Hydrocortisone Butyrate

Registered South African indications:

• Inflammatory skin conditions
• Psoriasis
• Lichen ruber planus
• Intertrigo
• Superficial corticosteroid responsive dermatoses which are expected to respond inadequately to less potent corticosteroids (lot (topical emulsion))

Contraindications

South African recommendations

Cream, ointment, lotion

• Hypersensitivity to the active ingredient or any of its excipients
• Use on broken skin
• Skin infections caused by bacteria, fungi or viruses (for example herpes simplex)
• Wound treatment especially ulcerous lesions
• Peri-oral dermatitis
• History of allergy to the ingredients

Lotion (topical emulsion)

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Breastfeeding
• Skin lesions caused by
  - Viral infections (e.g. varicella, herpes simplex, vaccinia herpes zoster, verrucae vulgaris, verrucae planae, condylomata, mollusca contagiosa)
  - Bacterial infections (e.g. pyodermas, luetic and tuberculous processes)
  - Mycotic and yeast infections
  - Parasitic infections (e.g. scabies)
• Ulcerous skin lesions, wounds and broken skin
• Adverse reactions induced by corticosteroids (e.g. dermatitis perioralis, striae atrophicae)
• Ichthyosis
• Juvenile dermatosis plantaris
• Acne vulgaris
• Acne rosacea
• Fragility of the skin vessels
• Skin atrophy
• Children <2 years

Recommendations in other jurisdictions

• Hypersensitivity to the active ingredient or any of its excipients
• Untreated viral, fungal, yeast or parasitic infections
• Tubercular or syphilitic lesions
• Peri-oral dermatitis
• Acne vulgaris and rosacea
• Bacterial infections unless used in connection with appropriate chemotherapy

Cautions

• Pregnancy (cre, oin, lot) (South African recommendations) 
• Breastfeeding (cre, oin, lot) (South African recommendations) 
• Pregnancy (Recommendations in other jurisdictions)
• Breastfeeding (Recommendations in other jurisdictions)
• Renal impairment
• Hepatic impairment
• Immediate (Type 1) allergic skin reactions or short-lived weal and flare reactions (cre)
• Granulomatous conditions and other inflammatory reactions involving the deeper regions of the dermis (cre)
• Psoriasis (see additional prescribing points)
• Infants and children, particularly in courses exceeding 7 days
• Dermatoses of infancy, especially napkin eruption where the napkin can act as an occlusive dressing (cre)
• Infected inflammatory lesions (cre)
• Prolonged application to the face (cre)
• Use under occlusive dressings (cre, oin)
• Application to the face, flexures and other areas of thin skin (oin, lot)
• Smoking or exposure to naked flames (oin, lot)
• Exposure of fabric that has been in contact with the product to naked flames (oin, lot)

Forms avail. in SA and covered in this monograph: cre, lot, oin, emulsion 

Dosages below include:

• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

South African registered indications and dosages

Inflammatory skin conditions
- Allergy and eczema
Psoriasis
Lichen ruber planus
Intertrigo
- Caused by chemical and/or mechanical irritation

• Topical (cre, oin, lot): Initial: Apply thinly to affected area, 2-4 times dly; After initial therapeutic response: Apply, dly OR 2-3 times, weekly

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Long term topical use with hydrocortisone butyrate should be avoided. The optimal therapeutic effect can only be obtained if the formulation is adapted to the nature of the skin disorder e.g., hydrocortisone butyrate cream has an oil-in-water base with a low fat content; hydrocortisone butyrate lipocream has an oil-in-water base with a high fat content; hydrocortisone butyrate ointment has an anhydrous ointment base; and hydrocortisone butyrate lotion has an alcohol-in-water solution base and contains no fat

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For cutaneous use. Gentle massage may facilitate penetration into the skin. In some cases, a better result is achieved with an occlusive dressing 

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Superficial corticosteroid responsive dermatoses which are expected to respond inadequately to less potent corticosteroids
- Not caused by microorganisms

• Topical (lot (emulsion)): Initial: Apply small amount to skin, 1-3 times dly; After improvement of the disorder: Apply, dly OR 2-3 times, weekly

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Long term topical use of corticosteroids should be avoided. Hydrocortisone butyrate emulsion is suitable for the treatment of weeping skin disorders on visible places and disorders of the hairy skin

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For cutaneous use. Hydrocortisone butyrate emulsion should be applied evenly in a thin layer onto the diseased skin. To promote penetration, it may be lightly massaged into the skin. Sometimes it may be advisable to cover weeping disorders afterwards with an occlusive dressing 22

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Indications and dosages registered in other jurisdictions

Inflammatory skin disorders not caused by microorganisms
- Eczema, dermatitis and psoriasis, excluding widespread plaque psoriasis

• Topical (cre, oin, lot): Apply an even thin layer to affected area, 1-2 times dly

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The cream and ointment are for cutaneous use. Application may be made under occlusion in the more resistant lesions such as thickened psoriatic plaques on elbows and knees. Due to the formulation of the base in the lipocream, it may be used both for dry scaly lesions and for moist or weeping lesions. The lotion is for cutaneous use on the scalp; and the emulsion is intended for topical application especially to the scalp or hirsute skin

