Home › NDC Lookup › Ingredients › Ondansetron › 00143-9891-25
Ondansetron 2 mg/mL Injection — NDC 00143-9891-25 package photo

Ondansetron 2 mg/mL Injection

by West-Ward Pharmaceuticals Corp · 25 VIAL, SINGLE-DOSE in 1 CARTON (0143-9891-25) / 2 mL in 1 VIAL, SINGLE-DOSE (0143-9891-01)
NDC 00143-9891-25
🏷️ FDA NDC (as labeled) 0143-9891-25 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Ondansetron (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Dec 30, 2025 — Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0246-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 0143-9891-25
Product NDC 0143-9891
11-digit billing NDC 00143989125
NCPDP billing unit ML — per mL (volume)
RxCUI 283504, 1740467
UNII NMH84OZK2B
Application # ANDA076780
SPL Set ID bb4bc810-db26-471b-9ce7-6e2fb3018af0
Established class (EPC) Serotonin-3 Receptor Antagonist
Mechanism of action Serotonin 3 Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2006-12-26
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION
Substance ONDANSETRON HYDROCHLORIDE
GPI-14 50250065052024
GPI class Ondansetron HCl
GCN Seq No 061716
GCN 97502
HICL code 033598
Ingredient (HICL) Ondansetron Hcl/Pf
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6J
Therapeutic class — specific (HIC3) Antiemetic/Antivertigo Agents
AHFS code 56:22.20.00
AHFS class 5-Ht3 Receptor Antagonists
FDB label name ONDANSETRON HCL 4 MG/2 ML VIAL
FDB brand name Ondansetron Hcl
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 0143-9891-25 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00143-9891-25. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Serotonin-3 Receptor Antagonist class.

Pharmacologic class Serotonin-3 Receptor Antagonist
Drug family (ATC) Serotonin (5HT3) antagonists
How it works Serotonin 3 Receptor Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerWest-Ward Pharmaceuticals Corp
Application holderHIKMA FARMACEUTICA (PORTUGAL) SA
FDA applicationANDA076780 (ANDA)
Labeler code00143
First marketedDec 2006
Product typeHuman Prescription Drug
Portfolio10 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name ONDANSETRON HCL 4 MG/2 ML VIAL Ingredient Ondansetron Hcl/Pf
📖 What it is MedlinePlus · NLM

