DIFICID Film-coated tablet Ref.[10868] Active ingredients: Fidaxomicin

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 [see Dosage and Administration (2.4)].

Table 1. Recommended Dosage of DIFICID Oral Suspension in Pediatric Patients, Based on Weight:

2.4 Preparation and Administration of DIFICID Oral Suspension

Preparation

1. Shake the glass bottle to ensure the granules move around freely and no caking has occurred.
2. Measure 130 mL of purified water, add to the glass bottle, and cap tightly.
3. Hold bottle in a horizontal position and shake bottle vigorously in that position for at least 2 minutes.
4. Verify that a homogeneous suspension is obtained. If not, repeat the shaking step.
5. Once a homogeneous suspension is visually confirmed, shake an additional 30 seconds.
6. Let bottle stand for 1 minute.
7. Verify that the suspension is still homogeneous. If not, repeat steps 3 through 6.
8. Once reconstituted, DIFICID oral suspension is white to yellowish white in color.
9. Write discard date (current date plus 12 days) on the bottle [see How Supplied/Storage and Handling (16.1, 16.2)].

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.

No cases of acute overdose have been reported in humans. No drug-related adverse effects were seen in dogs dosed with fidaxomicin tablets at 9600 mg/day (over 100 times the human dose, scaled by weight) for 3 months.

Tablets

Store DIFICID tablets at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F). See USP controlled room temperature. Store in the original bottle.

Granules for oral suspension

Store DIFICID granules for oral suspension at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F). Store in the original package. Do not open pouch until time of use.

Once reconstituted, store DIFICID oral suspension refrigerated at 2°C-8°C (36°F-46°F) for up to 12 days. Store capped in the original bottle.