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Ondansetron Hydrochloride (Ondansetron Hydrochloride)

Trade Name : Ondansetron Hydrochloride

West-Ward Pharmaceuticals Corp.

SOLUTION

Strength 4 mg/5mL

ONDANSETRON HYDROCHLORIDE Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]

Delivery Process

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Ondansetron Hydrochloride (Ondansetron Hydrochloride) which is also known as Ondansetron Hydrochloride and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 4 mg/5mL per ml. Read more

Ondansetron Hydrochloride (Ondansetron Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Ondansetronis indicated for the prevention of nausea and vomiting associated with:
  • Ondansetron is also indicated for the prevention of postoperative nausea and/or vomiting.
  • Ondansetron is a 5-HT receptor antagonist indicated for the prevention of:
  • No data
  • 2.2n- 8.6
  • Ondansetron Oral Solution USP, 4mg/5mL, is a clear, colorless solution available in a 50 mL bottle.
  • Oral Solution: 4 mg/5mL ()
  • Ondansetron is contraindicated in patients:
  • No data
  • Hypersensitivity Reactions Including Anaphylaxis and Bronchospasm
  • QT Interval Prolongation and n
  • Serotonin Syndrome
  • Masking of Progressive Ileus and/or Gastric Distention Following Abdominal Surgery or Chemotherapy-induced Nausea and Vomiting
  • The most common adverse reactions in adults for the:
  • No data
  • No data
  • Animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.
  • There is no specific antidote for ondansetron overdose. Patients should be managed with appropriate supportive therapy.
  • In addition to the adverse reactions listed above, the following adverse reactions have been described in the setting of ondansetron overdose: u201cSudden blindnessu201d (amaurosis) of 2 to 3 minutesu2019 duration plus severe constipation occurred in 1 patient that was administered 72 mg of ondansetron intravenously as a single dose. Hypotension (and faintness) occurred in a patient that took 48 mg of ondansetron tablets. Following infusion of 32 mg over only a 4-minute period, a vasovagal episode with transient second-degree heart block was observed. In all instances, the adverse reactions resolved completely.
  • Pediatric cases consistent with serotonin syndrome have been reported after inadvertent oral overdoses of ondansetron (exceeding estimated ingestion of 5 mg per kg) in young children. Reported symptoms included somnolence, agitation, tachycardia, tachypnea, hypertension, flushing, mydriasis, diaphoresis, myoclonic movements, horizontal nystagmus, hyperreflexia, and seizure. Patients required supportive care, including intubation in some cases, with complete recovery without sequelae within 1 to 2 days.
  • The active ingredient in ondansetron oral solution USP is ondansetron hydrochloride (HCl) USP as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT receptor type. Chemically it is 4H-carbazol-4-one, 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-, monohydrochloride, (u00b1)-, dihydrate. It has the following structural formula:
  • The empirical formula is CHNOu2022HClu20222HO, representing a molecular weight of 365.9.
  • Ondansetron hydrochloride USP dihydrate is a white to off-white powder that is soluble in water and normal saline.
  • Each 5 mL of Ondansetron Oral Solution USP contains 5 mg of ondansetron hydrochloride USP dihydrate equivalent to 4 mg of ondansetron (base) and the following inactive ingredients: anhydrous citric acid, glycerin, purified water, saccharin sodium, sodium citrate, sodium benzoate and strawberry flavor.
  • No data
  • Carcinogenic effects were not seen in 2-year studies in rats and mice with oral ondansetron doses up to 10 mg/kg per day and 30 mg/kg per day, respectively (approximately 4 and 6 times the maximum recommended human oral dose of 24 mg per day, based on body surface area).
  • Ondansetron was not mutagenic in standard tests for mutagenicity.
  • Oral administration of ondansetron up to 15 mg/kg per day (approximately 6 times the maximum recommended human oral dose of 24 mg per day, based on body surface area) did not affect fertility or general reproductive performance of male and female rats.
  • No data
  • Ondansetron Oral Solution USP
  • 4mg /5 mL oral solution is supplied as a (strawberry-flavored) clear, colorless solution.
  • NDC 0054-0064-47: Bottle of 50 mL
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.] Protect from light. Store bottles upright in carton.
  • QT Prolongation
  • Inform patients that ondansetron may cause serious cardiac arrhythmias such as QT prolongation. Instruct patients to tell their healthcare provider right away if they perceive a change in their heart rate, if they feel lightheaded, or if they have a syncopal episode.
  • Hypersensitivity Reactions
  • Inform patients that ondansetron may cause hypersensitivity reactions, some as severe as anaphylaxis and bronchospasm. Instruct patients to immediately report any signs and symptoms of hypersensitivity reactions, including fever, chills, rash, or breathing problems to their healthcare provider.
  • Masking of Progressive Ileus and Gastric Distension
  • Inform patients following abdominal surgery or those with chemotherapy-induced nausea and vomiting that ondansetron may mask signs and symptoms of bowel obstruction. Instruct patients to immediately report any signs or symptoms consistent with a potential bowel obstruction to their healthcare provider.
  • Drug Interactions
  • Distr. by: n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • 10003003/10
  • Revised November 2017
  • Ondansetron Oral Solution, USP, 4 mg/5 mL
  • NDC 0054-0064-47
  • Rx only

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