Granisetron Hydrochloride (Granisetron Hydrochloride)

Trade Name : Granisetron Hydrochloride

West-Ward Pharmaceuticals Corp.

TABLET

Strength 1 mg/1

GRANISETRON HYDROCHLORIDE Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Granisetron Hydrochloride (Granisetron Hydrochloride) which is also known as Granisetron Hydrochloride and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 1 mg/1 per ml. Read more

Granisetron Hydrochloride (Granisetron Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

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Granisetron hydrochloride tablets contain granisetron hydrochloride USP, an antinauseant and antiemetic agent. Chemically it is -N-(9-methyl-9-azabicyclo [3.3.1] non-3-yl)-1-methyl-1H-indazole-3-carboxamide hydrochloride with a molecular weight of 348.9 (312.4 free base). Its molecular formula is CHNOu2022HCl, while its chemical structure is:
Granisetron hydrochloride is a white to almost white powder that is readily soluble in water and normal saline at 20u00baC.
Tablets for Oral Administration
Granisetron hydrochloride tablets are available for oral administration containing 1.12 mg granisetron hydrochloride USP equivalent to granisetron, 1 mg. Each tablet contains the following inactive ingredients: hypromellose, lactose (anhydrous), magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

Granisetron is a selective 5-hydroxytryptamine (5-HT) receptor antagonist with little or no affinity for other serotonin receptors, including 5-HT; 5-HT; 5-HT; 5-HT; for alpha, alpha, or beta-adrenoreceptors; for dopamine-D; or for histamine-H; benzodiazepine; picrotoxin or opioid receptors.
Serotonin receptors of the 5-HT type are located peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. During chemotherapy that induces vomiting, mucosal enterochromaffin cells release serotonin, which stimulates 5-HT receptors. This evokes vagal afferent discharge, inducing vomiting. Animal studies demonstrate that, in binding to 5-HT receptors, granisetron blocks serotonin stimulation and subsequent vomiting after emetogenic stimuli such as cisplatin. In the ferret animal model, a single granisetron injection prevented vomiting due to high-dose cisplatin or arrested vomiting within 5 to 30 seconds.
In most human studies, granisetron has had little effect on blood pressure, heart rate or ECG. No evidence of an effect on plasma prolactin or aldosterone concentrations has been found in other studies.
Following single and multiple oral doses, granisetron hydrochloride tablets slowed colonic transit in normal volunteers. However, granisetron had no effect on oro-cecal transit time in normal volunteers when given as a single intravenous (IV) infusion of 50 mcg/kg or 200 mcg/kg.
Pharmacokinetics
In healthy volunteers and adult cancer patients undergoing chemotherapy, administration of granisetron tablets produced mean pharmacokinetic data shown in .
Absorption
When granisetron tablets were administered with food, AUC was decreased by 5% and C increased by 30% in non-fasted healthy volunteers who received a single dose of 10 mg.
Distribution
Plasma protein binding is approximately 65% and granisetron distributes freely between plasma and red blood cells.
Metabolism
Granisetron metabolism involves N-demethylation and aromatic ring oxidation followed by conjugation. liver microsomal studies show that granisetron's major route of metabolism is inhibited by ketoconazole, suggestive of metabolism mediated by the cytochrome P-450 3A subfamily. Animal studies suggest that some of the metabolites may also have 5-HT receptor antagonist activity.
Elimination
Clearance is predominantly by hepatic metabolism. In normal volunteers, approximately 11% of the orally administered dose is eliminated unchanged in the urine in 48 hours. The remainder of the dose is excreted as metabolites, 48% in the urine and 38% in the feces.
Subpopulations
Gender
The effects of gender on the pharmacokinetics of granisetron tablets have not been studied. However, after intravenous infusion of granisetron, no difference in mean AUC was found between males and females, although males had a higher C generally.
In elderly and pediatric patients and in patients with renal failure or hepatic impairment, the pharmacokinetics of granisetron was determined following administration of intravenous granisetron.
Elderly
The ranges of the pharmacokinetic parameters in elderly volunteers (mean age 71 years), given a single 40 mcg/kg intravenous dose of granisetron injection, were generally similar to those in younger healthy volunteers; mean values were lower for clearance and longer for half-life in the elderly.
Renal Failure Patients
Total clearance of granisetron was not affected in patients with severe renal failure who received a single 40 mcg/kg intravenous dose of granisetron injection.
Hepatically Impaired Patients
A pharmacokinetic study with intravenous granisetron in patients with hepatic impairment due to neoplastic liver involvement showed that total clearance was approximately halved compared to patients without hepatic impairment. Given the wide variability in pharmacokinetic parameters noted in patients, dosage adjustment in patients with hepatic functional impairment is not necessary.
Pediatric Patients
A pharmacokinetic study in pediatric cancer patients (2 to 16 years of age), given a single 40 mcg/kg intravenous dose of granisetron injection, showed that volume of distribution and total clearance increased with age. No relationship with age was observed for peak plasma concentration or terminal phase plasma half-life. When volume of distribution and total clearance are adjusted for body weight, the pharmacokinetics of granisetron are similar in pediatric and adult cancer patients.

