Ondansetron: profile and news

Taro Receives Tentative ANDA Approvals For Carvedilol Tablets and ... Apr 24, 2006
New Drug Applications ("ANDA") for Carvedilol Tablets, 3.125 mg, 6.25 mg, 12.5 mg and 25 mg ("carvedilol tablets") and for Ondansetron Hydrochloride Tablets ... - PharmaLive.com (press release),

Oral Ondansetron for Gastroenteritis in a Pediatric Emergency ... Apr 19, 2006
We conducted a double-blind trial to determine whether a single oral dose of ondansetron, an antiemetic, would improve outcomes in children with gastroenteritis ... - New England Journal of Medicine (subscription),

Hana Biosciences Reaffirms Expected Timing of First NDA Filing May 9, 2006
...a biopharmaceutical company focused on advancing cancer care, provided an update today on its most advanced drug candidate, Zensana(TM) (ondansetron HCl) Oral ... - Genetic Engineering News,

SCOLR Pharma First Quarter 2006 Financial Results May 9, 2006
...and marketing certain products based on SCOLR Pharma's proprietary CDT drug delivery platform; (ii) achievement of positive ondansetron clinical results ... - Black Enterprise,

Anti-Vomiting Drug Protects Kids From Dehydration Apr 19, 2006
But a new study finds that by giving one dose of an anti-vomiting medication called ondansetron, doctors could cut the need for IV rehydration by more than half ... - Forbes

Taro Pharma Granted Tentative ANDA Approvals For Carvedilol ... Apr 24, 2006
Administration for its Abbreviated New Drug Applications for Carvedilol Tablets, 3.125 mg, 6.25 mg, 12.5 mg and 25 mg and for Ondansetron Hydrochloride Tablets ... - Trading Markets,

Cancer drug stops vomiting in children Apr 19, 2006
...'We found that a single dose of ondansetron (Zofran) improves the success of oral rehydration in dehydrated children with gastroenteritis,' said Stephen ... - Monsters and Critics.com,

FDA approves 3 Taro drugs Apr 24, 2006
FDA) for its abbreviated new drug applications (ANDA) for carvedilol tablets, 3.125 mg, 6.25 mg, 12.5 mg and 25 mg and for ondansetron hydrochloride tablets ... - Globes,

Husband won't take wife home without drug Apr 20, 2006
...prevents her from keeping food down. Only one drug, Ondansetron, has been able to control the vomiting. But Mrs Piper's husband, Kevin ... - Stuff.co.nz,

Study finds antivomit drug helps, overused Apr 20, 2006
Another is to give children Zofran, GlaxoSmithKline Plc.'s brand name for Ondansetron, to stop the vomiting, according to a study published in this week's New ... - Boston Globe,

Hospital finds a way Apr 21, 2006
Mrs Piper, 45, has a degenerative nerve condition that causes continuous vomiting and the drug, Ondansetron, was the only thing that worked to stop the nausea. ... - Stuff.co.nz,

Taro Pharma Receives Tentative Approval From FDA For Carvedilol ... Apr 24, 2006
...that it has received tentative approval from the FDA for its Abbreviated New Drug Applications for Carvedilol Tablets and for Ondansetron Hydrochloride Tablets ... - Trading Markets,

Hana Biosciences Reports First Quarter 2006 Results May 4, 2006
On April 17, 2006, Hana's common shares began trading on the NASDAQ National Market under the symbol HNAB. -- Zensana(TM) (ondansetron HCl) Oral Spray. ... - Genetic Engineering News,

Preapertura EE.UU. May 10, 2006
...[+]. (MT) - Teva Beats Q4 EPS Estimates, Raises Dividend... [+. MT) - --Teva Gest Tentative FDA Okay of Ondansetron Injection USP... [+. - Bolsamania.com,

Anti-nausea drug to 'help children's platinum treatments' - 20th ... Apr 20, 2006
The drug ondansetron, branded as Zofran, could now be used to treat children who have uncontrolled vomiting. Writing in the latest ... - Platinum today,

