Hydrocortisone Acetate

Registered South African indications:

• Corticosteroid responsive dermatoses (10mg/g (cre))
• Itching (cre, oin)

Contraindications

South African recommendations

Topical (cre) 10mg/g

• Hypersensitivity to the active ingredient or any of its excipients
• Rosacea
• Acne
• Peri-oral dermatitis
• Tuberculosis of the skin
• Varicose ulcers
• Skin lesions caused by infection with viruses (e.g. herpes simplex, vaccinia or varicella), fungi (e.g. candidiasis, tinea) or bacteria (e.g. impetigo)

 Topical (oin) 10mg/g

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Breastfeeding
• The presence of vaginal discharge
• Cosmetic purposes
• External anal itching accompanied by bleeding
• Nappy rash
• Children <12 years (for indications pertaining to genital and anal use)
• Children <2 years
• Untreated bacterial (e.g., impetigo), viral (e.g., herpes simplex), or fungal (e.g., candida or dermatophyte) infections
• Scabetic infections
• Rosacea
• Perioral dermatitis

Topical (cre, oin) 5mg/g

• Pregnancy
• The presence of vaginal discharge
• Cosmetic purposes
• External anal itching accompanied by bleeding
• Nappy rash
• Children <12 years (for indications pertaining to genital and anal use)
• Children <2 years
• Use for longer than 7 days
• Exceeding recommended dose
• Presence of bacterial, fungal or viral infections

Recommendations in other jurisdictions

Topical (cre) 10mg/g

• Hypersensitivity to the active ingredient or any of its excipients
• Use on the eyes or face
  - In rosacea or perioral dermatoses
• Use on the ano-genital area or on broken or infected skin including impetigo, cold sores, acne, athlete's foot, or infected bites and stings
• Use in the presence of untreated infections of bacterial, viral, tuberculous or fungal origin
• Use with an occlusive dressing or on large areas of the body

Cautions

• Pregnancy (10mg/g cre) (South African recommendations) 
• Breastfeeding (10mg/g cre, 5mg/g cre, oin) (South African recommendations)
• Pregnancy (Recommendations in other jurisdictions)
• Breastfeeding (Recommendations in other jurisdictions)
• Renal impairment
• Hepatic impairment
• Elderly
• 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, oin 

Dosages below include:

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

South African registered indications and dosage

Corticosteroid responsive dermatoses

10mg/g

• Topical (cre): Initial: Apply to the affected area, 12hrly; Maintenance: When indicated may be achieved with less frequent applications

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A sufficient quantity of cream should be applied to completely cover the affected area and should be massaged gently and thoroughly into the skin21.1,21

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Itching
- Associated with minor skin irritations due to eczema, insect bites, poison plants, soaps, detergents, cosmetics, jewellery, seborrhoeic dermatitis
- External genital and anal itching

10mg/g and 5mg/g

• Topical (cre, oin): Apply to the affected area, 6-24hrly; Until improvement occurs, thereafter frequency of application may be reduced; Treatment duration: ≤7 days

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After thorough cleaning of the affected skin, a thin layer should be applied by smoothing gently into the affected area/s. No additional benefit is gained by vigorous rubbing

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See link: General prescribing points for steroids

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Indications and dosages registered in other jurisdictions

Irritant dermatitis
Allergic contact dermatitis
Insect bite reactions
Eczema - mild to moderate

• Topical (cre, oin): 1%: Apply to the affected area, 12-24hrly; Max duration: 7 days

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Wash hands after application unless these are the intended site of treatment

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Dermatological conditions requiring the use of a topical anti-inflammatory
- Eczema (including atopic, infantile, discoid and stasis eczemas)
- Prurigo nodularis
- Neurodermatoses
- Seborrhoeic dermatitis
- Intertrigo
- Contact sensitivity reactions
Insect bites
Otitis externa
Continuation therapy in mild cases of seborrhoeic or atopic eczema
- Once the acute inflammatory phase has passed

• Topical (cre, oin): 0.5%: Apply to the affected area, 8-12hrly

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Hydrocortisone cream is often appropriate for moist or weeping surfaces, and hydrocortisone ointment for dry-lichenified or scaly lesions, but this is not invariably so

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

Dosages below include:

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

South African registered indications and dosage

Itching
- Associated with minor skin irritations due to eczema, insect bites, poison plants, soaps, detergents, cosmetics, jewellery, seborrhoeic dermatitis

Topical (cre, oin) 10mg/g and 5mg/g

Younger than 2 years

• Contraindicated

Older than 2 years

• See adult dosage

- External genital and anal itching

Younger than 12 years

• Contraindicated

Older than 12 years

• See adult dosage

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Indications and dosages registered in other jurisdictions

Irritant dermatitis
Allergic contact dermatitis
Insect bite reactions
Eczema - mild to moderate

Topical (cre, oin) 1%

Younger than 10 years

• Not recommended for use

Older than 10 years

• See adult dosage

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Long term therapy in children should be avoided where possible

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Dermatological conditions requiring the use of a topical anti-inflammatory
- Eczema (including atopic, infantile, discoid and stasis eczemas)
- Prurigo nodularis
- Neurodermatoses
- Seborrhoeic dermatitis
- Intertrigo
- Contact sensitivity reactions
Insect bites
Otitis externa
Continuation therapy in mild cases of seborrhoeic or atopic eczema
- Once the acute inflammatory phase has passed

Topical (cre, oin): 0.5%

Younger than 10 years

• Not recommended for use

Older than 10 years

• Apply to the affected area, 8-12hrly; Max duration: 7 days

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Long term therapy in children should be avoided

Pregnancy

South African recommendations

• 10mg/g and 5mg/g: Contraindicated (cre, oin)
• 10mg/g: Caution; positive evidence of risk in animal studies (cre)
• Hydrocortisone acetate should not be used during pregnancy
• Corticosteroids have been shown to be teratogenic in animals following dermal application. As these agents are absorbed percutaneously, teratogenicity following topical application cannot be excluded

Recommendations in other jurisdictions

• Caution; positive evidence of risk in animal studies
• There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. Therefore there may be a small risk of such events to the human foetus. There is theoretical risk of such effects on the human foetus

Breastfeeding

South African recommendations

• 10mg/g: Caution; not recommended (cre)
• Safety in breastfeeding has not been established. In the absence of sufficient data, the use during breastfeeding is not recommended
   
• 10mg/g: Contraindicated (oin)
• Hydrocortisone acetate should not be used during breastfeeding
• Corticosteroids have been shown to be teratogenic in animals following dermal application. As these agents are absorbed percutaneously, teratogenicity following topical application cannot be excluded
   
• 5mg/g: Caution; no information available (cre, oin)

Recommendations in other jurisdictions

• 1%: Caution (cre, oin) 
• There is no evidence against use in lactating women. However, caution should be exercised when hydrocortisone cream is administered to nursing mothers. In this event, the product should not be applied to the chest area. There is theoretical risk of infant adrenal function impairment if maternal systemic absorption occurs
   
• 0.5%: Caution; no information available (cre, oin)

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) 5mg

• Dilucort (Pharmacare)
• Skin calm (Pharmacare)

Cream (per g) 10mg

• Biocort (Akacia)
• Mylocort (Pharmacare)
• Stop-itch (Adcock Ingram) originator
• Vari-Hydrocortisone 1% (Barrs) 

Ointment (per g) 5mg

• Dilucort (Pharmacare)

Ointment (per g) 10mg

• Mylocort (Pharmacare)
• Procutan (Bayer)