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GRANISETRON HYDROCHLORIDE is a brand name for Granisetron, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE .................................................................................. 3 CONTRAINDICATIONS ....................................................................................................... 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Adverse Drug Reaction Overview The most common adverse events reported by patients receiving intravenous granisetron hydrochloride in single-day chemotherapy trials are: headache, asthenia, somnolence, diarrhea, constipation, and abdominal pain (see Table 1 for the percentages of patients with these events).
The only two common adverse experiences recognized to be causally related to granisetron hydrochloride are constipation and headache. As for other 5-HT3 antagonists, cases of ECG modifications including QT prolongation have been reported with granisetron hydrochloride.
These ECG changes with granisetron hydrochloride were minor and generally not of clinical significance, specifically with no evidence of proarrhythmia (see WARNINGS AND PRECAUTIONS, Cardiovascular, DRUG INTERACTIONS, and ADVERSE REACTIONS, Post-marketing Reports of Adverse Events).
Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Chemotherapy-induced Nausea and Vomiting Intravenous granisetron hydrochloride was given as a single dose.
Patients received cancer chemotherapy which consisted primarily of cisplatin or cyclophosphamide regimens. V fluids were also given. Adverse events were recorded over seven days when granisetron hydrochloride was given on a single day and up to 28 days when granisetron hydrochloride was administered for 7 or 14 days.
In the absence of a placebo group, the relationship of observed adverse events to treatment with granisetron hydrochloride is difficult to judge. Table 1 gives the frequencies of the six adverse events most commonly reported by patients receiving intravenous granisetron hydrochloride in single-day chemotherapy trials.
This table does not include those events that are commonly associated with chemotherapy or the underlying malignant disease. Table 1. Principal Adverse Events in Clinical Trials of Single-Day Chemotherapy Percentage of Patients with Event Intravenous granisetron hydrochloride (10-40 mcg/kg) (n=1519) Headache 14% Asthenia 5% Page 7 of 25 Percentage of Patients with Event Intravenous granisetron hydrochloride (10-40 mcg/kg) (n=1519) Somnolence 4% Diarrhea 5% Constipation 4% Abdominal Pain 3% The only two common adverse experiences recognized to be causally related to granisetron hydrochloride are constipation and headache.
Carcinogenesis and Mutagenesis Granisetron hydrochloride has been associated with an increased occurrence of hepatocellular tumours in carcinogenicity studies performed in rodents at doses in excess of the recommended human dose. Although the clinical significance of these findings has not been determined, the use of this drug should be restricted to the treatment of nausea and vomiting in patients undergoing emetogenic cancer chemotherapy.
The recommended dosage of GRANISETRON HYDROCHLORIDE INJECTION USP should not be exceeded. Granisetron was administered to rats in the diet in a 24-month carcinogenicity study. The incidence of hepatocellular carcinomas and adenomas was significantly increased in male rats treated at doses of 5 mg/kg/day and in rats of both sexes treated with 25 mg/kg/day.
No increase in the rate of occurrence of liver tumours was observed in the 1 mg/kg/day treatment group (100 times the recommended human dose given intravenously). In another 24-month carcinogenicity study, mice were administered granisetron in the diet at doses of 1, 5, and 50 mg/kg/day.
There was a statistically significant increase in the incidence of hepatocellular carcinomas in males and hepatocellular adenomas in females dosed with 50 mg/kg/day. No statistically significant increase in liver tumours was observed in mice at a dose of 5 mg/kg/day (500 times the recommended human dose given intravenously).
Cardiovascular As for other 5-HT3 antagonists, cases of ECG modifications including QT prolongation have been reported with granisetron hydrochloride. These ECG changes with granisetron hydrochloride were minor and generally not of clinical significance, specifically with no evidence of proarrhythmia.
However, in patients with pre-existing arrhythmias or cardiac conduction disorders, this might lead to clinical consequences. Therefore, caution should be exercised in patients with cardiac co-morbidities, on cardio-toxic chemotherapy and/or with concomitant electrolyte abnormalities.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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g. anaphylaxis, shortness of breath, hypotension, urticaria) have been reported. Less Common Clinical Trial Adverse Drug Reactions (≤ 1%) Chemotherapy-induced Nausea and Vomiting The safety profile of granisetron hydrochloride has been evaluated in 3269 patients receiving intravenous granisetron hydrochloride (2 to 160 mcg/kg) in single-day and multiple-day clinical trials with emetogenic cancer therapies.
In the listings which follow, a COSTART-based dictionary terminology has been used to classify reported adverse experiences. The frequencies presented, therefore, represent the proportion of the patients who experienced an event of the type cited on at least one occasion while receiving granisetron hydrochloride.
Experiences are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: Frequent experiences are defined as: those occurring on one or more occasion in at least 1/100 patients Infrequent adverse experiences are defined as: those occurring in less than 1/100 but at least 1/1000 patients Rare experiences are defined as: those occurring in less than 1/1000 patients Many adverse experiences are observed in cancer chemotherapy patients.
