TRANEXAMIC ACID injection, solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

tranexamic acid (UNII: 6T84R30KC1) (tranexamic acid - UNII:6T84R30KC1)

Commercializzato da:

Alvogen Inc.

INN (Nome Internazionale):

tranexamic acid

Composizione:

tranexamic acid 100 mg in 1 mL

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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)]. 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

Dettagli prodotto:

Tranexamic Acid Injection is a clear, colorless solution supplied as follows: Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

TRANEXAMIC ACID- TRANEXAMIC ACID INJECTION, SOLUTION
ALVOGEN INC.
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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
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
• 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 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, giddiness, hypotension,