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TRANEXAMIC ACID 100 mg/mL Injection, Solution — NDC 51662-1532-03 package photo

TRANEXAMIC ACID 100 mg/mL Injection, Solution

by HF Acquisition Co LLC, DBA HealthFirst · 10 POUCH in 1 CASE (51662-1532-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1532-2) / 10 mL in 1 VIAL, SINGLE-DOSE
NDC 51662-1532-03
🏷️ FDA NDC (as labeled) 51662-1532-3 billing pads the package segment with a zero
This package
Contains10 mL in 1 vial, single-dose Pack sizes2 compare ↓
Also comes in: 10 ml 51662-1532-01
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for 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) 51662-1532-3
Product NDC 51662-1532
11-digit billing NDC 51662153203
RxCUI 238720
UNII 6T84R30KC1
Application # ANDA205035
SPL Set ID c53e2b38-6c49-acae-e053-2995a90ae9df
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 2021-06-20
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance TRANEXAMIC ACID
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 51662-1532-3 — 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 → 51662-1532-03. 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

LabelerHF Acquisition Co LLC, DBA HealthFirst
Application holderEUGIA PHARMA SPECIALITIES LTD
FDA applicationANDA205035 (ANDA)
Labeler code51662
First marketedJun 2021
Product typeHuman Prescription Drug
Portfolio333 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

📗 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 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 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 No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 10 ml
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 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/mL 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/mLthis 51662-1532-03 HF 10 pouches — 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

🏛️
2021
On the market since
Jun 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

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

Medicare Part D (outpatient prescription) spending for 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 NDCDescription Marketing startStatus
51662-1532-01 10 mL in 1 VIAL, SINGLE-DOSE (51662-1532-1) 2021-06-20 Active
51662-1532-03 You're viewing this 10 POUCH in 1 CASE (51662-1532-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1532-2) / 10 mL in 1 VIAL, SINGLE-DOSE 2021-06-20 Active

Pack size FAQ

What quantity is in NDC 51662-1532-03?
NDC 51662-1532-03 is listed by the FDA — 10 pouch in 1 case / 1 vial, single-dose in 1 pouch / 10 ml in 1 vial, single-dose.
What NDC number is used to bill for this package of TRANEXAMIC ACID 100 mg/mL Injection, Solution?
Bill NDC 51662-1532-03 — the 11-digit billing format is 51662153203. 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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 51662-1532-3, 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: 51662-1532-03, written without dashes as 51662153203. 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 51662-1532-03, the first segment (51662) is the labeler code FDA assigned to HF Acquisition Co LLC, DBA HealthFirst; the middle segment (1532) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 HF Acquisition Co LLC, DBA HealthFirst. 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 10 ml (51662-1532-01). 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?
HF Acquisition Co LLC, DBA HealthFirst 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 37 words ▾

1 INDICATIONS & 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.

⏱️ Dosage and Administration 214 words ▾

2. DOSAGE & ADMINISTRATION

2.1Recommended Dosage The recommended dose of tranexamic acid injection is 10 mg/kg actual body weight intravenously administered as a single dose, immediately before tooth extractions. Infuse no more than 1 mL/minute to avoid hypotension [see WARNINGS AND PRECAUTIONS (5.1)]. Following tooth extraction, tranexamic acid injection may be administered for 2 to 8 days at a dose of 10 mg/kg actual body weight 3 to 4 times daily, intravenously.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 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. Discard any unused portion.

The diluted mixture may be stored for up to 4 hours at room temperature prior to patient administration.

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: * Dose reduction is recommended for all doses, both before and after tooth extraction. DOSAGE

💊 Dosage Forms and Strengths 22 words ▾

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

⛔ Contraindications 57 words ▾

4 CONTRAINDICATIONS Tranexamic acid 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 hypersensitivity to tranexamic acid or any of the ingredients [see WARNINGS AND PRECAUTIONS (5.4)].

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS

5.1Thromboembolic 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)].

5.2Risk of Medication Errors Due to Incorrect Route of Administration Tranexamic acid is for intravenous use only. Serious adverse reactions including seizures and cardiac arrythmias have occurred when tranexamic acid was inadvertently administered intrathecally instead of intravenously. 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.

Syringes containing tranexamic acid should be clearly labeled with the intravenous route of administration.

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 into the neuraxial system). Tranexamic acid 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 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 195 words ▾

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 (5.3)] Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS (5.4)] Visual Disturbances [see WARNINGS AND PRECAUTIONS (5.5)] Dizziness [see WARNINGS AND PRECAUTIONS (5.6)]

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

🔄 Drug Interactions 45 words ▾

7 DRUG INTERACTIONS

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 (5.1), 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 contrace…

🆘 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.

📦 How Supplied / Storage and Handling 72 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Tranexamic acid injection USP, 1,000 mg per 10 mL (100 mg/mL) is a sterile, clear, colorless solution free from visible particles and is supplied as follows: 1,000 mg per 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].

📋 Description 68 words ▾

11 DESCRIPTION Tranexamic acid 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: C8H15NO2 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. DESCRIPTION

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