Heparin / Taurolidine
Heparin/taurolidine is an antimicrobial and anticoagulant combination used to reduce catheter-related bloodstream infections in adults with kidney failure on chronic hemodialysis.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Heparin / Taurolidine: Patient Information Guide
A plain-language walkthrough of Heparin / Taurolidine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Heparin/taurolidine is an antimicrobial and anticoagulant combination used as a catheter lock solution in a specific patient population.
- Defencath (intraluminal route) is approved to reduce the risk of catheter-related bloodstream infections (CRBSIs) in adults with kidney failure receiving chronic hemodialysis through a central venous catheter (CVC)
- Defencath is approved for use in this limited and specific population only — its safety and effectiveness have not been established for other patients or other uses
⚙️How it works▾
Defencath works through two different mechanisms. Taurolidine, the antimicrobial component, damages bacterial cell walls and prevents bacteria from sticking to the inside surfaces of the catheter. Heparin, the anticoagulant component, activates a blood protein called Antithrombin III, which then blocks key clotting factors (especially Factor Xa and thrombin/Factor IIa) from forming clots. Heparin also prevents a stable fibrin clot from forming by blocking the fibrin-stabilizing factor — though it cannot dissolve clots that have already formed.
Because Defencath sits inside the catheter rather than circulating through the body, it acts locally to protect the catheter between dialysis sessions.
💊How it's taken▾
Defencath is not taken by mouth or given as an injection into a vein. It is instilled directly into the lumens (internal channels) of a central venous catheter by a healthcare provider at the end of each hemodialysis session.
- The solution remains inside the catheter between sessions and is aspirated (drawn out) and discarded before the next session begins
- Each single-dose vial is intended for one patient and one use — any leftover solution must be discarded
- If the solution cannot be aspirated before the next session, standard catheter care should be followed and the catheter checked for problems
🤒Side effects — in detail▾
The most frequently reported side effects in clinical trials of Defencath (occurring in 2% or more of patients) included:
- Hemodialysis catheter malfunction
- Hemorrhage or bleeding (including at various sites such as the gastrointestinal tract, catheter site, and urinary tract)
- Nausea
- Vomiting
- Dizziness
- Musculoskeletal chest pain (non-cardiac chest discomfort)
- Low platelet count (thrombocytopenia)
- Low calcium levels (hypocalcemia) — less than 1% of patients
- Altered taste (dysgeusia) — less than 1% of patients
- Numbness or tingling (paresthesia) — reported in post-marketing use outside the US
Serious reactions to watch for and report immediately include signs of heparin-induced thrombocytopenia (HIT) — such as unusual bruising or unexpected clotting — and signs of an allergic reaction such as rash, swelling, or breathing difficulty.
⚠️Warnings & precautions▾
- Heparin-Induced Thrombocytopenia (HIT): A rare but serious immune reaction to heparin that causes a dangerous drop in platelets and can lead to blood clots. HIT occurred in about 0.3% of patients in clinical trials. If HIT develops, Defencath must be stopped right away and treated promptly. Defencath is contraindicated in anyone with a known history of HIT.
- Drug Hypersensitivity (Allergic Reactions): Allergic reactions to heparin or other components of Defencath were reported in about 0.5% of clinical trial patients. If any allergic reaction occurs, Defencath should be stopped and medical care sought immediately. Defencath is contraindicated in patients with known hypersensitivity to taurolidine, heparin, citrate, or pork products.
🔀What it interacts with▾
The FDA label for Defencath does not identify specific drug, food, or supplement interactions.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Do not use Defencath if you have ever had heparin-induced thrombocytopenia (HIT)
- Do not use Defencath if you are allergic to taurolidine, heparin, citrate, or pork products
- Defencath has not been approved for use in children — safety and effectiveness in pediatric patients have not been established
- Pregnant patients: Defencath is not intended to enter the bloodstream, so fetal exposure is not expected, but inform your care team if you are pregnant
- Breastfeeding patients: Because Defencath stays inside the catheter and is not absorbed systemically, infant exposure through breast milk is not expected — still, inform your care team
- Older adults (65 and over): Clinical trial data showed no meaningful difference in safety or effectiveness compared to younger adults
📡Pharmacodynamics — effects in the body▾
The overall pharmacodynamic effects of Defencath in the body are not fully characterized. The taurolidine component has been shown in laboratory studies to kill bacteria (bactericidal activity) by damaging microbial cell walls and preventing bacteria from adhering to biological surfaces. Heparin within the catheter blocks key steps in the blood-clotting process, helping to prevent clot formation inside the catheter lumen.
