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 diagnostic radiopharmaceutical presented as an injectable solution for intravenous use. It enables visualization of presynaptic dopamine transporters to aid diagnosis of Parkinsonian syndromes and related movement disorders in the central nervous system.\n\nGNH 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 to assess dopaminergic neuronal integrity in disorders affecting the central nervous system.\n\nParkinsonian syndrome: provides quantitative imaging of dopamine transporter loss to support diagnosis.\nEssential tremor vs. Parkinson's disease: helps differentiate tremor etiologies by visualizing presynaptic dopamine activity.\nNeurodegenerative disorder assessment: evaluates the extent of dopaminergic neuron loss in conditions such as multiple system atrophy or progressive supranuclear palsy.

How It Works

  • Ioflupane is a radiolabeled ligand that binds selectively to presynaptic dopamine transporters (DAT) located on nigrostriatal neurons. After intravenous injection, the compound crosses the blood‑brain barrier and accumulates in regions with intact DAT. Single‑photon emission computed tomography (SPECT) detects the emitted gamma photons, producing images that reflect the density and functional status of dopaminergic pathways, thereby indicating neuronal integrity.

Side Effects

  • Adverse reactions may occur following administration of Ioflupane (123i) Rotop.\n\nCommon Side Effects:\n- Headache: mild to moderate intensity.\n- Nausea or vomiting: transient gastrointestinal discomfort.\n- Dizziness or light‑headedness: often resolves spontaneously.\n- Injection site pain or erythema: mild local irritation.\n- Transient hypotension: temporary blood pressure drop.\n- Dry mouth: temporary reduction in salivation.\n\nSerious or Rare Side Effects:\n- Allergic reaction: rash, pruritus, or urticaria.\n- Anaphylaxis: severe, potentially life‑threatening hypersensitivity.\n- Severe hypotension: marked blood pressure decrease requiring intervention.\n- Radiation‑induced skin injury: localized erythema at injection site.\n- Seizures: rare neurologic events.\n- Persistent nausea/vomiting: may require anti‑emetic therapy.

Precautions & Warnings

  • Prior to using Ioflupane (123i) Rotop, consider the following safety measures.\n\nPregnancy: unknown safety; avoid unless essential for maternal care.\nBreastfeeding: unknown; weigh potential risks to infant before administration.\nRenal impairment: assess renal function as excretion is primarily renal.\nConcomitant dopamine‑blocking agents: may interfere with imaging results.\nRadiation safety: follow local regulations for handling and disposal of radioactive material.\nStore at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

  • Ioflupane (123i) Rotop may interact with other substances that affect dopamine transporter binding or radiation exposure.\n\nMajor Interactions (Avoid):\n- Cocaine or amphetamines: block DAT and markedly reduce tracer uptake.\n- Monoamine oxidase inhibitors (MAOIs): may alter dopamine metabolism and affect imaging.\n- Other radiopharmaceuticals: cumulative radiation dose may exceed safety limits.\n\nModerate Interactions (Monitor Closely):\n- Antidepressants (SSRIs, SNRIs): can modestly affect DAT binding.\n- Antihypertensive agents: may influence cerebral blood flow and tracer distribution.\n- Diuretics: potential alteration of renal clearance of the radiotracer.

Frequently Asked Questions

Ioflupane (123i) Rotop is a diagnostic radiopharmaceutical used in single‑photon emission computed tomography (SPECT) to image presynaptic dopamine transporters. It helps clinicians evaluate suspected Parkinsonian syndromes, differentiate movement disorders such as essential tremor from Parkinson's disease, and assess dopaminergic neuron loss in various neurodegenerative conditions.

After intravenous injection, Ioflupane, which is labeled with the radioactive isotope iodine‑123, binds selectively to dopamine transporters on the surface of nigrostriatal neurons. The bound tracer emits gamma photons that are captured by a SPECT scanner, producing images that reflect the density and functional status of dopaminergic pathways in the brain.

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

Safety data for Ioflupane in pregnancy and lactation are limited, and the product is classified as having an unknown risk. It should only be used when the potential diagnostic benefit outweighs any possible risk to the fetus or infant, and after careful consideration by the treating physician.

To place an order, 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 any required import documentation.

Ioflupane (123i) is one of several iodine‑123‑labeled ligands used for DAT imaging. Compared with alternatives such as 99mTc‑TRODAT‑1, Ioflupane offers high affinity for DAT and well‑characterized imaging protocols, making it a widely accepted choice in Europe and North America for evaluating Parkinsonian syndromes.

Ioflupane (123i) Rotop must be stored refrigerated at 2‑8 °C, protected from light, and should never be frozen or shaken. The vial should remain in its original packaging until use, and all handling must comply with local radiation safety regulations.

The product is supplied as a sterile injectable solution for intravenous administration. It is injected as a single bolus dose under the supervision of a qualified nuclear medicine physician or radiologist, after which the patient undergoes SPECT imaging at a predetermined time interval.

Serious risks include severe allergic reactions such as anaphylaxis, marked hypotension, radiation‑induced skin injury at the injection site, and rare neurologic events like seizures. Patients should be monitored closely during and after injection, and emergency measures should be readily available.

Ioflupane is contraindicated in individuals with known hypersensitivity to iodine‑123 or any component of the formulation, and in patients for whom the diagnostic information would not influence clinical management. Caution is also advised for those with severe renal impairment or uncontrolled hypertension.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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