Chemotherapy-Induced Nausea and Vomiting
Granisetron tablets prevent nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, as shown by 24-hour efficacy data from studies using both moderately- and highly-emetogenic chemotherapy.
Moderately Emetogenic Chemotherapy
The first trial compared granisetron tablets doses of 0.25 mg to 2 mg twice a day, in 930 cancer patients receiving, principally, cyclophosphamide, carboplatin, and cisplatin (20 mg/m to 50 mg/m). Efficacy was based on complete response (ie, no vomiting, no moderate or severe nausea, no rescue medication), no vomiting, and no nausea. summarizes the results of this study.
Results from a second double-blind, randomized trial evaluating granisetron tablets 2 mg once a day and granisetron tablets 1 mg twice a day were compared to prochlorperazine 10 mg twice a day derived from a historical control. At 24 hours, there was no statistically significant difference in efficacy between the two granisetron tablet regimens. Both regimens were statistically superior to the prochlorperazine control regimen (see ).
Results from a granisetron tablets 2 mg daily alone treatment arm in a third double-blind, randomized trial, were compared to prochlorperazine (PCPZ), 10 mg bid, derived from a historical control. The 24-hour results for granisetron tablets 2 mg daily were statistically superior to PCPZ for all efficacy parameters: complete response (58%), no vomiting (79%), no nausea (51%), total control (49%). The PCPZ rates are shown in .
Cisplatin-Based Chemotherapy
The first double-blind trial compared granisetron tablets 1 mg bid, relative to placebo (historical control), in 119 cancer patients receiving high-dose cisplatin (mean dose 80 mg/m). At 24 hours, granisetron tablets 1 mg bid was significantly (p<0.001) superior to placebo (historical control) in all efficacy parameters: complete response (52%), no vomiting (56%) and no nausea (45%). The placebo rates were 7%, 14%, and 7%, respectively, for the three efficacy parameters.
Results from a granisetron tablets 2 mg once a day alone treatment arm in a second double-blind, randomized trial, were compared to both granisetron tablets 1 mg twice a day and placebo historical controls. The 24-hour results for granisetron tablets 2 mg once a day were: complete response (44%), no vomiting (58%), no nausea (46%), total control (40%). The efficacy of granisetron tablets 2 mg once a day was comparable to granisetron tablets 1 mg twice a day and statistically superior to placebo. The placebo rates were 7%, 14%, 7%, and 7%, respectively, for the four parameters.
No controlled study comparing granisetron injection with the oral formulation to prevent chemotherapy-induced nausea and vomiting has been performed.
Radiation-Induced Nausea and Vomiting
Total Body Irradiation
In a double-blind randomized study, 18 patients receiving granisetron tablets, 2 mg daily, experienced significantly greater antiemetic protection compared to patients in a historical negative control group who received conventional (non-5-HT antagonist) antiemetics. Total body irradiation consisted of 11 fractions of 120 cGy administered over 4 days, with three fractions on each of the first 3 days, and two fractions on the fourth day. Granisetron tablets were given one hour before the first radiation fraction of each day.
Twenty-two percent (22%) of patients treated with granisetron tablets did not experience vomiting or receive rescue antiemetics over the entire 4-day dosing period, compared to 0% of patients in the historical negative control group (p<0.01).
In addition, patients who received granisetron tablets also experienced significantly fewer emetic episodes during the first day of radiation and over the 4-day treatment period, compared to patients in the historical negative control group. The median time to first emetic episode was 36 hours for patients who received granisetron tablets.
Fractionated Abdominal Radiation
The efficacy of granisetron tablets, 2 mg daily, was evaluated in a double-blind, placebo-controlled randomized trial of 260 patients. Granisetron tablets were given 1 hour before radiation, composed of up to 20 daily fractions of 180 to 300 cGy each. The exceptions were patients with seminoma or those receiving whole abdomen irradiation who initially received 150 cGy per fraction. Radiation was administered to the upper abdomen with a field size of at least 100 cm.
The proportion of patients without emesis and those without nausea for granisetron tablets, compared to placebo, was statistically significant (p<0.0001) at 24 hours after radiation, irrespective of the radiation dose. Granisetron was superior to placebo in patients receiving up to 10 daily fractions of radiation, but was not superior to placebo in patients receiving 20 fractions.
Patients treated with granisetron tablets (N=134) had a significantly longer time to the first episode of vomiting (35 days vs. 9 days, p<0.001) relative to those patients who received placebo (N=126), and a significantly longer time to the first episode of nausea (11 days vs. 1 day, p<0.001). Granisetron provided significantly greater protection from nausea and vomiting than placebo.

