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Ondansetron Hydrochloride Dihydrate

Ondansetron Hydrochloride Dihydrate
CAS Number: 103639-04-9

Ondansetron Hydrochloride Dihydrate

Therapeutic Category
Anti-Emetic
API Technology
Synthetic
Dose From
Oral Solids
Liquid
Dr Reddy's Development Status
Available
Available Regulatory Filing
USA
CEP
Japan
Korea
Canada
Malaysia
Saudi Arabia
Innovator Brand (USA)
Zofran

Mechanism of Action

Ondansetron is a selective 5-HT3 receptor antagonist. While its mechanism of action has not been fully characterized, ondansetron is not a dopamine-receptor antagonist. Serotonin receptors of the 5-HT3 type are present both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. It is not certain whether ondansetron’s antiemetic action is mediated centrally, peripherally, or in both sites. However, cytotoxic chemotherapy appears to be associated with release of serotonin from the enterochromaffin cells of the small intestine. In humans, urinary 5-hydroxyindoleacetic acid (5-HIAA) excretion increases after cisplatin administration in parallel with the onset of emesis. The released serotonin may stimulate the vagal afferents through the 5-HT3 receptors and initiate the vomiting reflex.

Indication

ZOFRAN is a 5-HT3 receptor antagonist indicated for the prevention of:

  • Nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2
  • Nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy
  • Nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen
  • Postoperative nausea and/or vomiting

Dr. Reddy's Expertise

Headquartered in Hyderabad, India, Dr. Reddy's Laboratories is one of the leading Active Pharmaceutical Ingredients (API) suppliers globally. Dr. Reddy's API business is a preferred partner to pharma companies across the US, Europe, Brazil, Latin America, Japan, China, Korea, Middle East and other emerging markets.

Dr. Reddy's API business thrives on the deep technical strengths established over the last 30+ years in the development and manufacture of complex APIs such as steroids, peptides, complex long chain molecules and highly potent APIs (HPAPIs / oncology drugs). This expertise is complemented by our prowess in intellectual property and regulatory affairs which helps us consistently meet and exceed regulatory standards. Dr. Reddy's Ondansetron Hydrochloride Dihydrate API is the outcome of the extensive expertise in R&D, IP, and Regulatory.

A key component in helping our customers be first to market is a responsive supply chain. We achieve this by making sure that all our facilities are operating efficiently and to the latest standards of quality, safety, and productivity. A strong interconnect between business and factories allows for a quick reaction to dynamic market changes, so that we can avert shortages and meet sudden surges in demand.

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Disclaimer

Products protected by valid patents are not offered for sale in countries where the sale of such products constitutes patent infringement. Availability may be restricted to certain markets or countries. Please Contact Us for more information on availability and product suitability.

All product information, including that with regard to active pharmaceutical ingredients (API), the indication, and possible mechanism(s) of action, is based on publicly available product label.