1.Evaluation of Antiemetic Therapy for Breakthrough Nausea and Vomiting in Patients with Hematopoietic Stem Cell Transplantation.
Jiyoon KIM ; So Yeon HONG ; Su Jeong JEON ; Hyung Wook NAMGUNG ; Eun Sook LEE ; Euni LEE ; Soo Mee BANG
Korean Journal of Clinical Pharmacy 2018;28(3):224-229
		                        		
		                        			
		                        			BACKGROUND: The patients receiving hematopoietic stem cell transplantation (HSCT) are known to have a high incidence of breakthrough nausea and vomiting due to the conditioning regimen. The purpose of this study was to evaluate the adequacy of antiemetic therapy for breakthrough nausea and vomiting in patients receiving HSCT and to propose an effective treatment regimen. METHODS: We retrospectively reviewed the electronic medical records of 109 adult patients. The collected data were used to identify (1) antiemetic and dosing regimens prescribed for controlling breakthrough nausea and vomiting, (2) the rate of patients who developed breakthrough nausea and vomiting, and (3) the percent of antiemetics prescribed on the day of symptom onset. Based on the National Comprehensive Cancer Network guideline, we assessed the suitability of antiemetics for breakthrough nausea and vomiting, and prescription timing. RESULTS: All patients were prescribed pro re nata antiemetics. About 40.0%, 41.4%, and 18.6% of patients were using one, two, and three or more additional drugs for breakthrough nausea and vomiting, respectively. The most frequently administered drugs were intravenous metoclopramide (43.8%) and granisetron patch (36.2%). Breakthrough nausea and vomiting occurred in 87 patients (79.1%) and they developed symptoms 320 cases. About 220 cases (68.8%) were treated with additional antiemetics on the day of symptom onset and the rate of symptom resolution was only 10.3% (9 patients). CONCLUSION: The breakthrough nausea and vomiting in patients receiving HSCT occurred very frequently and was hard to control, thus requiring more rapid and aggressive treatments.
		                        		
		                        		
		                        		
		                        			Adult
		                        			;
		                        		
		                        			Antiemetics
		                        			;
		                        		
		                        			Electronic Health Records
		                        			;
		                        		
		                        			Granisetron
		                        			;
		                        		
		                        			Hematopoietic Stem Cell Transplantation*
		                        			;
		                        		
		                        			Hematopoietic Stem Cells*
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Incidence
		                        			;
		                        		
		                        			Metoclopramide
		                        			;
		                        		
		                        			Nausea*
		                        			;
		                        		
		                        			Prescriptions
		                        			;
		                        		
		                        			Retrospective Studies
		                        			;
		                        		
		                        			Vomiting*
		                        			
		                        		
		                        	
2.Palonosetron-Induced Anaphylaxis During General Anesthesia: A Case Report.
Hyungjun PARK ; Kyunghwan OH ; Hoonhee LEE ; Ji Hyang LEE ; Sun Myoung KANG ; So Young PARK ; Hyouk Soo KWON ; You Sook CHO ; Hee Bom MOON ; Tae Bum KIM
Allergy, Asthma & Immunology Research 2017;9(1):92-95
		                        		
		                        			
		                        			Palonosetron is a 5-hydroxytryptamine-3 (5-HT-3) receptor antagonist used for preventing postoperative nausea and vomiting. Compared with ondansetron and granisetron, it is a better drug because of prolonged action and minimal side effects. Some adverse effects of palonosetron have been reported. In this report, we describe a 37-year-old male who developed severe hypersensitivity reactions to palonosetron during surgery for kidney donation. His medical history was unremarkable, except for inguinal hernia with herniorrhaphy 8 years ago. The surgery was uneventful until 2 hours 20 minutes. After palonosetron injection, his blood pressure dropped to 80/50 mm Hg, and facial edema, rash, conjunctival swelling, and wheezing developed. The patient was resuscitated by administration of ephedrine, hydrocortisone, and peniramine. Following the surgery, the patient was monitored for 3 days, and there were no subsequent anaphylactic reactions or other complications. The skin test on postoperative day 54 was positive for hypersensitivity to palonosetron. Although palonosetron is known for its safety, other hypersensitivity events have been reported. Ondansetron is another widely used 5-HT-3 antagonist, which has been reported to cause anaphylaxis. Therefore, clinicians should be aware of the possibility of patients experiencing severe adverse reactions to palonosetron.
		                        		
