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CYKLOKAPRON®(tranexamic acid)
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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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