Tranexamic acid (injection)

Tranexamic acid (injection)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Turky Alkathery, M.D. [2]

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Overview

Tranexamic acid (injection) is an antifibrinolytic agent that is FDA approved for the treatment of 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. Common adverse reactions include abdominal pain, anemia, arthralgia, backache, cramps, musculoskeletal pain, headache, migraine, nasal sinus problem and fatigue.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indication

• CYKLOKAPRON Injection is 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.

Dosage

• Immediately before tooth extraction in patients with hemophilia, administer 10 mg per kg body weight of CYKLOKAPRON intravenously together with replacement therapy.
• Following tooth extraction, intravenous therapy, at a dose of 10 mg per kg body weight three to four times daily, may be used for 2 to 8 days.
• Note: For patients with moderate to severe impaired renal function, the following dosages are recommended:

This image is provided by the National Library of Medicine.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Tranexamic acid in adult patients.

Non–Guideline-Supported Use

• Dental surgical procedure - Hemophilia - Hemorrhage.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

The drug has had limited use in pediatric patients, principally in connection with tooth extraction. The limited data suggest that dosing instructions for adults can be used for pediatric patients needing CYKLOKAPRON therapy.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Tranexamic acid in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Tranexamic acid in pediatric patients.

Contraindications

CYKLOKAPRON Injection is contraindicated:

• In patients with acquired defective color vision, since this prohibits measuring one endpoint that should be followed as a measure of toxicity.
• In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by CYKLOKAPRON in such patients.
• In patients with active intravascular clotting.
• In patients with hypersensitivity to tranexamic acid or any of the ingredients.

Warnings

There is limited information regarding Tranexamic acid (injection) Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Tranexamic acid (injection) Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Tranexamic acid (injection) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Tranexamic acid (injection) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Tranexamic acid (injection) in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Tranexamic acid (injection) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Tranexamic acid (injection) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Tranexamic acid (injection) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Tranexamic acid (injection) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Tranexamic acid (injection) in geriatric settings.

Gender

There is no FDA guidance on the use of Tranexamic acid (injection) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Tranexamic acid (injection) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Tranexamic acid (injection) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Tranexamic acid (injection) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Tranexamic acid (injection) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Tranexamic acid (injection) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Tranexamic acid (injection) Administration in the drug label.

Monitoring

There is limited information regarding Tranexamic acid (injection) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Tranexamic acid (injection) and IV administrations.

Overdosage

There is limited information regarding Tranexamic acid (injection) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Tranexamic acid (injection) Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Tranexamic acid (injection) Mechanism of Action in the drug label.

Structure

There is limited information regarding Tranexamic acid (injection) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Tranexamic acid (injection) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Tranexamic acid (injection) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Tranexamic acid (injection) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Tranexamic acid (injection) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Tranexamic acid (injection) How Supplied in the drug label.

Storage

There is limited information regarding Tranexamic acid (injection) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Tranexamic acid (injection) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Tranexamic acid interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Tranexamic acid (injection) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Tranexamic acid (injection) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.