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TRANEXAMIC ACID IN SODIUM CHLORIDE 10 mg/mL Injection, Solution, 100 mL — NDC 51754-0108-01 package photo

TRANEXAMIC ACID IN SODIUM CHLORIDE 10 mg/mL Injection, Solution, 100 mL

by Exela Pharma Sciences, LLC · 100 mL in 1 BAG (51754-0108-1)
NDC 51754-0108-01
🏷️ FDA NDC (as labeled) 51754-0108-1 billing pads the package segment with a zero
This package
Contains100 mL Medicaid pays$3.43 / unit · 12 mo Per package$342.60 / 100 ml · Medicaid Pack sizes2 compare ↓
Also comes in: 1000 ml 51754-0108-03
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Tranexamic Acid (different manufacturers) — 2 · 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
Class III · Sep 26, 2022 — Presence of Particulate Matter: Piece of metal found in a vial (AuroMedics Pharma LLC) · FDA recall D-1551-2022
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 51754-0108-1
Product NDC 51754-0108
11-digit billing NDC 51754010801
NCPDP billing unit ML — per mL (volume)
RxCUI 2170286
UNII 6T84R30KC1
Application # NDA212020
SPL Set ID db36ddf2-4ac5-47ac-bdce-e3fa6983073e
Established class (EPC) Antifibrinolytic Agent
Physiologic effect Decreased Fibrinolysis
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-06-01
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance TRANEXAMIC ACID
GPI-14 84100040202030
GPI class Tranexamic Acid-NaCl
GCN Seq No 079668
GCN 46206
HICL code 045697
Ingredient (HICL) Tranexamic Acid In Nacl,Iso-Os
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 1,000 MG/100ML-NACL
FDB brand name Tranexamic Acid-Nacl
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 51754-0108-1 — a 5-4-1 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 package segment → 51754-0108-01. 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

LabelerExela Pharma Sciences, LLC
Application holderEXELA PHARMA SCIENCES LLC
FDA applicationNDA212020 (NDA)
Labeler code51754
First marketedJun 2019
Product typeHuman Prescription Drug
Portfolio24 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name TRANEXAMIC 1,000 MG/100ML-NACL Ingredient Tranexamic Acid In Nacl,Iso-Os
📗 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 →
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 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • 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.

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $3.43 $342.60 / 100 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tranexamic Acid 10 mg/mL 14789-0115-05 Nexus 100 ml — AP FDA listed —
Tranexamic Acid 10 mg/mL 25021-0418-82 Sagent 100 ml — AP FDA listed —
Tranexamic Acid In Sodium Chloride 10 mg/mLthis 51754-0108-01 Exela 100 ml — AP FDA listed —
Tranexamic Acid In Sodium Chloride 10 mg/mL 65219-0534-10 Fresenius 100 ml — AP FDA listed —
Tranexamic Acid in Sodium Chloride 10 mg/mL 66298-5340-01 HP 100 ml — AP FDA listed —
Tranexamic Acid In Sodium Chloride 10 mg/mL 68083-0613-10 Gland 10 pouches — AP FDA listed —
Tranexamic Acid In Sodium Chloride 10 mg/mL 80830-2329-02 Amneal 10 pouches — AP FDA listed —
tranexamic acid in sodium chloride 10 mg/mL 83634-0403-51 Avenacy 10 vials — AP FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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
Jun 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 51754-0108-01, 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
1.2K
Units reimbursed last 4 qtrs
44.2K
Gross reimbursed last 4 qtrs
$151.4K
Avg / prescription
$127.68
Avg / unit
$3.4260
Latest quarter Q4 2025
225Rx
Fee-for-service vs managed care ⓘ
20% FFS 80% MCO
Fee-for-service · 242 Rx Managed care · 944 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 3,004 units · 52.4 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 11 units · 0.1 per 100k residents NY Vermont: no data reported VT New Hampshire: 1,718 units · 123 per 100k residents NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 36 units · 1.1 per 100k residents IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 154 units · 1.3 per 100k residents OH Pennsylvania: 1,442 units · 11.1 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 172 units · 2.5 per 100k residents MA California: 1,131 units · 2.9 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 28,300 units · 457 per 100k residents MO Kentucky: 1,256 units · 27.8 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 2,201 units · 30.9 per 100k residents TN North Carolina: 3,000 units · 27.7 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 1,775 units · 38.8 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.1457
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 Missouri 457 /100k
2 New Hampshire 123 /100k
3 Minnesota 52.4 /100k
4 Louisiana 38.8 /100k
5 Tennessee 30.9 /100k
6 Kentucky 27.8 /100k
7 North Carolina 27.7 /100k
8 Pennsylvania 11.1 /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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 ml this page51754-0108-01 1,186 Rx · $151,429
1 ml51754-0108-03 859 Rx · $198,502
Drug total (last 4 qtrs): 2,045 Rx · 78,009 units · $349,930 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Tranexamic Acid (matched by generic name) — 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.

