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Kytril Injection (Granisetron Hydrochloride) - Summary

 



SUMMARY

KYTRIL®
(granisetron hydrochloride)
INJECTION

KYTRIL (granisetron hydrochloride) Injection is an antinauseant and antiemetic agent.

KYTRIL Injection is indicated for:

  • The prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.
  • The prevention and treatment of postoperative nausea and vomiting. As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided during the postoperative period, KYTRIL Injection is recommended even where the incidence of postoperative nausea and/or vomiting is low.

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NEWS HIGHLIGHTS

Media Articles Related to Kytril Injection (Granisetron)

granisetron transdermal system (patch), Sancuso
Source: MedicineNet Antiemetics Specialty [2008.12.10]
Title: granisetron transdermal system (patch), Sancuso
Category: Medications
Created: 12/10/2008
Last Editorial Review: 12/10/2008

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Published Studies Related to Kytril Injection (Granisetron)

Randomized controlled study comparing two doses of intravenous granisetron (1 and 3 mg) for acute chemotherapy-induced nausea and vomiting in cancer patients: a non-inferiority trial. [2009.07]
OBJECTIVE: The aim of this study was to assess the non-inferiority of 1 mg to 3 mg granisetron (GRN) injection for the treatment of acute chemotherapy-induced nausea and vomiting (CINV) and to evaluate the tolerability of GRN given at 1 mg in Japanese cancer patients... CONCLUSIONS: Our data failed to show the non-inferiority of 1 mg of GRN to 3 mg of GRN administered as a single dose. However, the rate of complete protection from nausea and vomiting was similar in the two groups. Given the recommended dosage in the guidelines and the economic need for reduction of medical care expenses in Japan, prophylactic administration of GRN at 1 mg may be an appropriate, alternative treatment for acute CINV in cancer patients.

A randomized, double-blinded comparison of ondansetron, granisetron, and placebo for prevention of postoperative nausea and vomiting after supratentorial craniotomy. [2009.07]
Postoperative nausea and vomiting (PONV) are frequent and distressing complications after neurosurgical procedures... However, neither drugs prevented nausea effectively.

Does granisetron eliminate the gag reflex? A crossover, double-blind, placebo-controlled pilot study. [2009.03]
Although gagging is a frequent problem that, when severe, can jeopardize the dental procedure, no single protocol is used to alleviate this phenomenon... The true efficacy of granisetron in gagger patients with this treatment protocol has yet to be fully established, although it has been theorized that an increased dosage of granisetron may have a better effect.

Enhanced tolerability of the 5-hydroxytryptophane challenge test combined with granisetron. [2008.11.21]
AbstractA recently developed oral serotonergic challenge test consisting of 5-Hydroxytryptophane (5-HTP, 200 mg) combined with carbidopa (CBD, 100 mg + 50 mg) exhibited dose-related neuroendocrine responsiveness and predictable pharmacokinetics. However, its applicability is limited by nausea and vomiting...

Enhanced tolerability of the 5-hydroxytryptophane challenge test combined with granisetron. [2008.08.21]
Abstract A recently developed oral serotonergic challenge test consisting of 5-Hydroxytryptophane (5-HTP, 200 mg) combined with carbidopa (CBD, 100 mg + 50 mg) exhibited dose-related neuroendocrine responsiveness and predictable pharmacokinetics. However, its applicability is limited by nausea and vomiting...

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Clinical Trials Related to Kytril Injection (Granisetron)

A Study of Kytril (Granisetron) in the Prevention of Post-Operative Nausea and Vomiting (PONV) in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy [Active, not recruiting]
This 2 arm study will evaluate the efficacy and safety of a single intravenous injection of Kytril in preventing PONV in children. Patients will be randomized to receive a single dose of either 20 micrograms or 40 micrograms Kytril iv 15 minutes prior to the end of surgery with general anesthesia for tonsillectomy or adenotonsillectomy. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients [Completed]
Objective: to evaluate the bioavailability of subcutaneous granisetron. Patients receiving platinum-based chemotherapy will be randomized to receive granisetron 3 mg either subcutaneously or intravenously in a crossover manner during two cycles. Blood and urine samples will be collected after each cycle.

The Antigagging Effect of Granisetron (Kytril), an Antiemetic Drug, in Dental Situations [Not yet recruiting]
Antigagging effect of kytril (granisetron) an antiemetic drug in dental situations

Gagging in dental situations can be a problem to the patient and the operating dentist. There are not proven methods of eliminating this reflex which sometimes will not allow routine quality dental care.

Pharmacological and behavioral approaches to eliminate this reflex have been tried with limited success.

This suggested study will test a potent antiemetic drug used in other clinical situations such as antineoplastic treatment. Granisetron is a potential antagonist for the

5-hydroxytryptamine3-receptor - 5HT(3), The drug binds to the receptor and blocks the effect

of nausea and vomiting. Kytril mechanism of action was successfully proven for various medical situations as a potential antiemetic agent. Our Center for dental sedation and anesthesia in the oral medicine department have received approval to use Granisetron as an antigagging drug in dental situations based on several pilot studies conducted in other medical centers in different clinical situations such as strabismus corrections, post hysterectomy and others. Our preliminary clinical impression is that pre-emptive IV administration of this drug to patients with increased gag reflex is beneficial.

In our research we try to investigate the possibility of using kytril in dental situations.

In the first stage of this research we will study the INTRAVENOUS use of this drug and its effects On normal subjects compare them to themselves with placebo. According to the results of this study we will go on to the second stage of the research and try the same drug under oral administration.

The purpose of this study is to test the antigagging effect of this drug in a controlled manner in dental situations.

Our working hypothesis is that administration of this drug in dental situations with success, will allow many patients to receive good dental care

A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fed Conditions [Completed]
The objective of this study was to assess bioequivalence of a potential generic 1 mg granisetron tablet formulation compared with Roche Laboratories' 1 mg granisetron tablet, Kytril, following a single 1 mg dose, under fed conditions.

A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fasting Conditions [Completed]
The objective of this study was to assess bioequivalence of a potential generic 1 mg granisetron tablet formulation compared with Roche Laboratories' 1 mg granisetron tablet, Kytril, following a single 1 mg dose, under fasting conditions.

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Page last updated: 2009-10-20

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