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OCTREOTIDE is a brand name for Octreotide, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics 03/2023 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 .................................................................
4 1. INDICATIONS ............................................................................................................................. 1 Pediatrics ....................................................................................................................................
2 Geriatrics .................................................................................................................................... 5 2. CONTRAINDICATIONS ............................................................................................................
5 4. DOSAGE AND ADMINISTRATION ........................................................................................ 1 Dosing Considerations ...............................................................................................................
2 Recommended Dose and Dosage Adjustment ........................................................................... 3 Reconstitution: ...........................................................................................................................
5 Missed Dose ............................................................................................................................... 7 5. OVERDOSAGE ............................................................................................................................
7 6. DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ........................... 8 7. WARNINGS AND PRECAUTIONS .......................................................................................... 1 Special Populations ..................................................................................................................
1. Pregnant Women ............................................................................................................. 2. Breast-feeding..................................................................................................................
3. Pediatrics ......................................................................................................................... 4. Geriatrics .........................................................................................................................
13 8. ADVERSE REACTIONS .......................................................................................................... 1 Adverse Reaction Overview .....................................................................................................
). Endocrine and Metabolism • Glucose Metabolism OCTREOTIDE INJECTION therapy is occasionally associated with mild transient hypo- or hyperglycemia 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 INJECTION therapy and at each change of dosage for symptomatic evidence of hyper- and hypoglycemia. Insulin requirement of patients with type I diabetes mellitus may be reduced by administration of OCTREOTIDE INJECTION .
In non-diabetics and type II diabetics with partially intact insulin reserves, OCTREOTIDE INJECTION administration can result in prandial increases in glycemia. Severe hyperglycemia, subsequent pneumonia, and death following initiation of OCTREOTIDE INJECTION therapy was reported in one patient with no history of hyperglycemia.
Predicting the effect of OCTREOTIDE INJECTION on glucose tolerance in any given patients is not possible at this time. c. 10 Since following bleeding episodes from esophageal 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. • Thyroid function Data on the effect of chronic therapy with Octreotide Acetate Injection on hypothalamic/pituitary function have not been obtained. c. daily. Minimal impairment of thyroid function was recorded in some acromegalic patient following treatment with Octreotide acetate long-acting release.
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 Injection therapy may alter absorption of dietary fats in some patients.
, Monitoring and Laboratory Tests). , administered subcutaneously, for 7 consecutive days starting on the day of the operation at least one hour before laparatomy. v. infusion for 48 hours. In patients with high risk of re-bleeding, infusion should be maintained up to a maximum of 5 days.
Immediately prior to use, the contents of the single-use or multidose vial should be diluted in physiological saline. The volume of dilution will depend on the infusion system used and should be adjusted to ensure a continuous infusion of OCTREOTIDE INJECTION at the recommended rate.
Once diluted, the solution should be used within 24 hours. Discard unused portion. v. admixtures should be inspected visually for clarity, particulate matter, precipitation, discoloration and leakage prior to administration, whenever solution and container permit.
v. infusion: Immediately prior to use, the contents of the single-use vial or multidose vial should be diluted in physiological saline. The volume of dilution will depend on the infusion system used and should be adjusted to ensure a continuous infusion of OCTREOTIDE INJECTION at a rate of 25 mcg/hour.
v. admixtures should be inspected visually for clarity, particulate matter, precipitation, discoloration and leakage prior to administration, whenever solution and container permit. OCTREOTIDE INJECTION diluted in physiological saline is stable for 24 hours when stored at room temperature.
Discard unused portion. Octreotide acetate is not stable in Total Parenteral Nutrition (TPN) solutions. It is generally not recommended to mix other medicinal products with octreotide in the same infusion bag or in the same cannula. g.
with pantoprazole). 5 Missed Dose OCTREOTIDE INJECTION Solution for injection or Infusion If an injection is missed, the dose should not be doubled at the next injection. 5. OVERDOSAGE OCTREOTIDE INJECTION (Solution for Injection or Infusion) A limited number of accidental overdoses of Octreotide Acetate Injection in adults and children have been reported.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Octreotide in Canada.
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2 Clinical Trial Adverse Drug 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 ........................................................................................... 20 10. CLINICAL PHARMACOLOGY .........................................................................................
1 Mechanism of Action ........................................................................................................... 2 Pharmacodynamics ..............................................................................................................
3 Pharmacokinetics ................................................................................................................. 21 11. STORAGE, STABILITY AND DISPOSAL ........................................................................
21 12. SPECIAL HANDLING INSTRUCTIONS .......................................................................... 21 13. PHARMACEUTICAL INFORMATION ............................................................................ 22 14. CLINICAL TRIALS ..............................................................................................................
1 Trial Design and Study Demographics ................................................................................ 23 15. MICROBIOLOGY.................................................................................................................
23 16. NON-CLINICAL TOXICOLOGY […]
It is suggested that periodic quantitative 72-hour fecal fat and serum carotene determinations be performed to aid in the assessment of possible drug-induced aggravation of fat malabsorption. 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 Injection.
be evaluated at baseline and periodically (at about 6-month intervals) to assess the presence of 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 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 tumor. 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 INJECTION . Alternatively, a single measurement of IGF-1 (somatomedin C) level may be made two weeks after initiation of OCTREOTIDE INJECTION Injection or dosage change.
In patients with acromegaly, […]
). The adverse events reported were arrhythmia, hypotension, cardiac arrest, brain hypoxia, pancreatitis, hepatitis steatosis, diarrhoea, weakness, lethargy, weight loss, hepatomegaly, and lactic acidosis. Atrioventricular blocks (including complete atrioventricular block) were reported in patients receiving higher doses of continuous infusion (100 mcg/hr) and/or bolus of OCTREOTIDE INJECTION intravenously (50 mcg bolus) followed by 50 mcg/hr continuous infusion.
1-500 mcg/hour) or subcutaneously (50-100 mcg). The only adverse event reported was mild hyperglycaemia. 8 No unexpected adverse events have been reported in cancer patients receiving Octreotide Acetate Injection at doses of 3,000-30,000 mcg/day in divided doses subcutaneously.
The management of overdosage is symptomatic. 6. s. s. 2 OCTREOTIDE INJECTION - Single dose and Multidose Vials OCTREOTIDE INJECTION (octreotide acetate) single dose is supplied in 2-mL vials, each containing 50, 100 or 500 mcg in 1-mL of octreotide as acetate.
OCTREOTIDE INJECTION is available in boxes of 5 vials. OCTREOTIDE INJECTION is also available in 5 mL multidose vials. Each vial contains 1000 mcg of octreotide as acetate (200 mcg/mL). OCTREOTIDE INJECTION is available in boxes of 1 vial.
7. WARNINGS AND PRECAUTIONS General Sudden escape from symptomatic control by OCTREOTIDE INJECTION (octreotide acetate) may occur infrequently, with rapid recurrence of severe symptoms. Dosage adjustment therefore may be required. g. c.
be carefully monitored. If evidence of tumour expansion appears, alternative procedures may be advisable. For management of a suspected drug overdose, contact your regional poison control centre. 9 Octreotide alters the balance between the counter-regulatory hormones, insulin, glucagon and growth hormone, which may result in hypoglycemia or hyperglycemia.
Octreotide also suppresses secretion of thyroid stimulating hormone, which may result in hypothyroidism. Cardiac conduction abnormalities have also occurred during treatment with octreotide. […]