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See link: General prescribing points for steroids

Paed. forms avail. in SA and covered in this monograph: cre, lot, oin, emulsion

Dosages below include:

• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

South African registered indications and dosages

Inflammatory skin conditions
- Allergy and eczema
Psoriasis
Lichen ruber planus
Intertrigo
- Caused by chemical and/or mechanical irritation

Infants and young children

• Not recommended for use

Superficial corticosteroid responsive dermatoses which are expected to respond inadequately to less potent corticosteroids
- Not caused by microorganisms

Younger than 2 years

• Contraindicated

Older than 2 years

• See adult dosage

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Care should be taken in prescribing hydrocortisone butyrate to children. These corticosteroid preparations should not be used in the nappy areas of infants for flexural eruptions and ideally should not be used on infants and young children at all

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Long term topical use of corticosteroids should be avoided especially in children

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Indications and dosages registered in other jurisdictions

Inflammatory skin disorders not caused by microorganisms
- Eczema, dermatitis and psoriasis, excluding widespread plaque psoriasis

Younger than 3 months

• No information available

Older than 3 months (infants)

• Topical (cre, oin, lot): Apply an even thin layer to affected area, 1-2 times dly; Treatment duration: Limited to a maximum of 7 days

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Long term treatment, large amounts, and occlusion should be avoided in the paediatric population

Pregnancy

South African recommendations

• Contraindicated (lot (emulsion))
• Hydrocortisone butyrate topical emulsion should not be used during pregnancy
   
• Caution; positive evidence of risk in animal studies (cre, oin, lot)
• Corticosteroids such as hydrocortisone pass the placenta and may therefore influence the foetus
• This is only of significance when large areas are treated intensively with hydrocortisone butyrate
• Corticosteroids have been shown to be teratogenic in animal studies

Recommendations in other jurisdictions

• Caution; positive evidence of risk in animal studies
• There are no or limited amount of data from the use of hydrocortisone butyrate in pregnant women
• Animal studies are insufficient with respect to reproductive toxicity of hydrocortisone butyrate
• Although, animal studies have shown the more potent corticosteroids to be teratogenic after dermal application, the clinical relevance in humans has not been established
• Therefore, during pregnancy hydrocortisone butyrate should only be used when the potential benefit justifies the potential risk

Breastfeeding

South African recommendations

• Contraindicated (lot (emulsion))
• The use of hydrocortisone butyrate topical emulsion is not recommended during breastfeeding
   
• Caution (cre, oin, lot)
• Care should be taken when treating breastfeeding mothers with large quantities of hydrocortisone butyrate, as it is not known whether hydrocortisone butyrate absorbed through the skin is present in breastmilk
• Hydrocortisone butyrate can be used during breastfeeding, but it is recommended to avoid applying directly on the breast

Recommendations in other jurisdictions

• Caution 
• It is unknown whether hydrocortisone butyrate or its metabolites are present in maternal milk following topical application
• The use of hydrocortisone butyrate during breastfeeding is not expected to affect breastfed infants since the systemic absorption of topically applied hydrocortisone butyrate is low
• Hydrocortisone butyrate can be used during breastfeeding, but it is recommended to avoid applying it directly on the breast

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available 

Elderly

• No dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Endocrine and Metabolic Disorders 

• Adrenal suppression

Skin and Subcutaneous Tissue Disorders

• Skin atrophy
• Telangiectasia
• Skin striae
• Pustular acne  
• Perioral dermatitis
• Rebound effect
• Skin depigmentation
• Dermatitis
• Eczema
• Contact dermatitis

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity

Sensory Disorders

• Blurred vision

None known 

None routine. Specific case may require

• Hypothalamic pituitary axis suppression
• Ophthalmological exam

Additional observations

• Skin atrophy

Considerations for use

• There is no good evidence that topical corticosteroids are efficacious against immediate (Type 1) allergic skin reactions or short-lived weal and flare reactions from other causes
• Topical corticosteroids are ineffective in granulomatous conditions and other inflammatory reactions involving the deeper regions of the dermis

Psoriasis

• Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development of tolerance, risk of generalised pustular psoriasis, and local and systematic toxicity due to impaired barrier function of the skin. Careful patient supervision is important
• Lotion: Steroids may have a place in psoriasis of the scalp and chronic plaque psoriasis of the hands and feet. Careful patient supervision is important

Hydrocortisone, a glucocorticoid, has anti-inflammatory action due to reduction in the vascular component of the inflammatory response and reduction in the formation of inflammatory fluid and cellular exudates. The granulation reaction is also decreased due to the inhibition effect of hydrocortisone on connective tissue. Stabilisation of most cell granules and lysomal membranes decreases the mediators involved in inflammatory response and reduces release of enzymes in prostaglandin synthesis. The vasoconstrictor action of hydrocortisone may also contribute to its anti-inflammatory activity.

Cream (per g) 1mg 

• Locoid Cream (Adcock Ingram) originator
• Locoid Lipo-Cream (Adcock Ingram) originator

Ointment (per g) 1mg

• Locoid Ointment (Adcock Ingram) originator

Lotion (per ml) 1mg

• Locoid Lotion (Adcock Ingram) originator
• Locoid Crelo (Adcock Ingram) originator