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Tranexamic Acid 100 mg/mL Injection, Solution

by Eugia US LLC · 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-188-10) / 10 mL in 1 VIAL, SINGLE-DOSE

NDC 55150-0188-10

🏷️ FDA NDC (as labeled) 55150-188-10 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

🚨

Active recall for this product.

Class III · Sep 26, 2022 — Presence of Particulate Matter: Piece of metal found in a vial (AuroMedics Pharma LLC) · FDA recall D-1551-2022

Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

⚠️

Other active recalls for Tranexamic Acid (different manufacturers) — 1 · tap to view

These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.

Class III · Jun 13, 2023 — Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. (AVKARE LLC) · FDA recall D-0875-2023

Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 55150-188-10

Product NDC 55150-188

11-digit billing NDC 55150018810

NCPDP billing unit ML — per mL (volume)

RxCUI 238720

UNII 6T84R30KC1

UPC 0355150188109

Application # ANDA205035

SPL Set ID 246a3c6c-a7fb-45c7-9509-49a48a5bdcc6

Established class (EPC) Antifibrinolytic Agent

Physiologic effect Decreased Fibrinolysis

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2016-01-14

Route INTRAVENOUS

Dosage form INJECTION, SOLUTION

Substance TRANEXAMIC ACID

GPI-14 84100040002025

GCN Seq No 068183

GCN 30912

HICL code 002802

Ingredient (HICL) Tranexamic Acid

HIC1 code M

Therapeutic class — broad (HIC1) Blood

HIC2 code M9

Therapeutic class — intermediate (HIC2) Drugs Given To Alter Blood Coagulation

HIC3 code M9D

Therapeutic class — specific (HIC3) Antifibrinolytic Agents

AHFS code 20:28.16.00

AHFS class Hemostatics

FDB label name TRANEXAMIC ACID 1,000 MG/10 ML

FDB brand name Tranexamic Acid

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 55150-188-10 — 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 → 55150-0188-10. 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 Antifibrinolytic Agent class.

Pharmacologic class Antifibrinolytic Agent

Drug family (ATC) Amino acids

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

LabelerEugia US LLC

Application holderEUGIA PHARMA SPECIALITIES LTD

FDA applicationANDA205035 (ANDA)

Labeler code55150

First marketedJan 2016

Product typeHuman Prescription Drug

Portfolio241 products on file

🔎 All NDCs from Eugia US LLC

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 TRANEXAMIC ACID 1,000 MG/10 ML Ingredient Tranexamic Acid

📗 Our plain-language guide HelloPharmacist

It depends on the form. As an IV injection, it's used short-term in people with hemophilia to control bleeding during and after a tooth extraction. As a tablet — brands include Lys...
What exactly is tranexamic acid used for?
No — this is a firm contraindication. Using tranexamic acid tablets at the same time as combined hormonal contraceptives (the pill, patch, or ring) significantly raises your risk o...
Can I take the tablets if I'm on the pill or another hormonal birth control?

📖 Read our full Tranexamic Acid guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

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

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

🌿 Every supplement checked against Tranexamic Acid (17 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.

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

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.

1 inactive ingredient 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 system	Per mL	Per package
Retail pharmacies payNADAC · weekly	$0.387	$38.68 / 100 ml
Medicaid paysCMS SDUD · 12 mo	$1.25	$125.33 / 100 ml
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

