- Approval Id
- 5a0615fd935849e8
- Drug Name
- SANDOSTATIN INJECTION 0.1 MG/ML
- Product Name
- SANDOSTATIN INJECTION 0.1 MG/ML
- Approval Number
- SIN03808P
- Approval Date
- 1990-02-01
- Registrant
- NOVARTIS (SINGAPORE) PTE LTD
- Licence Holder
- NOVARTIS (SINGAPORE) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION
- Dosage
- <p><strong>DOSAGE REGIMEN AND ADMINISTRATION</strong></p>
<p><strong>Dosage Regimen</strong></p>
<p><strong>General target population</strong></p>
<p><strong>Acromegaly</strong></p>
<p>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.</p>
<p>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.</p>
<p><strong>Gastro-entero-pancreatic endocrine tumors</strong></p>
<p>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.</p>
<p>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.</p>
<p><strong>AIDS-related refractory diarrhoea</strong></p>
<p>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.</p>
<p>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.</p>
<p><strong>Complications following pancreatic surgery</strong></p>
<p>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.</p>
<p><strong>Bleeding gastro-oesophageal varices</strong></p>
<p>25 microgram/hour for 5 days by continuous i.v. infusion. Sandostatin can be used in dilution with physiological saline.</p>
<p>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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Special populations</strong></p>
<p><strong>Hepatic impairment</strong></p>
<p>In patients with liver cirrhosis, the half-life of the drug may be increased, necessitating adjustment of the maintenance dosage.</p>
<p><strong>Renal impairment</strong></p>
<p>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.</p>
<p><strong>Pediatric Patients (below 18 years)</strong></p>
<p>Experience with Sandostatin in children is limited.</p>
<p><strong>Geriatric Patients (65 years of age or above)</strong></p>
<p>There is no evidence of reduced tolerability or altered dosage requirements in elderly patients treated with Sandostatin.</p>
- Route Of Administration
- SUBCUTANEOUS
- Indication Info
- <p><strong>INDICATIONS</strong></p>
<p>Symptomatic control and reduction of growth hormone (GH) and IGF-1 plasma levels in patients with acromegaly who are inadequately controlled by surgery or radiotherapy.</p>
<p>Sandostatin treatment is also indicated for acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective.</p>
<p>Relief of symptoms associated with functional gastro-entero-pancreatic (GEP) endocrine tumors:</p>
<ul>
<li><p>Carcinoid tumours with features of the carcinoid syndrome.</p></li>
<li><p>VIPomas.</p></li>
<li><p>Glucagonomas.</p></li>
<li><p>Gastrinomas/Zollinger-Ellison syndrome, usually in conjunction with proton pump inhibitors, or H<sub>2</sub>-antagonist therapy.</p></li>
<li><p>Insulinomas, for pre-operative control of hypoglycaemia and for maintenance therapy.</p></li>
<li><p>GRFomas.</p></li>
</ul>
<p>Sandostatin is not an anti-tumor therapy and is not curative in these patients.</p>
<p>Control of refractory diarrhea associated with AIDS.</p>
<p>Prevention of complications following pancreatic surgery.</p>
<p>Emergency management to stop bleeding and to protect from re-bleeding owing to gastro-esophageal varices in patients with cirrhosis. Sandostatin is to be used in association with specific treatment such as endoscopic sclerotherapy.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong></p>
<p>Known hypersensitivity to octreotide or to any of the excipients, (see section DESCRIPTION AND COMPOSITION – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- H01CB02
- Atc Item Name
- octreotide
- Pharma Manufacturer Name
- NOVARTIS (SINGAPORE) PTE LTD
