The safety and effectiveness of octreotide acetate has not been demonstrated in pediatric patients. No formal studies have been performed to evaluate the safety and effectiveness of octreotide acetate in patients under the age of 6. Serious side effects including hypoxia, necrotizing enterocolitis, and death have been reported with its use in children, especially those under the age of 2.
DRUG INTERACTIONS: Octreotide acetate can alter nutrient absorption and may interfere with the absorption of some orally taken medications.
If taken with octreotide acetate, dose adjustments may be required for some medications including insulin, oral anti-diabetes medicines, beta blockers, calcium channel blockers (CCBs), and agents used to control fluid and electrolyte balance.
Octreotide may decrease the removal of certain drugs broken down by the CYP3A4 liver enzymes. Therefore, octreotide should be used cautiously with other drugs that are extensively metabolized by these enzymes or those that have a low therapeutic index.
Co-administration of octreotide and bromocriptine may increase the blood levels of bromocriptine (Cycloset).
PREGNANCY: There are no adequate and well-controlled studies of octreotide acetate use in pregnancy. There was no evidence of fetal harm in studies performed in rats and rabbits. However, as animal studies cannot be always used to predict response in humans, octreotide acetate should be used in pregnancy only if clearly needed. Octreotide acetate is classified as FDA pregnancy risk category B.
NURSING MOTHERS: It is not known if octreotide acetate can enter breast milk. As many drugs can enter human milk and cause side effects in the nursing infant, octreotide acetate should be used cautiously during breastfeeding.
REFERENCE: FDA Prescribing Information.
Quick GuideDigestive Disorders: Common Misconceptions
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Need help identifying pills and medications?
Use the pill identifier tool on RxList.