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

▲ Up 11% over the last 6 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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Tranexamic Acid 1 g/10mL 23155-0166-41	Heritage	10 vials	$0.387	AP	Availability likely	—
Tranexamic Acid 1 g/10mL 23155-0524-41	Heritage	10 vials	$0.387	AP	Availability likely	—
Tranexamic Acid 100 mg/mL 23155-0910-41	Heritage	10 vials	$0.387	AP	Availability likely	—
Tranexamic Acid 100 mg/mL 25021-0415-10	Sagent	10 vials	$0.387	AP	Availability likely	—
Tranexamic Acid 100 mg/mL 39822-1000-01	XGen	10 vials	$0.387	AP	Availability likely	—
Tranexamic Acid 100 mg/mL 43066-0008-10	Baxter	1 vial	$0.387	AP	Availability likely	—
Tranexamic Acid 100 mg/mLthis 55150-0188-10	Eugia	10 vials	$0.387	AP	Availability likely	—
Tranexamic Acid 100 mg/mL 60505-6169-01	Apotex	10 vials	$0.387	AP	Availability likely	—
Tranexamic Acid 100 mg/mL 65145-0106-10	Caplin	10 vials	$0.387	AP	Availability likely	—
Tranexamic Acid 100 mg/mL 67457-0197-10	Mylan	10 vials	$0.387	AP	Availability likely	—
Tranexamic Acid 100 mg/mL 72485-0510-10	Armas	10 vials	$0.387	AP	Availability likely	—
Tranexamic Acid 100 mg/mL 72603-0387-10	Northstar	10 vials	$0.387	AP	Availability likely	—
tranexamic acid 100 mg/mL 81284-0611-10	Provepharm	10 vials	$0.387	AP	Availability likely	—
tranexamic acid 100 mg/mL 81284-0612-10	Provepharm	10 vials	$0.387	AP	Availability likely	—
tranexamic acid 100 mg/mL 83634-0401-10	Avenacy,	10 vials	$0.387	AP	Availability likely	—
Cyklokapron 100 mg/mL 00013-1114-15	Pfizer	1 ampule	—	AP	FDA listed	—
Tranexamic Acid 100 mg/mL 00517-0960-01	American	1 vial	—	AP	Discontinued	—
Tranexamic Acid 1 g/10mL 14593-0318-01	Emcure	10 vials	—	AP	FDA listed	—
Tranexamic Acid 100 mg/mL 23155-0909-41	Heritage	10 ampules	—	AP	FDA listed	—
Tranexamic Acid 100 mg/mL 42571-0189-57	Micro	1 ampule	—	AP	FDA listed	—
Tranexamic Acid 100 mg/mL 42571-0314-89	Micro	1 vial	—	AP	FDA listed	—
Tranexamic Acid 100 mg/mL 51662-1532-01	HF	10 ml	—	AP	FDA listed	—
Tranexamic acid 100 mg/mL 68083-0160-10	Gland	10 vials	—	AP	FDA listed	—
Tranexamic Acid 100 mg/mL 70121-1398-01	Amneal	1 vial	—	AP	FDA listed	—
Tranexamic Acid 100 mg/mL 70518-4089-00	REMEDYREPACK	1 vial	—	AP	FDA listed	—
Tranexamic Acid 100 mg/mL 72485-0107-01	Armas	1 vial	—	AP	FDA listed	—
Tranexamic Acid 100 mg/mL 71357-0018-10	Milla	10 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

🏛️

2016

On the market since

Jan 2016

📍

2026

Currently FDA-listed

10 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 55150-0188-10, 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

1.3K

Units reimbursed last 4 qtrs

55.2K

Gross reimbursed last 4 qtrs

$69.2K

Avg / prescription

$53.70

Avg / unit

$1.2533

Latest quarter Q4 2025

356Rx

Medicaid pays / mL

$1.2533

gross reimbursed

NADAC / mL

$0.3868

acquisition cost

Spread

+$0.8665

+224% 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 ⓘ

17% FFS 83% MCO

Fee-for-service · 215 Rx Managed care · 1,073 Rx

State Medicaid map

Units reimbursed · per 100k residents

0.6731

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 Kentucky 731 /100k

2 New Mexico 150 /100k

3 Alaska 102 /100k

4 Virginia 69.8 /100k

5 California 20.9 /100k

6 Hawaii 17.1 /100k

7 Massachusetts 17.0 /100k

8 Missouri 13.7 /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 Tranexamic Acid — the program that covers self-administered drugs. 9 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 Tranexamic Acid. 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

$1.18M

Claims incl. refills

36.5K

Beneficiaries

33.4K

Spend / beneficiary

$35.38

Spend / claim

$32.37

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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
55150-0188-10 You're viewing this	10 VIAL, SINGLE-DOSE in 1 CARTON (55150-188-10) / 10 mL in 1 VIAL, SINGLE-DOSE	2016-01-14	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.

🚨 Boxed Warning 🎯 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

🚨 Boxed Warning 101 words ▾

WARNING: RISK OF MEDICATION ERRORS DUE TO INCORRECT ROUTE OF ADMINISTRATION Tranexamic acid injection is for intravenous use only. Serious, including fatal, adverse reactions including seizures and cardiac arrythmias have occurred when tranexamic acid injection was inadvertently administered via the neuraxial route [see Warnings and Precautions (5.1) ] . WARNING: RISK OF MEDICATION ERRORS DUE TO INCORRECT ROUTE OF ADMINISTRATION See full prescribing information for complete boxed warning.

