Octrea

Octrea Special Precautions

octreotide

Manufacturer:

Apexcela

Distributor:

Zuellig Pharma
Full Prescribing Info
Special Precautions
General: As growth hormone (GH) secreting pituitary tumors may sometimes expand, causing serious complications (e.g. visual field defect), it is essential that all patients be carefully monitored. If evidence of tumor expansion appears, alternative procedures should be considered.
The therapeutic benefits of a reduction in GH levels and normalisation of insulin like growth factor -1 (IGF-1) concentration in female acromegalic patients could potentially restore fertility. Contraception is recommended for acromegaly female patients (if necessary).
Because Octreotide suppresses secretion of TSH which may result in hypothyroidism. Thyroid function (TSH, total and/or free thyroxine [T4]) should be monitored in patients receiving long-term therapy with octreotide.
Cardiovascular related events: Cardiovascular effects occurring in less than 1% of patients receiving octreotide injection. Cardiovascular effects include hypertension, thrombophlebitis, ischemia, congestive heart failure, palpitation, orthostatic decrease in blood pressure, syncope and chest pain.
Sinus bradycardia has been reported 25% of patients with acromegaly treated with octreotide injection and 19% in patients with carcinoid syndrome treated with octreotide. Dose adjustment of Beta blocker, calcium channel blocker or agent to control fluid and electrolyte balance are necessary.
Gallbladder: Cholelithiasis is a very common event during Octreotide treatment and may be associated with cholecystitis and biliary duct dilatation. Ultrasonic examination of the gallbladder before, and at about 6-12 month intervals during Octreotide therapy is therefore recommended.
GEP endocrine tumors: During the treatment of Gastroenterohepatic (GEP) endocrine tumors, there may be rare instances of sudden escape from symptomatic control by octreotide, with rapid recurrence of severe symptoms.
Glucose metabolism: Because of octreotide-induced alterations in various hormones involved in glucose homeostasis, patients should be observed closely for symptomatic evidence of hypoglycemia or hyperglycemia whenever octreotide therapy is initiated or dosage is adjusted. Post-prandial hyperglycemia may occur in nondiabetic patients as result of chronic administration. Hypoglycemia has also been found.
Insulinoma, insulin requirement may be reduced in patients with type 1 diabetes mellitus during octreotide therapy.
Esophageal varices: Since, following bleeding episodes from esophageal varices, there is an increased risk for the development of insulin-dependent diabetes or for changes in insulin requirement in patients with pre-existing diabetes, an appropriate monitoring of blood glucose levels is mandatory.
Local site reactions: Pain and/or burning at the subcutaneous injection site occur frequently in patients receiving octreotide, (about 7.7% of patients with various conditions), but usually persist for only about 15 minutes after injection and may diminish in frequency and severity with continued use. It has been suggested that adverse local effects result principally from the injection volume and acidity (pH of approximately 4.2).
Nutrition: Octreotide may alter absorption of dietary fats in some patients. Depressed vitamin B12 levels and abnormal Schilling tests have been observed in some patients receiving octreotide therapy. Monitoring of vitamin B12 levels is recommended during therapy with octreotide in patients who have a history of vitamin B12 deprivation.
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