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

Ioflupan (123i) Rotop

Active Ingredient:
Ioflupane (123i)
Origin:
EU

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

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

Manufacturer / TM Owner

Rotop Radiopharmacy Gmbh

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Indications & Clinical Uses

Ioflupan (123i) Rotop is employed in diagnostic imaging of the dopaminergic system.

  • Parkinsonian syndromes: assists in confirming diagnosis by visualizing presynaptic dopamine transporter loss.
  • Differential diagnosis of movement disorders: helps distinguish Parkinson's disease from atypical parkinsonism.
  • Assessment of dopaminergic neuron loss: provides quantitative data on neuronal integrity for research and clinical monitoring.

How It Works

  • Ioflupane is labeled with iodine‑123 and binds selectively to presynaptic dopamine transporters in the striatum. After intravenous injection, the radiotracer accumulates in dopaminergic neurons, allowing single‑photon emission computed tomography (SPECT) to image transporter density and assess neuronal integrity.

Side Effects

Ioflupan (123i) Rotop may be associated with adverse reactions related to the radiopharmaceutical and its administration.

Common Side Effects

  • Nausea: mild to moderate nausea reported after injection.
  • Headache: transient headache occurring shortly after administration.
  • Injection site discomfort: mild pain or irritation at the intravenous site.
  • Dizziness: temporary sensation of light‑headedness.

Serious or Rare Side Effects

  • Allergic reaction: anaphylaxis or severe hypersensitivity requiring immediate medical attention.
  • Radiation‑induced thyroid dysfunction: altered thyroid hormone levels due to iodine exposure.
  • Severe hypotension: marked drop in blood pressure following injection.
  • Pulmonary embolism: rare occurrence of embolic events related to the radiotracer.

Precautions & Warnings

Before using Ioflupan (123i) Rotop, consider the following precautions to ensure patient safety and product integrity.

  • Pregnancy: avoid use unless clearly needed, as fetal exposure to radiation is unknown.
  • Breastfeeding: discontinue breastfeeding for an appropriate period after administration due to possible radiotracer excretion.
  • Renal impairment: assess kidney function, as reduced clearance may increase radiation dose.
  • Thyroid blocking: consider administering potassium iodide to reduce thyroid uptake of free iodine.
  • Contraindications: do not administer to patients with known hypersensitivity to iodine‑123 or any component of the formulation.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Ioflupan (123i) Rotop can interact with certain substances that affect iodine metabolism or imaging results.

Major Interactions (Avoid)

  • Thyroid hormone therapy: may interfere with tracer distribution and increase thyroid radiation dose.
  • Iodine‑containing contrast agents: can compete for uptake and reduce image quality; avoid within 24 hours of the scan.

Moderate Interactions (Monitor Closely)

  • Diuretics: may alter renal clearance of the radiotracer, requiring adjustment of imaging protocol.
  • Antihistamines: can mask mild allergic reactions, necessitating careful monitoring.
  • Other radiopharmaceuticals: concurrent administration may lead to cumulative radiation exposure; schedule appropriately.

Frequently Asked Questions

Ioflupan (123i) Rotop is a radiopharmaceutical used in single‑photon emission computed tomography (SPECT) to image presynaptic dopamine transporters. It helps clinicians evaluate Parkinsonian syndromes, differentiate movement disorders, and assess the extent of dopaminergic neuron loss.

Ioflupane is labeled with the radioactive isotope iodine‑123 and binds selectively to dopamine transporters on presynaptic nerve terminals. After intravenous injection, the tracer accumulates in brain regions rich in dopaminergic neurons, allowing SPECT cameras to visualize and quantify transporter density.

The administered activity of Ioflupan (123i) Rotop is determined by the prescribing physician or nuclear medicine specialist based on patient characteristics, imaging protocol, and regulatory guidelines. The exact dose is individualized and not standardized in public literature.

Safety in pregnancy and lactation has not been established. Use is generally avoided unless the diagnostic benefit outweighs potential risks, because the radiotracer exposes the fetus or infant to ionizing radiation. Consultation with a radiology and obstetrics specialist is recommended.

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 import documentation.

Ioflupan (Ioflupane) labeled with iodine‑123 is the most widely used SPECT tracer for dopamine transporter imaging. Alternatives include 99mTc‑TRODAT‑1 (also SPECT) and 18F‑FDOPA (PET). Ioflupan offers high specificity, well‑characterized kinetics, and broad regulatory acceptance, while PET agents provide higher resolution but require cyclotron facilities.

The product must be stored refrigerated at 2‑8 °C, protected from light, and must not be frozen or shaken. It should be kept in its original container until use to maintain radiochemical stability and to ensure accurate dosing.

Ioflupan is administered as a single intravenous injection by a qualified healthcare professional. After injection, a waiting period of about 3‑6 hours is typical before SPECT imaging to allow optimal brain uptake and clearance of background activity.

Serious risks include severe allergic reactions such as anaphylaxis, radiation‑induced thyroid dysfunction, significant hypotension, and rare embolic events. Patients should be monitored during and after injection, and thyroid‑blocking measures may be considered when appropriate.

The tracer is contraindicated in individuals with known hypersensitivity to iodine‑123 or any excipients in the formulation. It should also be avoided in patients where radiation exposure is unacceptable, such as pregnant women, unless the diagnostic benefit clearly outweighs the risk.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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