IMURAN TABLET 50 mg

DCH AURIGA SINGAPORE

DCH AURIGA SINGAPORE

Therapeutic

Prescription Only

TABLET, FILM COATED

**Dosage and Administration** _IMURAN_ tablets should be administered at least 1 hour before or 3 hours after food or milk (see Pharmacological Properties: Pharmacokinetics; Absorption – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **_IMURAN_ injection should be used ONLY when the oral route is impractical, and should be discontinued as soon as oral therapy is tolerated. It must be administered only by the i.v. route.** _IMURAN_ Injection, when reconstituted as directed, is a very irritant solution with a pH of 10 – 12. When the reconstituted solution is diluted as directed _(see Instructions for Use/Handling - Reconstitution and dilution of IMURAN injection_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_, the pH of the resulting solution may be expected to be within the range of pH 8.0 to 9.5 (the greater the dilution, the lower the pH). Where dilution of _IMURAN_ injection is not practicable, the reconstituted solution should be injected slowly over a period of not less than one minute and followed immediately by not less than 50 ml of one of the recommended infusion solutions _(see Instructions for Use/Handling - Reconstitution and dilution of IMURAN injection_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. Care must be taken to avoid perivenous injection, which may produce tissue damage. Specialist medical literature should be consulted for guidance as to clinical experience in particular conditions. - **Adults** **Transplants** Depending on the immunosuppressive regimen employed, a dosage of up to 5 mg/kg bodyweight/day may be given orally or intravenously on the first day of therapy. Maintenance dosage should range from 1 to 4 mg/kg bodyweight/day and must be adjusted according to clinical requirements and haematological tolerance. Evidence indicates that _IMURAN_ therapy should be maintained indefinitely, even if only low doses are necessary, because of the risk of graft rejection. **Other Indications** In general, starting dosage is from 1 to 3 mg/kg bodyweight/day, and should be adjusted, within these limits, depending on the clinical response (which may not be evident for weeks or months) and haematological tolerance. When therapeutic response is evident, consideration should be given to reducing the maintenance dosage to the lowest level compatible with the maintenance of that response. If no improvement occurs in the patient's condition within three months, consideration should be given to withdrawing _IMURAN_. The maintenance dosage required may range from less than 1 mg/kg bodyweight/day to 3 mg/kg bodyweight/day, depending on the clinical condition being treated and the individual patient response, including haematological tolerance. - **Children** - Overweight children Children considered to be overweight may require doses at the higher end of the dose range and therefore close monitoring of response to treatment is recommended (see Pharmacological Properties: Special Patient Populations; Overweight children – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Transplants and Other Indications** See _Dosage and Administration – Adults._ - **Elderly** There is limited experience of the administration of _IMURAN_ to elderly patients. Although the available data do not provide evidence that the incidence of side effects among elderly patients is higher than that among other patients treated with _IMURAN_, it is recommended that the dosages used should be at the lower end of the range. Particular care should be taken to monitor haematological response and to reduce the maintenance dosage to the minimum required for clinical response. - **Renal impairment** In patients with renal insufficiency, dosages should be given at the lower end of the normal range (see _Warnings and Precautions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - **Hepatic impairment** In patients with hepatic insufficiency, dosages should be given at the lower end of the normal range (see Warnings and Precautions and Pharmacological Properties: Special Patient Populations; Hepatic Impairment – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - **_Drug interactions_** The principal pathway for detoxification of _IMURAN_ is inhibited by allopurinol. In patients receiving _IMURAN_, the concomitant administration of allopurinol will require a reduction in dose to approximately 1/3 to 1/4 of the usual dose of _IMURAN_. Subsequent adjustment of doses of _IMURAN_ should be made on the basis of therapeutic response and any toxic effects (see Interactions – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - **TPMT-deficient patients** Patients with inherited little or no thiopurine S-methyltransferase (TPMT) activity are at increased risk for severe _IMURAN_ toxicity from conventional doses of _IMURAN_ and generally require substantial dose reduction. The optimal starting dose for homozygous deficient patients has not been established (see Warnings and Precautions: Monitoring and Pharmacokinetics – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Most patients with heterozygous TPMT deficiency can tolerate recommended _IMURAN_ doses, but some may require dose reduction. Genotypic and phenotypic tests of TPMT are available (see Warnings and Precautions: Monitoring and Pharmacokinetics – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).