- What is Dificid (fidaxomicin), and how is it used?
- What are the side effects of Dificid (fidaxomicin)?
- What is the dosage for Dificid (fidaxomicin)?
- What drugs interact with Dificid (fidaxomicin)?
- Is Dificid (fidaxomicin) safe to use while pregnant or breastfeeding?
- What else should I know about Dificid (fidaxomicin)?
What is Dificid (fidaxomicin), and how is it used?
Dificid is a macrolide antibacterial drug indicated in adults (≥18 years of age) for treatment of Clostridium difficile-associated diarrhea (CDAD). 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.
What are the side effects of Dificid (fidaxomicin)?
- nausea (11%),
- vomiting (7%),
- abdominal pain (6%),
- gastrointestinal hemorrhage (4%),
- anemia (2%), and
- neutropenia (2%).
Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of any other drug and may not reflect the rates observed in practice. The safety of Dificid 200 mg tablets taken twice a day for 10 days was evaluated in 564 patients with CDAD in two active-comparator controlled trials with 86.7% of patients receiving a full course of treatment. Thirty-three patients receiving Dificid (5.9%) withdrew from trials as a result of adverse reactions (AR). The types of AR resulting in withdrawal from the study varied considerably. Vomiting was the primary adverse reaction leading to discontinuation of dosing; this occurred at an incidence of 0.5% in both the fidaxomicin and vancomycin patients in Phase 3 studies.
The following adverse reactions were reported in <2% of patients taking Dificid tablets in controlled trials:
- abdominal distension,
- abdominal tenderness,
- intestinal obstruction,
- increased blood alkaline phosphatase,
- decreased blood bicarbonate,
- increased hepatic enzymes,
- decreased platelet count
Metabolism and Nutrition Disorders:
- metabolic acidosis
Skin and Subcutaneous Tissue Disorders:
- drug eruption,
What is the dosage for Dificid (fidaxomicin)?
The recommended dose is one 200 mg Dificid tablet orally twice daily for 10 days with or without food. 200 mg white to off-white film-coated, oblong tablets; each tablet is debossed with “FDX” on one side and “200” on the other side.
What drugs interact with Dificid (fidaxomicin)?
Fidaxomicin and its main metabolite, OP-1118, are substrates of the efflux transporter, P-glycoprotein (P-gp), which is expressed in the gastrointestinal tract.
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.
Is Dificid (fidaxomicin) safe to use while pregnant or breastfeeding?
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.
What else should I know about Dificid (fidaxomicin)?
Patients should be counseled that antibacterial drugs, including Dificid, should only be used to treat bacterial infections. They do not treat viral infections. Patients should be counseled that Dificid only treats Clostridium difficile-associated diarrhea and should not be used to treat any other infection. When Dificid tablets are prescribed, patients should be told that, although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Dificid or other antibacterial drugs in the future.
Dificid is a macrolide antibacterial drug indicated in adults (=18 years of age) for treatment of Clostridium difficile-associated diarrhea (CDAD). 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.
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Related Disease Conditions
Diarrhea is a change in the frequency and looseness of bowel movements. Symptoms associated with diarrhea are cramping, abdominal pain, and the sensation of rectal urgency. Causes of diarrhea include viral, bacterial, or parasite infection, gastroenteritis, food poisoning, and drugs. Absorbents and anti-motility medications are used to treat diarrhea.
Colitis refers to inflammation of the inner lining of the colon. Symptoms of the inflammation of the colon lining include diarrhea, pain, and blood in the stool. There are several causes of colitis, including infection, ischemia of the colon, inflammatory bowel disease (Crohn's disease, ulcerative colitis, infectious colitis like C. difficile, or microscopic colitis). Treatment depends on the cause of the colitis.
Is C. diff (Clostridium difficile) Contagious?
C. diff, or Clostridium difficile, is a bacteria that infects the colon. C. diff bacteria can be found on furniture, bathroom floors, telephones, fingernails, jewelry, toilet seats, and other places. Symptoms of C. diff infection are fever, abdominal pain, and cramps; however, not all people infected with C. diff have symptoms. Treatments for C. diff are antibiotics and surgery in some cases.
Clostridium Difficile Colitis (C. diff, C. difficle Colitis)
Clostridium difficile (C. difficile) is a bacterium, and is one of the most common causes of infection of the colon. C. difficile spores are found frequently in hospitals, nursing homes, extended care facilities, and nurseries for newborn infants.
Is Colitis Contagious?
Colitis is a term that us used to describe inflammation of the colon. The terms enteritis, proctitis, and inflammatory bowel disease (IBD) now include colitis. Colitis has many different causes. Some types of colitis are contagious and some are not contagious. Symptoms and signs of colitis include diarrhea, abdominal discomfort, cramping, pain, and blood in the stools. Treatment for colitis depends on the cause and type of colitis.
How Do You Get Rid of Diarrhea?
Diarrhea is characterized as loose or runny stools that happen an abnormally high number of times throughout the day. Diarrhea can be linked to autoimmune diseases like Crohn’s or irritable bowel syndrome but is more often a sign of food intolerance (lactose is common), viral infection, food poisoning or other infectious diseases of varying severity.
Treatment & Diagnosis
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
All content is from the U.S. Food and Drug Administration (FDA) prescribing information.