TRANEXAMIC ACID IN SODIUM CHLORIDE- tranexamic acid injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Exela Pharma Sciences, LLC

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Tranexamic Acid in Sodium Chloride Injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce the risk of hemorrhage during and following tooth extraction. Tranexamic Acid in Sodium Chloride 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 identified a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. There are no reports regarding the use of tranexamic acid during the first trimester of pregnancy; therefore, there are no data regarding the risk of major birth defects with use of tranexamic acid during pregnancy. However, tranexamic acid is known to pass the placenta and appears in cord blood at concentrations approximately equal to maternal concentration (see Data). Reproduction studies performed in mice, rats, and rabbits have not revealed any adverse effects on the fet

Produkt oppsummering:

Tranexamic Acid in Sodium Chloride Injection is supplied as a sterile, unpreserved, colorless solution in a single-dose polymeric bag containing 1000 mg tranexamic acid in 100 mL of solution (10 mg/mL) sealed with a Twist Off port and oversealed in an aluminum pouch (NDC 51754-0108-1). Discard any unused portion. 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]. Manufactured and Distributed by: Exela Pharma Sciences, LLC 1245 Blowing Rock Blvd Lenoir, NC 28645

Autorisasjon status:

New Drug Application

Preparatomtale

TRANEXAMIC ACID IN SODIUM CHLORIDE- TRANEXAMIC ACID INJECTION,
SOLUTION
EXELA PHARMA SCIENCES, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRANEXAMIC ACID IN SODIUM CHLORIDE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TRANEXAMIC ACID IN SODIUM
CHLORIDE INJECTION.
TRANEXAMIC ACID IN SODIUM CHLORIDE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1986
INDICATIONS AND USAGE
Tranexamic Acid in Sodium Chloride Injection is an antifibrinolytic
indicated in patients with hemophilia for short-term use
(two to eight 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 of tranexamic acid in 100 mL (10 mg/mL) sterile,
unpreserved, colorless solution in a single-dose bag
for intravenous use (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 [ENTER COMPANY NAME] OR
FDA AT 1-800-FDA-1088 OR
WWW.FDA.G O V/MEDWATCH.
DRUG INTERACTIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 4/2019
Before Extraction: Administer 10 mg/kg actual body weight of
Tranexamic Acid in Sodium Chloride Injection
intravenously with replacement therapy.
After Extraction: Administer 10 mg/kg actual body weight 3-4 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).
In patients with subarachnoid hemorrhage, due to risk of cerebral
edemaand 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).
Risk of Thrombosis with concomitant use