Tranexamic acid injection is for intravenous use only. Serious, including fatal, adverse reactions including seizures and cardiac arrythmias have occurred when tranexamic acid injection was inadvertently administered intrathecally via the neuraxial route. (5.1)

🎯 Indications and Usage 72 words ▾

1 INDICATIONS AND USAGE Tranexamic acid injection is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. Tranexamic acid injection is an antifibrinolytic indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Before Extraction: Administer 10 mg/kg actual body weight of tranexamic acid injection intravenously with replacement therapy as a single-dose. ( 2.1 ) After Extraction: Administer 10 mg/kg actual body weight of tranexamic acid injection intravenously 3 to 4 times daily for 2 to 8 days. ( 2.1 ) Infuse undiluted solution no more than 1 mL/minute to avoid hypotension.

(2.3) Reduce the dosage for patients with renal impairment. ( 2.2 , 8.6 )

2.1Recommended Dosage The recommended dose of tranexamic acid injection is 10 mg/kg actual body weight administered as a single intravenous dose immediately before tooth extractions. Following tooth extraction, tranexamic acid injection may be administered at a dose of 10 mg/kg actual body weight intravenously 3 to 4 times daily for 2 to 8 days.

2.2Recommended Dosage for Patients With Varying Degrees of Renal Impairment For patients with moderate to severe impaired renal function, the following dosages are recommended: Table 1. Recommended Dosage in Patients With Varying Degrees of Renal Impairment* *Dose reduction is recommended for all doses, both before and after tooth extraction. Serum Creatinine (mg/dL) Tranexamic Acid Injection Dosage 1.36 mg/dL to 2.8 3 mg/dL 10 mg/kg intravenously twice daily 2.83 mg/ dL to 5.66 mg/dL 10 mg/kg intravenously daily >5.66 mg/dL 10 mg/kg intravenously every 48 hours or 5 mg/kg intravenously every 24 hours

2.3Preparation and Administration Tranexamic acid injection is for intravenous administration only. Tranexamic acid injection can be administered undiluted or as a diluted solution. Use aseptic technique to prepare tranexamic acid injection.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Tranexamic acid injection is a clear and colorless solution. Discard the vial if particulate matter is observed.

Calculate the dose (mg) based on the patient’s actual body weight and the total volume (mL) of tranexamic acid solution required. If diluting tranexamic acid injection , follow the instructions below: From the diluent infusion bag, withdraw a volume equal to the volume of the tranexamic acid solution required for the patient’s dose. Withdraw the required volume of tranexamic acid solution from the vial and dilute with a compatible diluent (see below) to make a final concentration of 10 mg/mL or 20 mg/mL.

Discard any unused portion left in the vial. ○ For intravenous infusion, tranexamic acid injection may be mixed with most solutions for infusion such as electrolyte solutions, carbohydrate solutions, amino acid solutions, and Dextran solutions. ○ Heparin may be added to tranexamic acid injection. ○ Tranexamic acid injection should NOT be mixed with blood. ○ The drug is a synthetic amino acid and should NOT be mixed with solutions containing penicillin. Gently invert the infusion bag to mix the diluted solution. DO NOT SHAKE.

If not used immediately, store the diluted tranexamic acid infusion solution at room temperature 20ºC to 25°C (68ºF to 77°F) for up to 4 hours. Administration Infuse undiluted solution no more than 1 mL/minute to avoid hypotension [see Adverse Reactions (6.2) ] . Administer the undiluted and diluted solutions intravenously according to Table 2.

Table 2. Administration Rates for Undiluted and Diluted Solutions Undiluted solution Diluted solution Final concentration 100 mg/mL 10 mg/mL 20 mg/mL Administration rate 0.5 mL/minute (no more than 1 mL/minute) 5 mL/minute 2.5 mL/minute

💊 Dosage Forms and Strengths 30 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 1,000 mg/10 mL (100 mg/mL) clear and colorless solution in single-dose vials Injection: 1,000 mg/10 mL (100 mg/mL) in single-dose vials ( 3 )

⛔ Contraindications 121 words ▾

4 CONTRAINDICATIONS Tranexamic acid injection is contraindicated: As a neuraxial (i.e., intrathecal, epidural) injection [see Warnings and Precautions (5.1) ] . In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid in such patients.

