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Indications/Uses
Fusidic acid and hydrocortisone acetate (Fucidin H) Cream is indicated for the treatment of dermatitis, including atopic dermatitis and contact dermatitis, where an infection with bacteria sensitive to fusidic acid is suspected or confirmed. Because of its hydrocortisone content, Fucidin H Cream is particularly appropriate in cases where a milder corticosteroid is indicated, including milder inflammatory dermatoses - on the face and on children's skin.
Fucidin H Cream is cosmetically acceptable for use on the face and hands and convenient for use in the groin area and armpits.
Fucidin H Cream is cosmetically acceptable for use on the face and hands and convenient for use in the groin area and armpits.
Dosage/Direction for Use
Apply the cream three times daily for up to 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 adrenocorticalin-sufficiency 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 Fucidin H 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 Fucidin H 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, hydrocortisone acetate or to any of the excipients listed previously (see Description).
Due to the content of corticosteroid, Fucidin H is contraindicated in the following conditions: 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, Fucidin H is contraindicated in the following conditions: 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 Fucidin H cream should be avoided.
Depending on the application site, possible systemic absorption of hydrocortisone acetate should always be considered during treatment with Fucidin H.
Due to the content of corticosteroid, Fucidin H should be used with care near the eyes.
Avoid getting Fucidin H into the eyes (see Adverse Reactions).
Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur following systemic absorption of topical corticosteroids.
Fucidin H should be used with care in children as paediatric patients may be more susceptible to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than adult patients (see Adverse Reactions).
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 hydrocortisone acetate 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 immunosuppressant effect of corticosteroids, Fucidin H may be associated with increased susceptibility to infection, aggravation of existing infection, and activation of latent infection. It is advised to switch to systemic therapy if infection cannot be controlled with topical treatment (see Contraindications).
Fucidin H cream contains butyl hydroxyanisole, cetyl alcohol and potassium sorbate.
These excipients may cause local skin reactions (e.g. contact dermatitis). Butyl hydroxyanisole may also cause irritation to the eyes and mucous membranes.
Effects on Ability to Drive and Use Machines: Fucidin H has no or negligible influence on the ability to drive or to use machines.
Depending on the application site, possible systemic absorption of hydrocortisone acetate should always be considered during treatment with Fucidin H.
Due to the content of corticosteroid, Fucidin H should be used with care near the eyes.
Avoid getting Fucidin H into the eyes (see Adverse Reactions).
Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur following systemic absorption of topical corticosteroids.
Fucidin H should be used with care in children as paediatric patients may be more susceptible to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than adult patients (see Adverse Reactions).
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 hydrocortisone acetate 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 immunosuppressant effect of corticosteroids, Fucidin H may be associated with increased susceptibility to infection, aggravation of existing infection, and activation of latent infection. It is advised to switch to systemic therapy if infection cannot be controlled with topical treatment (see Contraindications).
Fucidin H cream contains butyl hydroxyanisole, cetyl alcohol and potassium sorbate.
These excipients may cause local skin reactions (e.g. contact dermatitis). Butyl hydroxyanisole may also cause irritation to the eyes and mucous membranes.
Effects on Ability to Drive and Use Machines: Fucidin H 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.
Hydrocortisone acetate: A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicates no malformative nor feto/neonatal toxicity of corticosteroids. Fucidin H can be used during pregnancy if clinically needed. However, based on a general knowledge about systemic corticosteroids, caution should be exercised when using Fucidin H during pregnancy.
Topical corticosteroids should not be used extensively, in large amounts or for prolonged periods in pregnant patients, as fetal abnormalities have been seen in animals due to systemic absorption.
Breastfeeding: No effects on the breastfed new-born/infant are anticipated since the systemic exposure of topically applied fusidic acid/hydrocortisone acetate to a limited area of skin of the breastfeeding woman is negligible.
Fucidin H can be used during breastfeeding but it is recommended to avoid applying Fucidin H on the breast.
Fertility: There are no clinical studies with Fucidin H regarding fertility.
Hydrocortisone acetate: A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicates no malformative nor feto/neonatal toxicity of corticosteroids. Fucidin H can be used during pregnancy if clinically needed. However, based on a general knowledge about systemic corticosteroids, caution should be exercised when using Fucidin H during pregnancy.
