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Components:
Betamethasone Dipropionate, Fusidic Acid
Method of action:
Antibacterial Local, Corticosteroids, Dermatological Preparations, Glucocorticoid
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Medically reviewed by Oliinyk Elizabeth Ivanovna, Pharmacy. Last updated on 2019.09.18

Name of the medicinal product

Acifusin B

Qualitative and quantitative composition

Betamethasone Dipropionate; Fusidic Acid

Therapeutic indications

The information provided in Therapeutic indications of Acifusin B is based on data of another medicine with exactly the same composition as the Acifusin B of the medicine (Betamethasone Dipropionate, Fusidic Acid). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Acifusin B directly from the package or from the pharmacist at the pharmacy.
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Acifusin B Lipid cream is indicated for the treatment of eczematous dermatoses including atopic eczema, discoid eczema, stasis eczema and seborrhoeic eczema when secondary bacterial infection is confirmed or suspected.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Acifusin B is based on data of another medicine with exactly the same composition as the Acifusin B of the medicine (Betamethasone Dipropionate, Fusidic Acid). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Acifusin B directly from the package or from the pharmacist at the pharmacy.
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Posology

Adults and children aged 6 years and over:

A small quantity should be applied to the affected area twice daily until a satisfactory response is obtained. A single treatment course should not normally exceed 2 weeks. In the more resistant lesions the effect of Acifusin B Lipid cream can be enhanced by occlusion with polythene film. Overnight occlusion is usually adequate.

Method of administration

Cutaneous use.

Contraindications

The information provided in Contraindications of Acifusin B is based on data of another medicine with exactly the same composition as the Acifusin B of the medicine (Betamethasone Dipropionate, Fusidic Acid). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Acifusin B directly from the package or from the pharmacist at the pharmacy.
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Due to the content of corticosteroid, Acifusin B 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.

Skin manifestations in relation to tuberculosis or syphilis, either untreated or uncontrolled by appropriate therapy.

Perioral dermatitis and rosacea.

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Acifusin B is based on data of another medicine with exactly the same composition as the Acifusin B of the medicine (Betamethasone Dipropionate, Fusidic Acid). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Acifusin B directly from the package or from the pharmacist at the pharmacy.
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Long-term continuous topical therapy with Acifusin B should be avoided.

Depending on the application site, possible systemic absorption of betamethasone valerate should always be considered during treatment with Acifusin B.

Due to the content of corticosteroid, Acifusin B should be used with care near the eyes. Avoid getting Acifusin B into the eyes.

Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur following systemic absorption of topical corticosteroids.

Acifusin B 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.

Due to the content of betamethasone valerate, prolonged topical use of Acifusin B 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 application 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, Acifusin B 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.

Acifusin B Lipid cream contains methyl and propyl parahydroxybenzoate (E218 and E216), cetostearyl alcohol and potassium sorbate as excipients. Methyl and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed). Potassium sorbate and cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Acifusin B is based on data of another medicine with exactly the same composition as the Acifusin B of the medicine (Betamethasone Dipropionate, Fusidic Acid). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Acifusin B directly from the package or from the pharmacist at the pharmacy.
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Acifusin B Lipid cream has no or negligible influence on the ability to drive or to use machines.

Undesirable effects

The information provided in Undesirable effects of Acifusin B is based on data of another medicine with exactly the same composition as the Acifusin B of the medicine (Betamethasone Dipropionate, Fusidic Acid). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Acifusin B directly from the package or from the pharmacist at the pharmacy.
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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

Immune system disorders

Uncommon:

(>1/1,000 and <1/100)

Hypersensitivity

Skin and subcutaneous tissue disorders

Uncommon:

(>1/1,000 and <1/100)

Dermatitis contact

Eczema (condition aggravated)

Skin burning sensation

Pruritus

Dry skin

Rare:

(>1/10,000 and <1/1,000)

Erythema

Urticaria

Rash (including rash erythematous and rash generalised)

General disorders and administration site conditions

Uncommon:

(>1/1,000 and <1/100)

Application site pain

Application site irritation

Rare:

(>1/10,000 and <1/1,000)

Application site swelling

Application site vesicles

Systemic undesirable class effects of corticosteroids like betamethasone valerate include adrenal suppression especially during prolonged topical administration.

Raised intra-ocular pressure, glaucoma and cataract may also occur after topical use of corticosteroids near the eyes, particularly with prolonged use and in patients predisposed to developing glaucoma and cataract.

Dermatological undesirable class effects of potent corticosteroids include: Atrophy, dermatitis (including 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 Acifusin B as described in the frequency table above.

Paediatric population

The observed safety profile is similar in children and adults.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Overdose

The information provided in Overdose of Acifusin B is based on data of another medicine with exactly the same composition as the Acifusin B of the medicine (Betamethasone Dipropionate, Fusidic Acid). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Acifusin B directly from the package or from the pharmacist at the pharmacy.
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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 3 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 Acifusin B does not exceed the oral daily dose of systemic treatment. A single oral overdose of corticosteroids is rarely a clinical problem.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Acifusin B is based on data of another medicine with exactly the same composition as the Acifusin B of the medicine (Betamethasone Dipropionate, Fusidic Acid). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Acifusin B directly from the package or from the pharmacist at the pharmacy.
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ATC code: D07CC01

Pharmacotherapeutic group: Betamethasone and antibiotics.

Acifusin B Lipid cream combines the well-known anti-inflammatory and antipruritic effects of betamethasone with the potent topical antibacterial action of fusidic acid. Betamethasone valerate is a topical steroid rapidly effective in those inflammatory dermatoses which normally respond to this form of therapy. More refractory conditions can often be treated successfully. When applied topically, fusidic acid is effective against Staphyloccus aureus, Streptococci, Corynebacteria, Neisseria and certain Clostridia and Bacteroides. Concentrations of 0.03 to 0.12 microgram per ml inhibit nearly all strains of S. aureus. The antibacterial activity of fusidic acid is not diminished in the presence of betamethasone.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Acifusin B is based on data of another medicine with exactly the same composition as the Acifusin B of the medicine (Betamethasone Dipropionate, Fusidic Acid). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Acifusin B directly from the package or from the pharmacist at the pharmacy.
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There are no data which define the pharmacokinetics of Acifusin B Lipid 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.

Pharmacotherapeutic group

The information provided in Pharmacotherapeutic group of Acifusin B is based on data of another medicine with exactly the same composition as the Acifusin B of the medicine (Betamethasone Dipropionate, Fusidic Acid). Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Acifusin B directly from the package or from the pharmacist at the pharmacy.
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Betamethasone and antibiotics.

Preclinical safety data

The information provided in Preclinical safety data of Acifusin B is based on data of another medicine with exactly the same composition as the Acifusin B of the medicine (Betamethasone Dipropionate, Fusidic Acid). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Acifusin B directly from the package or from the pharmacist at the pharmacy.
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Studies of corticosteroids in animals have shown reproductive toxicity (e.g. cleft palate, skeletal malformations, low birth weight).

Incompatibilities

The information provided in Incompatibilities of Acifusin B is based on data of another medicine with exactly the same composition as the Acifusin B of the medicine (Betamethasone Dipropionate, Fusidic Acid). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Acifusin B directly from the package or from the pharmacist at the pharmacy.
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Not applicable.

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Acifusin B is based on data of another medicine with exactly the same composition as the Acifusin B of the medicine (Betamethasone Dipropionate, Fusidic Acid). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Acifusin B directly from the package or from the pharmacist at the pharmacy.
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No special requirements for disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.