Drug Interaction:
Cyclosporine
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
Concentrations of fidaxomicin and OP-1118 may also be decreased
at the site of action (i.e., gastrointestinal tract) via P-gp inhibition;
however, concomitant P-gp inhibitor use had no attributable effect on safety
or treatment outcome of fidaxomicin-treated patients in controlled clinical trials.
Based on these results, fidaxomicin may be co-administered with P-gp inhibitors
and no dose adjustment is recommended
Indication:
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.
Drug Name- Dificid
Active Ingredient - Fidaxomicin
For the treatment of Clostridium difficile- associated diarrhea(CDAD)
Indication-
Treatment of Clostridium difficile- associated diarrhea(CDAD)
Approved by FDA on 27-5-2011 (Ref- FDA approved List- 2011)
Adverse Reaction:
ADVERSE REACTIONS
The most common adverse reactions are nausea (11%), vomiting (7%),
abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia (2%),
and neutropenia (2%) (6).
Contra-Indications:
CONTRAINDICATIONS
Hypersensitivity to fidaxomicin.
WARNINGS AND PRECAUTIONS
DIFICID should not be used for systemic infections.
Acute hypersensitivity reactions (angioedema, dyspnea, pruritus, and rash)
have been reported. In the event of a severe reaction, discontinue DIFICID.
Development of drug-resistant bacteria: Only use DIFICID for infection proven or
strongly suspected to be caused by C. difficile.
Not for Systemic Infections
Since there is minimal systemic absorption of fidaxomicin, DIFICID is not effective
for treatment of systemic infections.
Hypersensitivity Reactions
Acute hypersensitivity reactions, including dyspnea, rash, pruritus, and angioedema
of the mouth, throat, and face have been reported with fidaxomicin.
If a severe hypersensitivity reaction occurs, DIFICID should be discontinued
and appropriate therapy should be instituted.
Some patients with hypersensitivity reactions also reported a history of allergy
to other macrolides.
Physicians prescribing DIFICID to patients with a known macrolide allergy
should be aware of the possibility of hypersensitivity reactions.
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
DIFICID is a macrolide antibacterial drug indicated in adults (.18 years of age)
for treatment of Clostridium difficile-associated diarrhea
DOSAGE AND ADMINISTRATION
One 200 mg tablet orally twice daily for 10 days with or without food
DOSAGE FORMS AND STRENGTHS
Film-coated tablets: 200 mg
Patient Information:
1. Not to be used for Systemic Infections
Since there is minimal systemic absorption of fidaxomicin, DIFICID is not effective
for treatment of systemic infections.
2.Acute hypersensitivity reactions, including dyspnea, rash, pruritus, and angioedema
of the mouth, throat, and face have been reported with fidaxomicin.
If a severe hypersensitivity reaction occurs, discontinue the drug and appropriate
therapy should be instituted.
Pharmacology/ Pharmacokinetics:
DIFICID is a macrolide antibacterial drug indicated in adults (.18 years of age)
for treatment of Clostridium difficile-associated diarrhea
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1 Pregnancy
Pregnancy Category B.
Reproduction studies have been performed in rats and rabbits by the intravenous route
at doses up to 12.6 and 7 mg/kg, respectively.
The plasma exposures (AUC0-t) at these doses were approximately 200- and 66-fold
that in humans, respectively, and have revealed no evidence of harm to the fetus
due to fidaxomicin.
There are, however, no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of human response,
this drug should be used during pregnancy only if clearly needed.
2. Nursing Mothers
It is not known whether fidaxomicin is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised
when DIFICID is administered to a nursing woman.
3. Pediatric Use
The safety and effectiveness of DIFICID in patients <18 years of age have not been established.
4 Geriatric Use
Of the total number of patients in controlled trials of DIFICID, 50% were 65 years of age
and over, while 31% were 75 and over. No overall differences in safety or
effectiveness of fidaxomicin compared to vancomycin were observed between
these subjects and younger subjects.
In controlled trials, elderly patients (.65 years of age) had higher plasma
concentrations of fidaxomicin and its main metabolite, OP-1118,
versus non-elderly patients (<65 years of age).
However, greater exposures in elderly patients were not considered to be
clinically significant. No dose adjustment is recommended for elderly patients.
5.OVERDOSAGE
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.
Manufacturer Details