STILAMIN 3000 FOR INJECTION 3 MG/AMPOULE [SIN06135P]

Product Info

STILAMIN 3000 FOR INJECTION 3 MG/AMPOULE

[SIN06135P]

Indications and use

Stilamin® is indicated for:

• Severe acute haemorrhage from oesophageal varices.

• Severe acute haemorrhage from gastric or duodenal ulcers, or accompanying acute erosive or haemorrhagic gastritis.

• Adjuvant treatment in pancreatic, biliary and intestinal fistulae.

• Prophylaxis and treatment of postoperative complications following pancreatic surgery.

• Adjuvant treatment in diabetic ketoacidosis.

Dosage and administration

Stilamin® is given intravenously, by slow bolus injection (3 to 5 minutes) of 250 mcg or by continuous infusion at a rate of 250 mcg/hour (equivalent of approximately 3,5 mcg/kg body weight/hour).

The lyophilised powder should be reconstituted with the physiological sodium chloride solution immediately prior to use.

For continuous infusion Stilamin® contents should be used to prepare a 12 hours infusion. The solution may be either saline or 5% dextrose and should be adjusted to guarantee an outflow of 250 mcg somatostatin/hour. The use of a perfusion syringe is recommended.

• Treatment of severe acute bleeding from the upper gastro-intestinal tract, including from oesophageal varices.
  It is recommended to start by a slow intravenous injection of 250 mcg of Stilamin® as loading dose, then immediately followed by an intravenous infusion at a rate of 250 mcg/h. In case of interruption of more than 3 to 5 minutes between two infusions, an additional slow i.v. injection of 250 mcg is recommended to ensure a continuous treatment.
  Once the haemorrhage has stopped (usually in less than 12 to 24 hours), treatment should be continued for 48–72 hours in order to avoid rebleeding.
  Treatment up to 120 hours has been routinely performed in this indication.

• Adjuvant treatment in pancreatic, biliary and intestinal fistulae:
  A continuous infusion of Stilamin® at a rate of 250 mcg/h is recommended until closure of the fistula (2–20 days). This infusion should be performed in addition to total parenteral nutrition. Once the fistula has been closed, treatment should be continued for 1 to 3 days and stopped progressively in order to avoid rebound effect.

• Prophylactic treatment of postoperative complications following pancreatic surgery:
  Stilamin® is administered at the beginning of the surgical intervention at a rate of 250 mcg/h and treatment is continued for 5 days.

• Adjuvant treatment in diabetic ketoacidosis:
  In patients with ketoacidosis, infusion of 100–500 mcg/h of somatostatin associated with insulin therapy (bolus of 10 international units + infusion of 1–4.8 international units/h) was capable of restoring euglycemia within 4 hours and resolving acidosis within 3 hours.

Contraindications

• Known hypersensitivity to somatostatin or any of the excipients of Stilamin®

• During pregnancy and the immediate post- partum period (puerperium) as well as during lactation. There is no evidence of the drug’s safety in human pregnancy nor is there evidence from animal work that is free from hazard.
  Avoid in pregnancy unless there is no safer alternative.