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CYKLOKAPRON® (tranexamic acid)
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CYKLOKAPRON® Quick Finder
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...
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,...
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...
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...
5 WARNINGS AND PRECAUTIONS
5.1 Thromboembolic Risk
CYKLOKAPRON is contraindicated in patients with active intravascular clotting.
Tranexamic acid is an...
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Thromboembolic Risk [see Warnings and...
7 DRUG INTERACTIONS
7.1 Prothrombotic Medical Products
Avoid concomitant use of CYKLOKAPRON with medical products that are prothrombotic because concomitant use...
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Available data from...
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;...
11 DESCRIPTION
Tranexamic acid is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid is a white crystalline powder. The structural formula is
...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Tranexamic acid is a synthetic lysine amino acid derivative, which diminishes the dissolution of hemostatic fibrin...
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...
17 PATIENT COUNSELING INFORMATION
Thromboembolic Risk
Inform patients that CYKLOKAPRON may increase the risk of venous and arterial...
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