Brand Name
Dificid
Generic Name
Fidaxomicin
View Brand Information FDA approval date: May 27, 2011
Classification: Macrolide Antibacterial
Form: Tablet, Granule
What is Dificid (Fidaxomicin)?
Fidaxomicin tablets are a macrolide antibacterial indicated in adult patients for the treatment of C. difficile -associated diarrhea.
Approved To Treat
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Brand Information
Dificid (fidaxomicin)
1CONTRAINDICATIONS
DIFICID is contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in DIFICID
2DRUG INTERACTIONS
Fidaxomicin and its main metabolite, OP-1118, are substrates of the efflux transporter, P-glycoprotein (P-gp), which is expressed in the gastrointestinal tract.
2.1Cyclosporine
Cyclosporine is an inhibitor of multiple transporters, including P-gp. When cyclosporine was co-administered with DIFICID, plasma concentrations of fidaxomicin and OP-1118 were significantly increased but remained in the ng/mL range
3OVERDOSAGE
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.
4DESCRIPTION
DIFICID (fidaxomicin) is a macrolide antibacterial drug for oral administration. Its CAS chemical name is Oxacyclooctadeca-3,5,9,13,15-pentaen-2-one, 3-[[[6-deoxy-4-
DIFICID tablets are film-coated and contain 200 mg of fidaxomicin per tablet and the following inactive ingredients: butylated hydroxytoluene, hydroxypropyl cellulose, lecithin (soy), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, sodium starch glycolate, talc, and titanium dioxide.
DIFICID for oral suspension is supplied as granules in bottles containing 5.45 g of fidaxomicin (40 mg of fidaxomicin per mL after reconstitution) and the following inactive ingredients: citric acid, microcrystalline cellulose, mixed berry flavor, sodium benzoate, sodium citrate, sodium starch glycolate, sucralose, and xanthan gum.
5PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
6PRINCIPAL DISPLAY PANEL - 200 mg Tablet Bottle Carton
NDC 52015-080-01 20 tablets
DIFICID
(fidaxomicin) tablets
(fidaxomicin) tablets
200 mg per tablet
Rx only
7PRINCIPAL DISPLAY PANEL - 40 mg/mL Bottle Pouch Carton
NDC 52015-700-22
DIFICID
(fidaxomicin) for oral suspension
(fidaxomicin) for oral suspension
40 mg/mL
MUST BE RECONSTITUTED BY A PHARMACIST
See enclosed package insert for preparation instructions.
For pediatric use
Each mL contains 40 mg fidaxomicin after reconstitution
Mixed berry flavored