Topical corticosteroids should not be used extensively, in large amounts or for prolonged periods in pregnant patients, as fetal abnormalities have been seen in animals due to systemic absorption.
Breastfeeding: No effects on the breastfed new-born/infant are anticipated since the systemic exposure of topically applied fusidic acid/hydrocortisone acetate to a limited area of skin of the breastfeeding woman is negligible.
Fucidin H can be used during breastfeeding but it is recommended to avoid applying Fucidin H on the breast.
Fertility: There are no clinical studies with Fucidin H regarding fertility.
Adverse Reactions
The estimation of the frequency of adverse reactions is based on a pooled analysis of data from clinical studies and spontaneous reporting.
The most frequently reported adverse reactions during treatment are application site reactions including pruritus, burning and irritation.
Adverse reactions are listed by MedDRA system organ class (SOC) and the individual-adverse reactions 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 mild corticosteroids, like hydrocortisone, 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 mild corticosteroids like hydrocortisone include: Atrophy, dermatitis (incl. dermatitis contact, dermatitis acneiform and perioral dermatitis), skin striae, telangiectasia, rosacea, erythema, depigmentation, hypertrichosis and hyperhidrosis. Ecchymosis may also occur with prolonged use of topical corticosteroids.
Class effects for corticosteroids have been uncommonly reported for Fucidin H as described in the frequency table as previously mentioned.
Paediatric population: The observed safety profile is similar in children and adults (see Precautions).
The most frequently reported adverse reactions during treatment are application site reactions including pruritus, burning and irritation.
Adverse reactions are listed by MedDRA system organ class (SOC) and the individual-adverse reactions 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 mild corticosteroids, like hydrocortisone, 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 mild corticosteroids like hydrocortisone include: Atrophy, dermatitis (incl. dermatitis contact, dermatitis acneiform and perioral dermatitis), skin striae, telangiectasia, rosacea, erythema, depigmentation, hypertrichosis and hyperhidrosis. Ecchymosis may also occur with prolonged use of topical corticosteroids.
Class effects for corticosteroids have been uncommonly reported for Fucidin H 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
Instructions and Special Precautions for Handling and Disposal: No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Storage
To be stored up to 3 years at temperatures not exceeding 25°C.
Action
Pharmacotherapeutic Group: Corticosteroids, weak, combinations with antibiotics. ATC code: D07 CA01.
Pharmacology: Pharmacodynamics and Pharmacokinetics: Fucidin H Cream combines the potent topical antibacterial action of fusidic acid with the anti-inflammatory and antipruritic effects of hydrocortisone. 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.
There are no data which define the pharmacokinetics of Fucidin H 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. Hydrocortisone is absorbed following topical administration. The degree of absorption is dependent on various factors including skin condition and site of application. Absorbed hydrocortisone is extensively metabolised and rapidly eliminated in the urine.
Properties: Fucidin H Cream combines the antibacterial action of fusidic acid with the anti- inflammatory effect of hydrocortisone acetate.
Pharmacology: Pharmacodynamics and Pharmacokinetics: Fucidin H Cream combines the potent topical antibacterial action of fusidic acid with the anti-inflammatory and antipruritic effects of hydrocortisone. 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.
There are no data which define the pharmacokinetics of Fucidin H 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. Hydrocortisone is absorbed following topical administration. The degree of absorption is dependent on various factors including skin condition and site of application. Absorbed hydrocortisone is extensively metabolised and rapidly eliminated in the urine.
Properties: Fucidin H Cream combines the antibacterial action of fusidic acid with the anti- inflammatory effect of hydrocortisone acetate.
MedsGo Class
Topical Anti-Infectives with Corticosteroids
Features
Brand
FUCIDIN H
Full Details
Dosage Strength
20mg / 10mg per g
Drug Ingredients
- Fusidic Acid
- Hydrocortisone
Drug Packaging
Cream 5g
Generic Name
Fusidic Acid / Hydrocortisone
Dosage Form
Cream
Registration Number
DR-XY26102
Drug Classification
Prescription Drug (RX)