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Ondansetron 2 mg/mL Injection

by Civica, Inc. · 25 VIAL in 1 CARTON (72572-520-25) / 2 mL in 1 VIAL (72572-520-01)

NDC 72572-0520-25

🏷️ FDA NDC (as labeled) 72572-520-25 billing pads the product 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 Dr. Brian Staiger, PharmD

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) 72572-520-25

Product NDC 72572-520

11-digit billing NDC 72572052025

NCPDP billing unit ML — per mL (volume)

RxCUI 1740467

UNII NMH84OZK2B

Application # ANDA077541

SPL Set ID 70437694-0341-4f3b-824c-06843403443f

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 2019-11-18

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

TE code (Orange Book) AP · RLD · RS

Why two NDCs? The FDA registers this code as 72572-520-25 — a 5-3-2 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 product segment → 72572-0520-25. 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

LabelerCivica, Inc.

Application holderHIKMA PHARMACEUTICALS USA INC

FDA applicationANDA077541 (ANDA)

Labeler code72572

First marketedNov 2019

Product typeHuman Prescription Drug

Portfolio95 products on file

🔎 All NDCs from Civica, Inc.

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

📗 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 →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Ondansetron — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Ondansetron (195 interactions) — ranked by severity →

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 system	Per mL	Per package
Retail pharmacies payNADAC · weekly	$0.177	$8.86 / 50 ml
Medicaid paysCMS SDUD · 12 mo	$69.06	$3,453.03 / 50 ml
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J2405	$0.088 / J2405 unit	—

NADAC price history (per mL) — tap or hover for the price & month

▼ Down 2% over the last 15 months.

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.

🧾 Billing & reimbursement

FDA NDC (as labeled)72572-520-25

11-digit billing NDC72572-0520-25

Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)

HCPCS J-codeJ2405

DescriptorINJECTION, ONDANSETRON HYDROCHLORIDE, PER 1 MG

Billing units / pkg2 units

Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)

Where does this data come from?

The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Ondansetron 2 mg/mL 23155-0550-31	Heritage	1 vial	$0.170	AP	Availability likely	save 4%
Ondansetron 2 mg/mL 00641-6286-01	Hikma	20 ml	$0.170	AP	Availability likely	save 4%
Ondansetron 2 mg/mL 00641-6079-01	Hikma	20 ml	$0.170	AP	Availability likely	save 4%
Ondansetron 2 mg/mL 00409-4759-01	Hospira,	1 vial	$0.170	AP	Availability likely	save 4%
Ondansetron 2 mg/mL 23155-0549-31	Heritage	1 vial	$0.170	AP	Availability likely	save 4%
Ondansetron 2 mg/mL 72266-0124-01	Fosun	1 vial	$0.170	AP	Availability likely	save 4%
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/mLthis 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	+11%
Ondansetron 2 mg/mL 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

🏛️

2019

On the market since

Nov 2019

📍

2026

Currently FDA-listed

7 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 72572-0520-25, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

20.9K

Units reimbursed last 4 qtrs

31.5K

Gross reimbursed last 4 qtrs

$2.17M

Avg / prescription

$104.23

Avg / unit

$69.0595

Latest quarter Q4 2025

3.1KRx

Medicaid pays / mL

$69.0595

gross reimbursed

NADAC / mL

$0.1771

acquisition cost

Spread

+$68.8824

+38895% vs cost

What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.

Fee-for-service vs managed care ⓘ

30% FFS 70% MCO

Fee-for-service · 6,253 Rx Managed care · 14,614 Rx

State Medicaid map

Units reimbursed · per 100k residents

0.5245

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 Idaho 245 /100k

2 Iowa 67.9 /100k

3 Oregon 55.8 /100k

4 Utah 52.9 /100k

5 D.C. 50.4 /100k

6 Ohio 23.4 /100k

7 North Carolina 20.3 /100k

8 Missouri 19.8 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 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

Serious outcomes

Death15,162

Disabling2,793

Reports over time (by year) — tap or hover for the count & year

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 NDC	Description	Marketing start	Status
72572-0520-25 You're viewing this	25 VIAL in 1 CARTON (72572-520-25) / 2 mL in 1 VIAL (72572-520-01)	2019-11-18	Active

📄 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 197 words ▾

1 INDICATIONS AND USAGE Ondansetron Injection 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 is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin. Ondansetron Injection is approved for patients aged 6 months and older.

