Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
CAPSULE
**Dosage** 1. **Thyrotoxicosis** Patients should be rendered euthyroid medically whenever possible before giving radioiodine treatment for hyperthyroidism. In order to obtain an estimate of thyroid size and iodide uptake, a diagnostic dose of approximately 0.185 MBq (5microcurie) is administered first. This is followed by the appropriate therapeutic dose, usually in the range 185–555 MBq (5–15 mCi). 2. **Ablation of normal thyroid function** 0.925–1.85 GBq (25–50 mCi). 3. **Thyroid carcinoma** For total thyroid ablation following thyroidectomy, 2.22–3.7 GBq (60–100 mCi) repeated after an interval if necessary.
ORAL
Medical Information
**Applications** THERACAP131 can be used in place of sodium iodide \[131 I\] solution for radioiodine therapy. (8) This includes treatment of hyperthyroidism (1) in cases where surgery is contraindicated and the elimination of residual thyroid activity after thyroidectomy in cases of thyroid carcinoma. (2) (9) * * * **References** 1. WILSON, G M The Thyroid Physiology and Treatment of Disease in Treatment of Thyrotoxicosis by Radioiodine. Edited by Hersman, J M and Bray, G A, pp. 253–265, Pergamon Press, 1979. 2. GOOLDEN, A W G Recent Results in Cancer Research – Thyroid Cancer in Radiotherapy, Edited by Duncan, W, pp 116–119, Springer-Verlag Berlin, 1980. 3. VON SCHULTHESS, G K et al 131-Iodine capsules in thyroid therapy: an individually controlled study of their uptake kinetics as compared to liquid 131-Iodine, European Journal of Nuclear Medicine, vol 10, pp 25–28, 1985. 4. GOOLDEN, A W G et al Recent results in cancer research – Thyroid cancer. Springer-Verlag, Berlin, Radiotherapy, pp 116–119, 1980.
**Contraindications** - Hypersensitivity to the active substance or to any of the excipients. - For diagnostic purposes in children under 10 years of age. - Pregnancy (5) and breast-feeding. - Patients with dysphagia, oesophageal stricture, oesophageal stenosis, oesophagus diverticulum, active gastritis, gastric erosions and peptic ulcer. - Patients with suspected reduced gastrointestinal motility. - It should be avoided in persons with kidney insufficiency. * * * **References** 1. STOFFER, S S and HAMBURGER, J I Inadvertent 131I therapy for hyperthyroidism in the first trimester of pregnancy. Journal of Nuclear Medicine, vol 17, p 146, 1976.
V10XA01
sodium iodide (131I)
Manufacturer Information
GE HEALTHCARE PTE. LTD.
GE HEALTHCARE BUCHLER GMBH & CO KG
Active Ingredients
Documents
Package Inserts
Theracap Capsule PI.pdf
Approved: April 14, 2022