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OCTREOTIDE ACETATE is a brand name for Octreotide, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Octreotide Acetate Injection Solution for injection or infusion General Octreotide Acetate Injection (octreotide acetate) therapy is indicated for control of symptoms in patients with metastatic carcinoid and vasoactive intestinal peptide-secreting tumours (VIPomas) as well as in patients with acromegaly. Data are…
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics 11/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ......................................................................................
2 TABLE OF CONTENTS............................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ...............................................................
3 1 INDICATIONS ............................................................................................................... 1 Pediatrics ................................................................................................................
2 Geriatrics ................................................................................................................. 4 2 CONTRAINDICATIONS ................................................................................................
4 4 DOSAGE AND ADMINISTRATION............................................................................... 1 Dosing Considerations ............................................................................................ 2 Recommended Dose and Dosage Adjustment ........................................................
3 Reconstitution.......................................................................................................... 5 Missed Dose............................................................................................................
6 5 OVERDOSAGE ............................................................................................................. 6
). Endocrine and Metabolism Glucose Metabolism Octreotide acetate therapy is occasionally associated with mild transient hypo- or hyperglycaemia but may also result in overt diabetes due to alterations in the balance between the counter-regulatory hormones, insulin, glucagon and growth hormone.
Patients should be closely observed on introduction of Octreotide Acetate Injection therapy and at each change of dosage for symptomatic evidence of hyper- and hypoglycaemia. Insulin requirement of patients with type I diabetes mellitus may be reduced by administration of octreotide acetate.
In non- diabetics and type II diabetics with partially intact insulin reserves, octreotide acetate administration can result in prandial increases in glycaemia. Severe hyperglycaemia, subsequent pneumonia, and death following initiation of octreotide acetate injection therapy was reported in one patient with no history of hyperglycaemia.
Predicting the effect of octreotide acetate on glucose tolerance in any given patient is not possible at this time. c. Since following bleeding episodes from oesophageal varices, there is an increased risk for the development of insulin-dependent diabetes or for changes in insulin requirement in patients with pre-existing diabetes, an appropriate monitoring of blood glucose is required.
c. PrOctreotide Acetate Injection Page 9 of 38 Thyroid Function Data on the effect of chronic therapy with octreotide acetate on hypothalamic/pituitary function have not been obtained. c. daily. Therefore, baseline and periodic assessment of thyroid function (TSH, total and/or free T4) should be monitored during chronic therapy with octreotide acetate.
Gastrointestinal Nutrition There is evidence that octreotide acetate therapy may alter absorption of dietary fats in some patients. It is suggested that periodic quantitative 72-hour faecal fat and serum carotene determinations be performed to aid in the assessment of possible drug-induced aggravation of fat malabsorption.
4 Geriatrics 11/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ......................................................................................
2 TABLE OF CONTENTS............................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ...............................................................
3 1 INDICATIONS ............................................................................................................... 1 Pediatrics ................................................................................................................
2 Geriatrics ................................................................................................................. 4 2 CONTRAINDICATIONS ................................................................................................
4 4 DOSAGE AND ADMINISTRATION............................................................................... 1 Dosing Considerations ............................................................................................ 2 Recommended Dose and Dosage Adjustment ........................................................
3 Reconstitution.......................................................................................................... 5 Missed Dose............................................................................................................
6 5 OVERDOSAGE ............................................................................................................. 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ........................ 7 7 WARNINGS AND PRECAUTIONS ...............................................................................
Octreotide Acetate Injection (octreotide acetate) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Depressed vitamin B12 levels and abnormal Schilling’s tests have been observed in some patients receiving octreotide therapy. I. tract in patients with conditions producing such a loss. If such patients are receiving total parenteral nutrition (TPN), serum zinc may rise excessively when the fluid loss is reversed.
Patients on TPN and octreotide should have periodic monitoring of zinc levels. Hepatic/Biliary/Pancreatic Gallbladder and Related Events Single doses of octreotide acetate injection have been shown to inhibit gallbladder contractility and decrease bile secretion in normal volunteers.
In clinical trials with octreotide acetate injection (primarily patients with acromegaly or psoriasis) in patients who had not previously received octreotide, 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 injection for 12 months or longer was 52%. The incidence of gallbladder abnormalities did not appear to be related to age, sex or dose but was related to duration of exposure.