1.2Prevention of Postoperative Nausea and/or Vomiting Ondansetron Injection 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 is recommended even when the incidence of postoperative nausea and/or vomiting is low.

For patients who do not receive prophylactic Ondansetron Injection and experience nausea and/or vomiting postoperatively, Ondansetron Injection may be given to prevent further episodes. Ondansetron Injection 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 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 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 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 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 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 solution for particulate matter and discoloration before administration; discard if present. • Storage: After dilution, do not use beyond 24 hours.

Although Ondansetron Injection is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative. • Compatibility : Ondansetron Injection 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). C aution: Dilution of Ondansetron I njection 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/or Vomiting Important Preparation Instructions • Dilution of Ondansetron Injection is not required before administration to adult and pediatric patients. • Inspect Ondansetron Injection 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.

T able 1. Recommended Dose and Administration of Ondansetron Injection for Prevention of P ostoperative N…

💊 Dosage Forms and Strengths 38 words ▾

3 DOSAGE FORMS AND STRENGTHS Ondansetron Injection, USP, 2 mg/mL, is a clear, colorless, nonpyrogenic, sterile solution available as a 2 mL single dose vial. Ondansetron Injection, USP (2 mg/mL): 2 mL single dose vial. ( 3 )

⛔ Contraindications 88 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: 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 and Torsade de Pointes: QT prolongation occurs in a dose-dependent manner. Cases of Torsade de Pointes have been reported.

Avoid Ondansetron Injection in patients with congenital long QT syndrome. ( 5.2 ) Serotonin Syndrome: Serotonin syndrome has been reported with 5-HT 3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs. ( 5.3 ) Myocardial Ischemia: Do not exceed the recommended infusion rate and monitor patients during and after administration.

( 2.1 , 2.2 , 5.4 ) Masking of Progressive Ileus and/or Gastric Distention Following Abdominal Surgery or Chemotherapy-Induced Nausea and Vomiting: Monitor for decreased bowel activity, particularly in patients with risk factors for gastrointestinal obstruction. ( 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 in patients with congenital long QT syndrome.

Electrocardiogram (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 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 and other serotonergic drugs. If symptoms of serotonin syndrome occur, discontinue Ondansetron Injection and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if Ondansetron Injection is used concomitantly with other serotonergic drugs [see Drug Interactions (7.5), Overdosage (10) ] .

5.4Myocardial Ischemia Myocardial ischemia has been reported in patients treated with ondansetron. In some cases, predominantly during intravenous administration, the symptoms appeared immediately after administration but resolved with prompt treatment. Coronary artery spasm appears to be the most common underlying cause.

Therefore, do not exceed the recommended infusion rate of Ondansetron Injection and monitor patients for signs and symptoms of myocardial ischemia during and after administration [see Dosage and Administration (2.1 , 2.2 ) and Adverse React…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] QT Prolongation [see Warnings and Precautions ( 5.2 )] Serotonin Syndrome [see Warnings and Precautions ( 5.3 )] Myocardial Ischemia [see Warnings and Precautions ( 5.4 )] Masking of Progressive Ileus and Gastric Distention [see Warnings and Precautions ( 5.5 )] Chemotherapy-Induced Nausea and Vomiting : The most common adverse reactions (≥ 7%) in adults are diarrhea, headache, and fever.

( 6.1 ) Postoperative Nausea and/or Vomiting : The most common adverse reaction (≥ 10%) which occurs at a higher frequency compared with 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 Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 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 Injection across a range of dosages. A causal relationship to therapy with Ondansetron Injection (ondansetron) was unclear in many cases.

Chemotherapy-Induced Nausea and Vomiting T able 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 0.15 mg/kg x 3 (n = 419) Met oclopramide ( n = 156) P lacebo ( 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, and rare cases of grand mal seizure. Other: Rare cases of hypokalemia have been reported.

Po stoperative Nausea and/or 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. T able 3. Adverse Reactions Reported in ≥ 2 % (and with Greater Frequency than the P lacebo 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…

🔄 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 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-HT 3 receptor antagonists and other serotonergic drugs, including SSRIs and 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 Published epidemiological studies on the association between ondansetron use and major birth defects have reported inconsistent findings and have important methodological limitations that preclude conclusions about the safety of ondansetron use in pregnancy [see Data ] . Available postmarketing data have not identified a drug-associated risk of miscarriage or adverse maternal outcomes. 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 (BSA), respectively [see Data ] .

