Fidaxomicindosage

DIFICID is administered orally with or without food. Adults One 200 mg tablet orally twice daily for 10 days. Pediatrics (6 Months to Less than 18 Years of Age) Tablets Pediatric patients weighing at least 12.5 kg and able to swallow tablets: One 200 mg tablet orally twice daily for 10 days. Oral Suspension Pediatric patients weighing at least 4 kg: Weight-based dosing of the oral suspension twice daily for 10 days using an oral dosing syringe, as specified in Table 1 in the full prescribing information. For instructions on preparation and administration of DIFICID oral suspension, see full prescribing information.

2.1 Important

Administration Instructions DIFICID is available for oral administration as 200 mg tablets and as granules for oral suspension (40 mg/mL (200 mg/5 mL) when reconstituted). DIFICID is administered orally with or without food.

2.2 Adult Patients

The recommended dosage for adults is one 200 mg DIFICID tablet orally twice daily for 10 days.

2.3 Pediatric

Patients (6 Months to Less than 18 Years of Age) Tablets The recommended dosage for pediatric patients weighing at least 12.5 kg and able to swallow tablets is one 200 mg DIFICID tablet administered orally twice daily for 10 days. If unable to swallow tablets, pediatric patients may be dosed with DIFICID oral suspension as recommended in Table 1 below. Oral Suspension The recommended dosage for pediatric patients based on weight are shown in Table 1. Administer DIFICID oral suspension orally twice daily for 10 days using an oral dosing syringe.

Table 1: Recommended Dosage of DIFICID Oral Suspension in Pediatric Patients, Based on Weight Body Weight Dose Administered Twice Daily Volume of 40 mg/mL Suspension to be Administered Orally Twice Daily 4 kg to less than 7 kg 80 mg 2 mL 7 kg to less than 9 kg 120 mg 3 mL 9 kg to less than 12.5 kg 160 mg 4 mL 12.5 kg and above 200 mg 5 mL

2.4 Preparation and

Administration of DIFICID Oral Suspension Preparation Shake the glass bottle to ensure the granules move around freely and no caking has occurred. Measure 130 mL of purified water, add to the glass bottle, and cap tightly. Hold bottle in a horizontal position and shake bottle vigorously in that position for at least 2 minutes. Verify that a homogeneous suspension is obtained. If not, repeat the shaking step. Once a homogeneous suspension is visually confirmed, shake an additional 30 seconds. Let bottle stand for 1 minute. Verify that the suspension is still homogeneous. If not, repeat steps 3 through 6. Once reconstituted, DIFICID oral suspension is white to yellowish white in color. Write discard date (current date plus 12 days) on the bottle. Storage of Reconstituted Oral Suspension Store the reconstituted oral suspension in a refrigerator [between 36°F-46°F (2°C-8°C)] for up to 12 days. Discard after 12 days. Administration Remove bottle from refrigerator 15 minutes prior to each administration. Shake vigorously until suspension has an even consistency. Remove cap, then administer orally with or without food using an oral dosing syringe. Between doses, replace cap and store in a refrigerator.