🔬 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 tranexamic acid in sodium chloride (this brand).

Top reported reactions

Pyrexia340
Nausea311
Hypotension307
Diarrhoea301
Vomiting284
Haemorrhage281
Dyspnoea272

Age at onset

Neonate41
Infant30
Child75
Adolescent121
Adult927
Elderly404

Reporter sex

8,333 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization3,751
Life-threatening1,300
Death1,225
Disabling300
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 995 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
51754-0108-01 You're viewing this 100 mL in 1 BAG (51754-0108-1) 2019-06-01 Active
51754-0108-03 1000 mL in 1 CASE (51754-0108-3) 2019-06-01 Active

You're viewing the smallest of 2 pack sizes for this product.

In Medicaid, this is the most-dispensed pack of this product — about 58% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 51754-0108-01?
NDC 51754-0108-01 contains 100 mL — 100 ml in 1 bag.
What is the difference between NDC 51754-0108-01 and NDC 51754-0108-03?
Both are TRANEXAMIC ACID IN SODIUM CHLORIDE 10 mg/mL Injection, Solution — the drug itself is identical. NDC 51754-0108-01 is the 100 mL package, while NDC 51754-0108-03 is the 1000 ml package.
What NDC number is used to bill for this package of TRANEXAMIC ACID IN SODIUM CHLORIDE 10 mg/mL Injection, Solution?
Bill NDC 51754-0108-01 — the 11-digit billing format is 51754010801. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 51754-0108-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 51754-0108-01, written without dashes as 51754010801. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 51754-0108-01, the first segment (51754) is the labeler code FDA assigned to Exela Pharma Sciences, LLC; the middle segment (0108) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Exela Pharma Sciences, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1000 ml (51754-0108-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Exela Pharma Sciences, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 75 words ▾

1 INDICATIONS AND USAGE Tranexamic Acid in Sodium Chloride Injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce the risk of hemorrhage during and following tooth extraction. Tranexamic Acid in Sodium Chloride Injection is an antifibrinolytic indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction ( 1 ).

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION • Before Extraction: Administer 10 mg/kg actual body weight of Tranexamic Acid in Sodium Chloride Injection intravenously with replacement therapy. • After Extraction: Administer 10 mg/kg actual body weight 3-4 times daily for 2 to 8 days. Infuse no more than 10 mL/minute to avoid hypotension ( 2.1 ). • Reduce the dosage for patients with renal impairment ( 2.2 , 8.6 ).

2.1Recommended Dosage The recommended dose of Tranexamic Acid in Sodium Chloride Injection is 10 mg/kg actual body weight intravenously administered as a single dose, immediately before tooth extractions. Infuse no more than 10 mL/minute to avoid hypotension. Following tooth extraction, Tranexamic Acid in Sodium Chloride Injection may be administered for 2 to 8 days at a dose of 10 mg/kg actual body weight three to four times daily, intravenously.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use Tranexamic Acid in Sodium Chloride Injection if particulate matter or coloration is seen. Tranexamic Acid in Sodium Chloride Injection should NOT be mixed with blood.

The drug is a synthetic amino acid and should NOT be mixed with solutions containing penicillin. The premix flexible plastic container bag contains no preservative; discard any unused portion.

2.2Recommended Dosage for Patients with Varying Degrees of Renal Impairment The recommended dosage of Tranexamic Acid in Sodium Chloride Injection in patients with varying degrees of renal impairment is described in Table 1 [see Use in Specific Populations ( 8.6 )]. Table 1. Recommended Dosage in Patients with Varying Degrees of Renal Impairment* Serum Creatinine (mg/dL) Tranexamic Acid in Sodium Chloride Injection Intravenous Dosage 1.36 to 2.83 (120 to 250 micromol/L) 10 mg/kg twice daily 2.83 to 5.66 (250 to 500 micromol/L) 10 mg/kg daily >5.66 (>500 micromol/L) 10 mg/kg every 48 hours or 5 mg/kg every 24 hours *Dose reduction is recommended for all doses, both before and after tooth extraction.

