Sandostatin Lar Depot

Sandostatin Lar Depot

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

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

Sandostatin LAR Depot 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with Sandostatin Injection has been shown to be effective and tolerated.

1.1     Acromegaly

Long-term maintenance therapy in acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. The goal of treatment in acromegaly is to reduce GH and IGF-1 levels to normal [see Clinical Studies (14) and Dosage and Administration (2)].

1.2     Carcinoid Tumors

Long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors.

1.3     Vasoactive Intestinal Peptide Tumors (VIPomas)

Long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors.

1.4     Important Limitations of Use

In patients with carcinoid syndrome and VIPomas, the effect of Sandostatin Injection and Sandostatin LAR Depot on tumor size, rate of growth and development of metastases, has not been determined.

History

There is currently no drug history available for this drug.

Other Information

Octreotide is the acetate salt of a cyclic octapeptide. It is a long-acting octapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin. Octreotide is known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1- (hydroxy-methyl) propyl]-, cyclic (2→7)-disulfide; [R-(R*,R*)].

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

octreotide amino acid sequence

Sandostatin LAR Depot is available in a vial containing the sterile drug product, which when mixed with diluent, becomes a suspension that is given as a monthly intragluteal injection. The octreotide is uniformly distributed within the microspheres which are made of a biodegradable glucose star polymer, D,L-lactic and glycolic acids copolymer. Sterile mannitol is added to the microspheres to improve suspendability.

Sandostatin LAR Depot is available as: sterile 6-mL vials in 3 strengths delivering 10 mg, 20 mg, or 30 mg octreotide-free peptide. Each vial of Sandostatin LAR Depot delivers:

*Equivalent to 10/20/30 mg octreotide base.
Name of Ingredient 10 mg 20 mg 30 mg
octreotide acetate 11.2 mg* 22.4 mg* 33.6 mg*
D,L-lactic and glycolic acids copolymer 188.8 mg 377.6 mg 566.4 mg
mannitol 41.0 mg 81.9 mg 122.9 mg
Each syringe of diluent contains:
      carboxymethylcellulose sodium 14.0 mg
      mannitol 12.0 mg
      poloxamer 188 4.0 mg
      water for injection 2.0 mL

Sandostatin Lar Depot Manufacturers


  • Novartis Pharmaceuticals Corporation
    Sandostatin Lar Depot (Octreotide Acetate) Kit Sandostatin Lar Depot Demonstration Kit (Octreotide Acetate) Kit [Novartis Pharmaceuticals Corporation]

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