Country: Singapúr
Tungumál: enska
Heimild: HSA (Health Sciences Authority)
SODIUM FUSIDATE
DKSH SINGAPORE PTE. LTD.
J01XC01
250 mg
TABLET, FILM COATED
SODIUM FUSIDATE 250 mg
ORAL
Prescription Only
Laboratoires LEO
ACTIVE
1990-08-02
ADVERSE EFFECTS Fucidin ® tablets given orally may cause gastrointestinal disturbances (dyspepsia, nausea, vomiting) which can normally be avoided by giving Fucidin ® tablets with meals. Reversible increase of transaminases is reported at daily dosages of 1.5-3 g of Fucidin ® tablets. Reversible jaundice has been reported in some patients after administration of systemic Fucidin ® , most frequently in patients receiving intravenous Fucidin ® in high dosage and especially in serious Staph. aureus bacteremia. In some cases, instituting oral therapy may be beneficial. If the jaundice persists, Fucidin ® should be withdrawn, after which the serum bilirubin will return to normal. Allergic reactions are reported in very few cases. Musculoskeletal, connective tissue and bone disorders Frequency not known: Rhabdomyolysis (examples of signs and symptoms are: muscle weakness, swelling and pain, dark urine, myoglo- binuria, elevated serum creatine kinase, acute renal failure, cardiac arrhythmia). SEE DRUG INTERACTION. Rhabdomyolysis may be fatal. Hepatobiliary disorders Frequency not known: Cholestasis Blood and lymphatic system disorders Leukopenia* Thrombocytopenia Pancytopenia Anaemia *Haematological disorders affecting the white cell line (neutropenia, granulocytopenia, agranulocytosis) and more rarely disorders affecting the other two cell lines have been reported, either as isolated events or associated. This has been observed especially in case of treatment duration of more than 15 days and is reversible upon drug withdrawal. OVERDOSAGE Treatment should be restricted to symptomatic and supportive measures. Dialysis is of no benefit as the drug is not significantly dialysed. PRECAUTIONS As fusidic acid is metabolized in the liver and excreted mainly through the bile, periodic liver function tests should be carried out in patients with liver dysfunction, abnormalities in the biliary pathway, when fusidic acid is given in high doses for prolonged periods, or when it is given in combination with other antibio Lestu allt skjalið
FUCIDIN® ANTISTAPHYLOCOCCAL ANTIBIOTIC BRAND NAME Fucidin® ACTIVE INGREDIENTS AND STRENGTH Tablets: Sodium fusidate 250 mg PRESENTATION The tablet is an approximately 7.8 x 16.0 mm white to off-white greyish marbled film-coated oval biconvex tablet without embossing. THERAPEUTIC PROPERTIES Properties: Fusidic acid is an antibiotic which mode of action is as inhibitor of the bacterial protein synthesis resulting in a bactericidal effect. Fusidic acid has a powerful antibacterial activity against a number of gram-positive microorganisms. Staphylococci, including the strains resistant to penicillin, methicillin or other antibiotics, are particularly susceptible to fusidic acid. Fusidic acid shows no cross-resistance to any other antibiotic agent used in clinical practice. Fucidin® tablets has an unusually good ability to penetrate tissue and is widely distributed in the organism. It is of great clinical importance that Fucidin® tablets provides high concentrations not only in areas well supplied with blood, but also in relatively avascular tissue. Concentrations exceeding the M.I.C. for Staphylococcus aureus (0.03-0.16 mcg/ml) have been found in pus, sputum, soft tissue, heart tissue, bone tissue, synovial fluid, sequestra, burn crusts, brain abscesses, and intraocularly. Fusidic acid is metabolized in the liver and mainly excreted through the bile, little or none being excreted through the urine. Fucidin® tablets are generally atoxic and shows no crosshypersensitivity to other antibiotics in clinical use which is why Fucidin® tablets also can be used in many cases where other antibiotics are contraindicated, e.g. in patients allergic to penicillin or other antibiotics. In severe or deep-seated infections and when prolonged therapy is required, Fucidin® tablets should generally be given concurrently with other antistaphylococcal antibiotic therapy to minimize the risk of resistance development. Fucidin® tablets may be combined with penicillinasestable penicillins, cephalosporins, erythromycin, aminoglycoside Lestu allt skjalið