Pediatric Formulary

Granisetron

Generic name

Granisetron

Brand name

ATC Code

A04AA02

Compare …

Dosages

Side effects in children

Warnings & precautions in children

Contra-indications in children

Interactions

Renal impairment

References

Pharmacokinetics in children

The study by Wada et al. (N=7, 2-15 years) shows that the pharmacokinetic parameters of granisetron in children with oncological disorders have a pronounced inter-individual variation. The following pharmacokinetic parameters were found:

	Craft 1995			Wada 2001
Age	2-6 years	7-11 years	12-16 years	2-15 years
Cmax (mg/l)	59.9 ± 57.3	41.5 ± 18.3	45.2 ± 23.7	60.1 ± 26.6
t½ (h)	8.93 ± 7.14	6.22 ± 3.32	5.82 ± 6.31	20.9 ± 20.8
Cl (ml/h/kg)	193 ± 146	352 ± 341	360 ± 271	121 ± 76
Vd (l/kg)	1.44 ± 0.487	1.81 ± 0.712	1.32 ± 0.514	2.57 ± 1.87

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Prevention and treatment of post-operative nausea and vomiting
Oral ≥ 1 month and < 50 kg ^{[1] [2] [3] [8] [9] [10] [15] [16] [18] [19]} 40 microg./kg/dose, once only. Max: 2 mg/day. Repeat dose if the patient continues to vomit or is still nauseous after 6-12 hours.. To prevent post-operative nausea and vomiting, administration should be discontinued before the induction of anaesthesia. ≥ 50 kg ^{[1] [2] [3] [8] [9] [10] [15] [16] [18] [19]} 2 mg/day in 1 - 2 doses. To prevent post-operative nausea and vomiting, administration should be discontinued before the induction of anaesthesia. Intravenous 1 month up to 18 years ^{[1] [2] [3] [8] [9] [10] [15] [16] [18] [19]} 10 microg./kg/dose maximum twice daily. The interval between intravenous doses should be at least 10 minutes.

Prevention and treatment of post-operative nausea and vomiting

Oral
- ≥ 1 month and < 50 kg
  ^{[1]
  
  [2]
  
  [3]
  
  [8]
  
  [9]
  
  [10]
  
  [15]
  
  [16]
  
  [18]
  
  [19]}
  - 40 microg./kg/dose, once only. Max: 2 mg/day. Repeat dose if the patient continues to vomit or is still nauseous after 6-12 hours..
  - To prevent post-operative nausea and vomiting, administration should be discontinued before the induction of anaesthesia.
- ≥ 50 kg
  ^{[1]
  
  [2]
  
  [3]
  
  [8]
  
  [9]
  
  [10]
  
  [15]
  
  [16]
  
  [18]
  
  [19]}
  - 2 mg/day in 1 - 2 doses.
  - To prevent post-operative nausea and vomiting, administration should be discontinued before the induction of anaesthesia.
Intravenous
- 1 month up to 18 years
  ^{[1]
  
  [2]
  
  [3]
  
  [8]
  
  [9]
  
  [10]
  
  [15]
  
  [16]
  
  [18]
  
  [19]}
  - 10 microg./kg/dose maximum twice daily.
  - The interval between intravenous doses should be at least 10 minutes.

Nausea and vomiting in chemotherapy
Intravenous 1 month up to 18 years ^{[1] [2] [8] [9] [14] [17]} 40 microg./kg/dose maximum twice daily. Max single dose: 3 mg/dose. The interval between intravenous doses should be at least 10 minutes..