		                        		
		                        		
		                        			Adult
		                        			;
		                        		
		                        			Anaphylaxis*
		                        			;
		                        		
		                        			Anesthesia, General*
		                        			;
		                        		
		                        			Blood Pressure
		                        			;
		                        		
		                        			Drug Hypersensitivity
		                        			;
		                        		
		                        			Edema
		                        			;
		                        		
		                        			Ephedrine
		                        			;
		                        		
		                        			Exanthema
		                        			;
		                        		
		                        			Granisetron
		                        			;
		                        		
		                        			Hernia, Inguinal
		                        			;
		                        		
		                        			Herniorrhaphy
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Hydrocortisone
		                        			;
		                        		
		                        			Hypersensitivity
		                        			;
		                        		
		                        			Kidney
		                        			;
		                        		
		                        			Male
		                        			;
		                        		
		                        			Ondansetron
		                        			;
		                        		
		                        			Postoperative Nausea and Vomiting
		                        			;
		                        		
		                        			Respiratory Sounds
		                        			;
		                        		
		                        			Skin Tests
		                        			
		                        		
		                        	
3.Comparison of ondansetron and granisetron for antiemetic prophylaxis in maxillofacial surgery patients receiving general anesthesia: a prospective, randomised, and double blind study.
Kiran SAVANT ; Rakshit Vijay Sinai KHANDEPARKER ; Vikas BERWAL ; Purva Vijay KHANDEPARKER ; Hunny JAIN
Journal of the Korean Association of Oral and Maxillofacial Surgeons 2016;42(2):84-89
		                        		
		                        			
		                        			OBJECTIVES: To compare the efficacy of intravenous ondansetron (4 mg, 2 mL) and granisetron (2 mg, 2 mL) for preventing postoperative nausea and vomiting (PONV) in patients during oral and maxillofacial surgical procedures under general anesthesia. MATERIALS AND METHODS: A prospective, randomized, and double blind clinical study was carried out with 60 patients undergoing oral and maxillofacial surgical procedures under general anesthesia. Patients were divided into two groups of 30 individuals each. Approximately two minutes before induction of general anesthesia, each patient received either 4 mg (2 mL) ondansetron or 2 mg (2 mL) granisetron intravenously in a double blind manner. Balanced anesthetic technique was used for all patients. Patients were assessed for episodes of nausea, retching, vomiting, and the need for rescue antiemetic at intervals of 0-2, 3, 6, 12, and 24 hours after surgery. Incidence of complete response and adverse effects were assessed at 24 hours postoperatively. Data was tabulated and subjected to statistical analysis using the chi-square test, unpaired t-test, or the Mann-Whitney U-test as appropriate. A P-value less than 0.05 was considered statistically significant. RESULTS: There was no statistically significant difference between the two groups for incidence of PONV or the need for rescue antiemetic. Both study drugs were well tolerated with minimum adverse effects; the most common adverse effect was headache. The overall incidence of complete response in the granisetron group (86.7%) was significantly higher than the ondansetron group (60.0%). CONCLUSION: Granisetron at an intravenous dose of 2 mg was found to be safe, well tolerated, and more effective by increasing the incidence of complete response compared to 4 mg intravenous ondansetron when used for antiemetic prophylaxis in maxillofacial surgery patients receiving general anesthesia. Benefits of granisetron include high receptor specificity and high potency, which make it a valuable alternative to ondansetron.
		                        		
		                        		
		                        		
		                        			Anesthesia
		                        			;
		                        		
		                        			Anesthesia, General*
		                        			;
		                        		
		                        			Double-Blind Method*
		                        			;
		                        		
		                        			Granisetron*
		                        			;
		                        		
		                        			Headache
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Incidence
		                        			;
		                        		
		                        			Nausea
		                        			;
		                        		
		                        			Ondansetron*
		                        			;
		                        		
		                        			Postoperative Nausea and Vomiting
		                        			;
		                        		
		                        			Prospective Studies*
		                        			;
		                        		
		                        			Sensitivity and Specificity
		                        			;
		                        		
		                        			Surgery, Oral*
		                        			;
		                        		
		                        			Vomiting
		                        			
		                        		
		                        	
4.Granisetron Transdermal System for Treatment of Symptoms of Gastroparesis: A Prescription Registry Study.
Deena MIDANI ; Henry P PARKMAN
Journal of Neurogastroenterology and Motility 2016;22(4):650-655
		                        		
