Octreotide Acetate

Octreotide Acetate

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Questions & Answers

Side Effects & Adverse Reactions

Single doses of octreotide acetate have been shown to inhibit gallbladder contractility and decrease bile secretion in normal volunteers. In clinical trials (primarily patients with acromegaly or psoriasis), the incidence of biliary tract abnormalities was 63% (27% gallstones, 24% sludge without stones, 12% biliary duct dilatation). The incidence of stones or sludge in patients who received octreotide acetate for 12 months or longer was 52%. Less than 2% of patients treated with octreotide acetate for 1 month or less developed gallstones. The incidence of gallstones did not appear related to age, sex or dose. Like patients without gallbladder abnormalities, the majority of patients developing gallbladder abnormalities on ultrasound had gastrointestinal symptoms. The symptoms were not specific for gallbladder disease. A few patients developed acute cholecystitis, ascending cholangitis, biliary obstruction, cholestatic hepatitis, or pancreatitis during octreotide acetate therapy or following its withdrawal. One patient developed ascending cholangitis during octreotide acetate therapy and died.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Acromegaly

Octreotide acetate injection is indicated to reduce blood levels of growth hormone 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 (see DOSAGE AND ADMINISTRATION). In patients with acromegaly, octreotide acetate injection reduces growth hormone to within normal ranges in 50% of patients and reduces IGF-I (somatomedin C) to within normal ranges in 50% to 60% of patients. Since the effects of pituitary irradiation may not become maximal for several years, adjunctive therapy with octreotide acetate injection to reduce blood levels of growth hormone and IGF-I (somatomedin C) offers potential benefit before the effects of irradiation are manifested.

Improvement in clinical signs and symptoms or reduction in tumor size or rate of growth were not shown in clinical trials performed with octreotide acetate injection; these trials were not optimally designed to detect such effects.

Carcinoid Tumors

Octreotide acetate injection 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.

Octreotide acetate injection studies were not designed to show an effect on the size, rate of growth or development of metastases.

Vasoactive Intestinal Peptide Tumors (VIPomas)

Octreotide acetate injection is indicated for the treatment of the profuse watery diarrhea associated with VIP-secreting tumors. Octreotide acetate injection studies were not designed to show an effect on the size, rate of growth or development of metastases.

History

There is currently no drug history available for this drug.

Other Information

Octreotide acetate injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffered acetate solution for administration by deep subcutaneous (intrafat) or intravenous injection. Octreotide acetate, known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxymethyl)propyl]-, cyclic (2→7)-disulfide; [R-(R*, R*)] acetate salt, is a long-acting octapeptide with pharmacologic actions mimicking those of the natural hormone somatostatin.

Octreotide acetate injection is available as: sterile 1 mL single dose vials in 3 strengths, containing 50, 100, or 500 mcg octreotide (as acetate), and sterile 5 mL multiple dose vials in 2 strengths, containing 200 and 1000 mcg/mL of octreotide (as acetate).

Each single dose vial also contains:
  Glacial acetic acid, USP 2 mg
  Sodium acetate trihydrate, USP 2 mg
  Mannitol, USP 45 mg
  Water for injection, USP qs to 1 mL
   
Each mL of the multiple dose vials also contains:
  Glacial acetic acid, USP 2 mg
  Sodium acetate trihydrate, USP 2 mg
  Phenol liquefied, USP 5 mg
  Mannitol, USP 45 mg
  Water for injection, USP qs to 1 mL

Glacial acetic acid, USP and sodium acetate trihydrate, USP are added to provide a buffered solution, pH to 4.2 ± 0.5.

The molecular weight of octreotide acetate is 1019.3 (free peptide, C49H66N10O10S2) and its amino acid sequence is:

Chemical Structure

Octreotide Acetate Manufacturers


  • Teva Parenteral Medicines, Inc
    Octreotide Acetate Injection [Teva Parenteral Medicines, Inc]
  • Wockhardt Limited
    Octreotide Acetate Injection [Wockhardt Limited]
  • Wockhardt Usa Llc.
    Octreotide Acetate Injection [Wockhardt Usa Llc.]
  • Sun Pharmaceutical Industries Limited
    Octreotide Acetate Injection, Solution [Sun Pharmaceutical Industries Limited]
  • Mylan Institutional Llc
    Octreotide Acetate Injection, Solution [Mylan Institutional Llc]
  • Sandoz Inc
    Octreotide Acetate Injection, Solution [Sandoz Inc]
  • Sandoz Inc
    Octreotide Acetate Injection, Solution [Sandoz Inc]
  • Sandoz Inc
    Octreotide Acetate Injection, Solution [Sandoz Inc]
  • Bedford Laboratories
    Octreotide Acetate Injection, Solution [Bedford Laboratories]
  • Sagent Pharmaceuticals
    Octreotide Acetate Injection, Solution [Sagent Pharmaceuticals]

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