Posology : מינונים

4.2.   Posology and method of administration

Posology

General target population
Acromegaly
Initially 0.05 to 0.1 mg by subcutaneous (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 Octreostat, assessment of GH should be made every 6 months.

If no relevant reduction in GH levels and no improvement in clinical symptoms have been achieved within 3 months of starting treatment with Octreostat, therapy should be discontinued.

Gastro-entero-pancreatic endocrine tumours
Initially 0.05 mg once or twice daily by s.c. injection. Depending on clinical response, effect on levels of tumour-produced hormones (in cases of carcinoid tumours, 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 tumours, if there is no beneficial response within 1 week of treatment with Octreostat 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-oesophageal varices
25 micrograms/hour for 5 days by continuous intravenous (i.v.) infusion. Octreostat can be used in dilution with physiological saline.

In cirrhotic patients with bleeding gastro-oesophageal varices, Octreostat has been well tolerated at continuous i.v. doses of up to 50 micrograms/hour for 5 days. (see Section 4.9) 

Special populations

Geriatric Populations
There is no evidence of reduced tolerability or altered dosage requirements in elderly patients treated with Octreostat.


Pediatric Population
Experience with Octreostat in children is limited.

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 Octreostat is necessary.

Method of administration

Octreostat may be administered directly by subcutaneous (s.c.) injection or by intravenous (i.v.) infusion after dilution. For further instructions on handling and instructions for dilution of the medicinal product, refer to section 6.6.