Ondansetron injection is used to prevent nausea and vomiting caused by cancer chemotherapy and surgery. Ondansetron is in a class of medications called serotonin 5-HT3 receptor antagonists. It works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Not at all. Ondansetron is approved to prevent nausea and vomiting from cancer chemotherapy, radiation therapy to the abdomen or whole body, and surgery. So you might receive it be...
  • What exactly is ondansetron used for — is it just for chemo patients?
  • The regular tablet is swallowed like any other pill. The orally disintegrating tablet (ODT) is placed on your tongue and allowed to dissolve — don't chew or swallow it whole. For c...
  • How do I take the tablet or the dissolving tablet correctly?
📖 Read our full Ondansetron guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 0.5 mg / 1 mL UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 9 mg / 1 mL UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • 0.25 mg / 1 mL UNII B22547B95K
    A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ondansetron 2 mg/mL 23155-0550-31 Heritage 1 vial $0.170 AP Availability likely —
Ondansetron 2 mg/mL 00641-6286-01 Hikma 20 ml $0.170 AP Availability likely —
Ondansetron 2 mg/mL 00641-6079-01 Hikma 20 ml $0.170 AP Availability likely —
Ondansetron 2 mg/mL 00409-4759-01 Hospira, 1 vial $0.170 AP Availability likely —
Ondansetron 2 mg/mL 23155-0549-31 Heritage 1 vial $0.170 AP Availability likely —
Ondansetron 2 mg/mL 72266-0124-01 Fosun 1 vial $0.170 AP Availability likely —
Ondansetron 2 mg/mL 00409-0009-25 Hospira, 25 vials $0.177 AP Availability likely —
Ondansetron 2 mg/mL 00409-2271-25 Hospira, 25 vials $0.177 AP Availability likely —
Ondansetron 2 mg/mL 00409-4755-03 Hospira, 25 vials $0.177 AP Availability likely —
Ondansetron 2 mg/mL 00641-6078-25 Hikma 25 vials $0.177 AP Availability likely —
Ondansetron 2 mg/mL 00641-6080-25 Hikma 25 vials $0.177 AP Availability likely —
ondansetron 2 mg/mL 25021-0777-02 Sagent 25 vials $0.177 AP Availability likely —
Ondansetron Hydrochloride 2 mg/mL 36000-0012-25 Baxter 25 vials $0.177 AP Availability likely —
Ondansetron 2 mg/mL 60505-6130-05 Apotex 25 vials $0.177 AP Availability likely —
Ondansetron 2 mg/mL 63323-0373-02 Fresenius 25 vials $0.177 AP Availability likely —
Ondansetron 2 mg/mL 65219-0323-02 Fresenius 25 vials $0.177 AP Availability likely —
Ondansetron 2 mg/mL 72266-0123-25 Fosun 25 vials $0.177 AP Availability likely —
Ondansetron 2 mg/mL 72572-0520-25 Civica, 25 vials $0.177 AP Availability likely —
Ondansetron 2 mg/mL 55150-0125-02 Eugia 25 vials $0.197 — FDA listed —
Ondansetron 2 mg/mLthis 00143-9891-25 West-Ward 25 vials — — FDA listed —
Ondansetron 2 mg/mL 00404-9930-02 Henry 1 vial — AP FDA listed —
Ondansetron 2 mg/mL 23155-0547-41 Heritage 10 vials — AP FDA listed —
Ondansetron 2 mg/mL 23155-0548-41 Heritage 10 vials — AP FDA listed —
Ondansetron 2 mg/mL 50090-4935-00 A-S 25 vials — AP FDA listed —
Ondansetron 2 mg/mL 51662-1245-01 HF 2 ml — AP FDA listed —
Ondansetron 2 mg/mL 51662-1366-01 HF 2 ml — AP FDA listed —
Ondansetron 2 mg/mL 51662-1469-01 HF 2 ml — AP FDA listed —
Ondansetron 2 mg/mL 55154-2876-05 Cardinal 5 vials — AP FDA listed —
Ondansetron 2 mg/mL 55154-2877-05 Cardinal 5 vials — AP FDA listed —
Ondansetron Hydrochloride 2 mg/mL 55154-4453-05 Cardinal 5 vials — AP FDA listed —
Ondansetron 2 mg/mL 55154-6976-05 Cardinal 5 vials — AP FDA listed —
Ondansetron 2 mg/mL 67184-0507-05 Qilu 5 vials — AP FDA listed —
Ondansetron 2 mg/mL 68083-0113-01 Gland 5 vials — AP FDA listed —
Ondansetron 2 mg/mL 71872-7068-01 Medical 1 vial — AP FDA listed —
Ondansetron 2 mg/mL 71872-7140-01 Medical 1 vial — AP FDA listed —
Ondansetron 2 mg/mL 71872-7162-01 Medical 1 vial — AP FDA listed —
ondansetron hydrochloride 2 mg/mL 83270-0160-03 Onesource 25 vials — — FDA listed —
Ondansetron 2 mg/mL 84549-0130-05 ProPharma 2 ml — AP FDA listed —
Ondansetron 2 mg/mL 00143-9890-01 West-Ward 20 ml — — FDA listed —
Ondansetron 2 mg/mL 71872-7107-01 Medical 1 vial — — FDA listed —
Ondansetron 2 mg/mL 85766-0199-20 Sportpharm 1 vial — AP FDA listed —
Ondansetron 2 mg/mL 86211-0115-01 JVET 1 vial — AP FDA listed —
Ondansetron 2 mg/mL 51662-1377-01 HF 20 ml — AP FDA listed —
Ondansetron 2 mg/mL 68083-0114-01 Gland 1 vial — AP FDA listed —
Ondansetron 2 mg/mL 85766-0234-25 Sportpharm 25 vials — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2006
On the market since
Dec 2006
📍
2026
Currently FDA-listed
20 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Ondansetron ODT (matched by generic name) — the program that covers self-administered drugs. 10 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Ondansetron ODT. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$27.68M
Claims incl. refills
1.5M
Beneficiaries
1.2M
Spend / beneficiary
$23.24
Spend / claim
$18.06
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Ondansetron — the ingredient across all brands.

