ONDANSETRON for All Doctors & Pediatric

(ONDANSETRON)

INTRODUCTION:

Ondansetron is a compound, the first of new class of drugs-5HT3 receptor antagonists which is more effective than metoclopramide in preventing chemotherapy/radiotherapy induced and post operative nausea and vomiting having virtually no extra pyramidal side effects and therefore better tolerated and particularly valuable in children and elderly patients that acts by blocking Serotonin 5HT3 receptors preventing emesis through scrotonergic mechanisms. Its superior efficacy compared to metoclopramide coupled with better tolerability enhances the chances of the patients, afflicted by malignant disease, staying on and continuing with the potentially curative but highly emetogenic cancer treatment — a distinct advantage over the current chemotherapy thereby making the introduction of a brand containing ondansetron most welcome.

PHARMOKINETICS:

Following oral administration, Ondansetron is rapidly absorbed with peak plasma concentration of around 0.03 to 0.4ug/ml utilities 1.5 to 2 hours after an oral dose of I mg. The time to peak concentration is approximately 16 hours on oral administration of 8 mg.

An intravenous infusion of 8 mg Ondansetron over 5 minutes gives peak plasma values of 80 mg to 100 mcg/L; which fall steadily over the subsequent 15 hours.

Active metabolites exist do not circulate in the body. Chemotherapeutic agents do not alter clearance of ondansetron. Ondansetron is predominantly cleared from the body by metabolism rather than through kidney.

INDICATIONS:

Prevention and Treatment of nausea and vomiting induced by:

·         Respiratory Tract Infections

·         Fever

·         Gastroenteritis

·         Surgery of any kind

·         Chemotherapy and Radio therapy

DOSAGE AND ADMINISTRATION:

indications	Adults		Children
	Day 1	Day 2-5	Day 1	Day 2-5
Highly Emetogeni Chemotherapy	A single dose of 8 mg by slow intravenous injection immediately before chemotherapy or  A dose of 8 mg by slow intravenous injection immediately be form chemotherapy followed by two  further intravenous  doses of 8 mg, two to four hours apart or by constant infusion of 1 mg/hour for up to 24 hours. or A single dose of 32 mg diluted in50-100 ml of saline or other compatible infusion fluid and infused over a period of not less than 15 min immediately before chemotherapy	8 mg orally twice daily for up to 5 days 8 mg orally twice daily for up to 5 days 8 mg orally twice daily for up to 5 days	A single intravenous dose  of 5mg/m3 immediately before chemotherapy followed by 4 mg orally twelve hours later	4mg orally twice daily upto 5 days
Emetogenic Chemotherapy/ Radiotherapy	A single dose of 8mg administered as a slow intravenous injection immediately before chemotherapy/radiotherapy  or 8mg orally, 1-2 hours before chemotherapy/ radiotherapy	8 mg orally twice daily for upto 5 days 8 mg orally twice daily for upto 5 days	A single intravenous dose of 5mg/m3 immediately before chemotherapy followed by 4mg orally twelve hours later.	4mg orally twice daily upto 5 days
Post operative nausea and vomiting	8 mg given orally one hour prior to anesthesia followed by two further doses of 8mg at eight hourly intervals or  A single dose of undiluted 4mg given by slow intravenous injection at induction of anesthesia		Pediatric Patient Dosage
For the treatment of established post operative nausea and vomiting	A single dose of undiluted 4 mg given by slow intravenous injection		In pediatric patients a oral dose of 0.15 mg/kg is recommended, administered 30 minutes prior to chemotherapy, radiation therapy or immediately prior to surgery

               

PRECAUTIONS:

ü      Use in pregnancy

      Since there are no adequate and well-controlled studies in pregnant woman, ondansetron should be used during pregnancy only if the benefit outweighs the risks.

ü      Pediatric Use

      Little information is available about dosage in children 3 years of age or younger.

ADVERSE EFFECTS AND TOXICITY:

The common adverse effects reported in adults receiving 8 mg of ondansetron three times a day for three days include headache, constipation, abdominal pain, weakness and dryness of mouth. Overall, ondansetron is well tolerated by the patients receiving radiotherapy or chemotherapy. The most frequently reported an adverse event associated with ondansetron is headache, which responds to standard analgesics. Importantly, extra pyramidal effects such as those produced by metoclopramide would not be expected from the pharmacodynamic profile of ondansetron and have not been reported in clinical trials or in studies with healthy volunteers.

COMPATIBILITY WITH INTRAVANEOUS FLUIDS:

Ondansetron injectiàn should be only admixed with those infusion solutions, which are recommended

Ø      Sodium Chloride intravenous infusion BP 0.9 w/v

Ø      Glucose intravenous infusion BP 5% w/v

Ø      Mannitol intravenous infusion BP 10 % w/v

Ø      Ringers intravenous infusion

AVAILABILITY:

RANSAT-4 Tab Packing        10*10 Tab

RANSAT-8 Tab Packing        10*10 Tab

RANSAT Syp                         Packing 30ml

RANSAT Inj                          Packing 1ml and 2ml

COMPETITIVE BRANDS:

ONDEM         (BERGEN HEALTHCARE)

EMSET           (CIPLA)

PRESCRIBING DOCTORS:

All Doctors & Pediatric