		                        			
		                        			BACKGROUND/AIMS: Serotonin receptor (eg, 5-HT₃) antagonists are used to treat nausea and vomiting from a variety of causes. Granisetron transdermal system (GTS) is an appealing delivery system for patients with gastroparesis. To assess if GTS improves nausea and vomiting and other gastroparesis symptoms in patients with gastroparesis. METHODS: Patients with gastroparesis and symptoms of nausea and vomiting refractory to conventional treatment were treated with GTS. Symptoms of gastroparesis were assessed using a modified Gastroparesis Cardinal Symptom Index (GCSI). Following 2 weeks of treatment, patients were asked to assess their symptoms and indicate their therapeutic response using the Clinical Patient Grading Assessment Scale (CPGAS) reporting if symptoms of nausea and vomiting improved on a scale: 0 = no change to +7 = completely better. RESULTS: Fifty-one patients received GTS by prescription: average age was 40 ± 17 years, 44 female, 11 diabetics, 23 ± 20% retention at 4 hours on gastric emptying scintigraphy. Thirty-nine of the 51 (76%) patients stated improvement with GTS. There was significant improvement in nausea and vomiting as assessed with CPGAS at 2 weeks (2.28 ± 2.53; P < 0.05). Symptoms of nausea and vomiting significantly improved. Other symptoms including postprandial fullness, loss of appetite, upper abdominal pain, and early satiety improved. Side effects reported included redness at the site of the patch in 7 patients, pruritus in 5, and constipation in 5. CONCLUSIONS: GTS was moderately effective in reducing nausea and/or vomiting in 76% of gastroparesis patients. In addition to nausea and vomiting, symptoms of postprandial fullness, loss of appetite, upper abdominal pain, and early satiety also improved.
		                        		
		                        		
		                        		
		                        			Abdominal Pain
		                        			;
		                        		
		                        			Appetite
		                        			;
		                        		
		                        			Constipation
		                        			;
		                        		
		                        			Female
		                        			;
		                        		
		                        			Gastric Emptying
		                        			;
		                        		
		                        			Gastroparesis*
		                        			;
		                        		
		                        			Granisetron*
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Nausea
		                        			;
		                        		
		                        			Prescriptions*
		                        			;
		                        		
		                        			Pruritus
		                        			;
		                        		
		                        			Radionuclide Imaging
		                        			;
		                        		
		                        			Serotonin
		                        			;
		                        		
		                        			Vomiting
		                        			
		                        		
		                        	
5.Symptomatic Improvement of Gastroparesis with Granisetron Transdermal System.
Journal of Neurogastroenterology and Motility 2016;22(4):543-544
		                        		
		                        			
		                        			No abstract available.
		                        		
		                        		
		                        		
		                        			Gastroparesis*
		                        			;
		                        		
		                        			Granisetron*
		                        			
		                        		
		                        	
6.Palonosetron versus granisetron in combination with aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with gynecologic cancer.
Satoe FUJIWARA ; Yoshito TERAI ; Satoshi TSUNETOH ; Hiroshi SASAKI ; Masanori KANEMURA ; Masahide OHMICHI
Journal of Gynecologic Oncology 2015;26(4):311-319
		                        		
		                        			
		                        			OBJECTIVE: There is no research regarding the appropriate antiemetic agents for female patients, especially those receiving moderately emetogenic chemotherapy (MEC). We evaluated the antiemetic efficacy of a combination of 5-HT3 receptor with/without aprepitant in patients with gynecological cancer treated with the TC (paclitaxel and carboplatin) regimen of MEC. METHODS: We enrolled 38 patients diagnosed with gynecologic cancer and scheduled to receive the TC regimen. The patients were randomly assigned to receive a 5-HT3 receptor antagonist, either palonosetron in the first cycle followed by granisetron in the second cycle or vice versa. In the third cycle, all patients received a combination of the 5-HT3 receptor and dexamethasone with/without aprepitant. RESULTS: When three drugs were administered, palonosetron consistently produced an equivalent complete response (CR) rate to granisetron in the acute phase (89.5% vs. 86.8%, p=0.87) and delayed phase (60.5% vs. 65.8%, p=0.79). With regard to the change in dietary intake, palonosetron exhibited similar efficacy to granisetron in the acute phase (92.1% vs. 89.4%, p=0.19) and delayed phase (65.7% vs. 68.4%, p=0.14). However, in the delayed phase, the addition of aprepitant therapy with a 5-HT3 receptor antagonist and dexamethasone produced a higher CR rate than a 5-HT3 receptor antagonist with dexamethasone (93.3% vs. 47.8%, p<0.001) and allowed the patients to maintain a higher level of dietary intake (93.3% vs. 56.5%, p<0.001). CONCLUSION: The addition of aprepitant therapy was more effective than the control therapy of a 5-HT3 receptor antagonist, and dexamethasone in gynecological cancer patients treated with the TC regimen.
		                        		
