triCitrasol
Trisodium Citrate dihydrate · Solution · Extracorporeal
Uses
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
CONTRAINDICATIONS NOT FOR DIRECT INTRAVENOUS INFUSION.
Warnings
WARNINGS CONCENTRATED ANTICOAGULANT – DILUTE PRIOR TO USE.
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.
Side effects
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 .
Drug interactions
Drug Interactions There are no adverse reactions for the addition of the product to the rouleaux agent.
Pregnancy
Pregnancy Long-term studies in animals have not been performed to evaluate the effects of triCitrasol ® on pregnant women.
Pediatric use
Pediatric Use The safety and effectiveness of triCitrasol ® in children have not been established.
Overdosage
Since the bottle of triCitrasol ® contains only 30mL of the product, it is impossible to overdose the addition of the product to the 6% solution of HES. However, in the event of a reaction to the infusion of citrated blood products, evaluate the patient and institute appropriate corrective actions 1, 9 .
Description
DESCRIPTION triCitrasol ® Anticoagulant Sodium Citrate Concentrate, 46.7% Trisodium Citrate, is a sterile, non-pyrogenic solution of Trisodium Citrate (Dihydrate), USP. Each 30 mL of concentrate contains: Trisodium Citrate, dihydrate, USP 14.0 grams Water for Injection, USP q.s. pH adjusted with Citric Acid pH: 6.3 – 6.6 Single patient use only, on a single occasion. Chemical Structure
How supplied
HOW SUPPLIED triCitrasol ® Anticoagulant Sodium Citrate Concentrate 46.7% Trisodium Citrate REF SIZE CASE PN 6030-25 30 mL Vial 25 Vials/Case PN 6030-10 30 mL Vial 10 Vials/Case 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.
Storage
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.
Patient information
Information for Patients None.
Label text from the FDA structured product label by Citra Labs LLC (revised Feb 14, 2023). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Trisodium Citrate Dihydrate in 1 product
triCitrasol NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 23731-6030 | Trisodium Citrate Dihydrate 14 g/30mL Solution | Citra Labs LLC | NDA |
Frequently asked questions
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 for…
What are the side effects of triCitrasol?
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… See the full label for the complete list.
Who makes triCitrasol?
triCitrasol is listed by 1 labeler in the FDA NDC directory, including Citra Labs LLC.