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Octreotide Acetate

Pronouncation: (ock-TREE-oh-tide ASS-uh-TATE)
Class: Endocrine and metabolic agent

Trade Names:
Sandostatin
- Injection 0.05 mg/mL
- Injection 0.1 mg/mL
- Injection 0.2 mg/mL
- Injection 0.5 mg/mL
- Injection 1 mg/mL

Trade Names:
Sandostatin LAR Depot
- Injection 10 mg/5 mL
- Injection 20 mg/5 mL
- Injection 30 mg/5 mL

Pharmacology

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Actions mimic those of natural hormone somatostatin. Suppresses secretion of serotonin and gastroenteropancreatic peptides (eg, gastrin, insulin, glucagon, secretin, motilin). Also suppresses growth hormone.

Pharmacokinetics

Absorption

Octreotide is rapidly and completely absorbed (subcutaneous).

The bioavailability is 100% (subcutaneous). C _max is 5.2ߙng/mL.

Distribution

Vd is 13.6 L. Protein binding is 65% and is bound mainly to lipoprotein, and, to a lesser extent, albumin.

Elimination

The t _½ is 1.7 h. 32% is eliminated unchanged through the urine. Cl is 10ߙL/h.

Duration

May extend up to 12 h.

Special Populations

Elderly

There is a 46% increase in the half-life of the drug, and a 26% decrease in clearance. Dosage adjustment may be necessary.

Severe Renal Insufficiency

Clearance may be reduced by about 50%.

Indications and Usage

Symptomatic treatment of diarrhea associated with carcinoid tumors; treatment of profuse watery diarrhea associated with vasoactive intestinal peptide tumors (VIPoma); to reduce blood levels of growth hormone and IGF-1 in acromegaly patients who have had inadequate response to or cannot be treated with resection, pituitary irradiation and bromocriptine at maximally tolerated doses.

Unlabeled Uses

To reduce output from GI fistulas; for variceal bleeding; for relief of diarrhea associated with a variety of conditions; to reduce output from pancreatic fistulas; to treat irritable bowel syndrome; to treat dumping syndrome; to treat the following conditions: Enteric fistula; pancreatitis; pancreatic surgery; glucagonoma; insulinoma; gastrinoma (Zollinger-Ellison syndrome); intestinal obstruction; local radiotherapy; chronic pain management; antineoplastic therapy; decrease insulin requirements in diabetes mellitus; thyrotropin- and TSH-secreting tumors.

Contraindications

Standard considerations.

Dosage and Administration

Carcinoid Tumors
Adults

Subcutaneous 100 to 600 mcg/day in 2 to 4ߙdivided doses, adjusting to response.

VIPoma
Adults

Subcutaneous 200 to 300 mcg/day in 2 to 4ߙdivided doses, adjusting to response.

Acromegaly
Adults

Subcutaneous 50 mcg to 500 mcg/tid. Most common dose is 100 mcg/tid; doses more than 300 mcg/day seldom result in additional benefit.

General Advice

For subcutaneous administration only.
Do not administer if particulate matter or discoloration is observed.
Rotate sites for subcutaneous injection.
Open ampules just prior to withdrawing dose. Discard any unused solution. Do not store for future use.

Storage/Stability

For prolonged storage, store ampules and vials in refrigerator (36° to 48°F). Can be stored at controlled room temperature (70° to 86°F) for up to 14 days. Protect from light. Allow refrigerated medication to come to room temperature before administration. Discard multidose vials 14 days after initial use.

Drug Interactions

Cyclosporine

May decrease plasma levels of cyclosporine.

Incompatibility

Parenteral nutrition solutions.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Headache; dizziness; lightheadedness; fatigue; sinus bradycardia; conduction abnormalities; arrhythmias.

GI

Nausea; constipation; flatulence; diarrhea; abdominal pain or discomfort; loose stools; vomiting; fat malabsorption.

Hepatic

Increased liver transaminase.

Metabolic

Hyperglycemia; hypoglycemia.

Miscellaneous

Injection site pain; flushing; asthenia; weakness.

Precautions

Pregnancy

Category B .

Lactation

Undetermined.

Children

Has been used in children as young as 1 mo.

Elderly

Dose adjustments may be necessary due to significant increases in half-life and significant decrease in the clearance of octreotide.

Renal Function

Dosage reduction may be necessary.

Cardiac effects

In acromegalics, bradycardia, conduction abnormalities and arrhythmias have occurred. Other ECG changes observed include QT prolongation, axis shifts, early repolarization, low voltage, R/S transition and early wave progression. Dose adjustments in drugs such as beta blockers that have bradycardia effects may be necessary.

Pancreatitis

Several cases have occurred in patients receiving octreotide.

Cholelithiasis

Cholelithiasis may occur; periodically monitor gallbladder function.

Hypoglycemia or hyperglycemia

Serum glucose control may be altered; carefully monitor patient and adjust insulin requirements accordingly.

Overdosage

Symptoms

Possible hyperglycemia and hypoglycemia.

Patient Information

Instruct and observe return demonstration of correct technique for subcutaneous injection. Explain that preferred sites for injection are abdomen, thigh, and hip.
Caution patient to report the following symptoms to health care provider: icterus, jaundice, dark urine, or clay-colored stools.
Advise patient to notify health care provider of abdominal pain, edema, chest pain, fainting, dry mouth, or shortness of breath.