloperidol): alter dopaminergic signaling and could impact results.
  • Antihypertensives: monitor blood pressure as injection may cause transient changes.

Frequently Asked Questions

Ioflupane (123i) Rotop is a radiopharmaceutical used in SPECT imaging to visualize dopamine transporters. It helps clinicians differentiate Parkinsonian syndromes and assess other neurodegenerative disorders that involve the dopaminergic system.

After intravenous injection, Ioflupane binds selectively to presynaptic dopamine transporters in the brain. The attached radioactive isotope emits gamma photons that are captured by SPECT cameras, producing images that reflect the density and integrity of dopaminergic neurons.

The specific dose and administration schedule are determined by the prescribing physician or nuclear medicine specialist based on the imaging protocol, patient weight, and regulatory guidelines. No standard dose is provided here.

Safety data for Ioflupane in pregnancy and lactation are limited. It is generally avoided unless the diagnostic benefit outweighs potential risks to the fetus or infant. Physicians should discuss individual circumstances with the patient.

To request Ioflupane (123i) Rotop, 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 import documentation.

Ioflupane is one of several FDA‑ and EMA‑approved DAT tracers, such as ^123I‑FP‑CIT (DaTscan). It offers comparable sensitivity and specificity for detecting DAT loss, with a well‑characterized safety profile. Choice of tracer often depends on regional regulatory approval, imaging equipment, and institutional experience.

Ioflupane must be stored refrigerated at 2‑8 °C, protected from light, and kept in its original container. It should not be frozen or shaken, and any unused portion should be discarded according to local radiopharmaceutical waste regulations.

The product is supplied as a sterile solution for injection. It is administered intravenously by a qualified healthcare professional, typically in a controlled nuclear medicine suite, followed by a waiting period before SPECT imaging is performed.

Serious risks, although rare, include severe allergic reactions such as anaphylaxis, marked hypotension, pulmonary edema, seizures, and rare skin reactions like Stevens‑Johnson syndrome. Immediate medical attention is required if any of these occur.

Patients with known hypersensitivity to Ioflupane or any component of the formulation should avoid it. Additionally, individuals who are pregnant, breastfeeding, or have severe renal impairment should only receive it if the diagnostic benefit clearly outweighs the potential risks.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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