Across all trials, a few patients developed acute cholecystitis, ascending cholangitis, biliary obstruction, cholestatic hepatitis, or pancreatitis during octreotide therapy or following its withdrawal. One patient developed ascending cholangitis during octreotide acetate injection therapy and died.
Despite the high incidence of new gallstones in patients receiving octreotide, 1% of patients developed acute symptoms requiring cholecystectomy. Additionally, there have been post-marketing reports of cholelithiasis (gallstones) resulting in complications including cholecystitis, cholangitis, pancreatitis, and requiring cholecystectomy in patients taking octreotide acetate.
It is recommended that patients on extended therapy with Octreotide Acetate Injection be evaluated at baseline and periodically (at about 6-month intervals) to assess the presence of PrOctreotide Acetate Injection Page 10 of 38 gallstones using ultrasound evaluations of the gallbladder and bile ducts (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests).
If complications of cholelithiasis are suspected, discontinue Octreotide Acetate Injection and treat appropriately. Liver Impairment In patients with liver cirrhosis, the half-life of the drug may be increased, necessitating adjustment of the maintenance dosage.
Monitoring and Laboratory Tests Laboratory tests that may be helpful as biochemical markers in determining and following patient response depend on the specific tumour. Based on diagnosis, measurement of the following substances may be useful in monitoring the progress of therapy: Carcinoid: 5-HIAA (urinary 5-hydroxyindole acetic acid), plasma serotonin, plasma Substance P VIPoma: VIP (plasma vasoactive intestinal peptide) Acromegaly: Growth hormone - IGF-1 (somatomedin C) Responsiveness to octreotide may be evaluated by determining growth hormone levels at 1-4 hour intervals for 8-12 hours after subcutaneous injection of Octreotide Acetate Injection.
Alternatively, a single measurement of IGF-1 (somatomedin C) level may be made two weeks after initiation of Octreotide Acetate Injection or dosage change. In patients with acromegaly, if no relevant reduction of GH and IGF 1 levels and no […]
1 Special Populations ............................................................................................... 11 8 ADVERSE REACTIONS .............................................................................................
1 Adverse Reaction Overview .................................................................................. 2 Clinical Trial Adverse Reactions ............................................................................ 3 Less Common Clinical Trial Adverse Reactions ....................................................
5 Post-Market Adverse Reactions ............................................................................ 18 9 DRUG INTERACTIONS .............................................................................................. 2 Drug interactions overview ....................................................................................
4 Drug-Drug Interactions .......................................................................................... 5 Drug-Food Interactions .......................................................................................... 6 Drug-Herb Interactions ..........................................................................................
7 Drug-Laboratory Test Interactions ......................................................................... 19 10 CLINICAL PHARMACOLOGY .................................................................................... 1 Mechanism of Action ......................................................................................
2 Pharmacodynamics ........................................................................................ 3 Pharmacokinetics ........................................................................................... 20 11 STORAGE, STABILITY AND DISPOSAL ...................................................................
21 12 SPECIAL HANDLING INSTRUCTIONS ...................................................................... 21 13 PHARMACEUTICAL INFORMATION ......................................................................... 22 14 CLINICAL TRIALS ......................................................................................................
23 15 MICROBIOLOGY ........................................................................................................ 23 16 NON-CLINICAL TOXICOLOGY ..................................................................................
23 SUPPORTING PRODUCT MONOGRAPHS ........................................................................... 31 PATIENT MEDICATION INFORMATION ............................................................................... 32 PrOctreotide Acetate Injection Page 3 of 38 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Octreotide Acetate Injection Solution for injection or infusion General Octreotide Acetate Injection (octreotide acetate) therapy is indicated for control of symptoms in patients with metastatic carcinoid and vasoactive intestinal peptide-secreting tumours (VIPomas) as well as in patients with acromegaly.
Data are insufficient to determine whether octreotide acetate decreases the size, rate of growth, or development of metastases in patients with these tumours. Octreotide Acetate Injection is also indicated for the prevention of complications following pancreatic surgery in patients undergoing high risk procedures.
Octreotide Acetate Injection is also indicated for the emergency management of bleeding gastro-oesophageal varices in patients with cirrhosis and as protection from re-bleeding. Octreotide Acetate Injection is used in association with specific intervention such as endoscopic sclerotherapy.
Carcinoid Tumours Octreotide Acetate Injection is indicated for the symptomatic treatment of metastatic carcinoid tumours where it suppresses or inhibits the severe diarrhoea and flushing episodes associated with the […]