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Ondansetron (Ondansetron)

Trade Name : Ondansetron

West-Ward Pharmaceuticals Corp

INJECTION

Strength 2 mg/mL

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

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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 (Ondansetron) which is also known as Ondansetron and Manufactured by West-Ward Pharmaceuticals Corp. It is available in strength of 2 mg/mL per ml. Read more

Ondansetron (Ondansetron) 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

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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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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
  • Ondansetron Injection, USP is a 5-HT receptor antagonist indicated for the prevention of:
  • u2022 nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. ()
  • u2022 postoperative nausea and/or vomiting. ()
  • Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy ():
  • Prevention of postoperative nausea and/or vomiting ():
  • See full prescribing information for the recommended dosage and administration instructions for adult and pediatric patients 1 month of age and older.n
  • Patients with severe hepatic impairment ():
  • Ondansetron injection, 2 mg/mL is a clear, colorless, nonpyrogenic, sterile solution available as a 2 mL single dose vial and 20 mL multiple dose vial.
  • Ondansetron Injection (2 mg/mL): 2 mL single dose vial and 20 mL multiple dose vials. ()
  • Ondansetron injection is contraindicated for patients known to have hypersensitivity (e.g., anaphylaxis) to this product or any of its components. Anaphylactic reactions have been reported in patients taking ondansetron. .
  • The concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron.
  • u2022 Patients known to have hypersensitivity (e.g., anaphylaxis) to this product or any of its components. ()
  • u2022 Concomitant use of apomorphine. (, )
  • u2022 Hypersensitivity reactions including anaphylaxis and bronchospasm, have been reported in patients who have exhibited hypersensitivity to other selective 5-HT receptor antagonists. ()
  • u2022 QT prolongation occurs in a dose-dependent manner. Cases of Torsade de Pointes have been reported. Avoid Ondansetron Injection, USP in patients with congenital long QT syndrome. ()
  • u2022 Serotonin syndrome has been reported with 5-HTreceptor agonists alone but particularly with concomitant use of serotonergic drugs. ()
  • u2022 Use in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distention. () ()
  • Chemotherapy-Induced Nausea and Vomiting u2013
  • u2022 The most common adverse reactions (u2265 7%) in adults are diarrhea, headache, and fever. ()
  • Postoperative Nausea and Vomiting u2013
  • u2022 The most common adverse reaction (u2265 10%) which occurs at a higher frequency compared to placebo in adults is headache. ()
  • u2022 The most common adverse reaction (u2265 2%) which occurs at a higher frequency compared with placebo in pediatric patients aged 1 to 24 months is diarrhea. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-233-2001 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • 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. Individual intravenous doses as large as 150 mg and total daily intravenous doses as large as 252 mg have been inadvertently administered without significant adverse events. These doses are more than 10 times the recommended daily dose.
  • In addition to the adverse reactions listed above, the following events have been described in the setting of ondansetron overdose: u201cSudden blindnessu201d (amaurosis) of 2 to 3 minutesu2019 duration plus severe constipation occurred in one patient that was administered 72 mg of ondansetron intravenously as a single dose. Hypotension (and faintness) occurred in another patient that took 48 mg of ondansetron hydrochloride 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 events resolved completely.
  • Pediatric cases consistent with serotonin syndrome have been reported after inadvertent oral overdoses of ondansetron (exceeding estimated ingestion of 5 mg/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 of Ondansetron Injection, USP is ondansetron hydrochloride, a selective blocking agent of the serotonin 5-HT receptor type. Its chemical name is (u00b1) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula:
  • The empirical formula is CHNOu2022HClu20222HO, representing a molecular weight of 365.9.
  • Ondansetron HCl is a white to off-white powder that is soluble in water and normal saline.
