Eumedica Somatostatin

Eumedica Somatostatin

somatostatin

Manufacturer:

Eumedica

Distributor:

Zuellig

Marketer:

A. Menarini
Full Prescribing Info
Contents
Somatostatin.
Description
Each 250-mcg and 3-mg vial of lyophilized powder for IV injection contains hydrated somatostatin acetate equivalent to somatostatin 250 mcg and 3 mg, respectively.
Eumedica Somatostatin is supplied with a 1 mL ampule of 0.9% sodium chloride for injection.
Action
Somatostatin is a 14-amino acid oligopeptide which was originally isolated from the hypothalamus of animals and, later, found in both epithelial cells and nerve fibers throughout the whole of the digestive system. Somatostatin is thought to act mainly as a local transport substance, thus having a role in both the regulation of endocrine and exocrine secretions and of gastrointestinal motility. When administered at pharmacological doses, somatostatin will inhibit gastrointestinal function and motility, as well as resorption within the digestive tract.
Indications/Uses
Treatment of acute gastrointestinal hemorrhage, resulting from gastric or duodenal ulcers, hemorrhagic gastritis and bleeding esophageal varices, whether suspected solely on clinical grounds or proven by endoscopy.
Treatment of intestinal and pancreatic fistulae.
Symptomatic treatment of excessive secretion from endocrine tumors of the gastrointestinal tract.
The prevention of complications after pancreatic surgery or endoscopic retrograde cholangiopancreatography (ERCP).
Dosage/Direction for Use
Adults: The recommended dose is 3.5 mcg/kg body weight/hr, or usually 6 mg/24 hrs for a 75-kg patient, given as a continuous infusion of 250 mcg/hr. The infusion rate should then be adjusted for 12 or 24 hrs (for 3 or 6 mg respectively).
Treatment of Gastrointestinal Hemorrhage: Eumedica Somatostatin infusion should be initiated before endoscopy, as soon as possible after the first signs of bleeding, and continued during 5 days, the minimum duration being 48 hrs. In addition to the continuous infusion, a bolus injection of 3.5 mcg/kg body weight (1 vial of Eumedica Somatostatin 0.25 mg for a 75-kg patient) should be given immediately after the start of the continuous infusion and another bolus about 1 min before endoscopy. The bolus must be given slowly (at least 1 min). After endoscopic treatment, similar boluses should also be given when the patient shows clinical signs of bleeding.
Treatment of Fistulae or Excessive Secretion from Endocrine Tumors: A bolus injection is not necessary. Healing of fistulae may be expected in most patients within 7-14 days, although longer (or shorter) periods are possible. After healing, only half the dose should be infused for the next 48 hrs, in order to avoid a possible rebound effect.
Elderly: Adjustment of the dose is recommended in elderly patients with severe renal impairment (see Renal Impairment as follows).
Renal Impairment: In patients with severe renal failure (CrCl ≤30 mL/min), the dose should be reduced to 1.75 mcg/kg body weight/hr for continuous infusion and 1.75 mcg/kg body weight for bolus dose.
Hepatic Impairment: No dose adjustment is needed in patients with solely hepatic impairment. The patient should be closely monitored after treatment discontinuation.
Administration: Due to its short plasma t½, 1-2 min, Eumedica Somatostatin should be administered as a continuous IV infusion. It should be reconstituted immediately before use by adding the 1-mL ampule of sodium chloride solution (0.9%) for parenteral use.
Overdosage
Symptoms: Reported cases of somatostatin overdose did not reveal other safety hazard than the undesirable effects observed at recommended doses.
Treatment: Close monitoring of blood glucose level, cardiovascular parameters, renal function, and plasma electrolytes is recommended in case of somatostatin overdose.
After interruption of a somatostatin IV infusion given at therapeutic dose, the t½ of somatostatin in blood is about 2 min.
Treatment of overdose is symptomatic, no specific antidote is known.
Contraindications
Known hypersensitivity to somatostatin or somatostatin analogues.
Special Precautions
Somatostatin is intended for hospital use.
