Sandostatin

— THERAPEUTIC CATEGORIES —
  • Cytoprotective and supportive care agents
  • Pituitary disorders
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Sandostatin Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Octreotide acetate 50mcg, 100mcg, 500mcg; per vial; soln for IV or SC inj; contains mannitol, phenol.

    Pharmacological Class

    Somatostatin analogue.

    See Also

    How Supplied

    Ampules 50mcg/mL, 100mcg/mL, 500mcg/mL (1mL)—10; LAR kit—1 (6mL vial w. supplies)

    Manufacturer

    Novartis Pharmaceuticals Corp

    Mechanism of Action

    Octreotide acetate exerts pharmacologic actions similar to the natural hormone, somatostatin. It is an even more potent inhibitor of growth hormone (GH), glucagon, and insulin than somatostatin. Like somatostatin, it also suppresses luteinizing hormone (LH) response to gonadotropin releasing hormone (GnRH), decreases splanchnic blood flow, and inhibits release of serotonin, gastrin, vasoactive intestinal peptide (VIP), secretin, motilin, and pancreatic polypeptide.

    Sandostatin Indications

    Indications

    Severe diarrhea and flushing due to metastatic carcinoid tumors. Profuse watery diarrhea due to vasoactive intestinal peptide-secreting tumors (VIPomas).

    Sandostatin Dosage and Administration

    Adult

    Give by IV infusion over 15–30 minutes, IV push over 3 minutes, or deep SC (intrafat) inj. Carcinoid tumors: 100–600mcg/day in 2–4 divided doses for first 2 weeks; usual maintenance: 450mcg/day; max 1500mcg/day. VIPomas: Initially 200–300mcg/day in 2–4 divided doses for first 2 weeks; max 750mcg/day.

    Children

    Not recommended.

    Sandostatin Contraindications

    Not Applicable

    Sandostatin Boxed Warnings

    Not Applicable

    Sandostatin Warnings/Precautions

    Warnings/Precautions

    Diabetes. Hypothyroidism. Cardiovascular disease. Renal or hepatic impairment. Carcinoid tumors: monitor 5-HIAA, plasma serotonin, plasma Substance P. VIPomas: perform baseline and periodic total and/or free T4 measurements with chronic therapy. Monitor thyroid function, gallbladder, glucose, vitamin B12. Pregnancy. Nursing mothers.

    Sandostatin Pharmacokinetics

    Absorption

    Mean peak concentration of 2.8 ng/mL (100mcg dose) was reached in 0.7 hours after SC dosing in patients with acromegaly.

    Distribution

    In healthy volunteers, the volume of distribution: ~13.6 L; total body clearance: 7–10 L/hr.

    In patients with acromegaly, the volume of distribution: ~21.6 ± 8.5 L; total body clearance: 18 L/hr.

    Metabolism

    Hepatic.

    Elimination

    Renal, fecal. Half-life: 1.7–1.9 hours.

    Sandostatin Interactions

    Interactions

    Potentiates bromocriptine, CYP450 substrates (eg, quinidine, terfenadine), bradycardia-inducing drugs (eg, β-blockers). Antagonizes cyclosporine. Not compatible with TPN solutions. May need to adjust antidiabetic agents. May interfere with efficacy of lutetium Lu 177 dotatate inj; discontinue octreotide at least 24 hours (or, octreotide LAR at least 4 weeks) prior to each lutetium Lu dose.

    Sandostatin Adverse Reactions

    Adverse Reactions

    Gallbladder abnormalities (eg, gallstones, biliary sludge), sinus bradycardia, diarrhea, loose stools, nausea, abdominal discomfort, hyperglycemia, hypothyroidism.

    Sandostatin Clinical Trials

    See Literature

    Sandostatin Note

    Not Applicable

    Sandostatin Patient Counseling

    See Literature

    Sandostatin Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Octreotide acetate 50mcg, 100mcg, 500mcg; per vial; soln for IV or SC inj; contains mannitol, phenol.

    Pharmacological Class

    Somatostatin analogue.

    See Also

    How Supplied

    Ampules 50mcg/mL, 100mcg/mL, 500mcg/mL (1mL)—10; LAR kit—1 (6mL vial w. supplies)

    Manufacturer

    Novartis Pharmaceuticals Corp

    Mechanism of Action

    Octreotide acetate exerts pharmacologic actions similar to the natural hormone, somatostatin. It is an even more potent inhibitor of growth hormone (GH), glucagon, and insulin than somatostatin. Like somatostatin, it also suppresses luteinizing hormone (LH) response to gonadotropin releasing hormone (GnRH), decreases splanchnic blood flow, and inhibits release of serotonin, gastrin, vasoactive intestinal peptide (VIP), secretin, motilin, and pancreatic polypeptide.

    Sandostatin Indications

    Indications

    Acromegaly unresponsive to or that cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses.

    Sandostatin Dosage and Administration

    Adult

    Give by IV infusion over 15–30 minutes, IV push over 3 minutes, or deep SC (intrafat) inj. Initially 50mcg 3 times daily. Usual maintenance: 100mcg 3 times daily; max 500mcg 3 times daily. Reevaluate every 6 months. Pituitary irradiation recipients: withdraw therapy for 4 weeks once yearly to assess disease activity; resume if GH or IGF-1 levels increase or signs/symptoms recur.

    Children

    Not recommended.

    Sandostatin Contraindications

    Not Applicable

    Sandostatin Boxed Warnings

    Not Applicable

    Sandostatin Warnings/Precautions

    Warnings/Precautions

    Diabetes. Hypothyroidism. Cardiovascular disease. Renal or hepatic impairment. Monitor growth hormone, IGF-1 levels, thyroid function, gallbladder, glucose, vitamin B12. Discontinue and treat if cholelithiasis complications are suspected. Pregnancy. Nursing mothers.

    Sandostatin Pharmacokinetics

    Absorption

    Mean peak concentration of 2.8 ng/mL (100mcg dose) was reached in 0.7 hours after SC dosing in patients with acromegaly.

    Distribution

    In healthy volunteers, the volume of distribution: ~13.6 L; total body clearance: 7–10 L/hr.

    In patients with acromegaly, the volume of distribution: ~21.6 ± 8.5 L; total body clearance: 18 L/hr.

    Metabolism

    Hepatic.

    Elimination

    Renal, fecal. Half-life: 1.7–1.9 hours.

    Sandostatin Interactions

    Interactions

    Potentiates bromocriptine, CYP450 substrates (eg, quinidine, terfenadine), bradycardia-inducing drugs (eg, β-blockers). Antagonizes cyclosporine. Not compatible with TPN solutions. May need to adjust antidiabetic agents. May interfere with efficacy of lutetium Lu 177 dotatate inj; discontinue octreotide at least 24 hours (or, octreotide LAR at least 4 weeks) prior to each lutetium Lu dose.

    Sandostatin Adverse Reactions

    Adverse Reactions

    Gallbladder abnormalities (eg, gallstones, biliary sludge), sinus bradycardia, diarrhea, loose stools, nausea, abdominal discomfort, hyperglycemia, hypothyroidism.

    Sandostatin Clinical Trials

    See Literature

    Sandostatin Note

    Not Applicable

    Sandostatin Patient Counseling

    See Literature

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