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Fidaxomicin is a macrolide antimicrobial drug that exerts bactericidal effects by inhibiting bacterial RNA polymerase.
1. Common name: Fidaxomicin
2. English name: Fidaxomicin
3. Trade name: DIFICID®
1. For the treatment of Clostridium difficile-associated diarrhea (CDAD) in children and adults 6 months and older.
2. To reduce the occurrence of drug-resistant bacteria and maintain the effectiveness of DIFICID and other antibacterial drugs, DIFICID should only be used to treat infections proven or strongly suspected to be caused by Clostridium difficile.
Film-coated tablets: 200mg
1. Active ingredient: fidaxomicin.
2. Tablet excipients include:butylated hydroxytoluene, hydroxypropylcellulose, lecithin (soybean), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, sodium starch glycolate, talc, and titanium dioxide.
1. Route of administration: Take orally, with food or on an empty stomach.
2. Adults: Take 200mg (1 tablet) once, twice a day, for 10 days.
3. Pediatric patients (6 months to <18 years old):
Those weighing ≥12.5kg and able to swallow tablets: 200 mg (1 tablet) at a time, twice a day, 10 days of treatment.
Specific dose adjustment plan based on liver function, renal function or common adverse reactions. No dose adjustment is required in elderly patients.
1. Before and after meals: It can be taken with food or on an empty stomach. Food has no clinical significance on absorption.
2. Missed doses: The instructions do not clearly mention how to deal with missed doses. It is recommended to follow the general principles. If it is close to the next dose time, skip the missed dose and do not double the dose.
3. Vomiting: If vomiting occurs after taking the medicine, it is not recommended to take a supplementary dose. You should wait until the next scheduled medication time to take the regular dose.
4. It is only used to treat Clostridium difficile infection. Because of its minimal systemic absorption, it is ineffective in treating other infections.
5. Complete the entire course of treatment, even if you feel better, to reduce the risk of relapse and drug resistance.
1. Pregnant women:The existing data are insufficient to assess drug-related risks. Animal experiments have shown no evidence of fetal harm.
2. Lactation period: There is no relevant data, and the benefits of breastfeeding and the mother's clinical needs should be considered.
3. Children: The safety and effectiveness have been established for patients 6 months and above. Safety and effectiveness in patients under 6 months of age have not been established.
4. Elderly: No dose adjustment is required. Compared with young subjects, there was no overall difference in safety and efficacy, but the plasma concentration was higher and was considered to be of no clinical significance.
5. Hepatic/renal insufficiency: The impact on patients with hepatic insufficiency has not been evaluated, but since fidaxomicin does not undergo significant hepatic metabolism, the impact is expected to be small. No dosage adjustment is required in patients with renal insufficiency.
1. The most common adverse reactions in adults (incidence ≥2%) include: Nausea, vomiting, abdominal pain, gastrointestinal bleeding, anemia, and neutropenia.
2. The most common adverse reactions (incidence rate ≥5%) in pediatric patients include: Fever, abdominal pain, vomiting, diarrhea, constipation, elevated transaminases, and rash.
3. Adverse reactions reported after marketing: Hypersensitivity reactions (dyspnea, angioedema, rash, itching).
It is contraindicated in patients with known hypersensitivity reactions to fidaxomicin or any component of DIFICID.
1. Cyclosporine (P-gp inhibitor) will significantly increase the plasma concentration of fidaxomicin and its main metabolite OP-1118, but it is still at the ng/mL level. Based on clinical trial results, they can be used together without dose adjustment.
2. Fidaxomicin has no significant effect on the pharmacokinetics of digoxin (P-gp substrate), midazolam (CYP3A4 substrate), warfarin (CYP2C9 substrate), and omeprazole (CYP2C19 substrate). No dosage adjustment is required for coadministration with P-gp or CYP enzyme substrates.
Tablets: Store at room temperature 20°C-25°C (68°F-77°F), short-term storage allowed between 15°C-30°C (59°F-86°F). Store in original bottle.