Top reported reactions

Nausea14,459
Fatigue10,275
Diarrhoea9,488
Vomiting8,777
Dyspnoea5,971
Headache5,638
Death5,623

Reporter sex

121,840 reports

Serious outcomes

Death15,162
Disabling2,793
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 11,463 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00143-9891-25 You're viewing this 25 VIAL, SINGLE-DOSE in 1 CARTON (0143-9891-25) / 2 mL in 1 VIAL, SINGLE-DOSE (0143-9891-01) 2006-12-26 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 0143-9891-25, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00143-9891-25, written without dashes as 00143989125. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00143-9891-25, the first segment (00143) is the labeler code FDA assigned to West-Ward Pharmaceuticals Corp; the middle segment (9891) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (25) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by West-Ward Pharmaceuticals Corp. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
West-Ward Pharmaceuticals Corp is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 203 words ▾

1 INDICATIONS AND USAGE Ondansetron Injection, USP is a 5-HT 3 receptor antagonist indicated for the prevention of: • nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. ( 1.1 ) • postoperative nausea and/or vomiting. ( 1.2 )

1.1Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Cancer Chemotherapy Ondansetron Injection, USP is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin. Ondansetron is approved for patients aged 6 months and older.

1.2Prevention of Postoperative Nausea and/or Vomiting Ondansetron Injection, USP is indicated for the prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/‌or vomiting will occur postoperatively. In patients in whom nausea and/or vomiting must be avoided postoperatively, Ondansetron Injection, USP is recommended even when the incidence of postoperative nausea and/or vomiting is low.

For patients who do not receive prophylactic Ondansetron Injection, USP and experience nausea and/or vomiting postoperatively, Ondansetron Injection, USP may be given to prevent further episodes. Ondansetron Injection, USP is approved for patients aged 1 month and older.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy ( 2.1 ): Dilution of Ondansetron Injection, USP in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection is required before administration to adult and pediatric patients. Adults and pediatric patients 6 months of age and older: The recommended dosage is 0.15 mg/kg per dose for 3 doses (maximum of 16 mg per dose), infused intravenously over 15 minutes. Administer the first dose 30 minutes before the start of chemotherapy and subsequent doses 4 and 8 hours after the first dose.

Prevention of postoperative nausea and/or vomiting ( 2.2 ): Dilution of Ondansetron Injection, USP is not required before administration to adult and pediatric patients. See full prescribing information for the recommended dosage and administration instructions for adult and pediatric patients 1 month of age and older. Patients with severe hepatic impairment ( 2.3 ): Do not exceed a total daily dose of 8 mg.

2.1Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Chemotherapy Important Preparation Instructions Dilution of Ondansetron Injection, USP in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection is required before administration to adult and pediatric patients for the prevention of nausea and vomiting associated with emetogenic chemotherapy. For pediatric patients between 6 months and 1 year of age and/or 10 kg or less : Depending on the fluid needs of the patient, Ondansetron Injection, USP may be diluted in 10 to 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection.

Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright. Potency and safety are not affected. If a precipitate is observed, resolubilize by shaking the vial vigorously.

Do not mix Ondansetron Injection, USP with solutions for which physical and chemical compatibility has not been established. In particular, this applies to alkaline solutions as a precipitate may form. Inspect the diluted Ondansetron Injection, USP solution for particulate matter and discoloration before administration; discard if present.

Storage: After dilution, do not use beyond 24 hours. Although Ondansetron Injection, USP is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative. Compatibility: Ondansetron Injection, USP is compatible and stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.

Dosage and Administration The recommended dosage for adult and pediatric patients 6 months of age and older for prevention of nausea and vomiting associated with emetogenic chemotherapy is 0.15-mg/kg per dose for 3 doses (maximum of 16 mg per dose). Caution: Dilution of Ondansetron Injection, USP is required in adult and pediatric patients prior to administration. Infuse intravenously over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy and then repeat 4 and 8 hours after the first dose.

