Acromegaly: Octreotide acetate is indicated to reduce blood levels of growth hormones and IGF-I (somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses.

The goal is to achieve normalization of growth hormone and IGF-I (somatomedin C) levels .) In patients with acromegaly. Octreotide acetate reduces growth hormone to within normal ranges in 50% of patients and reduces IGF-I (somatomedin C) to within normal ranges in 50%-60% of patients. Since the effects of pituitary irradiation may not become maximal for several years, adjunctive therapy with octreotide acetate to reduce blood levels of growth hormone and IGF-I (somatomedin C) offers potential benefit before the effects of irradiation are manifested.
Carcinoid Tumors: Octreotide acetate is indicated for the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease.
Vasoactive Intestinal Peptide Tumors (VIPomas): Octreotide acetate is indicated for the treatment of the profuse watery diarrhea associated with VIP-secreting tumors.

Single doses of octreotide acetate have been shown to inhibit gallbladder contractility and decrease bile secretion in normal volunteers. In clinical trials ... click here to view more

Sensitivity to this drug or any of its components.

Gallbladder Abnormalities: Gallbladder abnormalities, especially stones and/or biliary sludge, frequently develop in patients on chronic octreotide acetate therapy. Cardiac: In acromegalics, sinus bradycardia (<50 bpm) developed in 21% conduction abnormalities and arrhythmias each developed in 9% of patients during octreotide acetate therapy.

Gastrointestinal: Diarrhea, loose stools, nausea and abdominal discomfort were each seen in 30%-58% of acromegalic patients in US studies although only 2% of the patients discontinued therapy due to these symptoms were seen in 5%-10% of patients with other disorders.The frequency of these symptoms was not dose-related, but diarrhea and abdominal discomfort generally resolved more quickly in patients treated with 300 mcg/day than in those treated with 750 mcg/day. Vomiting, flatulence, abnormal stools, distention, and constipation were each seen in less than 10% of patients.
Hypo/Hyperglycemia: Hypoglycemia and hyperglycemia occurred in 3% and 15% of acromegalic patients, respectively, but only in about 1.5% of other patients. Symptoms of hypoglycemia were noted in approximately 2% of patients.
Hypothyroidism: In acromegalics, biochemical hypothyroidism alone occurred in 12% while goiter occurred in 6% during octreotide acetate therapy (see PRECAUTIONS, General). In patients without acromegaly, hypothyroidism has only been reported in several isolated patients and goiter has not been reported.

Octreotide acetate has been associated with alterations in nutrient absorption, so it may have an effect on absorption of orally administered drugs. Concomitant administration of octreotide acetate with cyclosporine may decrease blood levels of cyclosporine and result in transplant rejection.

Patients receiving insulin, oral hypoglycemic agents, beta blockers, calcium channel blockers, or agents to control fluid and electrolyte balance, may require dose adjustments of these therapeutic agents.

No frank overdose has occurred in any patient to date. Intravenous bolus doses of 1 mg (1000 mcg) given to healthy volunteers and of 30 mg (30,000 mcg) IV over 20 minutes and of 120 mg (120,000 mcg) IV over 8 hours to research patients have not resulted in serious ill effects.Mortality occurred in mice and rats has given 72 mg/kg and 18 mg/kg IV, respectively.

Octreotide acetate may be administered subcutaneously or intravenously. Subcutaneous injection is the usual route of administration of octreotide acetate for control of symptoms. Pain with subcutaneous administration may be reduced by using the smallest volume that will deliver the desired dose.

Multiple subcutaneous injections at the same site within short periods of time should be avoided. Sites should be rotated in a systematic manner.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if particulates and/or discoloration are observed. Proper sterile technique should be used in the preparation of parenteral admixtures to minimize the possibility of microbial contamination. Octreotide acetate is not compatible in Total Parenteral Nutrition (TPN) solutions because of the formation of a glycosyl octreotide conjugate which may decrease the efficacy of the product.
Octreotide acetate is stable in sterile isotonic saline solutions of dextrose 5% in water for 24 hours. It may be diluted in volumes of 50-200 ml and infused intravenously over 15-30 minutes or administered by IV push over 3 minutes. In emergency situations (e.g., carcinoid crisis) it may be given by rapid bolus.
The initial dosage is 50 mcg, administered twice or three times daily. Upward dose titration is frequently required. Dosage information for patients with specific tumors follows.

Careful instruction in sterile subcutaneous injection technique should be given to the patients and to other persons who may administer octreotide acetate Injection.