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Indications/Uses
Use in inflammatory dermatoses where bacterial infection is present or likely to occur.
Dosage/Direction for Use
Apply a small quantity to the affected area twice daily until a satisfactory response is obtained. A single treatment course should not normally exceed 2 weeks.
Overdosage
For topically applied fusidic acid, no information concerning potential symptoms and signs due to overdose administration is available. Cushing's syndrome and adrenocortical insufficiency may develop following topical application of corticosteroids in large amounts and for more than three weeks.
Systemic consequences of an overdose of the active substances after accidental oral intake are unlikely to occur. The amount of fusidic acid in one tube of fusidic acid + betamethasone valerate (Fucicort) does not exceed the oral daily dose of systemic treatment. A single oral overdose of corticosteroids is rarely a clinical problem.
Systemic consequences of an overdose of the active substances after accidental oral intake are unlikely to occur. The amount of fusidic acid in one tube of fusidic acid + betamethasone valerate (Fucicort) does not exceed the oral daily dose of systemic treatment. A single oral overdose of corticosteroids is rarely a clinical problem.
Contraindications
Hypersensitivity to fusidic acid/sodium fusidate, betamethasone valerate or to any of the excipients.
Due to the content of corticosteroid, fusidic acid + betamethasone valerate (Fucicort) is contraindicated in the following conditions: Systemic fungal infections; Primary skin infections caused by fungi, virus or bacteria, either untreated or uncontrolled by appropriate treatment (see Precautions); Skin manifestations in relation to tuberculosis, either untreated or uncontrolled by appropriate therapy; Perioral dermatitis and rosacea.
Due to the content of corticosteroid, fusidic acid + betamethasone valerate (Fucicort) is contraindicated in the following conditions: Systemic fungal infections; Primary skin infections caused by fungi, virus or bacteria, either untreated or uncontrolled by appropriate treatment (see Precautions); Skin manifestations in relation to tuberculosis, either untreated or uncontrolled by appropriate therapy; Perioral dermatitis and rosacea.
Special Precautions
Long-term continuous topical therapy with fusidic acid + betamethasone valerate (Fucicort) should be avoided.
Depending on the application site, possible systemic absorption of betamethasone valerate should always be considered during treatment with fusidic acid + betamethasone valerate (Fucicort).
Due to the content of corticosteroid, fusidic acid + betamethasone valerate (Fucicort) should be used with care near the eyes. Avoid getting fusidic acid + betamethasone valerate (Fucicort) into the eyes (see Adverse Reactions).
Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur following systemic absorption of topical corticosteroids.
Fusidic acid + betamethasone valerate (Fucicort) should be used with care in children as paediatric patients may demonstrate greater susceptibility to topical corticosteroids-induced HPA axis suppression and Cushing's syndrome than adult patients. Avoid large amounts, occlusion and prolonged treatment (see Adverse Reactions).
Due to the content of betamethasone valerate, prolonged topical use of Fusidic acid + Betamethasone valerate (Fucicort) may cause skin atrophy.
Bacterial resistance has been reported to occur with the topical use of fusidic acid. As with all antibiotics, extended or recurrent use of fusidic acid may increase the risk of developing antibiotic resistance. Limiting therapy with topical fusidic acid and betamethasone valerate to no more than 14 days at a time will minimise the risk of developing resistance.
This also prevents the risk that the immunosuppressive action of corticosteroid might mask any potential symptoms of infections due to antibiotic-resistant bacteria.
Due to the content of corticosteroid having immunosuppressant effect, fusidic acid + betamethasone valerate (Fucicort) may be associated with increased susceptibility to infection, aggravation of existing infection, and activation of latent infection. It is advised to switch to systemic treatment if infection cannot be controlled with topical treatment (see Contraindications).
Fusidic acid + betamethasone valerate (Fucicort) cream contains cetostearyl alcohol and chlorocresol as excipients. Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis) and chlorocresol may cause allergic reactions.
Effects on the Ability to Drive and Use Machines: Fusidic acid + betamethasone valerate (Fucicort) has no or negligible influence on the ability to drive or to use machines.
Depending on the application site, possible systemic absorption of betamethasone valerate should always be considered during treatment with fusidic acid + betamethasone valerate (Fucicort).
Due to the content of corticosteroid, fusidic acid + betamethasone valerate (Fucicort) should be used with care near the eyes. Avoid getting fusidic acid + betamethasone valerate (Fucicort) into the eyes (see Adverse Reactions).
Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur following systemic absorption of topical corticosteroids.
Fusidic acid + betamethasone valerate (Fucicort) should be used with care in children as paediatric patients may demonstrate greater susceptibility to topical corticosteroids-induced HPA axis suppression and Cushing's syndrome than adult patients. Avoid large amounts, occlusion and prolonged treatment (see Adverse Reactions).
Due to the content of betamethasone valerate, prolonged topical use of Fusidic acid + Betamethasone valerate (Fucicort) may cause skin atrophy.
Bacterial resistance has been reported to occur with the topical use of fusidic acid. As with all antibiotics, extended or recurrent use of fusidic acid may increase the risk of developing antibiotic resistance. Limiting therapy with topical fusidic acid and betamethasone valerate to no more than 14 days at a time will minimise the risk of developing resistance.
This also prevents the risk that the immunosuppressive action of corticosteroid might mask any potential symptoms of infections due to antibiotic-resistant bacteria.
Due to the content of corticosteroid having immunosuppressant effect, fusidic acid + betamethasone valerate (Fucicort) may be associated with increased susceptibility to infection, aggravation of existing infection, and activation of latent infection. It is advised to switch to systemic treatment if infection cannot be controlled with topical treatment (see Contraindications).
Fusidic acid + betamethasone valerate (Fucicort) cream contains cetostearyl alcohol and chlorocresol as excipients. Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis) and chlorocresol may cause allergic reactions.
Effects on the Ability to Drive and Use Machines: Fusidic acid + betamethasone valerate (Fucicort) has no or negligible influence on the ability to drive or to use machines.
Use In Pregnancy & Lactation
Pregnancy: Fusidic acid: No effects during pregnancy are anticipated, since systemic exposure to fusidic acid is negligible.
Betamethasone valerate: There are no or limited amount of data from the use of topical betamethasone valerate in pregnant women. Studies in animals have shown reproductive toxicity. Fusidic acid + betamethasone valerate (Fucicort) should not be used during pregnancy unless the clinical condition of the woman requires treatment with fusidic acid and betamethasone valerate.
Breastfeeding: No effects on the breastfed newborn/infant are anticipated since the systemic exposure of topically applied fusidic acid and betamethasone valerate to a limited area of skin of the breastfeeding woman is negligible.
Fusidic acid + betamethasone valerate (Fucicort) can be used during breastfeeding but it is recommended to avoid applying fusidic acid + betamethasone valerate (Fucicort) on the breast.
Fertility: There are no clinical studies with fusidic acid + betamethasone valerate (Fucicort) regarding fertility.
Betamethasone valerate: There are no or limited amount of data from the use of topical betamethasone valerate in pregnant women. Studies in animals have shown reproductive toxicity. Fusidic acid + betamethasone valerate (Fucicort) should not be used during pregnancy unless the clinical condition of the woman requires treatment with fusidic acid and betamethasone valerate.
Breastfeeding: No effects on the breastfed newborn/infant are anticipated since the systemic exposure of topically applied fusidic acid and betamethasone valerate to a limited area of skin of the breastfeeding woman is negligible.
Fusidic acid + betamethasone valerate (Fucicort) can be used during breastfeeding but it is recommended to avoid applying fusidic acid + betamethasone valerate (Fucicort) on the breast.
Fertility: There are no clinical studies with fusidic acid + betamethasone valerate (Fucicort) regarding fertility.
Adverse Reactions
The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical studies and spontaneous reporting.
The most frequently reported adverse reaction during treatment is pruritus.
Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Very common ≥1/10; Common ≥1/100 and <1/10; Uncommon ≥1/1,000 and <1/100; Rare ≥1/10,000 and <1/1,000; Very rare <1/10,000. (See table.)
The most frequently reported adverse reaction during treatment is pruritus.
Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Very common ≥1/10; Common ≥1/100 and <1/10; Uncommon ≥1/1,000 and <1/100; Rare ≥1/10,000 and <1/1,000; Very rare <1/10,000. (See table.)
Systemic undesirable class effects of corticosteroids like betamethasone valerate include adrenal suppression especially during prolonged topical administration (see Precautions).
Raised intra-ocular pressure and glaucoma may also occur after topical use of corticosteroids near the eyes, particularly with prolonged use and in patients predisposed to developing glaucoma (see Precautions).
Dermatological undesirable class effects of potent corticosteroids include: Atrophy, dermatitis (incl. dermatitis contact and dermatitis acneiform), perioral dermatitis, skin striae, telangiectasia, rosacea, erythema, hypertrichosis, hyperhydrosis, and depigmentation.
