IMURAN TABLET 50 MG

EXCELLA GMBH & CO. KG - GERMANYASPEN SA OPERATIONS (PTY) LTD (SOUTH AFRICA)🇸🇬 Health Sciences Authority

Approval Date: Jun 24, 1988
Approval ID: 4b02e308fbcd6b38
Company: EXCELLA GMBH & CO. KG - GERMANYASPEN SA OPERATIONS (PTY) LTD (SOUTH AFRICA)
Type: Therapeutic

Approval Details

Approval Id: 4b02e308fbcd6b38
Drug Name: IMURAN TABLET 50 MG
Product Name: IMURAN TABLET 50 MG
Approval Number: SIN02082P
Approval Date: 1988-06-24
Registrant: DCH AURIGA SINGAPORE
Licence Holder: DCH AURIGA SINGAPORE
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET, FILM COATED
Dosage: 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. <ul> <li>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.</li> <li>Children <ul class="bullet"> <li>Overweight children</li> </ul> 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.</li> <li>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.</li> <li>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).</li> <li>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).</li> <li>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).</li> <li>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).</li> </ul>
Route Of Administration: ORAL
Indication Info: Indications IMURAN is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and procedures which influence the immune response. Therapeutic effect may be evident only after weeks or months and can include a steroid-sparing effect, thereby reducing the toxicity associated with high dosage and prolonged usage of corticosteroids. IMURAN, in combination with corticosteroids and/or other immunosuppressive agents and procedures, is indicated to enhance the survival of organ transplants, such as renal transplants, cardiac transplants and hepatic transplants. It also reduces the corticosteroid requirements of renal transplant recipients. IMURAN, either alone or more usually in combination with corticosteroids and/or other drugs and procedures, has been used with clinical benefit (which may include reduction of dosage or discontinuation of corticosteroids) in a proportion of patients suffering from the following: <ul class="nobull"> <li>severe rheumatoid arthritis</li> <li>systemic lupus erythematosus</li> <li>dermatomyositis and polymyositis</li> <li>auto-immune chronic active hepatitis</li> <li>pemphigus vulgaris</li> <li>polyarteritis nodosa</li> <li>auto-immune haemolytic anaemia</li> <li>chronic refractory idiopathic thrombocytopenic purpura</li> </ul>
Contraindications: Contraindications IMURAN is contraindicated in patients known to be hypersensitive to azathioprine or any other component of the preparation. Hypersensitivity to 6-mercaptopurine should alert the prescriber to probable hypersensitivity to IMURAN.
Atc Code: L04AX01
Atc Item Name: azathioprine
Pharma Manufacturer Name: DCH AURIGA SINGAPORE
Company Detail Path: /organization/dch-auriga-singapore

Active Ingredients

AZATHIOPRINE

50 mg

AZATHIOPRINE

50 mg

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Jun 24, 1988

Approval ID

4b02e308fbcd6b38

Type

Therapeutic

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