Tranexamic AcidInjection, USP

Tranexamic Acid Injection, USP

For Intravenous Injection

INDICATIONS AND USAGE

Tranexamic acid injection, USP 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.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
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.
In patients with hypersensitivity to tranexamic acid or any of the ingredients.

WARNINGS AND PRECAUTIONS
Thromboembolic Risk: Tranexamic acid injection is contraindicated in patients with active intravascular clotting.
Risk of Thrombosis with Concomitant Use of Factor IX: Avoid concomitant use.
Seizures: Inadvertent injection into neuraxial system may result in seizures.
Hypersensitivity Reactions: In case of severe reaction, discontinue use and seek immediate medical attention.
Visual Disturbances: Visual or ocular adverse effects may occur. Discontinue use if visual or ocular symptoms occur.
Dizziness: Advise patients not to drive if dizziness occurs.

ADVERSE REACTIONS
Most common adverse reactions are nausea, vomiting, diarrhea, allergic dermatitis, giddiness, hypotension, and thromboembolic events.
Hypersensitivity reactions and visual disturbances have been reported.

Postmarketing Experience
Anaphylaxis or anaphylactoid reactions have been reported that are suggestive of a causal relationship.

DRUG INTERACTIONS
Prothrombotic Medical Products: Avoid concomitant use; can further increase the risk of thromboembolic adverse reactions associated with tranexamic acid.

USE IN SPECIFIC POPULATIONS
Pregnancy Risk Summary: Tranexamic acid is known to pass the placenta and appears in cord blood at concentrations approximately equal to maternal concentration. It is not known whether tranexamic acid use in pregnant women may cause a drug-associated risk of miscarriage or adverse maternal or fetal outcomes.
Lactation Risk Summary: The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tranexamic acid injection and any potential adverse effects on the breastfed child from tranexamic acid injection or from the underlying maternal condition.
Females and Males of Reproductive Potential Contraception: Concomitant use of tranexamic acid injection, with hormonal contraceptives may increase the risk for thromboembolic adverse reactions.
Pediatric Use: There are limited data concerning the use of tranexamic acid injection in pediatric patients with hemophilia who are undergoing tooth extraction. The limited data suggest that there are no significant pharmacokinetic differences between adults and pediatric patients.
Geriatric Use: Care should be taken in dose selection, and it may be useful to monitor renal function.
Renal Impairment: Reduce the dosage of tranexamic acid injection in patients with renal impairment.

OVERDOSAGE: Cases of overdosage of tranexamic acid injection have been reported. Based on these reports, symptoms of overdosage may be gastrointestinal, hypotensive, thromboembolic, neurologic, myoclonus and rash.

For additional Safety Information, please see Full Prescribing Information.

You are encouraged to report adverse drug events to American Regent Inc., at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or by calling 1-800-FDA-1088.

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