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Ondansetron Hydrochloride (Zofran)

Trade Name : ZOFRAN

Novartis Pharmaceuticals Corporation

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 (Zofran) which is also known as ZOFRAN and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 4 mg/1 per ml. Read more

Ondansetron Hydrochloride (Zofran) 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

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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.

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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
  • ZOFRAN is indicated for the prevention of nausea and vomiting associated with:
  • ZOFRAN is also indicated for the prevention of postoperative nausea and/or vomiting.
  • ZOFRAN is a 5-HT receptor antagonist indicated for the prevention of:
  • No data
  • 2.2n- 8.6
  • ZOFRAN tablets are oval, film-coated tablets engraved with u201cZofranu201d on one side and are available in the following strengths:
  • ZOFRAN ODT orally disintegrating tablets are white, round, and plano-convex tablets available in the following strengths:
  • ZOFRAN oral solution, 4 mg/5 mL, is a clear, colorless to light yellow liquid with a characteristic strawberry odor available in a 50-mL bottle.
  • ZOFRAN is contraindicated in patients:
  • Patients known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any components of the formulation. ()
  • u2022
  • 4
  • 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:
  • Phenylketonuria:
  • The most common adverse reactions in adults for the:
  • To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or 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.
  • 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 3u00a0minutesu2019 duration plus severe constipation occurred in oneu00a0patient that was administered 72u00a0mg of ondansetron intravenously as a single dose. Hypotension (and faintness) occurred in a patient that took 48u00a0mg of ZOFRAN tablets. Following infusion of 32u00a0mg 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 ZOFRAN tablets and ZOFRAN oral solution is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT 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:
  • 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.
  • The active ingredient in ZOFRAN ODT orally disintegrating tablets is ondansetron base, the racemic form of ondansetron, and a selective blocking agent of the serotonin 5-HT 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. It has the following structural formula:
  • The empirical formula is CHNO representing a molecular weight of 293.4.
  • Each 4-mg ZOFRAN tablet for oral administration contains ondansetron hydrochloride dihydrate equivalent to 4u00a0mg of ondansetron. Each 8-mg ZOFRAN tablet for oral administration contains ondansetron hydrochloride dihydrate equivalent to 8u00a0mg of ondansetron. Each tablet also contains the inactive ingredients hypromellose, iron oxide yellow (8-mg tablet only), lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, triacetin, and titanium dioxide.
  • Each 4-mg ZOFRAN ODT orally disintegrating tablet for oral administration contains 4u00a0mg ondansetron base. Each 8-mg ZOFRAN ODT orally disintegrating tablet for oral administration contains 8u00a0mg ondansetron base. Each ZOFRAN ODT tablet also contains the inactive ingredients aspartame, gelatin, mannitol, methylparaben sodium, propylparaben sodium, and strawberry flavor. ZOFRAN ODT tablets are a freeze-dried, orally administered formulation of ondansetron which disintegrates on the tongue and does not require water to aid dissolution or swallowing.
  • Each 5u00a0mL of ZOFRAN oral solution contains 5u00a0mg of ondansetron hydrochloride dihydrate equivalent to 4u00a0mg of ondansetron. ZOFRAN oral solution contains the inactive ingredients citric acid anhydrous, purified water, sodium benzoate, sodium citrate, sorbitol, 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
  • ZOFRAN Tablets
  • ZOFRAN ODT Orally Disintegrating Tablets
  • ZOFRAN Oral Solution
  • Store upright between 15u00b0C and 30u00b0C (59u00b0F and 86u00b0F). Protect from light. Store bottles upright in cartons.
  • QT Prolongation
  • Inform patients that ZOFRAN 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 ZOFRAN 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 ZOFRAN 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
  • Administration of ZOFRAN ODT Orally Disintegrating Tablets
  • Instruct patients not to remove ZOFRAN ODT tablets from the blister until just prior to dosing.
  • Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
  • T2017-104October 2017
  • PRINCIPAL DISPLAY PANEL
  • NDC 0078-0679-19
  • Zofran ODTn
  • (ondansetron)
  • Orally Disintegrating Tablets
  • 4 mg
  • Each tablet contains 4 mg ondansetron base.
  • Store between 2 and 30C (36 and 86F).
  • Do not use if blisters are torn, broken, or missing.
  • Phenylketonurics: Contains phenylalanine.
  • See package insert for Dosage and Administration.
  • R only
  • 30 Tablets (3 blistercards each containing 10 tablets)
  • Novartis
  • PRINCIPAL DISPLAY PANEL
  • NDC 0078-0680-19
  • Zofran ODTn
  • (ondansetron)
  • Orally Disintegrating Tablets
  • 8 mg
  • Each tablet contains 8 mg ondansetron base.
  • Store between 2 and 30C (36 and 86F).
  • Do not use if blisters are torn, broken, or missing.
  • Phenylketonurics: Contains phenylalanine.
  • See package insert for Dosage and Administration.
  • R only
  • 30 Tablets (3 blistercards each containing 10 tablets)
  • Novartis
  • PRINCIPAL DISPLAY PANEL
  • NDC 0078-0675-15
  • R only
  • Zofrann
  • (ondansetron hydrochloride)
  • Tablets
  • 4 mg
  • Each tablets contains 5 mg of ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron.
  • 30 Tablets
  • Novartis
  • PRINCIPAL DISPLAY PANEL
  • NDC 0078-0676-15
  • R only
  • Zofrann
  • (ondansetron hydrochloride)
  • Tablets
  • 8 mg
  • Each tablets contains 10 mg of ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron.
  • 30 Tablets
  • Novartis

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