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CYKLOKAPRON®(tranexamic acid)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
CYKLOKAPRON® Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
CYKLOKAPRON® 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...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
The recommended dose of CYKLOKAPRON is 10 mg/kg actual body weight intravenously administered as a single dose,...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Injection: 1,000 mg tranexamic acid (100 mg/mL) clear and colorless solution in 10 mL single-dose ampules
Injection: 1,000 mg tranexamic acid (100 mg/mL) clear and colorless solution in 10...
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Contraindications
4 CONTRAINDICATIONS
CYKLOKAPRON Injection is contraindicated:
- In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by CYKLOKAPRON in...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Thromboembolic Risk
CYKLOKAPRON is contraindicated in patients with active intravascular clotting.
Tranexamic acid is an...
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Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Thromboembolic Risk [see
6.2 Postmarketing Experience...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Prothrombotic Medical Products
Avoid concomitant use of CYKLOKAPRON with medical products that are prothrombotic because concomitant use...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Available data from...
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Overdosage
10 OVERDOSAGE
Cases of overdosage of CYKLOKAPRON have been reported. Based on these reports, symptoms of overdosage may be gastrointestinal, e.g., nausea, vomiting, diarrhea; hypotensive, e.g., orthostatic symptoms;...
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Description
11 DESCRIPTION
Tranexamic acid is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid is a white crystalline powder. The structural formula is
...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Tranexamic acid is a synthetic lysine amino acid derivative, which diminishes the dissolution of hemostatic fibrin...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Tranexamic acid was not carcinogenic in a 2-year study in rats and mice at oral...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Thromboembolic Risk
Inform patients that CYKLOKAPRON may increase the risk of venous and arterial...
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Report Adverse Event
To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.
If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at https://vaers.hhs.gov or call (800) 822-7967.