		                        		
		                        		
		                        			Adult
		                        			;
		                        		
		                        			Aged
		                        			;
		                        		
		                        			Antiemetics/*administration & dosage
		                        			;
		                        		
		                        			Antineoplastic Combined Chemotherapy Protocols/adverse effects
		                        			;
		                        		
		                        			Carboplatin/administration & dosage/adverse effects
		                        			;
		                        		
		                        			Cross-Over Studies
		                        			;
		                        		
		                        			Diet
		                        			;
		                        		
		                        			Drug Administration Schedule
		                        			;
		                        		
		                        			Female
		                        			;
		                        		
		                        			Genital Neoplasms, Female/*drug therapy
		                        			;
		                        		
		                        			Granisetron/administration & dosage
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Isoquinolines/administration & dosage
		                        			;
		                        		
		                        			Middle Aged
		                        			;
		                        		
		                        			Morpholines/administration & dosage
		                        			;
		                        		
		                        			Nausea/chemically induced/*prevention & control
		                        			;
		                        		
		                        			Paclitaxel/administration & dosage/adverse effects
		                        			;
		                        		
		                        			Quinuclidines/administration & dosage
		                        			;
		                        		
		                        			Serotonin 5-HT3 Receptor Antagonists
		                        			;
		                        		
		                        			Vomiting/chemically induced/*prevention & control
		                        			
		                        		
		                        	
7.Preventive efficacy of ondansetron and granisetron for postoperative nausea and vomiting in high risk patients.
Xiang QUAN ; Bo ZHU ; Tie-hu YE
Acta Academiae Medicinae Sinicae 2011;33(4):445-448
OBJECTIVETo compare the efficacy of ondansetron and granisetron in the prevention of postoperative nausea and vomiting (PONV) in high-risk patients.
METHODSTotally 200 patients with three key risk factors for PONV (female, non-smoking and postoperative opioid use) were equally randomized into ondansetron group and granisetron group. Ondansetron (4 mg) or granisetron (3 mg) was intravenously administered upon the completion of surgery. The episodes of nausea and vomiting were observed for 24 hours after surgery.
RESULTSA significantly greater proportion of patients in granisetron group achieved a complete response (i.e., no PONV or rescue medication) during the first 24 hours postoperatively versus those in ondansetron group (62.6% vs. 46.9%, respectively; P=0.048). There were no significant differences in terms of postoperative nausea incidences (42.9% vs. 34.3%, respectively), postoperative vomiting incidences (25.5% vs. 20.2%, respectively) and postoperative rescue anti-emetics incidences (19.4% vs. 15.2%, respectively) (P>0.05).
CONCLUSIONGranisetron is more effective than ondansetron in preventing PONV in high-risk patients during the first 24 hours postoperatively.
Adolescent ; Adult ; Aged ; Antiemetics ; therapeutic use ; Double-Blind Method ; Female ; Granisetron ; therapeutic use ; Humans ; Male ; Middle Aged ; Ondansetron ; therapeutic use ; Postoperative Nausea and Vomiting ; prevention & control ; Treatment Outcome ; Young Adult
8.Ramosetron for the prevention of postoperative nausea and vomiting (PONV): a meta-analysis.
Won Oak KIM ; Bon Nyeo KOO ; Yong Kook KIM ; Hae Keum KIL
Korean Journal of Anesthesiology 2011;61(5):405-412
		                        		