In patients with active intravascular clotting [see Warnings and Precautions (5.2) ] . In patients with hypersensitivity to tranexamic acid or any of the ingredients [see Warnings and Precautions (5.4) ] . As a neuraxial (i.e., intrathecal, epidural) injection.

(4) In patients with subarachnoid hemorrhage, due to risk of cerebral edema and cerebral infarction. (4) In patients with active intravascular clotting. (4) In patients with severe hypersensitivity reactions to tranexamic acid or any of the ingredients.

(4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Risk of Thrombosis with Concomitant Use of Factor IX: Avoid concomitant use. (5.2) Seizures: Inadvertent injection into neuraxial system may result in seizures. ( 5.3 ) Hypersensitivity Reactions: In case of severe reaction, discontinue use and seek immediate medical attention.

( 5.4 ) Visual Disturbances: Visual or ocular adverse effects may occur. Discontinue use if visual or ocular symptoms occur. ( 5.5 ) Dizziness: Advise patients not to drive if dizziness occurs.

( 5.6 )

5.1Risk of Medication Errors Due to Incorrect Route of Administration Tranexamic acid is for intravenous use only. Serious, including fatal, adverse reactions including seizures and cardiac arrythmias have occurred when tranexamic acid was inadvertently administered via the neuraxial route. Confirm the correct route of administration for tranexamic acid and avoid confusion with other injectable solutions that might be administered at the same time as tranexamic acid.

Clearly label syringes containing tranexamic acid with the intravenous route of administration.

5.2Thromboembolic Risk Tranexamic acid is contraindicated in patients with active intravascular clotting. Tranexamic acid is an antifibrinolytic and may increase the risk of thromboembolic events. Venous and arterial thrombosis or thromboembolism has been reported in patients treated with tranexamic acid.

Avoid concomitant use of tranexamic acid and medical products that are pro-thrombotic, as the risk of thrombosis may be increased. These medications include but are not limited to, Factor IX Complex concentrates, Anti-inhibitor Coagulant concentrates, and hormonal contraceptives [see Drug Interactions (7.1), Use in Specific Populations (8.3) ] .

5.3Seizures Tranexamic acid may cause seizures, including focal and generalized seizures. The most common setting for tranexamic acid-induced seizures has been during cardiovascular surgery (a setting in which tranexamic acid is not FDA-approved and which uses doses of up to 10-fold higher than the recommended human dose and in patients inadvertently given tranexamic acid via the neuraxial route). Tranexamic acid is contraindicated for neuraxial administration (i.e., epidural, intrathecal).

Consider dose reduction during surgery and dose adjustments for patients with clinical conditions such as renal dysfunction. Closely monitor the patient during surgery. Consider electroencephalogram (EEG) monitoring for patients with history of seizures or who experience myoclonic movements, twitching, or show evidence of focal seizures.

Discontinue tranexamic acid if seizures occur.

5.4Hypersensitivity Reactions Cases of hypersensitivity reactions, including anaphylactic reactions, have occurred with use of intravenous tranexamic acid. Discontinue treatment with tranexamic acid if serious reaction occurs, provide appropriate medical management, and do not restart treatment. Tranexamic acid injection is contraindicated in patients with a history of hypersensitivity to tranexamic acid.

5.5Visual Disturbances Although not seen in humans, focal areas of retinal degeneration have been observed in cats and dogs following oral or intravenous tranexamic acid at doses between 250 to 1600 mg/kg/day (1.6 to 22 times the recommended usual human dose based on body surface area) from 6 days to 1 year. No retinal changes have been observed in eye examinations of patients treated with tranexamic acid for up to 8 years. Patients expected to be treated for greater than 3 months may consider ophthalmic monitoring including visual acuity and optical coherence tomography at regular intervals.

Discontinue tranexamic acid if changes in ophthalmological examination occurs.

5.6Dizziness Tranexamic acid may cause dizziness. Concomitant use of other drugs that may also cause dizziness may worsen this effect. Advise patients to avoid driving or using machines until they know how tranexamic acid affects them.

