Tricitrasol
Trisodium Citrate Dihydrate
Citra Labs Llc
Human Prescription Drug
NDC 23731-6030Tricitrasol also known as Trisodium Citrate Dihydrate is a human prescription drug labeled by 'Citra Labs Llc'. National Drug Code (NDC) number for Tricitrasol is 23731-6030. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Tricitrasol drug includes Trisodium Citrate Dihydrate - 14 g/30mL . The currest status of Tricitrasol drug is Active.
Drug Information:
| Drug NDC: | 23731-6030 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Tricitrasol |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Trisodium Citrate Dihydrate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Citra Labs Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | TRISODIUM CITRATE DIHYDRATE - 14 g/30mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | EXTRACORPOREAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 10 Jul, 2003 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | BN010409 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Citra Labs LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | B22547B95K
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Acidifying Activity [MoA]
Anti-coagulant [EPC]
Calcium Chelating Activity [MoA]
Calculi Dissolution Agent [EPC]
Decreased Coagulation Factor Activity [PE]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 23731-6030-1 | 10 VIAL, SINGLE-USE in 1 CASE (23731-6030-1) / 30 mL in 1 VIAL, SINGLE-USE (23731-6030-3) | 10 Jul, 2003 | N/A | No |
| 23731-6030-2 | 25 VIAL, SINGLE-USE in 1 CASE (23731-6030-2) / 30 mL in 1 VIAL, SINGLE-USE (23731-6030-3) | 10 Jul, 2003 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Tricitrasol trisodium citrate dihydrate trisodium citrate dihydrate anhydrous citric acid
Drug Interactions:
Drug interactions there are no adverse reactions for the addition of the product to the rouleaux agent.
Indications and Usage:
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
Read more... to perform the granulocytapheresis procedure.
Warnings:
Warnings concentrated anticoagulant â dilute prior to use.
General 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 â discard product if system is comprised.
Dosage 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.
Contraindications:
Contraindications not for direct intravenous infusion.
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 .
Drug Interactions:
Drug interactions there are no adverse reactions for the addition of the product to the rouleaux agent.
Use in 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:
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 â 6.6 single patient use only, on a single occasion. chemical structure
Clinical Pharmacology:
Clinical pharmacology a sodium citrate solution acts as an anticoagulant by the action of the citrate ion chelating free ionized calcium; thus, the calcium ion is unavailable to the coagulation system 1 .
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility long-term studies in animals have not been performed to evaluate the carcinogenic potential of tricitrasol ® .
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.
Information for Patients:
Information for patients none.
Package Label Principal Display Panel:
Principal display panel - 10 vial case label tricitrasol ® anticoagulant sodium citrate concentrate 46.7% trisodium citrate pn 6030 - 30 ml warning: concentrated anticoagulant dilute prior to use not for direct intravenous infusion this carton contains 10 sterile units - 30 ml each used with 6% hydroxyethyl starch 500 ml (diluent) for the collection of granulocytes by apheresis. do not use for other anticoagulant purposes. see package insert for directions for use. manufactured & distributed by: citra labs ⢠a biomet inc. company. 55 messina drive, braintree, ma 02184 â usa phone number: 1-800-299-3411 fax number: 781-848-6781 sterile â non-pyrogenic composition per 30 ml of concentrate: trisodium citrate (dihydrate), usp 14.0 g (ph adjusted with citric acid) caution: single procedure use - discard unused portion do not use unless solution is clear and seal is intact store between 15°c - 30° c (59° f - 86° f) rx only exp: lot: la6030-10b 5/15 principal display panel - 10 vial case label
Principal display panel - 25 vial case label tricitrasol ® anticoagulant sodium citrate concentrate 46.7% trisodium citrate pn 6030 - 30 ml warning: concentrated anticoagulant dilute prior to use not for direct intravenous infusion this carton contains 25 sterile units - 30 ml each used with 6% hydroxyethyl starch 500 ml (diluent) for the collection of granulocytes by apheresis. do not use for other anticoagulant purposes. see package insert for directions for use. manufactured & distributed by: citra labs ⢠a biomet inc. company. 55 messina drive, braintree, ma 02184 â usa phone number: 1-800-299-3411 fax number: 781-848-6781 sterile â non-pyrogenic composition per 30 ml of concentrate: trisodium citrate (dihydrate), usp 14.0 g (ph adjusted with citric acid) caution: single procedure use - discard unused portion do not use unless solution is clear and seal is intact store between 15°c - 30° c (59° f - 86° f) rx only exp: lot: la6030-25b 5/15 principal display panel - 25 vial case label