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, miscarriages, or other adverse outcomes. 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 Available data on ondansetron use in pregnant women from several published epidemiological studies preclude an assessment of a drug-associated risk of adverse fetal outcomes due to important methodological limitations, including the uncertainty of whether women who filled a prescription actually took the medication, the concomitant use of other medications or treatments, recall bias, and other unadjusted confounders. Ondansetron exposure in utero has not been associated with overall major congenital malformations in aggregate analyses.

One large retrospective cohort study examined 1970 women who received a prescription for ondansetron during pregnancy and reported no association between ondansetron exposure and major congenital malformations, miscarriage, stillbirth, preterm delivery, infants of low birth weight, or infants small for gestational age. Two large retrospective cohort studies and one case-control study have assessed ondansetron exposure in the first trimester and risk of cardiovascular defects with inconsistent findings. Relative risks (RR) ranged from 0.97 (95% CI 0.86 to 1.10) to 1.62 (95% CI 1.04, 2.54).

A subset analysis in one of the cohort studies observed that ondansetron was specifically associated with cardiac septal defects (RR 2.05, 95% CI 1.19, 3.28); however this association was not confirmed in other studies. Several studies have assessed ondansetron and the risk of oral clefts with inconsistent findings. A retrospective cohort study of 1.8 million pregnancies in the US Medicaid Database showed an increased risk of oral clefts among 88,467 pregnancies in which oral ondansetron was prescribed in the first trimester (RR 1.24, 95% CI 1.03, 1.48), but no such association was reported with intravenous ondansetron in 23,866 pregnancies (RR 0.95, 95% CI 0.63, 1.43).

In the subgroup of women who received both forms of administration, the RR was 1.07 (95% CI 0.59, 1.93). Two case-control studies, using data from birth defects surveillance programs, reported conflicting associations between maternal use of ondansetron and isolated cleft palate (OR 1.6 [95% CI 1.1, 2.3] and 0.5 [95% CI 0.3, 1.0]). 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).

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. A…

🤰 Pregnancy ~3 min read ▾

🧒 Pediatric Use 105 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 aged >4 to 24 months.

As a precaution, it is recommended that patients younger than 4 months receiving this drug be closely monitored [see Clinical Pharmacology (12.3) ].

🧓 Geriatric Use 142 words ▾

8.5Geriatric Use Of the total number of subjects enrolled in cancer chemotherapy-induced and postoperative nausea and vomiting 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 6 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 ECG. Multiday administration of ondansetron has been shown to slow colonic transit in normal volunteers.

Ondansetron has no effect on plasma prolactin concentrations. 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 Injection, 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 Ab sorption 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 area under curve (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. E limination M e tabolism: 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. I n 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 app…

🧬 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 78 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Ondansetron Injection, USP, 2 mg/mL, is available as follows: 2 mL Single Dose Vial packaged in 25s (NDC 72572-520-25) This product, including the packaging components, is not made with natural rubber latex. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light.

To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For Product Inquiry call 1-877-845-0689.

📋 Description 152 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 molecular formula is C 18 H 19 N 3 O•HCl•2H 2 O, representing a molecular weight of 365.9 g/mol.

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. Ondansetron Injection, USP is a clear, colorless, nonpyrogenic, sterile solution for intravenous 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 Hypersensitivity Reactions Inform patients that Ondansetron Injection 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 [see Warnings and Precautions ( 5.1 ) ] . QT Prolongation Patients should be informed that Ondansetron Injection 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 Injection should be avoided in these patients, since they may be more at risk for cardiac arrhythmias, such as QT prolongation and Torsade de Pointes [see Warnings and Precautions ( 5.2 )] . 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 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 Injection 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 [see Warnings and Precautions ( 5.3 )] . Myocardial Ischemia Inform patients that Ondansetron Injection may cause myocardial ischemia during or after the administration. Advise patients to seek immediate medical help if any symptoms suggestive of a myocardial ischemia occur, such as sudden chest pain or chest tightness [see Warnings and Precautions (5.4)] .