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Risk of Medication Errors Due to Incorrect Route of Administration [see Warnings and Precautions (5.1) ] Thromboembolic Risk [see Warnings and Precautions (5.2) ] Seizures [see Warnings and Precautions (5.3) ] Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] Visual Disturbances [see Warnings and Precautions (5.5) ] Dizziness [see Warnings and Precautions (5.6) ] Most common adverse reactions are nausea, vomiting, diarrhea, allergic dermatitis, giddiness, hypotension, and thromboembolic events.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Eugia US LLC at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of tranexamic acid. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal disturbances (nausea, vomiting, diarrhea) may occur and may resolve with dose-reduction.

Allergic dermatitis and giddiness have been reported. Hypotension has been reported when intravenous injection is too rapid. Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, and central retinal artery, vein obstruction and cases associated with concomitant use of combination hormonal contraceptives) have been rarely reported in patients receiving tranexamic acid for indications other than hemorrhage prevention in patients with hemophilia.

Convulsion, chromatopsia, and visual impairment have also been reported. Anaphylaxis or anaphylactoid reactions have been reported that are suggestive of a causal relationship.

🔄 Drug Interactions 71 words ▾

7 DRUG INTERACTIONS Prothrombotic Medical Products: Avoid concomitant use, can further increase the risk of thromboembolic adverse reactions associated with tranexamic acid. ( 5.2, 7.1, 8.3 )

7.1Prothrombotic Medical Products Avoid concomitant use of tranexamic acid with medical products that are prothrombotic because concomitant use can further increase the risk of thromboembolic adverse reactions associated with tranexamic acid [see Warnings and Precautions (5.2), Use in Specific Populations (8.3) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Available data from published studies, case series and case reports with tranexamic acid use in pregnant women in the second and third trimester and at the time of delivery have not clarified whether there is a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. There are 2 (0.02%) infant cases with structural abnormalities that resulted in death when tranexamic acid was used during conception or the first trimester of pregnancy; however, due to other confounding factors the risk of major birth defects with use of tranexamic acid during pregnancy is not clear.

Tranexamic acid is known to pass the placenta and appears in cord blood at concentrations approximately equal to maternal concentration (see Data) . Reproduction studies performed in mice, rats, and rabbits have not revealed any adverse effects on the fetus due to tranexamic acid administered during organogenesis. Doses examined were multiples of up to 3 times (mouse), 6 times (rat), and 3 times (rabbit) the maximum human dose based on body surface area in the mouse, rat, and rabbit, respectively (see Data) .

The estimated background risk for major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

It is not known whether tranexamic acid use in pregnant women may cause a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. For decisions regarding the use of tranexamic acid during pregnancy, the potential risk of tranexamic acid administration on the fetus should always be considered along with the mother’s clinical need for tranexamic acid; an accurate risk-benefit evaluation should drive the treating physician's decision. Data Human Data Tranexamic acid passes through the placenta.

The concentration in cord blood after an intravenous injection of 10 mg/kg to pregnant women is about 30 mg/L, as high as in the maternal blood. There were 13 clinical studies that described fetal and/or neonatal functional issues such as low Apgar score, neonatal sepsis, cephalohematoma and 9 clinical studies that discussed alterations to growth including low birth weight and preterm birth at 22 to 36 weeks of gestation in fetuses and infants exposed to tranexamic acid in-utero. Animal Data In embryo-fetal development studies, tranexamic acid was administered to pregnant mice from Gestation Day (GD) 6 through GD 12 and rats from GD 9 through GD 14 at daily doses of 0.3 or 1.5 g/kg.

There was no evidence of adverse developmental outcomes in mice and rats at multiple of 3 and 6 times the maximum recommended human dose based on body surface area in the mouse and rat, respectively. In rabbits, tranexamic acid was administered intravenously at doses of 50, 100, or 200 mg/kg/day or orally at doses of 100, 200, or 400 mg/kg/day from GD 6 through GD 18. There was no evidence of adverse developmental outcomes at dose multiples of 2 or 3 times, respectively, the maximum recommended human dose based on body surface area.

Intravenous doses of 200 mg/kg/day showed slightly retarded weight gain in pregnant rabbits.

8.2Lactation Risk Summary Published literature reports the presence of tranexamic acid in human milk. There are no data on the effects of tranexamic acid on the breastfed child or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tranexamic acid and any potential adverse effects on the breastfed child from tranexamic acid or from the underlying maternal condition.

8.3Females and Males of Reproductive Potential Contraception Concomitant use of tranexamic acid, which is an antifibrinolytic, with hormonal contra…

🤰 Pregnancy ~2 min read ▾

Intravenous doses of 200 mg/kg/day showed slightly retarded weight gain in pregnant rabbits.

