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NAT-GRANISETRON is a brand name for Granisetron, supplied as a tablet. 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 .............................................................................. 4…
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 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 Oral granisetron hydrochloride was given either as a single dose or divided dose for 1, 7, or 14 days.
Patients received cancer chemotherapy which consisted primarily of cisplatin or cyclophosphamide regimens. 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 oral 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. 0 mg once daily) (n=1322) Headache 22% Asthenia 15% Somnolence 2% Diarrhea 8% Constipation 17% Abdominal Pain 6% Page 7 of 27 27 The only two common adverse experiences recognized to be causally related to granisetron hydrochloride are constipation and headache.
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g. anaphylaxis, shortness of breath, hypotension, urticaria) have been reported. Radiation-Induced Nausea and Vomiting In controlled clinical trials, the adverse events reported by patients receiving granisetron hydrochloride tablets and concurrent radiation were similar to those reported by patients receiving granisetron hydrochloride tablets prior to chemotherapy.
5%). 7%), however, was less prevalent in this patient population. Table 2 lists the adverse experiences (>5%) in patients who received granisetron hydrochloride tablets or placebo. 25 - 20 mg) 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. Page 8 of 27 27 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 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: […]