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Ondansetron Hydrochloride (Ondansetron Hydrochloride)

Trade Name : Ondansetron Hydrochloride

KAISER FOUNDATION HOSPITALS

TABLET, FILM COATED

Strength 4 mg/1

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 Hydrochloride (Ondansetron Hydrochloride) which is also known as Ondansetron Hydrochloride and Manufactured by KAISER FOUNDATION HOSPITALS. It is available in strength of 4 mg/1 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
  • Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with:
  • Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.
  • Ondansetron tablets are a 5-HTn n n receptor antagonist indicated for the prevention of:n nn
  • nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/mn n n n n
  • nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy n n n n
  • 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 n n n n
  • postoperative nausea and/or vomiting n n n n
  • No data
  • See full prescribing information for the recommended dosage in adults and pediatrics. n n n n
  • Patients with severe hepatic impairment: do not exceed a total daily dose of 8 mg. n n n , n n n )n n n
  • No data
  • Tablets: 4 mg andu00a08 mg (n n n )n n n
  • Ondansetron tablets are contraindicated in patients:
  • Patients known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any components of the formulation. n n n n
  • Concomitant use of apomorphine. n n n n
  • No data
  • Hypersensitivity reactions including anaphylaxis and bronchospasm
  • QT interval prolongation and Torsade de Pointes
  • Serotonin syndromen- u00a0
  • 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, contactu00a0Risingu00a0Health, LLC at 1-833-395-6928u00a0or FDA at 1-800-FDA-1088 or n n n n
  • prevention of chemotherapy-induced (greater than or equal to 5%) are: headache, malaise/fatigue, constipation, diarrhea (n n n )n n n
  • prevention of radiation-induced nausea and vomiting (greater than or equal to 2%) are: headache, constipation, and diarrhea (n n n )n n n
  • prevention of postoperative nausea and vomiting (greater than or equal to 9%) are: headache and hypoxia (n n n )n n n
  • 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.n
  • There is no specific antidote for ondansetron overdose. Patients should be managed with appropriate supportive therapy.n n n n 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.n n n n 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.n nn
  • The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HTn n n receptor type. Chemically 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:n n n n n The molecular formula is Cn n n Hn n n Nn n n Ou2022HClu20222Hn n n O, representing a molecular weight of 365.9.n n n n Ondansetron hydrochloride USP (dihydrate) is a white to off-white powder that is soluble in water and normal saline. n n n n Ondansetron tablets, USP for oral administration contain ondansetron hydrochloride USP (dihydrate) equivalent to 4 mg or 8 mg of ondansetron. Each film-coated tablet also contains the inactive ingredients anhydrous lactose, microcrystalline cellulose, pregelatinized starch (maize), magnesium stearate, triacetin, titanium dioxide and hypromellose. In addition 8 mg tablet also contains iron oxide yellow.n nn
  • Meets USP dissolution test 6.
  • 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).n n n n Ondansetron was not mutagenic in standard tests for mutagenicity.n n n n 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.n nn
  • No data
  • Ondansetron Tablets USP, 4 mg
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Bottles of 1440u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 0179-0247-44n n n n n are yellow colored, oval shaped, film-coated tablets debossed with u2018Fu2019 on one side and u201892u2019 on the other side.n nn
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Bottles of 1440u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 0179-0248-44n n n n 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature]. Protect from light.n nn
  • QT Prolongationn n n n n- Arrayn- Arrayn- Array
  • Distributed by:n- Made in India
  • Repackaged by:
  • Kaiser Foundation Hospitalu00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0179-0247-44n n n n n n n n
  • 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

With shifting of pharma industry from synthetic molecules to biologic

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Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

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Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

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