Tranexamic Acid in Sodium Chloride 10 mg/mL

TRANEXAMIC ACID · INJECTION, SOLUTION · HP Halden Pharma AS

No Recall History

Plain English

Tranexamic Acid in Sodium Chloride is a injection, solution containing tranexamic acid at 10 mg/mL, taken intravenous. Manufactured by HP Halden Pharma AS.

Key Facts

Brand Name: Tranexamic Acid in Sodium Chloride
Generic Name: TRANEXAMIC ACID
NDC Code (Product): 66298-5340
Manufacturer: HP Halden Pharma AS
Strength: 10 mg/mL
Dosage Form: INJECTION, SOLUTION
Route: INTRAVENOUS
Marketing Status
Application #: ANDA218242
Drug Class: Antifibrinolytic Agent [EPC]
Marketing Start: 12/10/2024

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective606 reports

off label use596 reports

pyrexia325 reports

nausea307 reports

diarrhoea299 reports

hypotension286 reports

vomiting283 reports

haemorrhage265 reports

dyspnoea257 reports

pneumonia253 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Tranexamic Acid in Sodium Chloride Injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. Tranexamic Acid in Sodium Chloride Injection is an antifibrinolytic indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction ( 1 ).

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Before Extraction: Administer 10 mg/kg actual body weight of Tranexamic Acid in Sodium Chloride Injection intravenously with replacement therapy. After Extraction: Administer 10 mg/kg actual body weight 3 to 4 times daily for 2 to 8 days. Infuse no more than 10 mL/minute to avoid hypotension ( 2.1 ). Reduce the dosage for patients with renal impairment ( 2.2 , 8.6 ). 2.1 Recommended Dosage The recommended dose of Tranexamic Acid in Sodium Chloride Injection is 10 mg/kg actual body weight intravenously administered as a single dose, immediately before tooth extractions. Infuse no more than 10 mL/minute to avoid hypotension [see Warnings and Precautions ( 5.1 )] . Following tooth extraction, Tranexamic Acid in Sodium Chloride Injection may be administered for 2 to 8 days at a dose of 10 mg/kg actual body weight three to four times daily, intravenously. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use Tranexamic Acid in Sodium Chloride Injection if particulate matter or coloration is seen. Tranexamic Acid in Sodium Chloride Injection sho…

Contraindications

4 CONTRAINDICATIONS Tranexamic Acid in Sodium Chloride Injection is contraindicated: In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid in such patients. In patients with active intravascular clotting [see Warnings and Precautions ( 5.1 )] . In patients with hypersensitivity to tranexamic acid or any of the ingredients [see Warnings and Precautions ( 5.3 )] . In patients with subarachnoid hemorrhage, due to risk of cerebral edema and cerebral infarction ( 4 ). In patients with active intravascular clotting ( 4 ). In patients with severe hypersensitivity reactions to tranexamic acid or any of the ingredients ( 4 ).

Drug Interactions

7 DRUG INTERACTIONS Prothrombotic Medical Products: Avoid concomitant use, can further increase the risk of thromboembolic adverse reactions associated with tranexamic acid ( 5.1 , 7.1 , 8.3 ). 7.1 Prothrombotic Medical Products Avoid concomitant use of Tranexamic Acid in Sodium Chloride Injection with medical products that are prothrombotic because concomitant use can further increase the risk of thromboembolic adverse reactions associated with tranexamic acid [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.3 )].

Adverse Reactions

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Thromboembolic Risk [see Warnings and Precautions ( 5.1 )] Seizures [see Warnings and Precautions ( 5.2 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] Visual Disturbances [see Warnings and Precautions ( 5.4 )] Dizziness [see Warnings and Precautions ( 5.5 )] Most common adverse reactions are nausea, vomiting, diarrhea, allergic dermatitis, giddiness, hypotension, and thromboembolic events ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of tranexamic acid. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal disturbances (nausea, vomiting, diarrhea) may occur and may resolve with dose-reduction. Allergic dermatitis and giddiness have been reported. Hypotension has been reported when i…

Frequently Asked Questions

What is Tranexamic Acid in Sodium Chloride used for?

Tranexamic Acid in Sodium Chloride contains TRANEXAMIC ACID. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is Tranexamic Acid in Sodium Chloride a controlled substance?

Tranexamic Acid in Sodium Chloride is not classified as a controlled substance by the DEA.

What is the generic name for Tranexamic Acid in Sodium Chloride?

The generic name for Tranexamic Acid in Sodium Chloride is TRANEXAMIC ACID. There are 11 other brand versions of TRANEXAMIC ACID.

What is the NDC code for Tranexamic Acid in Sodium Chloride 10 mg/mL?

The NDC (National Drug Code) for Tranexamic Acid in Sodium Chloride 10 mg/mL is 66298-5340, listed by HP Halden Pharma AS.

Product NDC

66298-5340

Package NDC

66298-5340-1

Other Tranexamic Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)