Drugs List

Therapeutic Indications

Uses

Inflammatory skin conditions responsive to corticosteroid and antimicrobial

Treatment of eczema and dermatitis with secondary bacterial infections including atopic eczema, primary irritant dermatitis, allergic dermatitis and seborrhoeic dermatitis where the infective organism is sensitive to fusidic acid.

Dosage

For uncovered lesions, a small quantity of cream applied to the affected area twice daily until a satisfactory response has been achieved.

A single treatment course should not exceed 2 weeks.

For covered lesions less frequent applications may be sufficient.

Contraindications

Perioral dermatitis
Rosacea
Uncontrolled skin manifestation of tuberculosis

Precautions and Warnings

Children under 12 years
Pregnancy

Exclude fungal infection before treatment
Exclude primary bacterial infection before treatment
Exclude tubercular infection before treatment
Exclude viral infection before treatment
Contains butyl hydroxyanisole - may cause local skin reactions
Contains cetyl alcohol - may cause local skin reactions
Contains polysorbate
Avoid contact with mucous membranes
Avoid prolonged application to the face
Avoid use in or near eyes
Do not apply to atrophic skin
Not for use in open wounds
Risk of glaucoma if preparation enters eye
Adrenal suppression may occur even without occlusion
Discontinue if no improvement occurs within 7 days
Avoid long-term use particularly in infants and children
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

Prolonged or repeated administration may increase the risk of contact sensitisation and bacterial resistance.

Hydrocortisone with fusidic acid cream is not recommended in the following conditions: atrophic skin, cutaneous ulcer, acne vulgaris, fragile skin veins and perianal and genital pruritus.

Due to the immunosuppressant effect of corticosteroids, hydrocortisone with fusidic acid cream 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.

Pregnancy and Lactation

Pregnancy

Use hydrocortisone with fusidic acid cream with caution in pregnancy.

A large amount of data on pregnant women, over 1000, has shown no malformation or toxicity affecting the foetus or neonate after the use of corticosteroids.

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

Hydrocortisone with fusidic acid cream is considered safe for use in breastfeeding. However, the manufacturer recommends to avoid the application on the breast.

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

Adrenal suppression
Burning sensation (local)
Contact dermatitis
Dermatitis
Ecchymosis
Erythema
Exacerbation of pre-existing eczema
Glaucoma
Hyperhidrosis
Hypersensitivity reactions
Hypertrichosis
Pruritus
Rash
Rosacea
Skin atrophy
Skin depigmentation
Skin irritation
Striae (irreversible)
Telangiectasia

Presentation

Cream containing hydrocortisone acetate and fusidic acid

Drugs List

Therapeutic Indications

Uses

Inflammatory skin conditions responsive to corticosteroid and antimicrobial

Treatment of eczema and dermatitis with secondary bacterial infections including atopic eczema, primary irritant dermatitis, allergic dermatitis and seborrhoeic dermatitis where the infective organism is sensitive to fusidic acid.

Dosage

For uncovered lesions, a small quantity of cream applied to the affected area twice daily until a satisfactory response has been achieved.

A single treatment course should not exceed 2 weeks.

For covered lesions less frequent applications may be sufficient.

Contraindications

Perioral dermatitis
Rosacea
Uncontrolled skin manifestation of tuberculosis

Precautions and Warnings

Children under 12 years
Pregnancy

Exclude fungal infection before treatment
Exclude primary bacterial infection before treatment
Exclude tubercular infection before treatment
Exclude viral infection before treatment
Contains butyl hydroxyanisole - may cause local skin reactions
Contains cetyl alcohol - may cause local skin reactions
Contains polysorbate
Avoid contact with mucous membranes
Avoid prolonged application to the face
Avoid use in or near eyes
Do not apply to atrophic skin
Not for use in open wounds
Risk of glaucoma if preparation enters eye
Adrenal suppression may occur even without occlusion
Discontinue if no improvement occurs within 7 days
Avoid long-term use particularly in infants and children
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

Prolonged or repeated administration may increase the risk of contact sensitisation and bacterial resistance.

Hydrocortisone with fusidic acid cream is not recommended in the following conditions: atrophic skin, cutaneous ulcer, acne vulgaris, fragile skin veins and perianal and genital pruritus.

Due to the immunosuppressant effect of corticosteroids, hydrocortisone with fusidic acid cream 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.

Pregnancy and Lactation

Pregnancy

Use hydrocortisone with fusidic acid cream with caution in pregnancy.

A large amount of data on pregnant women, over 1000, has shown no malformation or toxicity affecting the foetus or neonate after the use of corticosteroids.

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

Hydrocortisone with fusidic acid cream is considered safe for use in breastfeeding. However, the manufacturer recommends to avoid the application on the breast.

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

Adrenal suppression
Burning sensation (local)
Contact dermatitis
Dermatitis
Ecchymosis
Erythema
Exacerbation of pre-existing eczema
Glaucoma
Hyperhidrosis
Hypersensitivity reactions
Hypertrichosis
Pruritus
Rash
Rosacea
Skin atrophy
Skin depigmentation
Skin irritation
Striae (irreversible)
Telangiectasia

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: February 2017

Reference Sources

Joint Formulary Committee. British National Formulary. 72nd ed. London: BMJ Group and Pharmaceutical Press; 2016.

Paediatric Formulary Committee. BNF for Children 2016-2017. London: BMJ Group, Pharmaceutical Press, and RCPCH Publications; 2016.

Summary of Product Characteristics: Fucidin H cream. Leo Laboratories Ltd. Revised October 2014.