FUCIDIN Sodium Fusidate 250mg Film-Coated Tablet 1's
RXDRUG-DR-1168-1pc
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Fucidin tablets and Fucidin suspension are indicated for the treatment of infections caused by susceptible organisms, especially staphylococci, e.g. osteomyelitis, septicaemia, endocarditis, superinfected cystic fibrosis, pneumonia, skin and soft tissue infections, surgical and traumatic wound infections.
Dosage/Direction for Use
Fucidin Tablet: Adults and children over 12 years: 500 mg (2 tablets) three times daily.
Recommended dosage in skin and soft tissue infections: 250 mg sodium fusidate (1 tablet) twice daily. Dosage may be doubled in severe cases. According to the metabolism and excretion of systemic sodium fusidate (Fucidin), no dosage adjustment is needed in renal impairment or in patients undergoing haemodialysis as fusidic acid is not significantly dialysed.
Fucidin Suspension: Children and infants: 1 ml of suspension (50 mg) per kg body weight daily divided into 3 equal doses.
1-5 years: 5 ml 3 times daily.
5-12 years: 10 ml 3 times daily.
Adult dose: 15 ml 3 times daily.
Recommended dosage in skin and soft tissue infections: 250 mg sodium fusidate (1 tablet) twice daily. Dosage may be doubled in severe cases. According to the metabolism and excretion of systemic sodium fusidate (Fucidin), no dosage adjustment is needed in renal impairment or in patients undergoing haemodialysis as fusidic acid is not significantly dialysed.
Fucidin Suspension: Children and infants: 1 ml of suspension (50 mg) per kg body weight daily divided into 3 equal doses.
1-5 years: 5 ml 3 times daily.
5-12 years: 10 ml 3 times daily.
Adult dose: 15 ml 3 times daily.
Overdosage
Acute symptoms of overdose include gastrointestinal disturbances. Management should be directed towards alleviation of symptoms. Dialysis will not increase the clearance of fusidic acid.
An overdose of 4 g/day for a duration of ten days in an adult has been reported without any adverse events.
An overdose of 1,250 mg/day for a duration of seven days in a child (three years old) has been reported without any adverse events.
An overdose of 4 g/day for a duration of ten days in an adult has been reported without any adverse events.
An overdose of 1,250 mg/day for a duration of seven days in a child (three years old) has been reported without any adverse events.
Administration
Should be taken with food.
Contraindications
Hypersensitivity to the active substance or to any of the excipients. Concomitant treatment with statins (HMG-CoA reductase inhibitors). (See Precautions and Interactions.)
Special Precautions
Statins (HMG-CoA reductase inhibitors) and systemic Fucidin must not be co-administered, (see Contraindications). There have been reports of rhabdomyolysis (including fatalities) in patients receiving this combination. Statin treatment should be discontinued throughout the duration of treatment with systemic Fucidin. The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness. Statin therapy may be re-introduced seven days after the last dose of systemic Fucidin. In exceptional circumstances, where prolonged systemic Fucidin is needed, e.g. for the treatment of severe infections, the need for co-administration of HMG-CoA reductase inhibitors and systemic Fucidin should only be considered on a case by case basis and under close medical supervision.
Fusidic acid is metabolised in the liver and excreted in the bile. Elevated liver enzymes and jaundice have occurred during systemic Fucidin therapy but are usually reversible on discontinuation of the drug.
Systemic Fucidin should be given with caution and liver function should be monitored if used in patients with hepatic dysfunction. Caution is required in patients with biliary disease and biliary tract obstruction. Caution is required in patients treated with HIV-protease inhibitors (See Interactions). Fusidic acid competitively inhibits binding of bilirubin to albumin. Caution is necessary if systemic Fucidin is administered to patients with impaired transport and metabolism of bilirubin. Particular care is advised in neonates due to the theoretical risk of kernicterus. Bacterial resistance has been reported to occur with the use of fusidic acid. As with all antibiotics, extended or recurrent use may increase the risk of developing antibiotic resistance.
Fucidin Tablet: In a few cases, serious cutaneous reactions putting life at risk such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, toxic epidermal necrolysis (Lyell's syndrome) and Stevens-Johnson syndrome have been reported with systemic Sodium fusidate (Fucidin).
