123I-Capsules
Clinical Summary
Quick overview from the medicine insert
Indication
Used for diagnostic imaging in nuclear medicine, particularly for thyroid imaging and evaluation.
Dosage (summary)
Administered as a single oral dose of 123I-Capsules, typically ranging from 5 to 370 MBq depending on the specific diagnostic requirement.
Onset of Action / Duration
The onset of imaging effects typically occurs within 24 hours post-administration, with peak uptake in the thyroid gland observed within 2-6 hours.
Special Populations
- Elderly patients may require dose adjustments.
- Patients with renal impairment should be monitored closely.
- Pediatric patients may require adjusted dosing based on weight.
Pregnancy & Breastfeeding
Use in pregnancy is contraindicated unless absolutely necessary due to potential harm to the fetus. Caution is advised during lactation as iodine can be excreted in breast milk.
Key Drug Interactions
- Concurrent use of other iodine-containing medications may affect imaging results.
- Antithyroid medications may alter the uptake of iodine.
Contraindications
- Hypersensitivity to iodine or any component of the formulation.
- Severe thyroid dysfunction (e.g., uncontrolled hyperthyroidism).
Common side effects
- Nausea
- Vomiting
- Allergic reactions (rare)
- Thyroid dysfunction (rare)
Counselling Points
- Inform patients about the purpose of the imaging study and the expected duration of effects.
- Advise patients to report any allergic reactions or unusual symptoms following administration.
- Instruct patients to avoid iodine-rich foods and supplements prior to the procedure.
Serious warnings
- Use caution in patients with a history of thyroid disease.
- Monitor thyroid function tests post-administration in at-risk populations.
Important Disclaimer
The 123I-Capsules professional information leaflet below is the property of Ithemba Labs and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic indications
Iodine-123 is suitable for diagnostic examinations of the thyroid and the diagnosis of thyroid cancer.
4.2 Posology and method of administration
One capsule to be administered orally before a diagnostic examination is conducted after a suitable lapse of time. The amount of iodine-123 in the capsule varies from 5 to 370 MBq according to the amount ordered for a specific diagnostic examination.
4.3 Contraindications
Sensitivity to iodine.
4.4 Special warnings and precautions for use
123 I-Capsules are radioactive and should only be handled and administered by legally authorised personnel. The 123 I-Capsules are not recommended for pregnant patients. Since iodine-123 is excreted in human milk, formula feeding should be substituted for breastfeeding if 123I-Capsules must be administered to the mother during lactation.
4.5 Interaction with other medicines and other forms of interaction
No interaction studies have been performed.
4.6 Fertility, pregnancy and lactation
The safety of this preparation in pregnancy has not been established. Since iodine-123 is excreted in human milk, formula feeding should be substituted for breastfeeding if 123I-Capsules must be administered to the mother during lactation (see section 4.4. Special warnings and precautions for use).
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8 Undesirable effects
No side-effects are known. Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8.
4.9 Overdose
No symptoms of overdosage are known.