💊 Dosage Forms and Strengths 50 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 1,000 mg of tranexamic acid in 100 mL (10 mg/mL), colorless solution in a single-dose bag for intravenous use Injection: 1,000 mg of tranexamic acid in 100 mL (10 mg/mL) sterile, unpreserved, colorless solution in a single-dose bag for intravenous use ( 3 ).

⛔ Contraindications 116 words ▾

4 CONTRAINDICATIONS Tranexamic Acid in Sodium Chloride Injection is contraindicated: • 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 ( 5.1 )]. • In patients with history of hypersensitivity to tranexamic acid or any of the ingredients [see Warnings and Precautions ( 5.3 )] . • In patients with subarachnoid hemorrhage, due to risk of cerebral edemaand 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 ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Risk of Thrombosis with concomitant use of Factor IX: Avoid concomitant use ( 5.1 ). • Seizures: Inadvertent injection into neuraxial system may result in seizures ( 5.2 ). • Hypersensitivity Reactions: In case of severe reaction, discontinue use seek immediate medical attention ( 5.3 ). • Visual Disturbances: Visual or ocular adverse effects may occur. Discontinue use if visual or ocular symptoms occur ( 5.4 ). • Dizziness may occur. Advise patients not to drive if dizziness occurs ( 5.5 ).

5.1Thromboembolic Risk Tranexamic Acid in Sodium Chloride Injection 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 in Sodium Chloride Injection 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 ) and Use in Specific Populations ( 8.3 )] .

5.2Seizures 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 in Sodium Chloride Injection is not FDA approved and which uses doses of up to ten-fold higher than the recommended human dose and in patients inadvertently given tranexamic acid into the neuraxial system). Tranexamic Acid in Sodium Chloride Injection is not approved and not recommended for neuraxial administration.

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

Discontinue Tranexamic Acid in Sodium Chloride Injection if seizures occur.

5.3Hypersensitivity Reactions Cases of hypersensitivity reactions, including anaphylactic reactions, have occurred with use of intravenous tranexamic acid. Discontinue treatment with Tranexamic Acid in Sodium Chloride Injection if serious reaction occurs, provide appropriate medical management, and do not restart treatment. Tranexamic Acid in Sodium Chloride Injection is contraindicated in patients with a history of hypersensitivity to tranexamic acid.

5.4Visual Disturbances Although not seen in humans, focal areas of retinal degeneration have been observed in cats, dogs and rats following oral or intravenous tranexamic acid at doses between 250 to 1600 mg/kg/day (6 to 40 times the recommended usual human dose) 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 in Sodium Chloride Injection if changes in ophthalmological examination occurs.

5.5Dizziness 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 in Sodium Chloride Injection affects them.

🤒 Adverse Reactions ~1 min read ▾

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

To report SUSPECTED ADVERSE REACTIONS, contact [Enter Company Name] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Postmarketing 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, cromatopsia, and visual impairment have also been reported. Anaphylaxis or anaphylactoid reactions have been reported that are suggestive of a causal relationship.

🔄 Drug Interactions 110 words ▾

7 DRUG INTERACTIONS • Prothrombotic Medical Products: Avoid concomitant use, can furtherincrease the risk of thromboembolic adverse reactions associated withtranexamic acid ( 5.1 , 7.1 , 8.3 ). • Chlorpromazine: May result in increased risk of bleeding ( 7.2 ).

7.1Prothrombotic Medical Products Avoid concomitant use of Tranexamic Acid in Sodium Chloride Injection 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 ( 5.1 ) and Use in Specific Populations ( 8.3 )].

7.2Chlorpromazine Concurrent use of chlorpromazine and Tranexamic Acid in Sodium Chloride Injectionmay result in increased risk of bleeding.

👥 Use in Specific Populations ~2 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 identified a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. There are no reports regarding the use of tranexamic acid during the first trimester of pregnancy; therefore, there are no data regarding the risk of major birth defects with use of tranexamic acid during pregnancy. However, 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. 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 2-4% and 15−20%, respectively. 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/liter, as high as in the maternal blood.