Patients should be advised to monitor cutaneous reactions as well as signs and symptoms suggestive of these reactions which usually appear in the first weeks of therapy. If such reactions are suspected to be due to systemic Sodium fusidate (Fucidin), treatment with systemic Sodium fusidate (Fucidin) should be stopped and it is recommended not to reintroduce the therapy.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine due to the content of lactose.
Fucidin Suspension: For Fucidin oral suspension only: Patients with rare hereditary problems of fructose intolerance should not take this medicine due to its content of sorbitol (E420).
Patients with rare glucose-galactose malabsorption should not take this medicine due to its content of glucose.
Fusidic acid is metabolised in the liver and excreted in the bile. Elevated liver enzymes and jaundice have occurred during systemic Fucidin therapy but are usually reversible on discontinuation of the drug.
Systemic Fucidin should be given with caution and liver function should be monitored if used in patients with hepatic dysfunction. Caution is required in patients with biliary disease and biliary tract obstruction. Caution is required in patients treated with HIV-protease inhibitors (See Interactions). Fusidic acid competitively inhibits binding of bilirubin to albumin. Caution is necessary if systemic Fucidin is administered to patients with impaired transport and metabolism of bilirubin. Particular care is advised in neonates due to the theoretical risk of kernicterus. Bacterial resistance has been reported to occur with the use of fusidic acid. As with all antibiotics, extended or recurrent use may increase the risk of developing antibiotic resistance.
Fucidin Tablet: In a few cases, serious cutaneous reactions putting life at risk such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, toxic epidermal necrolysis (Lyell's syndrome) and Stevens-Johnson syndrome have been reported with systemic Sodium fusidate (Fucidin).
Patients should be advised to monitor cutaneous reactions as well as signs and symptoms suggestive of these reactions which usually appear in the first weeks of therapy. If such reactions are suspected to be due to systemic Sodium fusidate (Fucidin), treatment with systemic Sodium fusidate (Fucidin) should be stopped and it is recommended not to reintroduce the therapy.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine due to the content of lactose.
Fucidin Suspension: For Fucidin oral suspension only: Patients with rare hereditary problems of fructose intolerance should not take this medicine due to its content of sorbitol (E420).
Patients with rare glucose-galactose malabsorption should not take this medicine due to its content of glucose.
Use In Pregnancy & Lactation
Pregnancy: There are no or limited data (less than 300 pregnancy outcomes) from the use of fusidic acid in pregnant women. Animal studies do not indicate direct or indirect harmful effect with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of systemic Fucidin during pregnancy.
Breast-feeding: Physico-chemical data suggest excretion of fusidic acid in human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from systemic Fucidin therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility: There are no clinical studies with systemic Fucidin regarding fertility. Pre-clinical studies did not show any effect of sodium fusidate on the fertility in rats.
Breast-feeding: Physico-chemical data suggest excretion of fusidic acid in human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from systemic Fucidin therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility: There are no clinical studies with systemic Fucidin regarding fertility. Pre-clinical studies did not show any effect of sodium fusidate on the fertility in rats.
Adverse Reactions
The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical trials and from spontaneous reporting.
The most frequently reported undesirable effects of Fucidin administered orally are gastrointestinal disorders like abdominal discomfort and pain, diarrhoea, dyspepsia, nausea and vomiting. Anaphylactic shock has been reported.
Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported. Within each frequency group, adverse reactions are presented in the order of decreasing seriousness. Very common (≥1/10); Common (≥1/100 to < 1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); *Not known (cannot be estimated from available data). (See Table 2.)
*For Fucidin Tablet only.
The most frequently reported undesirable effects of Fucidin administered orally are gastrointestinal disorders like abdominal discomfort and pain, diarrhoea, dyspepsia, nausea and vomiting. Anaphylactic shock has been reported.
Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported. Within each frequency group, adverse reactions are presented in the order of decreasing seriousness. Very common (≥1/10); Common (≥1/100 to < 1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); *Not known (cannot be estimated from available data). (See Table 2.)
*For Fucidin Tablet only.
Paediatric population: Frequency, type and severity of adverse reactions in children are expected to be the same as in adults, based on limited data.
Drug Interactions
Statins (HMG-CoA reductase inhibitors): Concomitant treatment with statins (HMG-CoA reductase inhibitors) is contraindicated.
Co-administration of systemic Fucidin and statins may cause possibly fatal rhabdomyolysis. Treatment with statins should therefore be discontinued throughout the duration of the treatment with systemic Fucidin. Statin therapy may be reintroduced seven days after the last dose of systemic Fucidin. (See Precautions, Contraindications).
