Drugs List

Therapeutic Indications

Uses

Inflammatory skin conditions responsive to corticosteroid and antimicrobial

Contraindications

Syphilis
Uncontrolled systemic infection
Acne vulgaris
Perioral dermatitis
Pregnancy
Rosacea
Skin infection
Tuberculosis

Precautions and Warnings

Children under 6 years

May mask symptoms or signs of infections
Exclude fungal infection before treatment
Exclude tubercular infection before treatment
Exclude viral infection before treatment
Not all available brands are licensed for all age groups
Avoid contact with eyes
Risk of glaucoma if preparation enters eye
Adrenal suppression may occur even without occlusion
Prolonged use may cause atrophic skin changes
Discontinue if hypersensitivity reactions occur
Avoid long term continuous therapy
Each course of treatment should not exceed 14 days
Advise patient residue on clothing/bedding may cause fire hazard
Fire hazard: Keep away from naked flames and potential sources of ignition
Nappy may act as an occlusive dressing

Bacterial resistance has been reported with the use of fusidic acid. Extended or recurrent applications may increase the risk of developing antibiotic resistance.

Occult extension of the infection may occur due to the masking of the steroid.

If the infection persists, systemic therapy may be required.

The steroid component of the cream may mask hypersensitivity reactions.

Pregnancy and Lactation

Pregnancy

Betamethasone with fusidic is contraindicated in pregnancy.

Betamethasone valerate
Topical application of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such effects in the human foetus but the relevance of this study has not been established in humans. Nevertheless, topical corticosteroids with the exception of very potent steroids can be used relatively safely in pregnancy (Schaefer, 2007).

Fusidic acid
At the time of writing no effects during pregnancy are anticipated, since systemic exposure to fusidic acid is negligible. Studies in animals have not shown teratogenic effects with fusidic acid. Limited studies in animals have shown negligible systemic absorption of topical fusidic acid.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Betamethasone with fusidic acid is considered safe for use in breastfeeding.

At the time of no effects on the infant are anticipated since the systemic exposure to the breastfeeding woman to fusidic acid and betamethasone is negligible. Fusidic acid with betamethasone should not be applied on the breasts to avoid accidental ingestion by the infant.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Acne (at application site)
Adrenal suppression
Allergic reaction
Burning sensation (local)
Contact dermatitis
Dry skin
Erythema
Exacerbation of acne
Exacerbation of pre-existing eczema
Folliculitis
Glaucoma
Hypertrichosis
Perioral dermatitis
Pruritus
Rash
Skin atrophy
Skin depigmentation
Skin irritation
Stinging
Striae
Telangiectasia
Urticaria
Worsening of rosacea

Presentation

Topical cream containing fusidic acid and betamethasone.

Drugs List

Therapeutic Indications

Uses

Inflammatory skin conditions responsive to corticosteroid and antimicrobial

Dosage

Adults

Elderly

Children

Contraindications

Syphilis
Uncontrolled systemic infection
Acne vulgaris
Perioral dermatitis
Pregnancy
Rosacea
Skin infection
Tuberculosis

Precautions and Warnings

Children under 6 years

May mask symptoms or signs of infections
Exclude fungal infection before treatment
Exclude tubercular infection before treatment
Exclude viral infection before treatment
Not all available brands are licensed for all age groups
Avoid contact with eyes
Risk of glaucoma if preparation enters eye
Adrenal suppression may occur even without occlusion
Prolonged use may cause atrophic skin changes
Discontinue if hypersensitivity reactions occur
Avoid long term continuous therapy
Each course of treatment should not exceed 14 days
Advise patient residue on clothing/bedding may cause fire hazard
Fire hazard: Keep away from naked flames and potential sources of ignition
Nappy may act as an occlusive dressing

Bacterial resistance has been reported with the use of fusidic acid. Extended or recurrent applications may increase the risk of developing antibiotic resistance.

Occult extension of the infection may occur due to the masking of the steroid.

If the infection persists, systemic therapy may be required.

The steroid component of the cream may mask hypersensitivity reactions.

Pregnancy and Lactation

Pregnancy

Betamethasone with fusidic is contraindicated in pregnancy.

Betamethasone valerate
Topical application of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such effects in the human foetus but the relevance of this study has not been established in humans. Nevertheless, topical corticosteroids with the exception of very potent steroids can be used relatively safely in pregnancy (Schaefer, 2007).

Fusidic acid
At the time of writing no effects during pregnancy are anticipated, since systemic exposure to fusidic acid is negligible. Studies in animals have not shown teratogenic effects with fusidic acid. Limited studies in animals have shown negligible systemic absorption of topical fusidic acid.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Betamethasone with fusidic acid is considered safe for use in breastfeeding.

At the time of no effects on the infant are anticipated since the systemic exposure to the breastfeeding woman to fusidic acid and betamethasone is negligible. Fusidic acid with betamethasone should not be applied on the breasts to avoid accidental ingestion by the infant.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Acne (at application site)
Adrenal suppression
Allergic reaction
Burning sensation (local)
Contact dermatitis
Dry skin
Erythema
Exacerbation of acne
Exacerbation of pre-existing eczema
Folliculitis
Glaucoma
Hypertrichosis
Perioral dermatitis
Pruritus
Rash
Skin atrophy
Skin depigmentation
Skin irritation
Stinging
Striae
Telangiectasia
Urticaria
Worsening of rosacea

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: June 2016

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press Accessed on 23 June 2016.

Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications Accessed on 23 June 2016.

Summary of Product Characteristics: FuciBET cream. Leo Laboratories Ltd. Revised September 2015.
Summary of Product Characteristics: Fucibet Lipid cream. Leo Laboratories Ltd. Revised September 2015.

Summary of Product Characteristics: Xemacort 20mg/g + 1mg/g cream. Mylan Ltd. Revised May 2015.