🧒 Pediatric Use 39 words ▾

8.4Pediatric Use There are limited data concerning the use of tranexamic acid in pediatric patients with hemophilia who are undergoing tooth extraction. The limited data suggest that there are no significant pharmacokinetic differences between adults and pediatric patients.

🧓 Geriatric Use 111 words ▾

8.5Geriatric Use Clinical studies of tranexamic acid did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Dosage and Administration (2.2) , Clinical Pharmacology (12.3) ] .

🆘 Overdosage 46 words ▾

10 OVERDOSAGE Cases of overdosage of tranexamic acid have been reported. Based on these reports, symptoms of overdosage may be gastrointestinal, e.g., nausea, vomiting, diarrhea; hypotensive, e.g., orthostatic symptoms; thromboembolic, e.g., arterial, venous, embolic; neurologic, e.g., visual impairment, convulsions, headache, mental status changes; myoclonus; and rash.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Tranexamic acid is a synthetic lysine amino acid derivative, which diminishes the dissolution of hemostatic fibrin by plasmin. In the presence of tranexamic acid, the lysine receptor binding sites of plasmin for fibrin are occupied, preventing binding to fibrin monomers, thus preserving and stabilizing fibrin’s matrix structure. The antifibrinolytic effects of tranexamic acid are mediated by reversible interactions at multiple binding sites within plasminogen.

Native human plasminogen contains 4 to 5 lysine binding sites with low affinity for tranexamic acid (Kd = 750 μmol/L) and 1 with high affinity (Kd = 1.1 μmol/L). The high affinity lysine site of plasminogen is involved in its binding to fibrin. Saturation of the high affinity binding site with tranexamic acid displaces plasminogen from the surface of fibrin.

Although plasmin may be formed by conformational changes in plasminogen, binding to and dissolution of the fibrin matrix is inhibited.

12.2Pharmacodynamics Tranexamic acid, in concentrations of 1 mg/mL and 10 mg/mL prolongs the thrombin time. An antifibrinolytic concentration of tranexamic acid remains in different tissues for about 17 hours, and in the serum, up to 7 or 8 hours. Tranexamic acid in concentrations up to 10 mg/mL blood has no influence on the platelet count, the coagulation time or various coagulation factors in whole blood or citrated blood from healthy subjects.

12.3Pharmacokinetics Distribution The initial volume of distribution is about 9 to 12 liters. The plasma protein binding of tranexamic acid is about 3% at therapeutic plasma levels and seems to be fully accounted for by its binding to plasminogen. Tranexamic acid does not bind to serum albumin.

Elimination After an intravenous dose of 1 g, the plasma concentration time curve shows a triexponential decay with a half-life of about 2 hours for the terminal elimination phase. Excretion Urinary excretion is the main route of elimination via glomerular filtration. Overall renal clearance is equal to overall plasma clearance (110 to 116 mL/min), and more than 95% of the dose is excreted in the urine as unchanged drug.

Excretion of tranexamic acid is about 90% at 24 hours after intravenous administration of 10 mg/kg body weight. Specific Populations Patients with Renal Impairment The blood levels of tranexamic acid are increased in patients with renal insufficiency. Urinary excretion following a single intravenous injection of tranexamic acid declines as renal function decreases.

Following a single 10 mg/kg intravenous injection of tranexamic acid, the 24-hour urinary fractions of tranexamic acid with serum creatinine concentrations 1.4 to 2.8, 2.8 to 5.7, and greater than 5.7 mg/dL were 51, 39, and 19%, respectively. The 24-hour tranexamic acid plasma concentrations for these patients demonstrated a direct relationship to the degree of renal impairment. Therefore, dose adjustment is needed in patients with renal impairment [see Dosage and Administration (2.2) , Use in Specific Populations (8.6) ] .

Drug Interaction Studies No studies of interactions between tranexamic acid and other drugs have been conducted.

🧬 Mechanism of Action 148 words ▾

Although plasmin may be formed by conformational changes in plasminogen, binding to and dissolution of the fibrin matrix is inhibited.