Oral anticoagulants: Systemic Fucidin administered concomitantly with oral anticoagulants such as coumarin derivatives or anticoagulants with similar actions may alter the anticoagulant effect. Adjustment of the oral anticoagulant dose may be necessary in order to maintain the desired level of anticoagulation.
HIV protease inhibitors: Co-administration of systemic Fucidin and HIV protease inhibitors such as ritonavir and saquinavir may cause increased plasma concentrations of both agents which may result in hepatotoxicity.
Concomitant use is not recommended. (See Precautions.)
Co-administration of systemic Fucidin and statins may cause possibly fatal rhabdomyolysis. Treatment with statins should therefore be discontinued throughout the duration of the treatment with systemic Fucidin. Statin therapy may be reintroduced seven days after the last dose of systemic Fucidin. (See Precautions, Contraindications).
Oral anticoagulants: Systemic Fucidin administered concomitantly with oral anticoagulants such as coumarin derivatives or anticoagulants with similar actions may alter the anticoagulant effect. Adjustment of the oral anticoagulant dose may be necessary in order to maintain the desired level of anticoagulation.
HIV protease inhibitors: Co-administration of systemic Fucidin and HIV protease inhibitors such as ritonavir and saquinavir may cause increased plasma concentrations of both agents which may result in hepatotoxicity.
Concomitant use is not recommended. (See Precautions.)
Caution For Usage
Fucidin Tablet: Instructions and Special Precautions for Handling and Disposal: No special requirements.
Fucidin Suspension: Incompatibilities: Not applicable.
Special Precautions for disposal and other handling: Shake well before use. No special requirement for disposal. Any unused product or waste material should be disposed of in accordance with local requirements.
Fucidin Suspension: Incompatibilities: Not applicable.
Special Precautions for disposal and other handling: Shake well before use. No special requirement for disposal. Any unused product or waste material should be disposed of in accordance with local requirements.
Storage
Store at temperatures not exceeding 30°C.
Shelf-life: Three years.
Shelf-life: Three years.
Action
Pharmacotherapeutic group: Steroid antibacterials. ATC code: J01XC01.
Pharmacology: Pharmacodynamics: Fucidin Tablet: Sodium fusidate is an antibiotic, of steroid structure, belonging to the fusidanine group.
Antibacterial Activity Spectrum: The critical concentrations separate susceptible from intermediately susceptible organisms and the latter from resistant ones: S≤ 2 mg/l and R> 16 mg/l.
Prevalence of acquired resistance can vary according to the geography and with time for certain species. It's useful to have information on prevalence of the local resistance, particularly when for the treatment severe infections. This information gives only an approximate guidance on probabilities whether microorganisms will be susceptible to this antibiotic or not.
When variability of the prevalence of resistance in France in known for an organism, it is reported in the following table: See Table 1.
Pharmacology: Pharmacodynamics: Fucidin Tablet: Sodium fusidate is an antibiotic, of steroid structure, belonging to the fusidanine group.
Antibacterial Activity Spectrum: The critical concentrations separate susceptible from intermediately susceptible organisms and the latter from resistant ones: S≤ 2 mg/l and R> 16 mg/l.
Prevalence of acquired resistance can vary according to the geography and with time for certain species. It's useful to have information on prevalence of the local resistance, particularly when for the treatment severe infections. This information gives only an approximate guidance on probabilities whether microorganisms will be susceptible to this antibiotic or not.
When variability of the prevalence of resistance in France in known for an organism, it is reported in the following table: See Table 1.
Fucidin Suspension: Fucidin exerts powerful activity against a number of gram-positive organisms. Staphylococci, including the strains resistant to penicillin and other antibiotics, are particularly susceptible to Fucidin. Concentrations of 0.03-0.12 mcg/ml inhibit nearly all strains of Staphylococcus aureus.
Pharmacokinetics: Fucidin Tablet: Absorption: Absorption is rapid following oral administration (by the 1st hour) and more than 90% of sodium fusidate is absorbed.
Distribution: Following single oral administration of 500 mg of sodium fusidate, maximum serum concentration is of the order of 30 mg/l on average at the 2nd hour. Mean serum half- life is 16 ± 3 hours.
Following repeated doses of 1.5 g/day, serum levels obtained gradually increase to reach steady state of between 50 and 100 mg/l, 8 hours after the last dose.
