CYKLOKAPRON® Dosage and Administration

(tranexamic acid)

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, immediately before tooth extractions Infuse no more than 1 mL/minute to avoid hypotension [see Warnings and Precautions (5.1)]. Following tooth extraction, CYKLOKAPRON may be administered for 2 to 8 days at a dose of 10 mg/kg actual body weight 3 to 4 times daily, intravenously.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

For intravenous infusion, CYKLOKAPRON Injection may be mixed with most solutions for infusion such as electrolyte solutions, carbohydrate solutions, amino acid solutions, and Dextran solutions. Heparin may be added to CYKLOKAPRON Injection. CYKLOKAPRON Injection should NOT be mixed with blood. The drug is a synthetic amino acid and should NOT be mixed with solutions containing penicillin.

Discard any unused portion.

The diluted mixture may be stored for up to 4 hours at room temperature prior to patient administration.

2.2 Recommended Dosage for Patients With Varying Degrees of Renal Impairment*

For patients with moderate to severe impaired renal function, the following dosages are recommended:

Table 1. Recommended Dosage in Patients With Varying Degrees of Renal Impairment
Serum Creatinine (mg/dL)CYKLOKAPRON Intravenous Dosage
* Dose reduction is recommended for all doses, both before and after tooth extraction.

1.36 to 2.83
(120 to 250 micromol/L)

10 mg/kg twice daily

2.83 to 5.66 (250 to 500 micromol/L)

10 mg/kg daily

>5.66 (>500 micromol/L)

10 mg/kg every 48 hours
or
5 mg/kg every 24 hours

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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, immediately before tooth extractions Infuse no more than 1 mL/minute to avoid hypotension [see Warnings and Precautions (5.1)]. Following tooth extraction, CYKLOKAPRON may be administered for 2 to 8 days at a dose of 10 mg/kg actual body weight 3 to 4 times daily, intravenously.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

For intravenous infusion, CYKLOKAPRON Injection may be mixed with most solutions for infusion such as electrolyte solutions, carbohydrate solutions, amino acid solutions, and Dextran solutions. Heparin may be added to CYKLOKAPRON Injection. CYKLOKAPRON Injection should NOT be mixed with blood. The drug is a synthetic amino acid and should NOT be mixed with solutions containing penicillin.

Discard any unused portion.

The diluted mixture may be stored for up to 4 hours at room temperature prior to patient administration.

2.2 Recommended Dosage for Patients With Varying Degrees of Renal Impairment*

For patients with moderate to severe impaired renal function, the following dosages are recommended:

Table 1. Recommended Dosage in Patients With Varying Degrees of Renal Impairment
Serum Creatinine (mg/dL)CYKLOKAPRON Intravenous Dosage
* Dose reduction is recommended for all doses, both before and after tooth extraction.

1.36 to 2.83
(120 to 250 micromol/L)

10 mg/kg twice daily

2.83 to 5.66 (250 to 500 micromol/L)

10 mg/kg daily

>5.66 (>500 micromol/L)

10 mg/kg every 48 hours
or
5 mg/kg every 24 hours
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