(tranexamic acid)

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2 DOSAGE AND ADMINISTRATION

2 DOSAGE AND ADMINISTRATION

     

2.1 Recommended Dosage

The recommended dose of CYKLOKAPRON is 10 mg/kg actual body weight administered as a single intravenous dose immediately before tooth extractions. Following tooth extraction, CYKLOKAPRON may be administered at a dose of 10 mg/kg actual body weight intravenously 3 to 4 times daily for 2 to 8 days.

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*
*
Dose reduction is recommended for all doses, both before and after tooth extraction.

Serum Creatinine (mg/dL)

CYKLOKAPRON Dosage

1.36 mg/dL to 2.83 mg/dL

10 mg/kg intravenously twice daily

2.83 mg/dL to 5.66 mg/dL

10 mg/kg intravenously daily

>5.66 mg/dL

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

2.3 Preparation and Administration

CYKLOKAPRON is for intravenous administration only.

CYKLOKAPRON can be administered undiluted or as a diluted solution.

•
Use aseptic technique to prepare CYKLOKAPRON.
•
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. CYKLOKAPRON is a clear and colorless solution. Discard the vial if particulate matter is observed.
•
Calculate the dose (mg) based on the patient’s actual body weight and the total volume (mL) of CYKLOKAPRON solution required.

If diluting CYKLOKAPRON, follow the instructions below:

•
From the diluent infusion bag, withdraw a volume equal to the volume of the CYKLOKAPRON solution required for the patient’s dose.
•
Withdraw the required volume of CYKLOKAPRON solution from the vial and dilute with a compatible diluent (see below) to make a final concentration of 10 mg/mL or 20 mg/mL. Discard any unused portion left in the vial.
o
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.
o
Heparin may be added to CYKLOKAPRON Injection.
o
CYKLOKAPRON Injection should NOT be mixed with blood.
o
The drug is a synthetic amino acid and should NOT be mixed with solutions containing penicillin.
•
Gently invert the infusion bag to mix the diluted solution. DO NOT SHAKE.
•
If not used immediately, store the diluted CYKLOKAPRON infusion solution at room temperature 20ºC to 25°C (68ºF to 77°F) for up to 4 hours.

Administration

Infuse undiluted solution no more than 1 mL/minute to avoid hypotension [see Adverse Reactions (6.2)].

Administer the undiluted and diluted solutions intravenously according to Table 2.

Table 2. Administration Rates for Undiluted and Diluted Solutions

Undiluted solution

Diluted solution

Final concentration

100 mg/mL

10 mg/mL

20 mg/mL

Administration rate

0.5 mL/minute
(no more than 1 mL/minute)

5 mL/minute

2.5 mL/minute

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