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CYKLOKAPRON® (tranexamic acid)

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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 OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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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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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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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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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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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6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

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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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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Available data from...

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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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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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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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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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16 HOW SUPPLIED/STORAGE AND HANDLING

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17 PATIENT COUNSELING INFORMATION

Thromboembolic Risk

Inform patients that CYKLOKAPRON may increase the risk of venous and arterial...

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This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

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