2.2Prevention of Postoperative Nausea and Vomiting Important Preparation Instructions Dilution of Ondansetron Injection, USP is not required before administration to adult and pediatric patients. Inspect Ondansetron Injection, USP visually for particulate matter and discoloration before administration; discard if present. Dosage and Administration The recommended dose and administration instructions for adult and pediatric patients 1 month of age and older for prevention of postoperative nausea and vomiting are shown in Table 1.

Table 1. Recommended Dose and Administration of Ondansetron Injection, USP for Preventi…

💊 Dosage Forms and Strengths 48 words ▾

3 DOSAGE FORMS AND STRENGTHS 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. ( 3 )

⛔ Contraindications 91 words ▾

4 CONTRAINDICATIONS 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. [See Adverse Reactions (6.2 )] . 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. • Patients known to have hypersensitivity (e.g., anaphylaxis) to this product or any of its components.

( 4 ) • Concomitant use of apomorphine. ( 4 , 7.2 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Hypersensitivity reactions including anaphylaxis and bronchospasm, have been reported in patients who have exhibited hypersensitivity to other selective 5-HT 3 receptor antagonists. ( 5.1 ) • 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. ( 5.2 ) • Serotonin syndrome has been reported with 5-HT 3 receptor agonists alone but particularly with concomitant use of serotonergic drugs. ( 5.3 ) • Use in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distention.

( 5.4 ) ( 5.5 )

5.1Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis and bronchospasm, have been reported in patients who have exhibited hypersensitivity to other selective 5-HT 3 receptor antagonists.

5.2QT Prolongation Ondansetron prolongs the QT interval in a dose-dependent manner [see Clinical Pharmacology (12.2 )] . In addition, postmarketing cases of Torsade de Pointes have been reported in patients using ondansetron. Avoid Ondansetron Injection, USP in patients with congenital long QT syndrome.

ECG monitoring is recommended in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or patients taking other medicinal products that lead to QT prolongation.

5.3Serotonin Syndrome The development of serotonin syndrome has been reported with 5-HT 3 receptor antagonists. Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). Some of the reported cases were fatal.

Serotonin syndrome occurring with overdose of Ondansetron Injection, USP alone has also been reported. The majority of reports of serotonin syndrome related to 5-HT 3 receptor antagonist use occurred in a post-anesthesia care unit or an infusion center. Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, with or without gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Patients should be monitored for the emergence of serotonin syndrome, especially with concomitant use of Ondansetron Injection, USP and other serotonergic drugs. If symptoms of serotonin syndrome occur, discontinue Ondansetron Injection, USP and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if ondansetron is used concomitantly with other serotonergic drugs [see Drug Interactions (7.5) , Overdosage (10) , Patient Counseling Information (17) ] .

5.4Masking of Progressive Ileus and Gastric Distension The use of Ondansetron Injection, USP in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and gastric distention.

5.5Effect on Peristalsis Ondansetron Injection, USP is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Chemotherapy-Induced Nausea and Vomiting – • The most common adverse reactions (≥ 7%) in adults are diarrhea, headache, and fever. ( 6.1 ) Postoperative Nausea and Vomiting – • The most common adverse reaction (≥ 10%) which occurs at a higher frequency compared to placebo in adults is headache. ( 6.1 ) • The most common adverse reaction (≥ 2%) which occurs at a higher frequency compared with placebo in pediatric patients aged 1 to 24 months is diarrhea.

( 6.1 ) 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.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The following adverse reactions have been reported in clinical trials of adult patients treated with ondansetron, the active ingredient of intravenous ondansetron across a range of dosages. A causal relationship to therapy with Ondansetron Injection, USP was unclear in many cases.

Chemotherapy-Induced Nausea and Vomiting Table 2. Adverse Reactions Reported in > 5% of Adult Patients Who Received Ondansetron at a Dosage of Three 0.15-mg/‌kg Doses Adverse Reaction Number of Adult Patients with Reaction Ondansetron Injection, USP 0.15 mg/kg x 3 (n = 419) Metoclopramide (n = 156) Placebo (n = 34) Diarrhea 16% 44% 18% Headache 17% 7% 15% Fever 8% 5% 3% Cardiovascular Rare cases of angina (chest pain), electrocardiographic alterations, hypotension, and tachycardia have been reported. Gastrointestinal Constipation has been reported in 11% of chemotherapy patients receiving multiday ondansetron.

