DIFICID fidaxomicin tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FIDAXOMICIN (UNII: Z5N076G8YQ) (FIDAXOMICIN - UNII:Z5N076G8YQ)

Available from:

Avera McKennan Hospital

INN (International Name):

FIDAXOMICIN

Composition:

FIDAXOMICIN 200 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

DIFICID- FIDAXOMICIN TABLET, FILM COATED
AVERA MCKENNAN HOSPITAL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIFICID SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR DIFICID.
DIFICID (FIDAXOMICIN) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2011
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF DIFICID AND OTHER
ANTIBACTERIAL DRUGS, DIFICID SHOULD BE USED ONLY TO TREAT INFECTIONS
THAT ARE PROVEN OR STRONGLY SUSPECTED TO
BE CAUSED BY _CLOSTRIDIUM DIFFICILE_.
INDICATIONS AND USAGE
DIFICID is a macrolide antibacterial drug indicated in adults (≥18
years of age) for treatment of _Clostridium difficile_-
associated diarrhea. (1.1)
DOSAGE AND ADMINISTRATION
One 200 mg tablet orally twice daily for 10 days with or without food
(2)
DOSAGE FORMS AND STRENGTHS
Film-coated tablets: 200 mg (3)
CONTRAINDICATIONS
Hypersensitivity to fidaxomicin (4)
WARNINGS AND PRECAUTIONS
DIFICID should not be used for systemic infections. (5.1)
Acute hypersensitivity reactions (angioedema, dyspnea, pruritus, and
rash) have been reported. In the event of a
severe reaction, discontinue DIFICID. (5.2)
Development of drug-resistant bacteria: Only use DIFICID for infection
proven or strongly suspected to be caused by
_C. difficile_. (5.3)
ADVERSE REACTIONS
The most common adverse reactions are nausea (11%), vomiting (7%),
abdominal pain (6%), gastrointestinal hemorrhage
(4%), anemia (2%), and neutropenia (2%). (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MERCK SHARP & DOHME
CORP., A SUBSIDIARY OF MERCK &
CO., INC., AT 1-877-888-4231 OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH.
USE IN SPECIFIC POPULATIONS
Pediatrics: The safety and effectiveness of DIFICID has not been
studied in patients <18 years of age. (8.4)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 3/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 _Clostridium difficile_-Associated Diarrhea
2 DOSAGE AND ADMINISTRATION
3 DOSAGE