Man keeps wife in hospital to get drug Apr 20, 2006
The drug Ondansetron controls her vomiting, but her husband Kevin said they can only get free access to it while Mrs Piper stays in hospital. ... - New Zealand Herald,

Man takes drastic action for drugs Apr 21, 2006
..."At the moment I've got vomiting every day and all day," Joanne says. Joanne says the only drug that effectively controls her nausea is one called ondansetron. ... - TVNZ,

Taro Pharmaceutical Gets Tentative ANDA OK For Two Drugs Apr 24, 2006
...approval from the US Food and Drug Administration for its abbreviated new drug applications for carvedilol tablets and for ondansetron hydrochloride tablets. ... - Therapeutics Daily (subscription) (press release),

Oral Zofran Eases Vomiting in Kids With Gastroenteritis Apr 20, 2006
TORONTO, April 20 - A single oral dose of the antiemetic Zofran (ondansetron) can reduce vomiting by more than half and facilitate oral rehydration in children ... - MedPage Today,

AUDIO SUMMARY Apr 19, 2006
...on the efficacy and safety of corticosteroids for persistent ARDS, a therapeutic intervention for prehypertension, oral ondansetron for gastroenteritis in a ... - New England Journal of Medicine (subscription),

Other information

Indication
For treatment of chemotherapy-induced nausea and vomiting

Pharmacology
Ondansetron is an antinauseant and antiemetic agent indicated for the prevention of nausea and vomiting associated with moderately-emetogenic cancer chemotherapy and for the prevention of postoperative nausea and vomiting. Ondansetron is a highly specific and selective serotonin 5-HT₃ receptor antagonist, not shown to have activity at other known serotonin receptors and with low affinity for dopamine receptors.

Mechanism Of Action
Ondansetron is a selective serotonin 5-HT₃ receptor antagonist. The serotonin 5-HT₃ receptors are located on the nerve terminals of the vagus in the periphery and centrally in the chemoreceptor trigger zone of the area postrema. It is thought that chemotherapeutic agents produce nausea and vomiting by releasing serotonin from the enterochromaffin cells of the small intestine, and that the released serotonin then activates 5-HT₃ receptors located on vagal efferents to initiate the vomiting reflex. Therefore Ondansetron works by blocking the reception of serotonin at these 5-HT₃ receptors.

Drug Category
Anti-anxiety Agents; Antipsychotics; Antipruritics; Antiemetics; Serotonin Antagonists; ATC:A04AA01

Brand Names/Synonyms
Zophren; Zofran; Zudan; Zofran ODT

Dosage Forms
TABLET; LIQUID

Absorption
Ondansetron is well absorbed after oral administration and undergoes limited first-pass metabolism.

Interactions
Interactions for Ondansetron: Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver. Because ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes (CYP3A4, CYP2D6, CYP1A2), inducers or inhibitors of these enzymes may change the clearance and, hence, the half-life of ondansetron. On the basis of limited available data, no dosage adjustment is recommended for patients on these drugs. Phenytoin, Carbamazepine, and Rifampicin: In patients treated with potent inducers of CYP3A4 (i.e., phenytoin, carbamazepine, and rifampicin), the clearance of ondansetron was significantly increased and ondansetron blood concentrations were decreased. However, on the basis of available data, no dosage adjustment for ondansetron is recommended for patients on these drugs.1,3 Tramadol: Although no pharmacokinetic drug interaction between ondansetron and tramadol has been observed, data from 2 small studies indicate that ondansetron may be associated with an increase in patient controlled administration of tramadol.4,5 Chemotherapy: Tumor response to chemotherapy in the P 388 mouse leukemia model is not affected by ondansetron. In humans, carmustine, etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron. In a crossover study in 76 pediatric patients, I.V. ondansetron did not increase blood levels of high-dose methotrexate.

Chemical IUPAC Name
9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-1,2,3,9-tetrahydrocarbazol-4-one

Chemical Formula
C18H19N3O

Half Life
5.7 hours

Drug Type
Approved Drug

# Accession No
APRD00481

CAS Registry Number
99614-02-5