Renal impaiment in children > 3 months

No data is known about dosage adjustments for renal function disorders in children. The manufacturer states that no special precautions are required in patients with renal insufficiency.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Headaches, lower abdominal pain, obstipation, diarrhoea, sleepiness and insomnia.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Given that granisetron can reduce intestinal motility, patients with symptoms of acute or subacute intestinal obstruction after granisetron is administered should be monitored closely. There are studies in which a small, clinically non-relevant, QT interval extension has been observed in children. For the sake of safety, caution should be exercised in children with risk factors for QT extension.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

ANTIEMETICS AND ANTINAUSEANTS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Serotonin (5HT3) antagonists
	Ondansetron Related Medicines Menu">	A04AA01
	Palonosetron Related Medicines Menu">	A04AA05

Other antiemetics
	(Fos)Aprepitant Related Medicines Menu">	A04AD12

References

Aksoylar S, et al, Comparison of tropisetron and granisetron in the control of nausea and vomiting in children receiving combined cancer chemotherapy, Pediatr Hematol Oncol, 2001, 18, 397-406
Berrak SG, et al, A double-blind, crossover, randomized dose-comparison trial of granisetron for the prevention of acute and delayed nausea and emesis in children receiving moderately emetogenic carboplatin-based chemotherapy, Support Care Cancer, 2007, 15, 1163-8
Cieslak GD, et al, The dose-response relation and cost-effectiveness of granisetron for the prophylaxis of pediatric postoperative emesis, Anesthesiology, 1996, 85, 1076-85
Fujii Y, et al, Treatment of vomiting after paediatric strabismus surgery with granisetron, droperidol, and metoclopramide, Ophthalmologica., 2002, 216, 359-62
Fujii Y, et al, Preoperative oral granisetron for the prevention of vomiting following paediatric surgery, Paediatr Anaesth, 2002, 12, 267-71
Fujii Y, et al, Prevention of postoperative vomiting with granisetron in paediatric patients with and without a history of motion sickness, Paediatr Anaesth., 1999, 9, 527-30
Fujii Y, et al, Granisetron reduces post-operative vomiting in children: a dose-ranging study., Eur J Anaesthesiol, 1999, 16, 62-5
Hählen K, et al, A randomized comparison of intravenously administered granisetron versus chlorpromazine plus dexamethasone in the prevention of ifosfamide-induced emesis in children., J Pediatr, 1995, 126, 309-13
Komada Y, et al, A randomised dose-comparison trial of granisetron in preventing emesis in children with leukaemia receiving emetogenic chemotherapy, Eur J Cancer, 1999, 35, 1095-101
Wada I, et al, Pharmacokinetics of granisetron in adults and children with malignant diseases, Biol Pharm Bull, 2001, 24, 432-5
Mylan BV, SmPC Granisetron (RVG 30753/4) , www.cbg-meb.nl
EMA, Rapporteurs Public Assessment Report for paediatric data in EU Worksharing procedure.Kytril/granisetron. UK/W/0014/pdWS/001, Geraadpleegd 1 juli 2013
Roche Nederland BV, SmPC Kytril IV (RVG 20958), www.cbg-meb.nl
Siddique R, et al. , Ondansetron versus granisetron in the prevention of chemotherapy induced nausea and vomiting in children with acute lymphoblastic leukemia, Mymensingh Med J. , 2011, Oct;20(4), 680-8.
Gombar S et al., Superior anti-emetic efficacy of granisetron-dexamethasone combination in children undergoing middle ear surgery, Acta Anaesthesiologica Scandinavica , 2007, 51, 621-4
Munro HM et al., Oral granisetron for strabismus surgery in children, Can J Anaesth, 1999, 46(1), 45-8
Craft AW et al. , Granisetron as antiemetic therapy in children with cancer., Med Pediatr Oncol., 1995 , Jul;25(1), 28-32
Riad W et al. , Combination therapy in the prevention of PONV after strabismus surgery in children: granisetron, ondansetron, midazolam with dexamethasone. , Middle East J Anaesthesiol., 2009 , Oct;20(3), 431-6
Sinha R et al. , Granisetron versus granisetron-dexamethasone for prevention of postoperative nausea and vomiting in pediatric strabismus surgery: a randomized double-blind trial., Anesthesiol Res Pract., 2016, 4281719

Granisetron

Granisetron

Granisetron

Pharmacokinetics in children

dose recommendation of formulary compared to licensed use (on-label versus off-label)

Available formulations

Dosages

Renal impaiment in children > 3 months

Side effects in children

Contra-indications

Warnings & precautions in children

Interactions

ANTIEMETICS AND ANTINAUSEANTS

References

Changes

Therapeutic Drug Monitoring

Overdose