Data from FDA - Curated by EPG Health - Last updated 01 April 2018

Indication(s)

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.

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Advisory information

contraindications
CONTRAINDICATIONS NOT FOR DIRECT INTRAVENOUS INFUSION.
Special warnings and precautions
PRECAUTIONS General Aseptic technique must be maintained at all times. triCitrasol ® Anticoagulant Sodium Citrate Concentrate is a clear/colorless solution. If the product shows any cloudiness or turbidity, the concentrate should be discarded. The cap/stopper system provides a biological barrier and should be intact – discard product if system is comprised. Information for Patients None. Laboratory Tests There are no laboratory tests for the drug product at this time. Drug Interactions There are no adverse reactions for the addition of the product to the rouleaux agent. Carcinogenesis, mutagenesis, impairment of fertility Long-term studies in animals have not been performed to evaluate the carcinogenic potential of triCitrasol ®. Pregnancy Long-term studies in animals have not been performed to evaluate the effects of triCitrasol ® on pregnant women. Pediatric Use The safety and effectiveness of triCitrasol ® in children have not been established.
Adverse reactions
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.

Usage information

Dosing and administration
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.

Interactions

Drug Interactions There are no adverse reactions for the addition of the product to the rouleaux agent.

More information

Category Value
Authorisation number BN010409
Agency product number B22547B95K
Orphan designation No
Product NDC 23731-6030
Date Last Revised 23-02-2018
Type HUMAN PRESCRIPTION DRUG
Storage and handling It is recommended that the product be stored at ambient room temperature, 24°C (75°F); however, the product can be stored between 15°C (59°F) and 30°C (86°F). Protect from freezing and exposure to excessive heat should be minimized.
Marketing authorisation holder Citra Labs LLC