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HOME >> API >> API List 3 >> Octreotide Acetate >> Precautions

Octreotide Acetate CAS Registry Number 79517-01-4

PRECAUTIONS
Octreotide Acetate CAS Registry Number 79517-01-4

# Before starting octreotide treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). Do not take aspirin, or products containing aspirin unless your doctor specifically permits this.
# Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category B (there is no evidence of risk in humans based on negative animal studies. Use in pregnancy only if clearly needed). For both men and women: Do not conceive a child (get pregnant) while taking octreotide. Barrier methods of contraception, such as condoms, are recommended
Do not breast feed while taking this medication.

General
octreotide acetatealters the balance between the counter-regulatory hormones, insulin, glucagon and growth hormone, which may result in hypoglycemia or hyperglycemia. octreotide Acetate also suppresses secretion of thyroid stimulating hormone, which may result in hypothyroidism. Cardiac conduction abnormalities have also occurred during treatment with octreotide Acetate. However, the incidence of these adverse events during long-term therapy was determined vigorously only in acromegaly patients who, due to their underlying disease and/or the subsequent treatment they receive, are at an increased risk for the development of diabetes mellitus, hypothyroidism, and cardiovascular disease. Although the degree to which these abnormalities are related to octreotide Acetate therapy is not clear, new abnormalities of glycemic control, thyroid function and ECG developed during octreotide Acetate therapy as described below.

Risk of Pregnancy with Normalization
In patients with concomitant Type I diabetes mellitus, octreotide Acetate Injection and octreotide Acetate LAR® Depot (octreotide acetate for injectable suspension) are likely to affect glucose regulation, and insulin requirements may be reduced. Symptomatic hypoglycemia, which may be severe, has been reported in these patients. In non-diabetics and Type II diabetics with partially intact insulin reserves, octreotide Acetate Injection or octreotide Acetate LAR Depot administration may result in decreases in plasma insulin levels and hyperglycemia. It is therefore recommended that glucose tolerance and antidiabetic treatment be periodically monitored during therapy with these drugs.Several cases of pancreatitis have been reported in patients receiving octreotide Acetate therapy.octreotide Acetate may alter absorption of dietary fats in some patients.Acromegaly: Growth Hormone, IGF-I (somatomedin C) Responsiveness to octreotide Acetate may be evaluated by determining growth hormone levels at 1-4 hour intervals for 8-12 hours post dose. Alternatively, a single measurement of IGF-I (somatomedin C) level may be made two weeks after drug initiation or dosage change.Carcinoid: 5-HIAA (urinary 5-hydroxyindole acetic acid), plasma serotonin, plasma Substance P
Nursing Mothers

It is not known whether octreotide is excreted into human milk. Because many drugs are excreted in human milk, caution should be exercised when octreotide is administered to a nursing woman.
Pediatric Use

Experience with octreotide Acetate in the pediatric population is limited. Although formal controlled clinical trials have not been performed to evaluate safety and effectiveness in this age group, there are reports of 49 cases in the literature of neonates and infants with congenital hyperinsulinism [also called familial hyperinsulinism (HI), persistent hyperinsulinemic hypoglycemia of infancy (PHHI), or nesidioblastosis] who have received octreotide Acetate as an inhibitor of insulin release.

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