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 solution for injection for intravenous use. It binds to presynaptic dopamine transporters to enable imaging of dopaminergic neuron integrity, aiding differential diagnosis of Parkinsonian syndromes and assessment of movement disorders.

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 used in nuclear medicine to image dopamine transporters in disorders of the basal ganglia.

  • Parkinsonian syndromes: assists in differential diagnosis by visualizing dopaminergic neuron loss.
  • Essential tremor: helps distinguish tremor etiology through dopamine transporter imaging.
  • Other movement disorders: provides assessment of dopaminergic system integrity for clinical evaluation.

How It Works

  • After intravenous administration, Ioflupane (123i) binds selectively and with high affinity to presynaptic dopamine transporters (DAT) located on dopaminergic neurons. The radiolabelled compound emits gamma photons detectable by single‑photon emission computed tomography (SPECT), producing a spatial map of DAT density that reflects the functional status of nigrostriatal pathways. Reduced tracer uptake indicates loss of dopaminergic neurons, supporting diagnosis of Parkinsonian and related movement disorders.

Side Effects

Adverse reactions to Ioflupane (123i) Rotop are generally related to the radiopharmaceutical nature of the product and the injection procedure.

Common Side Effects

  • Injection site pain: mild discomfort at the venipuncture site.
  • Nausea: transient feeling of queasiness following administration.
  • Headache: mild to moderate headache reported in some patients.
  • Flushing: temporary reddening of skin, especially face or neck.

Serious or Rare Side Effects

  • Allergic reaction: urticaria, rash, or anaphylaxis requiring immediate medical attention.
  • Severe hypotension: marked drop in blood pressure post‑injection.
  • Radiation‑related toxicity: unlikely but possible exposure‑related effects in high cumulative doses.

Precautions & Warnings

When using Ioflupane (123i) Rotop, clinicians should observe several safety and handling precautions.

  • Patient selection: confirm indication for dopamine transporter imaging before administration.
  • Pregnancy: avoid use unless benefits outweigh potential fetal radiation exposure.
  • Breastfeeding: discontinue breastfeeding for an appropriate period after injection due to possible tracer excretion.
  • Renal function: assess kidney function as impaired clearance may affect tracer distribution.
  • Concomitant medications: review drugs that may interfere with dopamine transporter binding, such as certain antidepressants or stimulants.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake the vial.

Avoid Interactions

Ioflupane (123i) Rotop may interact with substances that affect dopamine transporter availability or alter radiopharmaceutical distribution.

Major Interactions (Avoid)

  • Cocaine or amphetamines: these drugs occupy dopamine transporters and can markedly reduce tracer binding, compromising image quality.
  • Certain antidepressants (e.g., bupropion, sertraline): strong DAT inhibition may lead to false‑negative results.

Moderate Interactions (Monitor Closely)

  • Antipsychotics (e.g., haloperidol): may modestly affect DAT binding; consider timing of medication relative to scan.
  • MAO‑B inhibitors (e.g., selegiline): can alter tracer uptake; assess risk‑benefit.
  • Thyroid hormones: high levels may influence radiotracer kinetics; monitor thyroid status.

Frequently Asked Questions

Ioflupane (123i) Rotop is a radiopharmaceutical employed in nuclear medicine to visualize dopamine transporters in the brain using single‑photon emission computed tomography (SPECT). It assists clinicians in differentiating Parkinsonian syndromes from other movement disorders by revealing the integrity of nigrostriatal dopaminergic neurons.

After intravenous injection, the iodine‑123‑labeled Ioflupane molecule binds with high affinity to presynaptic dopamine transporters (DAT) on dopaminergic neurons. The bound tracer emits gamma photons that are captured by a SPECT camera, producing a quantitative map of DAT density that reflects neuronal health and allows detection of dopaminergic loss.

The administered activity of Ioflupane (123i) Rotop is determined by the prescribing physician or nuclear medicine specialist based on patient weight, age, and the specific 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 radiopharmaceutical delivers ionising radiation to the fetus or infant. Use is generally avoided unless the diagnostic benefit outweighs potential risks, and appropriate radiation protection measures are applied. Breastfeeding should be discontinued for a period advised by the treating physician.

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 handling if needed—and necessary import documentation.

Ioflupane (123i) is an iodine‑123‑labeled tracer, offering high‑resolution SPECT images and a favorable radiation dose compared with older agents such as ^99mTc‑based compounds. Its strong DAT affinity provides reliable quantification, while alternatives like ^18F‑FP‑CIT are PET tracers requiring different imaging infrastructure. Choice depends on available equipment, regulatory status, and clinical preference.

Ioflupane (123i) Rotop must be stored refrigerated at 2‑8 °C, protected from light, and kept in its original sealed vial. Do not freeze or shake the solution, as physical stress can affect radiochemical stability. Prior to use, allow the vial to reach room temperature if required by the imaging protocol.

The product is supplied as a sterile solution for injection. It is administered intravenously by a qualified healthcare professional, typically as a single bolus injection. After injection, a waiting period of about 3‑6 hours is observed before SPECT imaging to allow optimal brain uptake and clearance of background activity.

The most significant concerns are allergic reactions, including anaphylaxis, and radiation‑related effects, particularly in repeated exposures. Severe hypotension may occur shortly after injection. Patients should be monitored for immediate hypersensitivity signs, and cumulative radiation dose should be considered in the context of overall diagnostic imaging history.

Contra‑indications include patients with known hypersensitivity to iodine‑123‑labeled compounds or any component of the formulation, and individuals for whom the radiation exposure is deemed unjustifiable, such as pregnant women without a compelling clinical indication. Caution is also advised in patients with severe renal impairment or those taking strong DAT‑blocking medications.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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