  • Each 1 mL of aqueous solution in the 2 mL single-dose vial contains 2 mg of ondansetron as the hydrochloride dihydrate; 9 mg of Sodium Chloride, USP; and 0.5 mg of Citric Acid Monohydrate, USP and 0.25 mg of Sodium Citrate Dihydrate, USP as buffers in Water for Injection, USP.
  • Each 1 mL of aqueous solution in the 20 mL multiple dose vial contains 2 mg of ondansetron as the hydrochloride dihydrate; 8.3 mg of Sodium Chloride, USP; 0.5 mg of Citric Acid Monohydrate, USP and 0.25 mg of Sodium Citrate Dihydrate, USP as buffers; and 1.2 mg of Methylparaben, NF and 0.15 mg of Propylparaben, NF as preservatives in Water for Injection, USP. Ondansetron Injection, USP is a clear, colorless, nonpyrogenic, sterile solution for intravenousu00a0or intramuscular use. The pH of the injection solution is 3.3 to 4.0.
  • No data
  • Carcinogenic effects were not seen in 2-year studies in rats and mice with oral ondansetron doses up to 10 and 30 mg/kg per day, respectively (approximately 3.6 and 5.4 times the recommended human intravenous dose of 0.15 mg/kg given three times a 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 3.8 times the recommended human intravenous dose, based on body surface area) did not affect fertility or general reproductive performance of male and female rats.
  • The clinical efficacy of ondansetron hydrochloride, the active ingredient of Ondansetron Injection, USP, was assessed in clinical trials as described below.
  • Ondansetron Injection, USP 2 mg/mL, is supplied as follows:
  • NDC 0143-9891-25u00a0 2 mL single dose vials (Carton of 25)
  • NDC 0143-9890-01 20 mL multi dose vial (Carton of 1)
  • NDC 0143-9890-10 20 mL multi dose vial (Carton of 10)
  • Storage:
  • QT Prolongation
  • Patients should be informed that ondansetron may cause serious cardiac arrhythmias such as QT prolongation. Patients should be instructed 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.
  • Patients should be informed that the chances of developing severe cardiac arrhythmias such as QT prolongation and Torsade de Pointes are higher in the following people:
  • u00a0u00a0u00a0u00a0u00a0u00a0 Ondansetron should be avoided in these patients, since they may be more at risk for cardiac arrhythmias such as QT prolongation and Torsade de Pointes.
  • Hypersensitivity Reactions
  • Inform patients that Ondansetron Injection, USP may cause hypersensitivity reactions, some as severe as anaphylaxis and bronchospasm. The patient should report any signs and symptoms of hypersensitivity reactions, including fever, chills, rash, or breathing problems.
  • Masking of Pogressive Ileus and Gastric Distension
  • Inform patients following abdominal surgery or those with chemotherapy-induced nausea and vomiting that Ondansetron Injection, USP 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
  • u2022 Instruct the patient to report the use of all medications, especially apomorphine, to their healthcare provider. Concomitant use of apomorphine and Ondansetron Injection, USP may cause a significant drop in blood pressure and loss of consciousness.
  • u2022 Advise patients of the possibility of serotonin syndrome with concomitant use of ondansetron and another serotonergic agent such as medications to treat depression and migraines. Advise patients tou00a0 seek immediate medical attention if the following symptoms occur: changes in mental status, autonomic instability, neuromuscular symptoms with or without gastrointestinal symptoms.u00a0u00a0u00a0u00a0
  • Manufactured by:n
  • Distributed by:n
  • Revised: April 2017
  • PIN139-WES/15
  • NDC 0143-9891-01n n INJECTION, USPn n 2 mL Single Dose Vialn See package insert.Store at 20u00ba to 25u00baC (68u00ba to 77u00baF) [SeeUSP Controlled Room Temperature].Protect from light.
  • NDC 0143-9890-01n n INJECTION, USPn n 20 mL Multipleu00a0Dose VialEach 1 mL of aqueous solution in the 20 mL multidosevial contains 2 mg of ondansetron as the hydrochloridedihydrate; 8.3 mg of Sodium Chloride, USP; 0.5 mg ofCitric Acid Monohydrate, USP and 0.25 mg TrisodiumCitrate Dihydrate, USP as buffers; and 1.2 mg ofMethylparaben, NF and 0.15 mg of propylparaben aspreservatives in Water for Injection, USP.n See package insert.Store at 20u00ba to 25u00baC (68u00ba to 77u00baF) [See USP ControlledRoom Temperature].Protect from light.
  • NDC 0143-9890-10n n 10 x 20 mL Multiple Dose VialsEach 1 mL of aqueous solution in the 20 mLmultiple dose vial contains 2 mg of ondansetronas the hydrochloride dihydrate; 8.3 mg sodiumchloride, USP; 0.5 mg of citric acid monohydrate,USP and 0.25 mg trisodium citrate dihydrate, USPas buffers; and 1.2 mg of methylparaben, NF and0.15 mg of propylparaben as preservatives inWater for Injection, USP.n u00a0See package insert.n n
  • Arrayn- Array
  • No data

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