Pronunciation
(fye DAX
oh mye sin)
Index Terms
DifimicinLipiarrmycinOPT-80PAR-101Tiacumicin B
Dosage Forms
Excipient
information presented when available (limited, particularly for generics);
consult specific product labeling.
Tablet,
Oral:
Dificid:
200 mg [contains soybean lecithin]
Brand Names:U.S.
Dificid
Pharmacologic Category
Antibiotic, Macrolide
Pharmacology
Inhibits
RNA polymerase sigma subunit resulting in inhibition of protein synthesis and
cell death in susceptible organisms including C. difficile;
bactericidal
Absorption
Oral:
Minimal systemic absorption
Distribution
Largely
confined to the gastrointestinal tract; in single- and multiple-dose studies,
fecal concentrations of fidaxomicin and its active metabolite (OP-1118) are
very high while serum concentrations are minimally detectable to undetectable
Metabolism
Intestinal
hydrolysis to less active metabolite (OP-1118)
Excretion
Feces
(>92% as unchanged drug and metabolites); urine (<1% as metabolite)
Special Populations: Elderly
Plasma
concentrations were approximately 2- to 4-fold higher in elderly patients versus
nonelderly patients.
Use: Labeled Indications
Treatment
of Clostridium difficile-associated diarrhea (CDAD)
Contraindications
Hypersensitivity
to fidaxomicin
Dosing: Adult
Treatment
of diarrhea due to Clostridium difficile (CDAD): Oral: 200 mg twice daily for 10 days
Dosing: Geriatric
Refer to
adult dosing.
Dosing: Renal Impairment
No dosage
adjustment necessary (minimal systemic absorption).
Dosing: Hepatic Impairment
There are
no dosage adjustments provided in the manufacturer’s label (has not been
studied); However, due to minimal systemic absorption no dosage adjustment
predicted.
Administration
May be
administered with or without food.
Storage
Store at
20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to
86°F).
Drug Interactions
Lactobacillus
and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus
and Estriol.Monitor therapy
Mizolastine:
Macrolide Antibiotics may increase the serum concentration of
Mizolastine. Avoid combination
Sodium
Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium
Picosulfate. Management: Consider using an alternative product for bowel
cleansing prior to a colonoscopy in patients who have recently used or are
concurrently using an antibiotic. Consider therapy modification
Adverse Reactions
>10%:
Gastrointestinal: Nausea (11%)
2% to
10%:
Gastrointestinal:
Gastrointestinal hemorrhage (4%), abdominal pain, vomiting
Hematologic
& oncologic: Anemia (2%), neutropenia (2%)
<2%
(Limited to important or life-threatening): Abdominal distention, abdominal
tenderness, angioedema, decreased platelet count, decreased serum bicarbonate,
dyspepsia, dysphagia, dyspnea, fixed drug eruption, flatulence, hepatotoxicity
(idiosyncratic) (Chalasani, 2014), hyperglycemia, hypersensitivity reaction,
increased liver enzymes, increased serum alkaline phosphatase, intestinal
obstruction, megacolon, metabolic acidosis, pruritus, skin rash
Warnings/Precautions
Concerns
related to adverse effects:
•
Hypersensitivity: Hypersensitivity reactions (angioedema [mouth, face, throat],
dyspnea, pruritus, and rash) to fidaxomicin have been reported. If a severe
reaction occurs, discontinue drug and institute supportive care.
•
Macrolide allergy: Use with caution in patients with a history of macrolide
allergy; may be at increased risk for hypersensitivity.
Other
warnings/precautions:
•
Appropriate use: Do not use for systemic infections; fidaxomicin systemic
absorption is negligible. Use only in patients with proven or strongly suspected Clostridium
difficile (C. difficile) infections.
Pregnancy Risk Factor
B
Pregnancy Considerations
Adverse
events were not observed in animal reproduction studies. Due to the limited
systemic absorption of fidaxomicin, exposure to the fetus is expected to be
low.
Patient Education
• Discuss
specific use of drug and side effects with patient as it relates to treatment.
(HCAHPS: During this hospital stay, were you given any medicine that you had
not taken before? Before giving you any new medicine, how often did hospital
staff tell you what the medicine was for? How often did hospital staff describe
possible side effects in a way you could understand?)
• Patient
may experience nausea or vomiting. Have patient report immediately to
prescriber black, tarry, or bloody stools; vomiting blood; chills; pharyngitis;
severe constipation; severe abdominal pain, or severe loss of strength and
energy (HCAHPS).
• Educate
patient about signs of a significant reaction (eg, wheezing; chest tightness;
fever; itching; bad cough; blue skin color; seizures; or swelling of face,
lips, tongue, or throat). Note: This is not a comprehensive
list of all side effects. Patient should consult prescriber for additional
questions.
Intended
Use and Disclaimer: Should
not be printed and given to patients. This information is intended to serve as
a concise initial reference for healthcare professionals to use when discussing
medications with a patient. You must ultimately rely on your own discretion,
experience and judgment in diagnosing, treating and advising patients.
在对照试验中
吸收
