SANDOSTATIN INJECTION 0.1 mg/ml

NOVARTIS (SINGAPORE) PTE LTD

NOVARTIS (SINGAPORE) PTE LTD

Therapeutic

Prescription Only

INJECTION

**DOSAGE REGIMEN AND ADMINISTRATION** **Dosage Regimen** **General target population** **Acromegaly** Initially 0.05 to 0.1 mg by s.c. injection every 8 or 12 hours. Dosage adjustment should be based on monthly assessment of GH and IGF-1 levels (target: GH < 2.5 ng/mL; IGF-1 within normal range) and clinical symptoms, and on tolerability. In most patients, the optimal daily dose will be -0.3 mg. A maximum dose of 1.5 mg per day should not be exceeded. For patients on a stable dose of Sandostatin, assessment of IGF-1 and/or GH should be made every 6 months. If no relevant reduction in IGF-1 and/or GH levels and no improvement in clinical symptoms have been achieved within 3 months of starting treatment with Sandostatin, therapy should be discontinued. **Gastro-entero-pancreatic endocrine tumors** Initially 0.05 mg once or twice daily by s.c. injection. Depending on clinical response, effect on levels of tumor-produced hormones (in cases of carcinoid tumors, on the urinary excretion of 5-hydroxyindole acetic acid), and on tolerability, dosage can be gradually increased to 0.1 to 0.2 mg 3 times daily. Under exceptional circumstances, higher doses may be required. Maintenance doses have to be adjusted individually. In carcinoid tumors, if there is no beneficial response within 1 week of treatment with Sandostatin at the maximum tolerated dose, therapy should not be continued. **AIDS-related refractory diarrhoea** The data suggest that 0.1 mg 3 times per day by s.c. injection is the optimal starting dose. If diarrhea is not controlled after 1 week of treatment, the dose should be titrated on an individual basis up to 0.25 mg 3 times per day. Dose adjustment should be based on assessment of stool output and on tolerability. If within 1 week of treatment with Sandostatin at a dose of 0.25 mg 3 times per day no improvement is achieved, therapy should be discontinued. **Complications following pancreatic surgery** 0.1 mg 3 times daily by s.c. injection for 7 consecutive days, starting on the day of operation at least 1 hour before laparotomy. **Bleeding gastro-oesophageal varices** 25 microgram/hour for 5 days by continuous i.v. infusion. Sandostatin can be used in dilution with physiological saline. In cirrhotic patients with bleeding gastro-esophageal varices, Sandostatin has been well tolerated at continuous i.v. doses of up to 50 microgram/hour for 5 days (see section OVERDOSAGE – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Special populations** **Hepatic impairment** In patients with liver cirrhosis, the half-life of the drug may be increased, necessitating adjustment of the maintenance dosage. **Renal impairment** Impaired renal function did not affect the total exposure (AUC) to octreotide administered as s.c. injection, therefore no dose adjustment of Sandostatin is necessary. **Pediatric Patients (below 18 years)** Experience with Sandostatin in children is limited. **Geriatric Patients (65 years of age or above)** There is no evidence of reduced tolerability or altered dosage requirements in elderly patients treated with Sandostatin.