triCitrasol

triCitrasol is an FDA-registered drug product whose active ingredient is TRISODIUM CITRATE DIHYDRATE. It is labelled by Citra Labs LLC taken by extracorporeal and marketed as a human prescription drug product. Identifiers on file: NDC 23731-6030, application BN010409, label effective 20230214. It is one of 2 FDA drug label records sharing the active ingredient TRISODIUM CITRATE DIHYDRATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing TRISODIUM CITRATE DIHYDRATE are most often described in connection with: resultant solution, hes bag, usage tricitrasol, anticoagulant sodium, citrate concentrate, granulocytapheresis procedures, granulocyte collection, apheresis just. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS AND USAGE triCitrasol ® Anticoagulant Sodium Citrate Concentrate, 46.7% Trisodium Citrate, is an anticoagulant used in granulocytapheresis procedures (granulocyte collection by apheresis). Just prior to performing granulocytapheresis, aseptically add 30 mL of triCitrasol ® to 500 mL of the 6% solution of Hydroxyethyl Starch (HES), e.g. Hespan ® 2-8 . Agitate the resultant solution for 1 minute to assure a uniform concentration of anticoagulant. The resultant solution of triCitrasol ® and 6% solution of HES contains the following concentration depending upon the volume used: Volume of triCitrasol ® Volume of HES Total Volume Final Concentration of triCitrasol ® 30 mL 500 mL (measured from HES bag) 530 mL 2.6% 30 mL 558 mL (injected directly into HES bag) 588 mL 2.4% The triCitrasol ® /HES solution is stable for up to 24 hours at room temperature after mixing. Refer to the manufacturer's Operator's Manual of the apheresis medical device for the directions to perform the granulocytapheresis procedure.

DOSAGE AND ADMINISTRATION The apheresis system will control the amount of the citrate/6% solution of HES that is added to the whole blood and the method of administration of the solution. Refer to the Operator's Manual of the apheresis medical device.

CONTRAINDICATIONS NOT FOR DIRECT INTRAVENOUS INFUSION.

WARNINGS CONCENTRATED ANTICOAGULANT – DILUTE PRIOR TO USE.

ADVERSE REACTIONS Citrate reactions or toxicity may occur with the infusion of blood products containing citrate anticoagulant 1. 9 11 . The recipient of the citrated blood product should be monitored for the signs and symptoms of citrate toxicity 1. 9 11 . 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 chills, stomach cramps, or pressure in the chest, followed by more severe reactions that are characterized by hypotension and possible cardiac arrhythmia 1. 9 11 . Citrate toxicity may occur more frequently in patients that are hypothermic 10 , have impaired liver or renal function 10 , or have low calcium levels because of an underlying disease 9 .

FDA lists 2 drug label records with TRISODIUM CITRATE DIHYDRATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is triCitrasol used for?
INDICATIONS AND USAGE triCitrasol ® Anticoagulant Sodium Citrate Concentrate, 46.7% Trisodium Citrate, is an anticoagulant used in granulocytapheresis procedures (granulocyte collection by apheresis). Just prior to performing granulocytapheresis, aseptically add 30 mL of triCitrasol ® to 500 mL of the 6% solution of Hydroxyethyl Starch (HES), e.g. Hespan ® 2-8 . Agitate the resultant solution …

Who makes triCitrasol?
Citra Labs LLC is the labeler of record for triCitrasol. 2 FDA label records share the active ingredient TRISODIUM CITRATE DIHYDRATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does triCitrasol come in?
administered by extracorporeal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is triCitrasol prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing TRISODIUM CITRATE DIHYDRATE?
Yes. 2 FDA drug label records list TRISODIUM CITRATE DIHYDRATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has triCitrasol been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.