The recommended dosage and administration by infection is shown in the table as follows: (see Table 1)
Click on icon to see table/diagram/image
The usual treatment duration of TIRONEM therapy is 5-14 days and should be guided by the severity, site of the infection, and the patient's clinical response. TIRONEM was given for up to 14 days in clinical studies and the safety of longer durations of therapy has not been established. After commencing treatment with intravenous TIRONEM, a switch to appropriate oral therapy to complete the treatment course is possible once clinical improvement has been established.
Dosage in pediatric patients
: TIRONEM is not recommended for use in children below 18 years of age due to a lack of safety and efficacy data.
Dosage in patients with impaired renal function:
In patients with mild renal impairment (i.e. creatinine clearance (CrCl) is 51-79 mL/min), no dosage adjustment is necessary. In patient with moderate renal impairment (CrCl 30-50 mL/min), the dosage of TIRONEM should be 250 mg every 8 hours. In patients with severe renal impairment (CrCl < 30 mL/min), the dosage of TIRONEM should be 250 mg every 12 hours. Due to limited clinical data and an expected increased exposure of TIRONEM and its metabolite, TIRONEM should be used with caution in patients with severe renal impairment.
Dosage in patients on dialysis:
TIRONEM is hemodialyzable, however, there is insufficient information to make dose adjustment recommendation in patients on dialysis. Therefore, TIRONEM is not recommended for patients on any type of dialysis.
Dosage in elderly patients (> 65 years of age):
No dosage adjustment is necessary in elderly patients, except in cases of moderate to severe renal insufficiency (see Dosage in patients with impaired renal function mentioned previously).
Dosage in patients with impaired hepatic function:
No dosage adjustment is necessary.
METHOD FOR ADMINISTRATION
: TIRONEM is to be reconstituted and then further diluted prior to administration by intravenous infusion over a period of one or four hours.
Reconstitution with NaCl 9 mg/mL (0.9%) as solvent: Make suspension by dissolve 10 mL purified water or NaCl 0.9% solution.
Suspension inspections by visual to see whether there is foreign object. Notes: suspension is not directly use for infusion.
Take a suspension with syringe and needle, and add to 100 mL NaCl 0.9% solution infusion bag. Infusion all solution with 500 mg TIRONEM dose.
Reconstitution with dextrose 50 mg/mL (5%) as solvent: Add 10 mL water for injections to 500 mg TIRONEM vial and shake until suspension is formed.
After reconstituted with water for injections, colour of suspension is white to slightly yellowish.
Check suspension by visual to see whether there is foreign object. Notes: suspension is not directly use for infusion.
Take a suspension with syringe and needle, and add to 100 mL dextrose 5% infusion bag. Infusion all solution with 500 mg TIRONEM dose.
After reconstituted with water for injection or NaCl 0.9% solution for injection, TIRONEM in vial may be held up for up to 1 hour below 25˚C prior to transfer and dilution in the infusion bag.
Following dilution in the infusion bag with NaCl 0.9% solution for injection or Dextrose 5% solution for injection, TIRONEM infusions stored at controlled room temperature or under refrigeration should be completed according to the stability times.
Reconstitution stability used: (see Table 2)
Click on icon to see table/diagram/image
Once removed from the refrigerator, infusions should be completed within the room temperature stability time, provided the total refrigeration time, time to reach room temperature and infusion time does not exceed refrigeration stability time.
Dextrose 5% solution for injection should not be used for infusion durations greater than 1 hour.
Product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°-8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
TIRONEM solution for infus usually clear color and no color to clear and slightly yellowish. Intensity of color solution will increase as storage time increases. This color variation does not affect product potential.
All unused residual product must be thrown away in accordance with applicable regulations.