SUPRAX (Page 2 of 7)

2.3 Renal Impairment

Suprax may be administered in the presence of impaired renal function. Normal dose and schedule may be employed in patients with creatinine clearances of 60 mL/min or greater. Refer to Table 2 for dose adjustments for adults with renal impairment. Neither hemodialysis nor peritoneal dialysis removes significant amounts of drug from the body.

Table 2. Doses for Adults with Renal Impairment
*
The preferred concentrations of oral suspension to use are 200 mg/5 mL or 500 mg/5 mL for patients with this renal dysfunction
Renal Dysfunction Suprax ( cefixime ) for Oral Suspension Tablet Chewable Tablet
Creatinine Clearance (mL/min) 100 mg / 5 mL 200 mg / 5 mL 500 mg / 5 mL 400 mg 200 mg
Dose/Day (mL) Dose/Day (mL) Dose/Day (mL) Dose/Day Dose/Day
60 or greater Normal dose Normal dose Normal dose Normal dose Normal dose
21 to 59*OR renal hemodialysis * 13 6.5 2.6 Not Appropriate Not Appropriate
20 or less OR continuous peritoneal dialysis 8.6 4.4 1.8 0.5 tablet 1 tablet

2.4 Reconstitution Directions for Oral Suspension

Strength Bottle Size Reconstitution Directions
100 mg/5 mL and 200 mg/5 mL 100 mL To reconstitute, suspend with 68 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.
100 mg/5 mL and 200 mg/5 mL 75 mL To reconstitute, suspend with 51 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.
100 mg/5 mL and 200 mg/5 mL 50 mL To reconstitute, suspend with 34 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.
200 mg/5 mL 37.5 mL To reconstitute, suspend with 26 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.
200 mg/5 mL 25 mL To reconstitute, suspend with 17 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.
500 mg/5 mL 20 mL To reconstitute, suspend with 14 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.
500 mg/5 mL 10 mL To reconstitute, suspend with 8 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.

After reconstitution, the suspension may be kept for 14 days either at room temperature, or under refrigeration, without significant loss of potency. Keep tightly closed. Shake well before using. Discard unused portion after 14 days.

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