TRANEXAMIC ACID injection, solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

Tranexamic Acid (UNII: 6T84R30KC1) (Tranexamic Acid - UNII:6T84R30KC1)

Verfügbar ab:

Virtus Pharmaceuticals, LLC

INN (Internationale Bezeichnung):

Tranexamic Acid

Zusammensetzung:

Tranexamic Acid 100 mg in 1 mL

Verabreichungsweg:

INTRAVENOUS

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Tranexamic acid 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: 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 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

Produktbesonderheiten:

Tranexamic Acid Injection 100 mg/mL NDC 69543-376-22 1 x 10 mL single-dose ampule NDC 69543-376-23 10 x 10 mL single-dose ampules 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].

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

TRANEXAMIC ACID- TRANEXAMIC ACID INJECTION, SOLUTION
VIRTUS PHARMACEUTICALS, LLC
----------
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 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
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions are nausea, vomiting, diarrhea, allergic
dermatitis, giddiness, hypotension, and
thromboembolic events. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT VIRTUS PHARMACEUTICALS,
LLC AT 1-888-848-3593 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: 6/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
Before Extraction: Administer 10 mg/kg actual body weight of
tranexamic acid 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)
Injection: 1000 mg tranexamic acid (100 mg/mL) in 10 mL single-dose
ampules (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