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Ondansetron Hydrochloride (Ondansetron)

Trade Name : Ondansetron

Proficient Rx LP

SOLUTION

Strength 4 mg/5mL

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

Delivery Process

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Product information is meant for

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Disclaimer

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) which is also known as Ondansetron and Manufactured by Proficient Rx LP. It is available in strength of 4 mg/5mL per ml. Read more

Ondansetron Hydrochloride (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

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
  • Ondansetron oral solution, USP is indicated for the prevention of nausea and vomiting associated with:
  • Ondansetron oral solution, USP 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, 4 mg/5 mL, is a clear, colorless liquid with a characteristic strawberry odor available in a brown, 50-mL bottle.
  • u00a0
  • 3
  • Ondansetron oral solution, USP is contraindicated in patients:
  • No data
  • Hypersensitivity reactions including anaphylaxis and bronchospasm
  • QT interval prolongation and Torsade de Pointes
  • 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:
  • To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-844-834-0530 or FDA at 1-800-FDA-1088 or .
  • 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 one 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 as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT receptor type. u00a0Chemically it 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 hydrochloride 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 dihydrate equivalent to
  • 4 mg of ondansetron. Ondansetron oral solution, USP contains the inactive ingredients citric acid anhydrous, glycerin, purified water, sodium benzoate, strawberry flavor, and sucrose. Sodium citrate maybe added for pH adjustment.
  • 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 a clear, colorless liquid with a characteristic strawberry odor, contains 5 mg of ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron per 5 mL in brown bottles of 50 mL (NDC 71205-109-50) with child-resistant closures.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F), [See USP Controlled Room Temperature]. Protect from light. Store bottles upright in cartons.
  • QT Prolongation
  • Inform patients that ondansetron oral solution, USP 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 oral solution, USP 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 oral solution, 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
  • Distributed by:Lannett Company, Inc.Philadelphia, PA 19154
  • Revised 10/2017u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 10-1109
  • Relabeled By;:Proficient Rx LP.Thousand Oaks CA 91320
  • No data

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Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

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Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

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Validated Cold Chain Shipment

Validated Cold Chain Shipment

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Clinical Trials Supply

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Pharmaceutical Contract Manufacturing

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