صيدلية اونلاين
  • DIFICLIR TABS 20 x 200 mg

    $8,620.25 $2,329.80


    DIFICLIR

    Alimentary System

    Alimentary System

    Gastro-intestinal infections; Diarrhea

    ACTIVE INGREDIENTS


    Fidaxomicin 200 mg.

    FIDAXOMICIN

    PRESENTATION AND DOSSAGE

    TABS: 20 x 200 mg

    RELATED INFORMATION


    INDICATIONS

    Treatment of Clostridium difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD).


    DRUG INTERACTION

    Effect of P-gp inhibitors on fidaxomicin: Fidaxomicin is a substrate of P-gp. Co-administration of single doses of the P-gp inhibitor cyclosporine A and Fidaxomicin in healthy volunteers, resulted in a 4- and 2-fold increase in fidaxomicin Cmax and AUC, respectively and in a 9.5 and 4-fold increase in Cmax and AUC, respectively, of the main active metabolite OP-1118. As the clinical relevance of this increase in exposure is unclear, co-administration of potent inhibitors of P-gp, such as cyclosporine, ketoconazole, erythromycin, clarithromycin, verapamil, dronedarone and amiodarone are not recommended.

    Effect of fidaxomicin on P-gp substrates: Fidaxomicin may be a mild to moderate inhibitor of intestinal P-gp. Fidaxomicin (200 mg twice daily) had a small but not clinically relevant effect on digoxin exposure. However, a larger effect on P-gp substrates with lower bioavailability more sensitive to intestinal P-gp inhibition such as dabigatran etexilat cannot be excluded.

    Effect of fidaxomicin on other transporters: Fidaxomicin does not have a clinically significant effect on the exposure of rosuvastatin, a substrate  for the transporters OATP2B1 and BCRP.

    See prescribing information for full details.


    CONTRAINDICATIONS

    Hypersensitivity to the active substance or to any of the excipients.


    SPECIAL PRECAUTIONS

    Hypersensitivity reactions including severe angioedema have been reported. If a severe allergic reaction occurs during treatment with fidaxomicin, the medicinal product should be discontinued and appropriate measures taken. Some patients with hypersensitivity reactions reported a history of allergy to macrolides. Fidaxomicin  should be used with caution in patients with a known macrolides allergy. Due to limited clinical data, fidaxomicin should be used with caution in patients with severe renal impairment or moderate to severe hepatic impairment. Due to limited clinical data, fidaxomicin should be used with caution in patients with severe renal impairment or moderate to severe hepatic impairment. Due to limited clinical data, fidaxomicin should be used with caution in patients with pseudomembranous colitis, fulminant or life threatening CDI.

    There are no data in patients with concomitant inflammatory bowel disease. Fidaxomicin should be used with caution in these patients due to the risk of enhanced absorption and potential risk of systemic adverse reactions. Co-administration of potent P-glycoprotein inhibitors such as cyclosporine, ketoconazole, erythromycin, clarithromycin, verapamil, dronedarone and amiodarone is not recommended.

    See prescribing information for full details.


    SIDE EFFECTS

    Vomiting, nausea,and constipation. See prescribing information for full details.


    DOSAGE

    Posology: Adults and older people (≥ 65 years of age): The recommended dose is 200 mg (one tablet) administered twice daily (once every 12 hours) for 10 days.

    Paediatric population: The safety and efficacy of fidaxomicin in children aged below 18 years has not yet been established. No data are available.

    Renal impairment: No dose adjustment is considered necessary. Due to the limited clinical data in this population, fidaxomicin should be used with caution in patients with severe renal impairment.

    Hepatic impairment: No dose adjustment is considered necessary. Due to the limited clinical data in this population, fidaxomicin should be used with caution in patients with moderate to severe hepatic impairment.

    Method of administration: The drug is intended for oral administration, can be taken with or without food.


    OVERDOSE

    No cases of acute overdose have been reported.


    PREGNANCY & LACTATION

    Pregnancy: There are no data available from the use of fidaxomicin in pregnant women.

    Lactation: It is unknown whether fidaxomicin and its metabolites are excreted in human milk.

    See prescribing information for full details.


    IMPORTANT NOTES

    Storage: Store below 25 ċ.


    MANUFACTURER & DISTRIBUTER:

    Manufacturer: Astellas Pharma Europe BV, The Netherlands

    License Holder: Astellas Pharma International B.V., Israel

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