Hepatic In comparative trials in cisplatin chemotherapy patients with normal baseline values of aspartate transaminase (AST) and alanine transaminase (ALT), these enzymes have been reported to exceed twice the upper limit of normal in approximately 5% of patients. The increases were transient and did not appear to be related to dose or duration of therapy. On repeat exposure, similar transient elevations in transaminase values occurred in some courses, but symptomatic hepatic disease did not occur.

Integumentary Rash has occurred in approximately 1% of patients receiving ondansetron. Neurological There have been rare reports consistent with, but not diagnostic of, extrapyramidal reactions in patients receiving Ondansetron Injection, USP, and rare cases of grand mal seizure. Other Rare cases of hypokalemia have been reported.

Postoperative Nausea and Vomiting The adverse reactions in Table 3 have been reported in ≥ 2% of adults receiving ondansetron at a dosage of 4 mg intravenous over 2 to 5 minutes in clinical trials. Table 3. Adverse Reactions Reported in ≥ 2% (and with Greater Frequency than the Placebo Group) of Adult Patients Receiving Ondansetron at a Dosage of 4 mg Intravenous over 2 to 5 Minutes Adverse Reaction a,b Ondansetron Injection 4 mg Intravenous (n = 547) Placebo (n = 547 ) Headache 92 (17%) 77 (14%) Drowsiness/sedation 44 (8%) 37 (7%) Injection site reaction 21 (4%) 18 (3%) Fever 10 (2%) 6 (1%) Cold sensation 9 (2%) 8 (1%) Pruritus 9 (2%) 3 (< 1%) Paresthesia 9 (2%) 2 (< 1%) a Adverse Reactions: Rates of these reactions were not significantly different in the ondansetron and placebo groups b Patients were receiving multiple concomitant perioperative and postoperative medications Pediatric Use Rates of adverse reactions were similar in both the ondansetron and placebo groups in pediatric patients receiving ondansetron (a single 0.1-mg/kg dose for pediatric patients weighing 40 kg or less, or 4 mg for pediatric patients weighing more than 40 kg) administered intravenously over at least 30 seconds.

Diarrhea was seen more frequently in patients taking Ondansetron Injection, USP (2%) compared with placebo (<1%)…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS

7.1Drugs Affecting Cytochrome P-450 Enzymes Ondansetron does not appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver. Because ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes (CYP3A4, CYP2D6, CYP1A2), inducers or inhibitors of these enzymes may change the clearance and, hence, the half-life of ondansetron [see Clinical Pharmacology (12.3) ] . On the basis of limited available data, no dosage adjustment is recommended for patients on these drugs.

7.2Apomorphine Based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron, the concomitant use of apomorphine with ondansetron is contraindicated [see Contraindications (4) ] .

7.3Phenytoin, Carbamazepine, and Rifampin In patients treated with potent inducers of CYP3A4 (i.e., phenytoin, carbamazepine, and rifampin), the clearance of ondansetron was significantly increased and ondansetron blood concentrations were decreased. However, on the basis of available data, no dosage adjustment for ondansetron is recommended for patients on these drugs [see Clinical Pharmacology (12.3) ] .

7.4Tramadol Although there are no data on pharmacokinetic drug interactions between ondansetron and tramadol, data from two small trials indicate that concomitant use of ondansetron may result in reduced analgesic activity of tramadol. Patients on concomitant ondansetron self-administered tramadol more frequently in these trials, leading to an increased cumulative dose in patient-controlled administration (PCA) of tramadol.

7.5Serotonergic Drugs Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT3 receptor antagonists and other serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs) [see Warnings and Precautions (5.3) ].

7.6Chemotherapy In humans, carmustine, etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron. In a crossover trial in 76 pediatric patients, intravenous ondansetron did not increase blood levels of high-dose methotrexate.

7.7Temazepam The coadministration of ondansetron had no effect on the pharmacokinetics and pharmacodynamics of temazepam.

7.8Alfentanil and Atracurium Ondansetron does not alter the respiratory depressant effects produced by alfentanil or the degree of neuromuscular blockade produced by atracurium. Interactions with general or local anesthetics have not been studied.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Available data do not reliably inform the association of Ondansetron Injection, USP and adverse fetal outcomes. Published epidemiological studies on the association between ondansetron and fetal outcomes have reported inconsistent findings and have important methodological limitations hindering interpretation [see Data ]. Reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered intravenously during organogenesis at approximately 3.6 and 2.9 times the maximum recommended human intravenous dose of 0.15 mg/kg given three times a day, based on body surface area, respectively [see Data ].

