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Octreotide information from DrugsUpdate  

See Available Brands of Octreotide in India

P - Caution when used during pregnancy
L - Caution when used during lactation
FI - Food *

Octreotide (brand name Sandostatin, Novartis Pharmaceuticals) is an octapeptide that mimics natural somatostatin pharmacologically, though it is a more potent inhibitor of growth hormone, glucagon, and insulin than the natural hormone. It was first synthesized in 1979 by the chemist Wilfried Bauer.

Pharmacodynamics

After subcutaneous injection, Octreotide is absorbed rapidly and completely from the injection site. Peak concentrations of 5.2 ng/mL (100 mcg dose) were reached 0.4 hours after dosing. Using a specific radioimmunoassay, intravenous and subcutaneous doses were found to be bioequivalent. Peak concentrations and area under the curve values were dose proportional after intravenous single doses up to 200 mcg and subcutaneous single doses up to 500 mcg and after subcutaneous multiple doses up to 500 mcg t.i.d. (1,500 mcg/day).

Pharmacokinetics

Octreotide is a synthetic analogue of somatostatin which acts by suppressing basal and stimulated secretion of growth hormone (GH). It also suppresses LH response to gonadotrophin-releasing hormone and reduces the secretion of gastrin, vasoactive intestinal peptide (VIP), insulin, glucagon, secretin, motilin and pancreatic polypeptide.

Absorption
Rapidly absorbed (SC); peak plasma concentrations after 25-30 min.

Distribution
65% plasma protein bound.

Excretion
Via urine (as unchanged); 1.5 hr (elimination half-life), prolonged in elderly.

Octreotide Indications / Octreotide Uses

Information Not Available

Octreotide Adverse Reactions / Octreotide Side Effects

Local pain, stinging, tingling at site of inj; anorexia, nausea, vomiting, abdominal pain, bloating, flatulence, loose stools, steatorrhoea; biliary tract abnormalities. Hypoglycaemia and hyperglycaemia, hypothyroidism, cardiac conduction abnormalitles, pancreatitis.

Precautions

Octreotide acetate alters the balance between the counter-regulatory hormones, insulin, glucagon and growth hormone, which may result in hypoglycemia or hyperglycemia. Octreotide acetate also suppresses secretion of thyroid stimulating hormone, which may result in hypothyroidism. Cardiac conduction abnormalities have also occurred during treatment with Octreotide acetate. However, the incidence of these adverse events during long-term therapy was determined vigorously only in acromegaly patients who, due to their underlying disease and/or the subsequent treatment they receive, are at an increased risk for the development of diabetes mellitus, hypothyroidism, and cardiovascular disease. Although the degree to which these abnormalities are related to Octreotide acetate therapy is not clear, new abnormalities of glycemic control, thyroid function and ECG developed during Octreotide acetate therapy as described below.

Special Precautions

Renal disease; risk of gall bladder disease; DM; hypothyroidism. Pregnancy, lactation, children, elderly. Monitor levels of vitamin B12 during long term therapy.

Other Drug Interactions

Dosage adjustment of concurrent therapy may be necessary with calcium channel blockers, oral hypoglycaemics, β-blockers, diuretics. May increase concentration of bromocriptine.

Potentially Fatal: Requirements of insulin may be reduced requiring careful blood-glucose monitoring. Reduction in ciclosporin bioavailability and efficacy.

Other Interactions

Food Interactions


Schedule injections between meals to decrease adverse GI effects.

Dosage

Intravenous
Variceal haemorrhage in patients with cirrhosis
Adult: As continuous IV infusion: 25 mcg/hr for 48 hr (up to 5 days in patients at high risk of re-bleeding).
Child: ≥1 mth: 1 mcg/kg/hr (up to 50 mcg/hr); given as continuous IV infusion. Higher doses may be needed initially, reduce dose gradually over 24 hr until bleeding has stopped.
Renal impairment: Dosage may need to be reduced in severe renal impairment requiring dialysis.

Intramuscular
Acromegaly
Adult: Following initial control with SC therapy: As a depot preparation, initially 20 mg every 4 wk. Adjust if required after 3 mth to 10-30 mg every 4 wk. Max: 40 mg every 4 wk.
Renal impairment: Dosage may need to be reduced in severe renal impairment requiring dialysis.

Subcutaneous
Secretory neoplasms
Adult: Initially, 50 mcg 1-2 times daily, increased gradually to up to 600 mcg daily in 2-4 divided doses according to response. Continued treatment is not recommended if there is no benefit within a wk of starting treatment for carcinoid tumour. Initial dose may be given via IV admin of a rapid response is required.
Renal impairment: Dosage may need to be reduced in severe renal impairment requiring dialysis.

Subcutaneous

Acromegaly
Adult: Initially 50 mcg tid, increased as necessary to usual dose 100-200 mcg tid. Max: 500 mcg tid.
Renal impairment: Dosage may need to be reduced in severe renal impairment requiring dialysis.

Subcutaneous
Prevention of complications following pancreatic surgery
Adult: 100 mcg tid of a rapid-acting preparation given for 7 consecutive days, starting at least 1 hr before operation.
Renal impairment: Dosage may need to be reduced in severe renal impairment requiring dialysis.

Subcutaneous
HIV-associated diarrhoea
Adult: Initial dose 100 mcg tid. If symptoms are not controlled after 1 wk, increase dose to 250 mcg tid, if still not effective after 1 wk stop therapy.

Renal impairment
Dosage may need to be reduced in severe renal impairment requiring dialysis.

Incompatibility
Incompatible with most TPN solutions due to formation of a glycosyl octreotide conjugate, which may decrease efficacy.

Food(before/after)

Information Not Available

List of Contraindications

Octreotide and Pregnancy

Caution when used during pregnancy.


Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

Octreotide and Lactation

Caution when used during lactation

Octreotide and Children

Experience with Octreotide acetate in the pediatric population is limited.

Octreotide and Geriatic

Clinical studies of Octreotide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Octreotide and Other Contraindications

Information Not Available

Storage

Intramuscular
Store at 2-8°C. Stable at room temperature for up to 14 days.

Intravenous
Store at 2-8°C. Stable at room temperature for up to 14 days.

Subcutaneous
Store at 2-8°C. Stable at room temperature for up to 14 days.

Lab interference

Intramuscular
Store at 2-8°C. Stable at room temperature for up to 14 days.

Intravenous
Store at 2-8°C. Stable at room temperature for up to 14 days.

Subcutaneous
Store at 2-8°C. Stable at room temperature for up to 14 days.

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