TRANEXAMIC ACID injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRANEXAMIC ACID (UNII: 6T84R30KC1) (TRANEXAMIC ACID - UNII:6T84R30KC1)

Available from:

Mylan Institutional LLC

INN (International Name):

TRANEXAMIC ACID

Composition:

TRANEXAMIC ACID 100 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tranexamic acid injection is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. Tranexamic acid injection is contraindicated: Available data from published studies, case series and case reports with tranexamic acid use in pregnant women in the second and third trimester and at the time of delivery have not clarified whether there is a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. There are 2 (0.02%) infant cases with structural abnormalities that resulted in death when tranexamic acid was used during conception or the first trimester of pregnancy; however, due to other confounding factors the risk of major birth defects with use of tranexamic acid during pregnancy is not clear. Tranexamic acid is known to pass the placenta and appears in cord blood at concentrations approximately equal to maternal concentration (see Data) . Reproduction studies pe

Product summary:

Tranexamic Acid Injection USP, 1,000 mg/10 mL (100 mg/mL), a clear, colorless solution, is available in: NDC 67457-197-10 10 mL single-dose vial, packages of 10 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Sterile, Non-pyrogenic. Discard unused portion.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRANEXAMIC ACID- TRANEXAMIC ACID INJECTION, SOLUTION
MYLAN INSTITUTIONAL LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRANEXAMIC ACID
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TRANEXAMIC ACID
INJECTION.
TRANEXAMIC ACID INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1986
RECENT MAJOR CHANGES
Warnings and Precautions, Risk of Medication Errors Due to Incorrect
Route of Administration.
(5.2) 12/2020
INDICATIONS AND USAGE
Tranexamic acid injection is an antifibrinolytic indicated in patients
with hemophilia for short-term use (2 to
8 days) to reduce or prevent hemorrhage and reduce the need for
replacement therapy during and
following tooth extraction. (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Injection: 1,000 mg tranexamic acid (100 mg/mL) in 10 mL single-dose
vials (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions are nausea, vomiting, diarrhea, allergic
dermatitis, giddiness,
hypotension, and thromboembolic events. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-
RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
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)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 11/2021
Before Extraction: Administer 10 mg/kg actual body weight of
tranexamic acid injection intravenously
with replacement therapy. (2.1)
After Extraction: Administer 10 mg/kg actual body weight 3 to 4 times
daily for 2 to 8 days. Infuse no
more than 1 mL/minute to avoid hypotension. (2.1).
Reduce the dosage for patients with renal impairment. (2.2, 8.6)
In patients with subarachnoid hemorrhage, due to risk of cerebral
edema and cerebral infarction. (4)
In patients with active intravascular clotting. (4)
In pa