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Kytril Injection (Granisetron Hydrochloride) - Summary



(granisetron hydrochloride)

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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Published Studies Related to Kytril Injection (Granisetron)

Comparison of an extended-release formulation of granisetron (APF530) versus palonosetron for the prevention of chemotherapy-induced nausea and vomiting associated with moderately or highly emetogenic chemotherapy: results of a prospective, randomized, double-blind, noninferiority phase 3 trial. [2015]
highly emetogenic chemotherapy (HEC)... CONCLUSIONS: A single subcutaneous APF530 injection offers a convenient

Randomized, double-blind, crossover study of palonosetron compared with granisetron for the prevention of chemotherapy-induced nausea and vomiting in a Chinese population. [2011.03]
The objective of this study was to compare the efficacy and tolerability of palonosetron and granisetron in a Chinese population receiving highly emetogenic cisplatin-based chemotherapy or moderately emetogenic chemotherapy. Patients were stratified by chemotherapy with cisplatin (yes/no) and then randomly assigned to receive either palonosetron (0.25 mg i.v.) in the first cycle followed by granisetron (3 mg i.v.) in the second cycle or vice versa...

Efficacy and tolerability of transdermal granisetron for the control of chemotherapy-induced nausea and vomiting associated with moderately and highly emetogenic multi-day chemotherapy: a randomized, double-blind, phase III study. [2011]
the control of chemotherapy-induced nausea and vomiting (CINV)... CONCLUSIONS: The GTDS provides effective, well-tolerated control of CINV

Dexamethasone with either granisetron or ondansetron for postoperative nausea and vomiting in laparoscopic surgery. [2010.02]
In a prospective randomized double-blind study, we compared the effectiveness of dexamethasone 8 mg with either granisetron 1 mg or ondansetron 4 mg in the prevention of postoperative nausea and vomiting in patients undergoing laparoscopic surgery. Hundred ASA I and II patients scheduled for laparoscopic surgery were enrolled in the study and 84 patients completed it...

Reduction of severity of pruritus after elective caesarean section under spinal anaesthesia with subarachnoid morphine: a randomised comparison of prophylactic granisetron and ondansetron. [2010.01]
BACKGROUND: The incidence of pruritus after elective caesarean section under spinal anaesthesia with subarachnoid morphine may be 60-100%, and is a common cause of maternal dissatisfaction. Ondansetron has been shown to reduce pruritus but the effect is short-lived. The objective of this randomized double-blind trial was to evaluate the anti-pruritic efficacy of granisetron compared with ondansetron... CONCLUSIONS: Administration of granisetron 3mg i.v. reduces the severity of pruritus and the use of rescue anti-pruritic medication, and improves satisfaction but does not reduce the overall incidence of pruritus in women who have received subarachnoid morphine 150 microg compared to ondansetron 8 mg i.v. Copyright 2009 Elsevier Ltd. All rights reserved.

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Clinical Trials Related to Kytril Injection (Granisetron)

PK, Tolerability and Safety of the co-Administration of Sancuso� (Transdermal Granisetron) and IV Granisetron [Completed]
This study has been designed to investigate the pharmacokinetic and safety profile of the co-administration of intravenous (IV) and transdermal granisetron, as well as characterise the pharmacokinetics of multiple transdermal dosing.

Safety Study of Electrocardiogram (ECG) Effects of Sancuso® (Granisetron TDS) [Completed]

An Investigation on the Effect of Age and BMI on the Pharmacokinetics of Transdermal Granisetron [Completed]

Study on the Effect of Granisetron on Myofascial Pain in the Orofacial Muscles [Active, not recruiting]
The aim of this study is to to investigate if local treatment with intramuscular injections of granisetron are effective in alleviating pain in patients with chronic myofascial pain in the orofacial muscles The study hypothesis is that local administration of granisetron reduces pain and allodynia/hyperalgesia in patients with chronic myofascial pain in the orofacial muscles and that this effect of granisetron on pain is larger than the effect from placebo

Patient Satisfaction, Efficacy and Compliance of Antiemetic Patch vs Pill in Malignant Glioma Patients [Withdrawn]
The purpose of this study is to assess patient satisfaction, the efficacy and compliance of granisetron patch versus ondansetron pills for radiation induced nausea and vomiting in malignant glioma patients receiving six weeks of radiation therapy (RT) and concomitant temozolomide (TMZ). Use of the patch may benefit brain tumor patients by increasing compliance. All eligible adult malignant glioma subjects should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily TMZ for a total of six weeks. Subjects will be randomized to receive either granisetron patch or ondansetron for three weeks. Weeks 3-6, they will received the other medication. The granisetron transdermal delivery system (supplied as a 52

cm^2 patch containing 34. 3 mg of granisetron - 3. 1 mg/day) is applied once per week 24

hours before the weekly radiation and chemotherapy, while the ondansetron 8 mg oral tablet is taken once a day 30-60 minutes prior to each dose of chemotherapy. Subjects will fill out questionnaires regarding the effectiveness of the medication and their satisfaction, and which anti-emetic they prefer. Safety will be assessed throughout the six weeks of radiation by the clinical research nurse using the Common Toxicity Criteria for Adverse Events (CTCAE), version 4. 0. All subjects who receive both ondansetron and Granisetron Transdermal Delivery System (GTDS) treatment will be included in analyses of treatment preference. However, all other efficacy and safety analyses will include all subjects who received ondansetron or GTDS.

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Page last updated: 2015-08-10

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