All adverse experiences are included except those for which the drug cause was remote, those reported in general terms that are uninformative and those already listed in Table 1.
Body As A Whole:
Frequent: Abdominal pain Infrequent: Abdomen enlarged, chills, fever, malaise Rare: Allergic reaction, chest pain Cardiovascular System: Infrequent: Hypertension, hypotension, migraine, syncope, vasodilatation Rare: Arrhythmia, bradycardia, palpitation, postural hypotension, tachycardia, ventricular arrhythmia, angina pectoris, and atrial fibrillation Page 8 of 25 Gastrointestinal System: Frequent: Decreased appetite Infrequent: Dry mouth, dyspepsia, flatulence, jaundice, liver function tests abnormal [Elevation of AST and ALT (>2 times the upper limit of normal)], nausea Rare: Gastrointestinal haemorrhage, hepatic coma, ileus, liver damage, melena, vomiting Hemic and Lymphatic System: Rare: Coagulation time increased, eosinophilia, leukopenia, anemia, thrombocytopenia Metabolic and Nutritional: Infrequent: Hypokalemia Rare: Bilirubinemia, edema, hyperphosphatemia, hyponatremia Nervous System: Infrequent: Agitation, anxiety, dizziness, drugged feeling, insomnia, nervousness, paresthesia, tremor Rare: Coma, depersonalisation, grand mal convulsion, vertigo Respiratory System: Infrequent: Dyspnea, hiccup Rare: Epistaxis, rhinitis, sinusitis Skin and Appendages: Infrequent: Pruritus, rash, sweating Rare: Photosensitivity Special Searches: Rare: Puncture site pain Special Senses: Infrequent: Taste perversion Rare: Abnormal vision Urogenital System: Infrequent: Dysuria Rare: Urinary incontinence Post-marketing Reports of Adverse Events The post-marketing safety experience in over 4 million patients is consistent with the clinical trial safety information.
Cases of cardiac arrest, ventricular fibrillation, ventricular tachycardia, ECG QT prolonged, sudden death and syncope were […]
See also DRUG INTERACTIONS and ADVERSE REACTIONS, Post-marketing Reports of Adverse Events. Gastrointestinal GRANISETRON HYDROCHLORIDE INJECTION USP is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction.
The use of GRANISETRON HYDROCHLORIDE INJECTION USP in patients with chemotherapy- induced nausea and vomiting may mask a progressive ileus and/or gastric distension. Patients with signs of sub-acute intestinal obstruction should be monitored following administration of GRANISETRON HYDROCHLORIDE INJECTION USP.
Sensitivity/Resistance Hypersensitivity reactions may occur in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists. Serotonin Syndrome/Neuroleptic Malignant Syndrome-like Events Page 5 of 25 Cases of life-threatening serotonin syndrome have been reported with 5-HT3 receptor antagonist antiemetics, including granisetron hydrochloride, particularly when given in combination with other serotonergic and/or neuroleptic drugs.
, nausea, vomiting, diarrhea). As this syndrome may result in potentially life-threatening conditions, treatment should be discontinued if such events occur and supportive symptomatic treatment should be initiated. If concomitant treatment of GRANISETRON HYDROCHLORIDE INJECTION USP with a drug affecting the serotonergic neurotransmitter system is clinically warranted, careful observations of the patient is advised, particularly during treatment initiation and dose increases (see DRUG INTERACTIONS).
Special Populations Pregnant Women:
The use of granisetron hydrochloride in pregnant women has not been studied and is not recommended. Reproduction studies performed in pregnant rats given granisetron at intravenous dosages up to 9 mg/kg/day and pregnant rabbits at intravenous dosage up to 3 mg/kg/day revealed no evidence of impaired fertility or harm to the fetus due to granisetron (see TOXICOLOGY, Reproduction).
Nursing Women:
It is not known whether granisetron is excreted in human milk. Nursing is not recommended during treatment with GRANISETRON HYDROCHLORIDE INJECTION USP.
Pediatrics:
The safety and efficacy of granisetron hydrochloride has not been adequately studied in children or adolescents under 18 years of age (see INDICATIONS AND CLINICAL USES and DOSAGE AND ADMINISTRATION).
Geriatrics (> 65 years of age):
During clinical trials, 713 patients 65 years of age or older received intravenous granisetron hydrochloride and of 325 patients 65 years of age or older who received oral granisetron hydrochloride, 298 were 65 to 74 years of age and 27 were 75 years of age or older.
The efficacy and safety of granisetron hydrochloride did not appear to be age dependent (see INDICATIONS AND CLINICAL USES and DOSAGE AND ADMINISTRATION). Information for Patients Effect on Ability to Drive and Use Machinery In healthy subjects, no clinically relevant effects on resting EEG or on the performance of psychometric tests were observed after IV granisetron hydrochloride at any dose tested (up to 200 mcg/kg).
There are no data on the effect of granisetron hydrochloride on the ability to drive. As there have been occasional reports of somnolence in clinical studies, patients should be advised to avoid driving a car or operating hazardous machinery until they are reasonably certain that the drug treatment does not affect them adversely.
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