Ketofusidate, a metabolite which is only slightly active from a microbiological standpoint, is found in blood at levels equivalent to 10 to 15% of fusidic acid levels.
Humoral and tissue spread: Half of all fusidic acid is found in the peripheral compartment, indicating that about 50% of fusidic acid is distributed in tissues. It spreads through the majority of tissues, even those with a poor blood supply.
It is found in the skin (subcutaneous fat, crusts of burns), aseptic or infected bone (by way of an indication, mean levels in infected bone reach 7.5 μg/kg on the 8th day of treatment at the daily dosage of 1.5 g/day), in infected connective tissue, synovium, hepatobiliary secretions, bronchial secretions, mucus, the eye (aqueous humor or vitreous humor) and in pus regardless of the amount or its site (in particular intracranial pus).
Plasma protein binding is more than 90%.
Biotransformation: 95% is excreted in inactive (metabolized) form in bile. Seven metabolites have been detected, three of which, accounting for about 30% of the total, still have antibacterial activity, though less than that of fusidic acid.
Excretion: Fusidic acid is mainly eliminated in bile and is subject to an enterohepatic cycle. In contrast, urinary elimination is virtually nil, accounting for less than 1%.
Fucidin Suspension: Fucidin readily penetrates the central nervous system when the meninges are inflamed and is widely distributed in the body. Bactericidal levels have been assayed in bone and necrotic tissue. Blood levels are cumulative, reaching concentrations of 50-100 mcg/ml after oral administration of 1.5 g daily for 3 to 4 days. Fucidin is excreted mainly in the bile, little or none being excreted in the urine.
Toxicology: Preclinical Safety data: Fucidin Suspension: There are no preclinical data of relevance to the prescriber which are additional to that already included in other areas of the SPC.
Pharmacokinetics: Fucidin Tablet: Absorption: Absorption is rapid following oral administration (by the 1st hour) and more than 90% of sodium fusidate is absorbed.
Distribution: Following single oral administration of 500 mg of sodium fusidate, maximum serum concentration is of the order of 30 mg/l on average at the 2nd hour. Mean serum half- life is 16 ± 3 hours.
Following repeated doses of 1.5 g/day, serum levels obtained gradually increase to reach steady state of between 50 and 100 mg/l, 8 hours after the last dose.
Ketofusidate, a metabolite which is only slightly active from a microbiological standpoint, is found in blood at levels equivalent to 10 to 15% of fusidic acid levels.
Humoral and tissue spread: Half of all fusidic acid is found in the peripheral compartment, indicating that about 50% of fusidic acid is distributed in tissues. It spreads through the majority of tissues, even those with a poor blood supply.
It is found in the skin (subcutaneous fat, crusts of burns), aseptic or infected bone (by way of an indication, mean levels in infected bone reach 7.5 μg/kg on the 8th day of treatment at the daily dosage of 1.5 g/day), in infected connective tissue, synovium, hepatobiliary secretions, bronchial secretions, mucus, the eye (aqueous humor or vitreous humor) and in pus regardless of the amount or its site (in particular intracranial pus).
Plasma protein binding is more than 90%.
Biotransformation: 95% is excreted in inactive (metabolized) form in bile. Seven metabolites have been detected, three of which, accounting for about 30% of the total, still have antibacterial activity, though less than that of fusidic acid.
Excretion: Fusidic acid is mainly eliminated in bile and is subject to an enterohepatic cycle. In contrast, urinary elimination is virtually nil, accounting for less than 1%.
Fucidin Suspension: Fucidin readily penetrates the central nervous system when the meninges are inflamed and is widely distributed in the body. Bactericidal levels have been assayed in bone and necrotic tissue. Blood levels are cumulative, reaching concentrations of 50-100 mcg/ml after oral administration of 1.5 g daily for 3 to 4 days. Fucidin is excreted mainly in the bile, little or none being excreted in the urine.
Toxicology: Preclinical Safety data: Fucidin Suspension: There are no preclinical data of relevance to the prescriber which are additional to that already included in other areas of the SPC.
MedsGo Class
Other Antibiotics
Features
Brand
Fucidin
Full Details
Dosage Strength
250mg
Drug Ingredients
- Fusidate
Drug Packaging
Film-Coated Tablet 1's
Generic Name
Sodium Fusidate
Dosage Form
Film-Coated Tablet
Registration Number
DR-1168
Drug Classification
Prescription Drug (RX)
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