CYKLOKAPRON Solution for injection Ref.[10795] Active ingredients: Tranexamic acid

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:

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

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; thromboembolic, e.g., arterial, venous, embolic; neurologic, e.g., visual impairment, convulsions, headache, mental status changes; myoclonus; and rash.

Store at 20ºC to 25°C (68ºF to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].