Masking of Progressive Ileus and Gastric Distention Inform patients following abdominal surgery or those with chemotherapy-induced nausea and vomiting that Ondansetron Injection 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 [see Warnings and Precautions ( 5.5 )] . Distributed by: Civica, Inc.

Lehi, Utah 84048 Manufactured by: Hikma Pharmaceuticals USA Inc. Cherry Hill, New Jersey 08003 462-818-03

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

in vivo: In a living person or animal rather than in a laboratory dish.

serotonergic: Acting on serotonin, a chemical messenger involved in mood, sleep, and digestion.

Active ingredient: The part of a medicine that produces its intended effect on the body.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agitation: A state of feeling restless and upset and being unable to relax, sometimes with pacing or fidgeting.

ALT: A liver enzyme (alanine aminotransferase) checked by a blood test; raised levels can signal that the liver is irritated or damaged.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

antagonist: A substance that blocks a target in the body so a natural signal or another medicine cannot produce its usual effect.

antidote: A treatment that reverses or counteracts the effects of a specific medicine or poison.

AST: A liver enzyme (aspartate aminotransferase) measured in a blood test; higher levels may point to liver or sometimes muscle injury.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

bronchospasm: A sudden tightening of the muscles around the airways in the lungs that narrows them and makes breathing harder.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

crossover: A study design in which each person takes one treatment for a time, then switches to the other, acting as their own comparison.

CYP1A2: A liver enzyme that breaks down certain medicines and whose activity can be changed by cigarette smoke.

CYP2D6: A liver enzyme that breaks down many medicines; people inherit different versions, so it works faster in some and slower in others.

CYP3A4: One of the most important liver and gut enzymes, responsible for breaking down a large share of all medicines.

depression: A lasting low mood with loss of interest that affects everyday life.

diaphoresis: Heavy or excessive sweating.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

electrocardiogram: A quick, painless test that records the heart's electrical activity to check its rhythm and rate.

electrolyte: A mineral in the blood and body fluids, such as sodium, potassium, or calcium, that carries a small electric charge and helps the body work.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

emesis: The medical word for vomiting, or bringing up the contents of the stomach through the mouth.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

gestational age: How far along a pregnancy is, usually counted in weeks from the mother's last menstrual period.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hyperreflexia: Overactive or exaggerated reflexes, such as an unusually strong knee-jerk response.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypokalemia: A lower-than-normal level of potassium, an important mineral, in the blood.

hypomagnesemia: A lower-than-normal level of magnesium, a mineral, in the blood.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

ileus: A slowdown or stop in the normal movement of the intestines, so food and waste do not pass through.

in utero: Inside the womb, describing a baby before it is born.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

infusion: Slowly delivering fluid or medicine into a vein over a period of time, usually through a drip.

intramuscular: An injection given deep into a muscle; often written as IM.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

ischemia: Reduced blood flow to a part of the body, so that area does not get enough oxygen.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

mydriasis: Widening of the pupil, the dark center of the eye.

myoclonus: Sudden, brief, jerking movements of a muscle or group of muscles.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

nystagmus: Rapid, involuntary back-and-forth movements of the eyes that a person cannot control.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

paresthesia: A tingling, prickling, or "pins and needles" feeling in the skin, often in the hands or feet.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

potency: How much of a medicine is needed to produce a given effect; a more potent medicine works at a smaller dose.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

prophylaxis: Treatment given to prevent an infection or illness before it starts, rather than to treat one that is already present.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

pruritus: Itching of the skin.

QT prolongation: A longer-than-normal electrical recovery time between heartbeats, seen on a heart tracing (ECG), which can raise the chance of a dangerous heart rhythm.

QTc: A number from a heart tracing (ECG) that measures the heart's electrical recovery time, adjusted for the heart rate.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

sedation: A calm, sleepy, slowed-down state caused by a medicine that relaxes the brain and body.

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

serotonin syndrome: A potentially dangerous reaction from too much of the brain chemical serotonin, causing agitation, fast heartbeat, sweating, and muscle twitching.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

stillbirth: The death of a baby in the womb late in pregnancy or during birth.

substrate: A drug or other substance that a particular enzyme or transporter acts on.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

tachypnea: Breathing that is faster than normal.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

upper limit of normal: The highest value considered normal for a lab test; results above it are flagged as elevated.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 72572-0511-40 · Civica, 72572-0540-24 · Civica, →

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.

Ondansetron 2 mg/mL Injection

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