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:

XGen Pharmaceuticals DJB, Inc.

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 (5.3)]. 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

Product summary:

Tranexamic Acid Injection 100 mg/mL NDC 39822-1001-7 10 x 10 ml single-dose vials Store at 20°C to 25°C (68°F 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, SOLUTION
XGEN PHARMACEUTICALS DJB, INC.
----------
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
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 10
mL/minute to avoid hypotension. (2.1).
• Reduce the dosage for patients with renal impairment. (2.2, 8.6)
DOSAGE FORMS AND STRENGTHS
Injection: 1000 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)
• Seizures: Inadvertent injection into neuraxial system may result
in seizures. (5.2)
• Hypersensitivity Reactions: In case of severe reaction,
discontinue use and seek immediate medical attention. (5.3)
• Visual Disturbances: Visual or ocular adverse effects may occur.
Discontinue use if visual or ocular symptoms occur. (5.4)
• Dizziness: Advise patients not to drive if dizziness occurs (5.5).
ADVERSE REACTIONS
Most common adverse reactions are nausea, vomiting, diarrhea, allergic
dermatitis, g