Half of the recommended dose should be given to patients with severe renal failure (CrCl ≤30 mL/min). Patients receiving Eumedica Somatostatin should be kept under strict medical observation. The bolus doses should be given slowly over at least 1 min. The infusion must be given continuously. At the beginning of the infusion, hypoglycemia may occur, possibly followed 2-3 hrs later by a rise in blood sugar due to alterations in the balance between the counterregulatory hormones, insulin and glucagon. For this reason, blood sugar must be measured every 4-6 hrs.
Precaution is recommended in case of simultaneous administration of any form of sugar (see Interactions).
Somatostatin may induce the following pharmacodynamic cardiovascular effects: Transient systemic hypertension, transiently reduced cardiac output, increased pulmonary arterial pressure and central venous pressure, systemic hypotension, bradycardia, atrioventricular block.
Consequently, patient's vital signs should be monitored during the initial phase of somatostatin administration, especially after bolus injection. Caution should be exercised in patients with compromised cardiovascular status or history of cardiac arrhythmia, who may not be able to compensate for these effects.
As glomerular filtration rate, urine flow and sodium blood level may be decreased during somatostatin treatment, regular checks of the renal function and plasma electrolytes are recommended.
Eumedica Somatostatin causes inhibition of the intestinal absorption of certain nutriments. It also inhibits other gastrointestinal hormone secretions. Abrupt interruption of infusion may result in a rebound effect, especially in patients treated for fistulae. Therefore, after healing of fistulae, only half of the dose should be infused for the next 48 hrs, in order to avoid a possible rebound effect.
The effects of somatostatin on vital signs, glycemia, and renal function should be taken into consideration for the patient's follow-up after treatment discontinuation.
Use in pregnancy & lactation: There are no adequate data from the use of somatostatin in pregnant women. Animal reproduction studies were not performed. Somatostatin should not be used during pregnancy unless clearly necessary.
Somatostatin should not be used during lactation.
No studies have been reported concerning the pharmacokinetics of somatostatin in pregnancy and lactation in animals.
Use in children & adolescents: No adequate clinical studies establishing safety and efficacy of Eumedica Somatostatin in children and adolescents have been done. Therefore, use is not recommended in this population of patients.
Use In Pregnancy & Lactation
There are no adequate data from the use of somatostatin in pregnant women. Animal reproduction studies were not performed. Somatostatin should not be used during pregnancy unless clearly necessary.
Somatostatin should not be used during lactation.
No studies have been reported concerning the pharmacokinetics of somatostatin in pregnancy and lactation in animals.
Adverse Reactions
The following adverse reactions have been spontaneously reported: Cardiac Disorders: Atrioventricular block, bradycardia, arrhythmia, ventricular extrasystole.
Gastrointestinal Disorders: Abdominal pain, diarrhea, nausea, vomiting.
Metabolism and Nutrition Disorders: Hyperglycemia, hypoglycemia.
Vascular Disorders: Hypertension, hypotension, hot flushes. Abrupt interruption of the continuous infusion may result in a rebound effect of the treated disease, especially in patients treated for fistula.
Drug Interactions
Taking into account the wide range of somatostatin pharmacodynamic effects on various regulating systems, there is a potential for many pharmacodynamic interactions.
Pharmacodynamic interactions with possible clinical relevance have been observed with drugs that also influence blood glucose regulation, plasma renin level and arterial blood pressure, showing that somatostatin may modify the effects of these drugs on these parameters.
Simultaneous administration of any form of sugar (including glucose and fructose solutions or total parenteral nutrition) favors glycemic disturbances and requires a closer monitoring of blood sugar. Administration of insulin may be required.
Incompatibilities: None known.
Somatostatin is compatible with glucose (5% and 10%) and fructose solutions (40%).
Storage
250-mcg Vial: Store at 2-8°C.
3-mg Vial: Store at temperature between 15 and 25°C.
ATC Classification
H01CB01 - somatostatin ; Belongs to the class of antigrowth hormone. Used in hypothalamic hormone preparations.
Presentation/Packing
Inj (lyo) for soln (vial) 250 mcg x 1's. 3 mg x 1's.
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