🔬Pharmacokinetics — how your body processes it▾
No pharmacokinetic studies (studies measuring how the drug is absorbed, distributed, metabolized, and eliminated) were conducted for Defencath. Because it is designed to be instilled only into the catheter lumens and is not intended for systemic administration, it is not expected to circulate through the body in meaningful amounts.
📦How to store it▾
stored at a controlled room temperature of 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) . Do not freeze. stored in the commercial carton, prior to the instillation in central venous catheters.
📄 Written from Heparin / Taurolidine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Heparin / Taurolidine — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Defencath and why has my doctor prescribed it? ▾
How is Defencath given — do I take a pill or get an injection? ▾
What side effects should I watch out for and when should I call someone? ▾
Is Defencath safe if I'm pregnant or breastfeeding? ▾
I've had a bad reaction to heparin before — can I still use Defencath? ▾
What happens if the solution can't be removed from my catheter before my next dialysis session? ▾
Is Heparin / Taurolidine available over the counter? ▾
When was Heparin / Taurolidine first available? ▾
Who makes Heparin / Taurolidine? ▾
💬 Answers drafted from Heparin / Taurolidine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Heparin / Taurolidine comes
Heparin / Taurolidine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Oral solution
How this form is used
- Defencath is used to reduce the incidence of catheter-related bloodstream infections (CRBSIs) in adults with kidney failure receiving chronic hemodialysis through a central venous catheter
- Defencath is instilled into each lumen of the central venous catheter at the conclusion of each hemodialysis session — it is not given by mouth or injected into a vein
- Defencath should be aspirated from the catheter and discarded before the next hemodialysis session begins
- Defencath must not be used as a catheter flush product and is not intended for systemic (whole-body) administration
- Each Defencath single-dose vial is for one patient and one instillation only — discard any unused portion remaining in the vial
📊 Heparin / Taurolidine across the U.S. market
How Heparin / Taurolidine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Heparin / Taurolidine is used
A general measure of how commonly Heparin / Taurolidine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Heparin / Taurolidine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Heparin / Taurolidine prescribed? Of the 1,596 medications we measure, Heparin / Taurolidine ranks #1,221 by Medicaid prescriptions — more than 23% of them.
Utilization by Heparin / Taurolidine product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
3 ML heparin sodium, porcine 1000 UNT/ML / taurolidine 13.5 MG/ML Injection
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2670461
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Heparin / Taurolidine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 2 listed Heparin / Taurolidine NDCs with Medicaid activity.
🔍 Compare Heparin / Taurolidine products
A representative set of FDA-listed product records for Heparin / Taurolidine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Oral solution | ||||
| TAUROLIDINE 40.5 mg/3 mL; HEPARIN 3000 [USP'U]/3 mL | Intraluminal | CorMedix Inc. × 2 listings | NDA | View NDC → |
| 3000; 40.5 [USP'U]/3 mL; mg/3 mL | Intraluminal | CorMedix Inc. | NDA | View NDC → |
| 5000; 67.5 [USP'U]/5 mL; mg/5 mL | Intraluminal | CorMedix Inc. | NDA | View NDC → |
| HEPARIN 3000 [USP'U]/3 mL; TAUROLIDINE 40.5 mg/3 mL | — | ROVI Pharma Industrial Services SA | DRUG FOR FURTHER PROCESSING | View NDC → |
| HEPARIN 5000 [USP'U]/5 mL; TAUROLIDINE 67.5 mg/5 mL | — | ROVI Pharma Industrial Services SA | DRUG FOR FURTHER PROCESSING | View NDC → |
Showing 6 of 6 products — FDA National Drug Code Directory. See every product, package size and price: browse all 6 Heparin / Taurolidine NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Heparin / Taurolidine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Heparin / Taurolidine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Heparin / Taurolidine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.
RxCUI 2670456 1 dose form · 1 strength
-
Dose form (SCDF) Injection RxCUI 2670458No current FDA listingClinical drug / strength (SCD) 3 ML heparin sodium, porcine 1000 UNT/ML / taurolidine 13.5 MG/MLRxCUI 2670461
Look up RxCUI 2670456 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Heparin / Taurolidine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Heparin / Taurolidine belongs to the Antiinfectives class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. CorMedix Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.