Sodium Citrate w/v Anticoagulant 4 g/100mL
TRISODIUM CITRATE DIHYDRATE · INJECTION, SOLUTION · Terumo BCT, Ltd
Sodium Citrate is an injectable anticoagulant solution administered through a vein that works by preventing blood from clotting. It is commonly used in medical settings such as dialysis, blood collection, and laboratory procedures where preventing coagulation is necessary.
Key Facts
- Brand Name
- Sodium Citrate w/v Anticoagulant
- Generic Name
- TRISODIUM CITRATE DIHYDRATE
- NDC Code (Product)
14537-883- Manufacturer
- Terumo BCT, Ltd
- Strength
- 4 g/100mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- Application #
- BA125608
- Drug Class
- Acidifying Activity [MoA]; Anti-coagulant [EPC]
- Marketing Start
- 06/26/2018
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures. [See Dosage and Administration (2) .] SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is added to tubing sets during apheresis procedures. ( 2 ) SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP may only be used with apheresis devices. For instructions on the use of the solution see the apheresis device operator's manual. ( 2.1 ) Follow the directions for connecting the SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP bag to the apheresis system. ( 2.2 ) 2.1 General Dosing Information SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is added to tubing sets during apheresis procedures. The solution bag is connected to the tubing set in an apheresis collection. The recommended dose is determined by the apheresis device and metered into the tubing set by the apheresis device. It is not intended for direct intravenous infusion. For instructions on the use of the solution with the apheresis device and tubing set, see the device operator's manual. 2.2 Administration Ensure solution is the SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP and is within the expiration date. Inspect the bag. Do not use if the container is damaged, leaking or if there is any visible sign of deterioration. Use only if s…
Contraindications
4 CONTRAINDICATIONS DO NOT INFUSE SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP DIRECTLY TO THE DONOR. DO NOT INFUSE SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP DIRECTLY TO THE DONOR. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS Citrate reactions or toxicity may occur with the infusion of blood products to patients and return of blood containing citrate anticoagulant to donors. The recipient of the blood containing citrate should be monitored for the signs and symptoms of citrate toxicity. The signs and symptoms of citrate toxicity begin with paresthesia, a "tingling" sensation around the mouth or in the extremities, followed by severe reactions that are characterized by hypotension and possible cardiac arrhythmia. Citrate toxicity may occur more frequently in patients who are hypothermic, have impaired liver or renal function, or have low calcium levels because of an underlying disease. Citrate reactions or toxicity may occur with the infusion and return of blood containing citrate anticoagulant. The recipient of the blood containing citrate should be monitored for the signs and symptoms of citrate toxicity. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Terumo BCT, Inc. at 1-877-339-4228 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Frequently Asked Questions
What is Sodium Citrate w/v Anticoagulant used for?
Sodium Citrate is an injectable anticoagulant solution administered through a vein that works by preventing blood from clotting. It is commonly used in medical settings such as dialysis, blood collection, and laboratory procedures where preventing coagulation is necessary.
Is Sodium Citrate w/v Anticoagulant a controlled substance?
Sodium Citrate w/v Anticoagulant is not classified as a controlled substance by the DEA.
What is the generic name for Sodium Citrate w/v Anticoagulant?
The generic name for Sodium Citrate w/v Anticoagulant is TRISODIUM CITRATE DIHYDRATE. There are 5 other brand versions of TRISODIUM CITRATE DIHYDRATE.
What is the NDC code for Sodium Citrate w/v Anticoagulant 4 g/100mL?
The NDC (National Drug Code) for Sodium Citrate w/v Anticoagulant 4 g/100mL is 14537-883, listed by Terumo BCT, Ltd.