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 in Sodium Chloride Injection and any potential adverse effects on the breastfed child from Tranexamic Acid in Sodium Chloride Injection or from the underlying maternal condition.

8.3Females and Males of Reproductive Potential Contraception Concomitant use of Tranexamic Acid in Sodium Chloride Injection, which is an antifibrinolytic, with hormonal contraceptives may increase the risk for thromboembolic adverse reactions. Advise patients to use an effective alternative (nonhormonal) contraceptive method [see Warnings and Precautions ( 5.5 ) and Drug Interactions ( 7.1 )].

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 adult and pediatric patients.

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 [Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 )].

8.6Renal Impairment Reduce the dosage of Tranexamic Acid in Sodium Chloride Injection in patients with renal impairment, based on the patient’s serum creatinine [see Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 )].

🤰 Pregnancy 217 words ▾

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 identified a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. There are no reports regarding the use of tranexamic acid during the first trimester of pregnancy; therefore, there are no data regarding the risk of major birth defects with use of tranexamic acid during pregnancy. However, 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. 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 2-4% and 15−20%, respectively. 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/liter, as high as in the maternal blood.

🧒 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 adult and pediatric patients.

🧓 Geriatric Use 112 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 [Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 )].

🆘 Overdosage 47 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; visual impairment; mental status changes; myoclonus and rash. Tranexamic acid is not dialyzable.

🧬 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 (K d = 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 seven or eight 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 the unchanged drug.

Excretion of tranexamic acid is about 90% at 24 hours after intravenous administration of 10 mg/kg body weight. Specific Populations Renal Impairment The effect of renal impairment on the disposition of Tranexamic Acid in Sodium Chloride Injection has not been evaluated. 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 – 2.8, 2.8 – 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 ) and Use in Specific Populations ( 8.6 )].

Drug Interaction Studies No studies of interactions between Tranexamic Acid in Sodium Chloride Injection and other drugs have been conducted.

🧬 Mechanism of Action 149 words ▾

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 (K d = 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.

📦 How Supplied / Storage and Handling 93 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Tranexamic Acid in Sodium Chloride Injection is supplied as a sterile, unpreserved, colorless solution in a single-dose polymeric bag containing 1000 mg tranexamic acid in 100 mL of solution (10 mg/mL) sealed with a Twist Off port and oversealed in an aluminum pouch (NDC 51754-0108-1). Discard any unused portion. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Manufactured and Distributed by: Exela Pharma Sciences, LLC 1245 Blowing Rock Blvd Lenoir, NC 28645 Exela Logo

📋 Description 77 words ▾

11 DESCRIPTION Tranexamic acid is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid is a white crystalline powder. The structural formula is Empirical Formula: C8H15NO2 Molecular Weight: 157.2 Tranexamic Acid in Sodium Chloride Injection is a clear to colorless sterile, nonpyrogenic injectable solution for intravenous administration.

Each IV bag contains 1000 mg tranexamic acid, USP, 700 mg of sodium chloride, USP and Water for Injection, USP. The aqueous solution has a pH of 6.5 to 8.0. Structural Formula

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Thromboembolic Risk • Inform patients that Tranexamic Acid in Sodium Chloride Injection may cause 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 in Sodium Chloride Injection may increase the risk for thromboembolic adverse reactions and to use effective alternative (nonhormonal) contraception during therapy with Tranexamic Acid in Sodium Chloride Injection [see Warnings and Precautions ( 5.1 ), Drug Interactions ( 7.1 ) and Use in Specific Populations ( 8.3 )].

Seizures Inform patients that Tranexamic Acid in Sodium Chloride Injection may cause seizures and to contact their healthcare provider for any signs or symptoms suggestive of seizures [see Warnings and Precautions ( 5.2 )]. Hypersensitivity Reactions Inform patients that Tranexamic Acid in Sodium Chloride Injection may cause hypersensitivity reactions and to contact their healthcare provider for any signs or symptoms of hypersensitivity reactions [see Warnings and Precautions ( 5.3 )]. Visual Disturbances Inform patients that Tranexamic Acid in Sodium Chloride Injection 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 ( 5.4 )] .

Risk of Driving and Operating Machinery Inform patients that Tranexamic Acid in Sodium Chloride Injectionmay cause dizziness, and that the patient should be cautioned about driving, operating machinery, or performing hazardous tasks while taking Tranexamic Acid in Sodium Chloride Injection [see Warnings and Precautions ( 5.5 )] .

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.