Generic name: FIDAXOMICIN 200mg
Dosage form: tablet, film coated
Drug class: Macrolides
Medically reviewed by Drugs.com. Last updated on Sep 19, 2022.
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.
The recommended dosage for adults is one 200 mg DIFICID tablet orally twice daily for 10 days.
Pediatric Patients (6 Months to Less than 18 Years of Age)
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.
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)].
|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|
Preparation and Administration of DIFICID Oral Suspension
- 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 [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.
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