Somaset 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 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, and atrioventricular block.
Consequently, the 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 a 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.
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.
Effects on Ability to Drive and Use Machines: Not applicable.
Use in Pregnancy & Lactation: See Use in Pregnancy & Lactation section for further information.
Use in Children: No adequate clinical studies establishing safety and efficacy of Somatostatin in children and adolescents have been done. Therefore, use is not recommended in this population of patients.