		                        			
		                        			BACKGROUND: Postoperative nausea and vomiting (PONV) remains a challenge for patients and health professionals despite various newly developed prophylactic interventions. We reviewed the efficacy and safety of ramosetron in randomized controlled trials (RCTs) for the prevention of PONV. METHODS: We reviewed 18 randomized controlled trials investigating the efficacy and safety of ramosetron in comparison with placebo or any other drugs. Relevant studies were searched in the MEDLINE, SCOPUS, and the Cochrane database libraries. Our end points of concern were prevention of PONV and adverse effects as dichotomous data. RESULTS: The prophylactic effect of 0.3 mg ramosetron was observed in early PON (relative risk, RR: 0.4; 95% CI 0.3-0.6), early POV (RR: 0.3; 95% CI 0.1-0.6), late POV (RR: 0.3; 95% CI 0.1-0.6), but not late PON (RR: 0.7; 95% CI 0.5-1.0). Compared with placebo, the efficacy of 0.3 mg ramosetron in adults and 6 microg/kg in children were consistently beneficial in preventing PONV overall (RR: 0.4; 95% CI: 03-0.6). The effects of 0.3 mg ramosetron and 3 mg granisetron were similar. No serious side effects or adverse events resulted from ramosetron and other active drugs, and incidence was similar to those of the placebo group. CONCLUSIONS: Ramosetron is effective and safe in children and adults without serious adverse effects compared with placebo or other active drugs, as shown in pooled data of RCTs, in terms of the prevention of PONV.
		                        		
		                        		
		                        		
		                        			Adult
		                        			;
		                        		
		                        			Antiemetics
		                        			;
		                        		
		                        			Benzimidazoles
		                        			;
		                        		
		                        			Child
		                        			;
		                        		
		                        			Granisetron
		                        			;
		                        		
		                        			Health Occupations
		                        			;
		                        		
		                        			Humans
		                        			;
		                        		
		                        			Incidence
		                        			;
		                        		
		                        			Postoperative Nausea and Vomiting
		                        			
		                        		
		                        	
9.Determination of dimethyl sulphate residual in granisetron hydrochloride by headspace gas chromatography.
Journal of Zhejiang University. Medical sciences 2008;37(2):156-158
OBJECTIVETo develop a headspace gas chromatography method for determining dimethyl sulphate residual in granisetron hydrochloride.
METHODSAn Angilent INNOWAX capillary column with nitrogen gas as carrier and FID as detector was applied in this study. Dimethyl sulphate was tested under a constant column temperature.
RESULTDimethyl sulphate had different retention time from other organic solvents such as alcohol,acetoacetate, isopropanol, dichlormethane and chloroform, which might exist in granisetron hydrochloride. The detection limit of dimethyl sulphate;s was 0.0016%.
CONCLUSIONThe method can be used for the determination of dimethyl sulphate residual in granisetron hydrochloride.
Chromatography, Gas ; methods ; Drug Contamination ; prevention & control ; Granisetron ; analysis ; Pharmaceutical Preparations ; analysis ; Sulfuric Acid Esters ; analysis
10.A randomized double-blind study of prevention of postoperative nausea and vomiting with ondansetron, tropisetron, or granisetron in patients undergoing general anesthesia.
Xiang QUAN ; Tie-Hu YE ; Bo ZHU
Acta Academiae Medicinae Sinicae 2007;29(1):107-110
OBJECTIVETo compare the efficacy of different 5-hydroxytryptamine 3 receptor antagonists in the prevention of postoperative nausea and vomiting (PONV) in patients undergoing general anesthesia.
METHODSTotally 360 patients, American Society of Anesthesiologists (ASA) grade I - II, aged 18-75 years, and having received elective operation with endotracheal intubation general anesthesia, were randomly divided into three double-blind groups: ondansetron group, tropisetron group, and granisetron group, with 120 patients in each group. Before anesthesia induction, patients were intravenously given ondansetron (4 mg), tropisetron (5 mg), or granisetron (3 mg), respectively. The episodes of nausea and vomiting were recorded for 24 hours after operation.
RESULTSNo significant differences were observed in the terms of complete inhibition rate of PONV among ondansetron group (70.0%), tropisetron group (68.6%), and granisetron group (72.9%) within 24 hours postoperatively (P >0.05), and so did postoperative nausea incidences (22.5%, 25.4%, and 20.3%, respectively), and postoperative vomiting incidences (10.0%, 13.6%, and 8.5%, respectively) (P > 0.05). No remarked antiemetic-related adverse effects were observed within 24 hours postoperatively.
CONCLUSIONIntravenous ondansetron (4 mg), tropisetron (5 mg), or granisetron (3 mg) before anesthesia induction can prevent PONV with similar efficacy and safety.
Adolescent ; Adult ; Aged ; Anesthesia, General ; adverse effects ; Antiemetics ; therapeutic use ; Double-Blind Method ; Female ; Granisetron ; therapeutic use ; Humans ; Indoles ; therapeutic use ; Male ; Middle Aged ; Ondansetron ; therapeutic use ; Postoperative Nausea and Vomiting ; etiology ; prevention & control ; Young Adult
            
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