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the US general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Methodological limitations of the epidemiology studies preclude a reliable evaluation of the potential risk of adverse fetal outcomes with the use of ondansetron in pregnancy.

Two large retrospective cohort studies of ondansetron use in pregnancy have been published. In one study with 1,349 infants born to women who reported the use of ondansetron or received an ondansetron prescription in the first trimester, no increased risk for major congenital malformations was seen in aggregate analysis. In this same study, however, a sub-analysis for specific malformations reported an association between ondansetron exposure and cardiovascular defect (odds ratio (OR) 1.62 [95% CI (1.04, 2.14)]) and cardiac septal defect (OR 2.05 [95% CI (1.19, 3.28)]).

The second study examined 1970 women who received ondansetron prescription during pregnancy and reported no association between ondansetron exposure and major congenital malformations, miscarriage or stillbirth, and infants of low birth weight or small for gestational age. Important methodological limitations with these studies include the uncertainty of whether women who filled a prescription actually took the medication, the concomitant use of other medications or treatments, and other unadjusted confounders that may account for the study findings.

A case-control study evaluating associations between several common non-cardiac malformations and multiple antiemetic drugs reported an association between maternal use of ondansetron and isolated cleft palate (reported adjusted OR = 2.37 [95% CI (1.18, 4.76)]). However, this association could be a chance finding, given the large number of drugs-birth defect comparisons in this study. It is unknown whether ondansetron exposure in utero in the cases of cleft palate occurred during the time of palate formation (the palate is formed between the 6th and 9th weeks of pregnancy) or whether mothers of infants with cleft palate used other medications or had other risk factors for cleft palate in the offspring.

In addition, no cases of isolated cleft palate were identified in the aforementioned two large retrospective cohort studies. At this time, there is no clear evidence that ondansetron exposure in early pregnancy can cause cleft palate. Animal Data In embryo-fetal development studies in rats and rabbits, pregnant animals received intravenous doses of ondansetron up to 10 mg/kg/day and 4 mg/kg/day, respectively, during the period of organogenesis.

With the exception of short periods of maternal weight loss and a slight increase in the incidence of early uterine deaths at the high dose level in rabbits, there were no significant effects of ondansetron on the maternal animals or the development of the offspring. At doses of 10 mg/kg/day in rats and 4 mg/kg/day in rabbits, the maternal exposure margin was approximately 3.6 and 2.9 times the maximum recommended human oral dose of 0.15 mg/kg given three times a day, respectively, based on body surface area. No intraveno…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Available data do not reliably inform the association of Ondansetron Injection, USP and adverse fetal outcomes. Published epidemiological studies on the association between ondansetron and fetal outcomes have reported inconsistent findings and have important methodological limitations hindering interpretation [see Data ]. Reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered intravenously during organogenesis at approximately 3.6 and 2.9 times the maximum recommended human intravenous dose of 0.15 mg/kg given three times a day, based on body surface area, respectively [see Data ].

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the US general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Methodological limitations of the epidemiology studies preclude a reliable evaluation of the potential risk of adverse fetal outcomes with the use of ondansetron in pregnancy.

Two large retrospective cohort studies of ondansetron use in pregnancy have been published. In one study with 1,349 infants born to women who reported the use of ondansetron or received an ondansetron prescription in the first trimester, no increased risk for major congenital malformations was seen in aggregate analysis. In this same study, however, a sub-analysis for specific malformations reported an association between ondansetron exposure and cardiovascular defect (odds ratio (OR) 1.62 [95% CI (1.04, 2.14)]) and cardiac septal defect (OR 2.05 [95% CI (1.19, 3.28)]).

The second study examined 1970 women who received ondansetron prescription during pregnancy and reported no association between ondansetron exposure and major congenital malformations, miscarriage or stillbirth, and infants of low birth weight or small for gestational age. Important methodological limitations with these studies include the uncertainty of whether women who filled a prescription actually took the medication, the concomitant use of other medications or treatments, and other unadjusted confounders that may account for the study findings.