📦 How Supplied / Storage and Handling 78 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Tranexamic acid injection USP, 1,000 mg/10 mL (100 mg/mL) is a sterile, clear, colorless solution free from visible particles and is supplied as follows: 1,000 mg/10 mL (100 mg/mL) 10 mL Single-Dose Vials Packaged in a Carton of 10 NDC 55150-188-10 Store at 20ºC to 25°C (68ºF to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. The vial stopper is not made with natural rubber latex.

📋 Description 73 words ▾

11 DESCRIPTION Tranexamic acid, USP is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid USP is a white or almost white, crystalline powder. The structural formula is Molecular Formula: C 8 H 15 NO 2 Molecular Weight: 157.2 Each mL of the sterile,clear, colorless solution for intravenous injection contains 100 mg tranexamic acid USP and water for injection to 1 mL.

The aqueous solution for injection has a pH of 6.5 to 8.0. tranexamic-acid-structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Thromboembolic Risk Inform patients that tranexamic acid may increase the risk of venous and arterial thrombosis or thromboembolism and to contact their healthcare provider for any signs or symptoms suggestive of thromboembolism. Advise patients using hormonal contraception that combined use with tranexamic acid may increase the risk for thromboembolic adverse reactions and to use effective alternative (nonhormonal) contraception during therapy with tranexamic acid [see Warnings and Precautions (5.2) , Drug Interactions (7.1) , Use in Specific Populations (8.3) ] .

Seizures Inform patients that tranexamic acid may cause seizures and to contact their healthcare provider for any signs or symptoms suggestive of seizures [see Warnings and Precautions (5.3) ] . Hypersensitivity Reactions Inform patients that tranexamic acid may cause hypersensitivity reactions and to contact their healthcare provider for any signs or symptoms of hypersensitivity reactions [see Warnings and Precautions (5.4) ] . Visual Disturbances Inform patients that tranexamic acid can cause visual disturbance and that they should report any eye symptoms or change in their vision to their healthcare provider and to follow-up with an ophthalmologist for a complete ophthalmologic evaluation, including dilated retinal examination of the retina [see Warnings and Precautions (5.5) ] .

Risk of Driving and Operating Machinery Inform patients that tranexamic acid may cause dizziness, and that the patient should be cautioned about driving, operating machinery, or performing hazardous tasks while taking tranexamic acid [see Warnings and Precautions (5.6) ] . This product's labeling may have been updated. For the most recent prescribing information, please visit eugiaus.com.

Distributed by: Eugia US LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: EugiaPharma Specialities Limited Hyderabad - 500032 India

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

case series: A report describing what happened to a small group of patients, with no comparison group.

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

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

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

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

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.

contraception: Methods used to prevent pregnancy, such as birth control pills, condoms, or an intrauterine device.

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

convulsion: Uncontrolled, rapid shaking of the body caused by muscles rapidly tightening and relaxing, often during a seizure.

deep vein thrombosis: A blood clot that forms in a deep vein, usually in the leg, causing swelling and pain.

dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.

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

diluent: The liquid used to dissolve or thin a medicine before it is given.

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.

dose reduction: Lowering the amount of a medicine, often to ease side effects or fit a person's needs.

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.

edema: Swelling caused by extra fluid trapped in the body's tissues.

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.

embolism: A blockage of a blood vessel by a clot or other material that has traveled from elsewhere in the body.

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

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

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

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

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

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

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

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

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.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

intrathecal: Injected into the fluid that surrounds the spinal cord.

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

lactation: The making and release of milk from a mother's breasts after giving birth.

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

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.

neonatal: Relating to a newborn baby during its first four weeks of life.

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.

parenteral: Given by injection or drip into the body rather than swallowed by mouth.

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.

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

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

preterm birth: Birth of a baby earlier than usual, before 37 weeks of pregnancy.

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

pulmonary embolism: A blood clot that has traveled to the lungs and blocks blood flow there, which can make breathing hard.

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

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

reproductive potential: The ability to have children, meaning a person who could become pregnant or could father a child.

sepsis: A serious, body-wide reaction to an infection in which the body's own response can start to injure its tissues and organs.

serum creatinine: A waste product measured in a blood test; higher levels can mean the kidneys are not filtering as well as normal.

thromboembolism: A blood clot that forms in one place and travels through the bloodstream to block a vessel somewhere else.

thrombosis: The forming of a blood clot inside a blood vessel, which can block normal blood flow.

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

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

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

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 ↗

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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.

Tranexamic Acid 100 mg/mL Injection, Solution

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