TRANEXAMIC ACID- tranexamic acid injection TRANEXAMIC ACID- tranexamic acid injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Micro Labs Limited

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: - In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid injection 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 ( 5.4 )] . Risk Summary 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

Product summary:

Tranexamic Acid Injection 100 mg/mL is a clear, colorless solution and is available as follows. Mono Carton of 10 mL glass ampule (10 mL fill in 10 mL glass ampule) NDC 42571-189-56 Outer Carton of 10 x 10 mL (10 mono cartons of 10 mL glass ampules)      NDC 42571-189-57 Tranexamic Acid Injection 100 mg/mL is a clear, colorless solution and is available as follows. Mono Carton of 10 mL glass vials (10 mL fill in 10 mL glass vials) NDC 42571-314-88 Outer Carton of 10 x 10 mL (10 mono cartons of 10 mL glass vials)           NDC 42571-314-89 Store at 20ºC to 25°C (68ºF to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRANEXAMIC ACID - TRANEXAMIC ACID INJECTION
TRANEXAMIC ACID - TRANEXAMIC ACID INJECTION
MICRO LABS LIMITED
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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
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)
DOSAGE FORMS AND STRENGTHS
Injection: 1,000 mg tranexamic acid (100 mg/mL) in 10 mL single-dose
ampules ( 3)
Injection: 1,000 mg tranexamic acid (100 mg/mL) in 10 mL single-dose
vials ( 3)
CONTRAINDICATIONS
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)
WARNINGS AND PRECAUTIONS
Risk of Thrombosis with Concomitant Use of Factor IX: Avoid
concomitant use. ( 5.1)
Risk of Medication Errors Due to Incorrect Route of Administration:
FOR INTRAVENOUS USE ONLY. ( 5.2)
Seizures: Inadvertent injection into neuraxial system may result in
seizures. ( 5.3)
Hypersensitivity Reactions: In case of severe reaction, discontinue
use and seek immediate medical
attent