A case-control study evaluating associations between several common non-cardiac malformations and multiple antiemetic drugs reported an association between maternal use of ondansetron and isolated cleft palate (reported adjusted OR = 2.37 [95% CI (1.18, 4.76)]). However, this association could be a chance finding, given the large number of drugs-birth defect comparisons in this study. It is unknown whether ondansetron exposure in utero in the cases of cleft palate occurred during the time of palate formation (the palate is formed between the 6th and 9th weeks of pregnancy) or whether mothers of infants with cleft palate used other medications or had other risk factors for cleft palate in the offspring.

In addition, no cases of isolated cleft palate were identified in the aforementioned two large retrospective cohort studies. At this time, there is no clear evidence that ondansetron exposure in early pregnancy can cause cleft palate. Animal Data In embryo-fetal development studies in rats and rabbits, pregnant animals received intravenous doses of ondansetron up to 10 mg/kg/day and 4 mg/kg/day, respectively, during the period of organogenesis.

With the exception of short periods of maternal weight loss and a slight increase in the incidence of early uterine deaths at the high dose level in rabbits, there were no significant effects of ondansetron on the maternal animals or the development of the offspring. At doses of 10 mg/kg/day in rats and 4 mg/kg/day in rabbits, the maternal exposure margin was approximately 3.6 and 2.9 times the maximum recommended human oral dose of 0.15 mg/kg given three times a day, respectively, based on body surface area. No intravenous pre- and post-natal develop…

🧒 Pediatric Use 108 words ▾

8.4Pediatric Use Little information is available about the use of ondansetron in pediatric surgical patients younger than 1 month. [See Clinical Studies (14.2) ] .Little information is available about the use of ondansetron in pediatric cancer patients younger than 6 months. [See Clinical Studies (14.1) , Dosage and Administration (2) ] . The clearance of ondansetron in pediatric patients aged 1 month to 4 months is slower and the half-life is ~2.5 fold longer than patients who are > 4 to 24 months. As a precaution, it is recommended that patients less than 4 months receiving this drug be closely monitored. [See Clinical Pharmacology (12.3) ] .

🧓 Geriatric Use 143 words ▾

8.5Geriatric Use Of the total number of subjects enrolled in cancer chemotherapy-induced and postoperative nausea and vomiting in US- and foreign-controlled clinical trials, 862 were aged 65 years and older. No overall differences in safety or effectiveness were observed between subjects 65 years and older and younger subjects. A reduction in clearance and increase in elimination half-life were seen in patients older than 75 years compared with younger subjects [see Clinical Pharmacology (12.3) ].

There were an insufficient number of patients older than 75 years of age and older in the clinical trials to permit safety or efficacy conclusions in this age-group. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dosage adjustment is not needed in patients over the age of 65 .

🆘 Overdosage 206 words ▾

10 OVERDOSAGE 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: “Sudden blindness” (amaurosis) of 2 to 3 minutes’ 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.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Ondansetron is a selective 5-HT 3 receptor antagonist. While ondansetron’s mechanism of action has not been fully characterized, it is not a dopamine-receptor antagonist.

12.2Pharmacodynamics In normal volunteers, single intravenous doses of 0.15 mg/kg of ondansetron had no effect on esophageal motility, gastric motility, lower esophageal sphincter pressure, or small intestinal transit time. In another trial in six normal male volunteers, a 16 mg dose infused over 5 minutes showed no effect of the drug on cardiac output, heart rate, stroke volume, blood pressure, or electrocardiogram (ECG). Multiday administration of ondansetron has been shown to slow colonic transit in normal volunteers.

Ondansetron has no effect on plasma prolactinconcentrations. In a gender balanced pharmacodynamic trial (n = 56), ondansetron 4 mg administered intravenously or intramuscularly was dynamically similar in the prevention of nausea and vomiting using the ipecacuanha model of emesis. Cardiac Electrophysiology QTc interval prolongation was studied in a double-blind, single intravenous dose, placebo- and positive-controlled, crossover trial in 58 healthy subjects.