Ecchymosis may also occur with prolonged use of topical corticosteroids.
Class effects for corticosteroids have been uncommonly reported for fusidic acid + betamethasone valerate (Fucicort) as described in the frequency table as previously mentioned.
Paediatric population: The observed safety profile is similar in children and adults (see Precautions).
Raised intra-ocular pressure and glaucoma may also occur after topical use of corticosteroids near the eyes, particularly with prolonged use and in patients predisposed to developing glaucoma (see Precautions).
Dermatological undesirable class effects of potent corticosteroids include: Atrophy, dermatitis (incl. dermatitis contact and dermatitis acneiform), perioral dermatitis, skin striae, telangiectasia, rosacea, erythema, hypertrichosis, hyperhydrosis, and depigmentation.
Ecchymosis may also occur with prolonged use of topical corticosteroids.
Class effects for corticosteroids have been uncommonly reported for fusidic acid + betamethasone valerate (Fucicort) as described in the frequency table as previously mentioned.
Paediatric population: The observed safety profile is similar in children and adults (see Precautions).
Caution For Usage
FOR EXTERNAL USE ONLY.
Instructions and Special Precautions for Handling and Disposal: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Instructions and Special Precautions for Handling and Disposal: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Storage
Store below 30°C.
Action
ATC Code: D07CC01.
Pharmacology: Pharmacodynamics: Fusidic acid + betamethasone valerate (Fucicort) Cream combines the potent topical antibacterial action of fusidic acid with the anti- inflammatory and antipruritic effects of betamethasone valerate.
Fusidic acid and its salts exhibit fat and water solubility properties with strong surface activity, and show unusual ability to penetrate intact skin. Concentrations of 0.03 - 0.12 mcg/ml inhibit nearly all strains of Staphylococcus aureus. Topical Fucidin is also active against Streptococci, Corynebacteria, Neisseria and certain Clostridia.
Betamethasone valerate is a potent topical corticosteroid rapidly effective in those inflammatory dermatoses which normally respond to this form of therapy.
Pharmacokinetics: There are no data which define the pharmacokinetics of Fusidic acid + betamethasone valerate (Fucicort) Cream, following topical administration in man.
However, in vitro studies show that fusidic acid can penetrate intact human skin. The degree of penetration depends on factors such as the duration of exposure to fusidic acid and the condition of the skin. Fusidic acid is excreted mainly in the bile with little excreted in the urine. Betamethasone is absorbed following topical administration. The degree of absorption is dependent on various factors including skin condition and site of application. Betamethasone is metabolised largely in the liver but also to a limited extent in the kidneys, and the inactive metabolites are excreted with the urine.
Pharmacology: Pharmacodynamics: Fusidic acid + betamethasone valerate (Fucicort) Cream combines the potent topical antibacterial action of fusidic acid with the anti- inflammatory and antipruritic effects of betamethasone valerate.
Fusidic acid and its salts exhibit fat and water solubility properties with strong surface activity, and show unusual ability to penetrate intact skin. Concentrations of 0.03 - 0.12 mcg/ml inhibit nearly all strains of Staphylococcus aureus. Topical Fucidin is also active against Streptococci, Corynebacteria, Neisseria and certain Clostridia.
Betamethasone valerate is a potent topical corticosteroid rapidly effective in those inflammatory dermatoses which normally respond to this form of therapy.
Pharmacokinetics: There are no data which define the pharmacokinetics of Fusidic acid + betamethasone valerate (Fucicort) Cream, following topical administration in man.
However, in vitro studies show that fusidic acid can penetrate intact human skin. The degree of penetration depends on factors such as the duration of exposure to fusidic acid and the condition of the skin. Fusidic acid is excreted mainly in the bile with little excreted in the urine. Betamethasone is absorbed following topical administration. The degree of absorption is dependent on various factors including skin condition and site of application. Betamethasone is metabolised largely in the liver but also to a limited extent in the kidneys, and the inactive metabolites are excreted with the urine.
MedsGo Class
Topical Anti-Infectives with Corticosteroids
Features
Brand
Fucicort
Full Details
Dosage Strength
20mg / 1mg per g
Drug Ingredients
- Betamethasone
- Fusidic Acid
Drug Packaging
Cream 5g
Generic Name
Fusidic Acid / Betamethasone Valerate
Dosage Form
Cream
Registration Number
DR-XY2673
Drug Classification
Prescription Drug (RX)