Granisetron hydrochloride tablets are indicated for the prevention of:

Granisetron hydrochloride is contraindicated in patients with known hypersensitivity to the drug or any of its components.

Serotonin Syndrome
The development of serotonin syndrome has been reported with 5-HT receptor antagonists. Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). Some of the reported cases were fatal. Serotonin syndrome occurring with overdose of another 5-HT receptor antagoinist alone has also been reported. The majority of reports of serotonin syndrome related to 5-HT receptor antagonist use occurred in a post-anesthesia care unit or an infusion center.
Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, with or without gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome, especially with concomitant use of granisetron and other serotonergic drugs. If symptoms of serotonin syndrome occur, discontinue granisetron and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if granisetron is used concomitantly with other serotonergic drugsn

Granisetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of granisetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distention.
An adequate QT assessment has not been conducted, but QT prolongation has been reported with granisetron. Therefore, granisetron should be used with caution in patients with pre-existing arrhythmias or cardiac conduction disorders, as this might lead to clinical consequences. Patients with cardiac disease, on cardio-toxic chemotherapy, with concomitant electrolyte abnormalities and/or on concomitant medications that prolong the QT interval are particularly at risk.

QT prolongation has been reported with granisetron .
Chemotherapy-Induced Nausea and Vomiting
Over 3700 patients have received granisetron tablets in clinical trials with emetogenic cancer therapies consisting primarily of cyclophosphamide or cisplatin regimens.
In patients receiving granisetron tablets 1 mg bid for 1, 7 or 14 days, or 2 mg daily for 1 day, adverse experiences reported in more than 5% of the patients with comparator and placebo incidences are listed in .
Other adverse events reported in clinical trials were:
Gastrointestinal:
Hepatic:
Cardiovascular:
Central Nervous System:
Hypersensitivity:
Other:
Over 5000 patients have received injectable granisetron in clinical trials.
Table 5
In the absence of a placebo group, there is uncertainty as to how many of these events should be attributed to granisetron, except for headache, which was clearly more frequent than in comparison groups.
Radiation-Induced Nausea and Vomiting
In controlled clinical trials, the adverse events reported by patients receiving granisetron tablets and concurrent radiation were similar to those reported by patients receiving granisetron tablets prior to chemotherapy. The most frequently reported adverse events were diarrhea, asthenia, and constipation. Headache, however, was less prevalent in this patient population.
Postmarketing Experience
QT prolongation has been reported with granisetron and .

There is no specific treatment for granisetron hydrochloride overdosage. In case of overdosage, symptomatic treatment should be given. Overdosage of up to 38.5 mg of granisetron hydrochloride injection has been reported without symptoms or only the occurrence of a slight headache.

Emetogenic Chemotherapy
The recommended adult dosage of oral granisetron hydrochloride is 2 mg once daily or 1 mg twice daily. In the 2 mg once-daily regimen, two 1 mg tablets are given up to 1 hour before chemotherapy. In the 1 mg twice-daily regimen, the first 1 mg tablet is given up to 1 hour before chemotherapy, and the second tablet, 12 hours after the first. Either regimen is administered only on the day(s) chemotherapy is given. Continued treatment, while not on chemotherapy, has not been found to be useful.
Use in the Elderly, Renal Failure Patients or Hepatically Impaired Patients
No dosage adjustment is recommended .
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Radiation (Either Total Body Irradiation or Fractionated Abdominal Radiation)
The recommended adult dosage of oral granisetron is 2 mg once daily. Two 1 mg tablets or are taken within 1 hour of radiation.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Use in the Elderly
No dosage adjustment is recommended.

Granisetron Hydrochloride Tablets USP
1 mg tablets are supplied as round, white, biconvex tablet, debossed with u201c54 922u201d on one side and plain on the other side
NDC 0054-0143-87: Bottle of 2 Tablets
NDC 0054-0143-07: Bottle of 20 Tablets
NDC 0054-0143-08: 2x10 Unit-Dose
Storage
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.] Keep container closed tightly. Protect from light.

Advise patients of the possibility of serotonin syndrome with concomitant use of granisetron and another serotonergic agent such as medications to treat depression and migraines. Advise patients to seek immediate medical attention if the following symptoms occur: changes in mental status, autonomic instability, neuromuscular symptoms with or without gastrointestinal symptoms.
Distr. by: n
Eatontown, NJ 07724
10005496/07
Revised August 2016

NDC 0054-0143-87

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Granisetron Hydrochloride (Granisetron Hydrochloride)

Trade Name : Granisetron Hydrochloride

TABLET

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

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Granisetron Hydrochloride (Granisetron Hydrochloride)

Trade Name : Granisetron Hydrochloride

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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