The maximum mean (95% upper confidence bound) difference in QTcF from placebo after baseline correction was 19.5 (21.8) ms and 5.6 (7.4) ms after 15 minute intravenous infusions of 32 mg and 8 mg ondansetron, respectively. A significant exposure-response relationship was identified between ondansetron concentration and ΔΔQTcF. Using the established exposure-response relationship, 24 mg infused intravenously over 15 minutes had a mean predicted (95% upper prediction interval) ΔΔQTcF of 14.0 (16.3) ms.

In contrast, 16 mg infused intravenously over 15 minutes using the same model had a mean predicted (95% upper prediction interval) ΔΔQTcF of 9.1 (11.2) ms. In this study, the 8-mg dose infused over 15 minutes did not prolong the QT interval to any clinically relevant extent.

12.3Pharmacokinetics In normal adult volunteers, the following mean pharmacokinetic data have been determined following a single 0.15 mg/kg intravenous dose. Table 4 . Pharmacokinetics in Normal Adult Volunteers Age-group (years) n Peak Plasma Concentration (ng/mL) Mean Elimination Half-life (h) Plasma Clearance (L/h/kg) 19-40 11 102 3.5 0.381 61-74 12 106 4.7 0.319 ≥ 75 11 170 5.5 0.262 Absorption A trial was performed in normal volunteers (n = 56) to evaluate the pharmacokinetics of a single 4-mg dose administered as a 5-minute infusion compared with a single intramuscular injection.

Systemic exposure as measured by mean AUC were equivalent, with values of 156 [95% CI 136, 180] and 161 [95% CI 137, 190] ng•h/mL for intravenous and intramuscular groups, respectively. Mean peak plasma concentrations were 42.9 [95% CI 33.8, 54.4] ng/mL at 10 minutes after intravenous infusion and 31.9 [95% CI 26.3, 38.6] ng/mL at 41 minutes after intramuscular injection. Distribution Plasma protein binding of ondansetron as measured in vitro was 70% to 76%, over the pharmacologic concentration range of 10 to 500 ng/mL.

Circulating drug also distributes into erythrocytes. Elimination Metabolism Ondansetron is extensively metabolized in humans, with approximately 5% of a radiolabeled dose recovered as the parent compound from the urine. The primary metabolic pathway is hydroxylation on the indole ring followed by subsequent glucuronide or sulfate conjugation.

Although some nonconjugated metabolites have pharmacologic activity, these are not found in plasma at concentrations likely to significantly contribute to the biological activity of ondansetron. The metabolites are observed in the urine. In vitro metabolism studies have shown that ondansetron is a substrate for multiple human hepatic cytochrome P-450 enzymes, including CYP1A2, CYP2D6, and CYP3A4.

In terms of overall ondansetron turnover, CYP3A4 plays a predominant role while formation of the major in vivo metabolites is apparently medi…

🧬 Mechanism of Action 28 words ▾

12.1Mechanism of Action Ondansetron is a selective 5-HT 3 receptor antagonist. While ondansetron’s mechanism of action has not been fully characterized, it is not a dopamine-receptor antagonist.

📦 How Supplied / Storage and Handling 62 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Ondansetron Injection, USP 2 mg/mL, is supplied as follows: NDC 0143-9891-25 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: Store vials between 20° to 25ºC (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

📋 Description 216 words ▾

11 DESCRIPTION The active ingredient of Ondansetron Injection, USP is ondansetron hydrochloride, a selective blocking agent of the serotonin 5-HT 3 receptor type. Its chemical name is (±) 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 C 18 H 19 N 3 O•HCl•2H 2 O, 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 intravenous or intramuscular use. The pH of the injection solution is 3.3 to 4.0. Structural formula

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION 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: Patients with a personal or family history of abnormal heart rhythms, such as congenital long QT syndrome; Patients who take medications, such as diuretics, which may cause electrolyte abnormalities Patients with hypokalemia or hypomagnesemia 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 • 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. • 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 to seek immediate medical attention if the following symptoms occur: changes in mental status, autonomic instability, neuromuscular symptoms with or without gastrointestinal symptoms. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL Distributed by: WEST-WARD A Hikma Company Eatontown, NJ 07724 USA Revised: April 2017 PIN139-WES/15

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00143-9890-01 · West-Ward 00143-9899-91 · Hikma →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.