Somatostatin Hikma

SOMATOSTATIN HIKMA 1 mg/2 ml
SOMATOSTATIN HIKMA 2.5 mg/2 ml
SOMATOSTATIN HIKMA 3 mg/2 ml
SOMATOSTATIN H01CB01
EQUIVALENT MEDICINAL PRODUCT

Composition:
Each vial of powder for solution for intravenous infusion contains:
Somatostatin Hikma
1 mg 2.5 mg 3 mg
Active substance:
somatostatin 1 mg 2.5 mg 3 mg
One solvent vial contains 2 ml of physiological solution.

Pharmaceutical form and content
Powder and solvent for solution for intravenous infusion.
Somatostatin Hikma 1 mg: pack containing 3 vials of powder for solution for intravenous infusion + 3 solvent vials of 2 ml
Somatostatin Hikma 2.5 mg: pack containing 3 vials of powder for solution for intravenous infusion + 3 solvent vials of 2 ml
Somatostatin Hikma 3 mg: pack containing 3 vials of powder for solution for intravenous infusion + 3 solvent vials of 2 ml

Therapeutic category
Growth-inhibiting hormone

Marketing Authorization Holder and Manufacturer
Hikma Italia S.p.A.
Viale Certosa, 10 – 27100 Pavia

Therapeutic indications
Severe acute bleeding from the upper gastrointestinal tract (bleeding due to gastric, duodenal and gastroduodenal ulcers, hemorrhagic gastritis, esophageal varices).
Prophylactic treatment of postoperative complications following pancreatic surgery.
Treatment of pancreatic fistulas and acute pancreatitis.
Adjunctive treatment of diabetic ketoacidosis.

Contraindications
Hypersensitivity to the components or to other substances closely related from a chemical standpoint.
Pregnancy, postpartum period and breastfeeding.

Precautions for use
Somatostatin must be administered under strict medical supervision.

Interactions
Somatostatin must not be administered with solutions containing glucose or fructose.
It prolongs the hypnotic effect of hexobarbital and enhances the convulsant action of pentetrazol.
Therefore, it must not be administered concomitantly with these drugs, but only after their effects have ceased.

Special warnings
Somatostatin is contraindicated during pregnancy, postpartum period and breastfeeding.
Due to its inhibitory effect on insulin and glucagon secretion, somatostatin must be administered with caution in insulin-dependent patients with hemorrhage. In such patients, temporary hypoglycemia may occur, followed after 2–3 hours by hyperglycemia. Therefore, blood glucose levels should be monitored regularly (every 3–4 hours), and additional sugar intake should be avoided.

Dosage, method and duration of administration
Unless otherwise prescribed, in acute upper gastrointestinal bleeding, administer 3.5 mcg/kg/hour by continuous intravenous infusion in sterile, pyrogen-free physiological solution. In some cases, the intravenous infusion may be preceded by a slow intravenous injection (over not less than 3 minutes) of one vial of Somatostatin Hikma, monitoring arterial pressure values.
After hemostasis has been achieved, treatment should be continued for 48–72 hours to prevent rebleeding.
In any case, the total duration of treatment should not exceed 120 hours, as the benefit of longer infusion periods has not yet been established.
For the prevention of postoperative complications following pancreatic surgery, it is advisable to administer the product at the time of surgery and maintain prophylactic treatment for 5 days after the operation.
For the treatment of pancreatic fistulas and acute pancreatitis, administration of 3.5 mcg/kg/hour (2 vials of Somatostatin Hikma 3 mg) by continuous intravenous infusion for 7–10 days is recommended.
If the severity of the case requires it, or at the physician’s discretion, administration of the product may be extended for up to 15 consecutive days of therapy.
As an adjunct in the treatment of diabetic ketoacidosis, somatostatin has been successfully used concomitantly with insulin: infusion of 100–500 mcg/hour of somatostatin, accompanied by simultaneous insulin administration (10 U bolus + 1–4.8 U/hour infusion), has proven effective in normalizing blood glucose levels within 4 hours and resolving acidosis within 3 hours.

Undesirable effects
Administration of somatostatin may cause transient nausea, sometimes accompanied by vomiting, dizziness and facial flushing. This occurs especially when the drug is injected too rapidly intravenously, rather than during continuous infusion.
Orthostatic hypotension has been reported rarely, which can be avoided by administering the injection while the patient is lying down.
It has been reported that intravenous bolus administration of somatostatin may lead to respiratory arrest.
Additionally, vomiting, diarrhea, abdominal pain, rebound hypersecretion of growth hormone and other hormones after discontinuation of treatment, and less frequently, reduced glucose tolerance, arrhythmia, and hyponatremia have been reported.
Patients are advised to inform their doctor or pharmacist of any adverse effects not described in this leaflet.

Expiry date and storage
Caution: do not use the medicinal product after the expiry date stated on the packaging. Keep the medicinal product out of the reach of children.
Store below 25°C and protect from light.
After reconstitution, the somatostatin solution may be stored at room temperature for 12 hours.