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 enables imaging of dopamine transporters to aid diagnosis of Parkinsonian syndromes and other movement disorders.

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 used in the evaluation of dopaminergic neuronal integrity within the Parkinsonian disease spectrum and related movement disorders.

  • Parkinsonian syndromes: provides visualization of presynaptic dopaminergic neuron integrity to support diagnosis.
  • Differential diagnosis of movement disorders: helps distinguish Parkinson's disease from essential tremor and atypical parkinsonism.
  • Clinical research of the dopaminergic system: enables quantitative assessment of dopamine transporter density in investigational studies.

How It Works

  • Ioflupane binds selectively to presynaptic dopamine transporters (DAT) on nigrostriatal neurons. The molecule is labeled with the gamma‑emitting radioisotope iodine‑123, allowing single‑photon emission computed tomography (SPECT) to generate images that reflect DAT density and thus dopaminergic neuronal integrity.

Side Effects

Ioflupan (123i) Rotop may cause adverse reactions related to the injection and the radioactive tracer.

Common Side Effects

  • Injection site pain: mild discomfort at the venipuncture site.
  • Nausea: transient feeling of queasiness.
  • Headache: mild to moderate headache after administration.
  • Transient flushing: brief warmth or redness of the skin.

Serious or Rare Side Effects

  • Anaphylaxis: severe allergic reaction requiring immediate medical attention.
  • Severe hypotension: marked drop in blood pressure post‑injection.
  • Radiation‑induced thyroid dysfunction: potential alteration of thyroid hormone levels.
  • Seizure: rare occurrence of convulsive activity.

Precautions & Warnings

Before using Ioflupan (123i) Rotop, consider the following safety measures.

  • Pregnancy: safety unknown; avoid unless essential for diagnosis.
  • Breastfeeding: safety unknown; consider discontinuing breastfeeding.
  • Thyroid function: assess baseline thyroid status due to iodine content.
  • Renal impairment: evaluate renal function as the tracer is renally excreted.
  • Concomitant iodine contrast: avoid administration within 24 hours of iodinated contrast agents.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Ioflupan (123i) Rotop may interact with other agents that affect iodine handling or physiological responses.

Major Interactions (Avoid)

  • Iodine‑containing contrast agents: can interfere with tracer uptake and imaging quality.
  • Thyroid hormone therapy: may alter iodine metabolism and affect imaging results.

Moderate Interactions (Monitor Closely)

  • Antihistamines: may mask mild allergic reactions.
  • Diuretics: could modify renal clearance of the tracer.
  • Calcium channel blockers: potential influence on blood pressure during injection.

Frequently Asked Questions

Ioflupan (123i) Rotop is a diagnostic radiopharmaceutical containing ioflupane labeled with iodine‑123. It is used in single‑photon emission computed tomography (SPECT) to image dopamine transporters in the brain, supporting the diagnosis of Parkinsonian syndromes and aiding the differential diagnosis of movement disorders.

Ioflupane is a ligand that binds selectively to presynaptic dopamine transporters (DAT) on nigrostriatal neurons. The iodine‑123 radioisotope attached to the molecule emits gamma photons detectable by SPECT, producing a visual map of DAT density that reflects dopaminergic neuronal integrity.

The administered activity and volume are determined by the prescribing physician or nuclear medicine specialist based on patient weight, age, and the imaging protocol. Dosage is individualized and should follow local regulatory guidelines and the product’s prescribing information.

Safety data in pregnant or lactating women are limited, and the product is classified as pregnancy category unknown. It should be used only if the potential diagnostic benefit outweighs any possible risk to the fetus or infant, and breastfeeding may be discontinued as a precaution.

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

Ioflupan (123i) Rotop uses iodine‑123, offering high‑resolution SPECT images and a well‑characterized safety profile. Alternative agents such as ^18F‑FP‑CIT are PET tracers, providing higher sensitivity but requiring PET facilities. Choice depends on equipment availability, regulatory status and clinical workflow.

The product must be stored refrigerated at 2–8 °C, protected from light, and kept in its original container. It should not be frozen or shaken. Prior to use, allow the vial to reach room temperature if required by the imaging protocol, and handle with radiation safety precautions.

Ioflupan (123i) Rotop is administered as a single intravenous injection under the supervision of a qualified nuclear medicine professional. After injection, a waiting period of typically 3–6 hours allows tracer uptake before SPECT imaging is performed.

Serious adverse events, though rare, include severe allergic reactions (anaphylaxis), significant hypotension, and radiation‑induced thyroid dysfunction. Immediate medical attention is required if symptoms such as difficulty breathing, rapid drop in blood pressure, or thyroid abnormalities occur after administration.

The tracer should be avoided in patients with known hypersensitivity to ioflupane or iodine‑123, those who have received iodine‑containing contrast media within the preceding 24 hours, and individuals in whom the diagnostic information would not alter clinical management. Caution is also advised for patients with severe renal impairment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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