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.
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-esophageal 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 OVERDOSAGE).
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 or above): There is no evidence of reduced tolerability or altered dosage requirements in elderly patients treated with Sandostatin.