Summary of medicine characteristics - LOCOID SCALP LOTION
1 NAME OF THE MEDICINAL PRODUCT
Locoid Scalp Lotion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of Locoid Scalp Lotion contains 1 mg hydrocortisone butyrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cutaneous solution.
The product is a clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Locoid Scalp Lotion is indicated in adults, children and infants above 3 months of age. The product is recommended for treatment of inflammatory skin disorders not caused by micro-organisms e.g. eczema, dermatitis and psoriasis.
Topical corticosteroids are acceptable in psoriasis excluding widespread plaque psoriasis provided warnings are given; see section 4.4 Special warnings and precautions for use.
4.2 Posology and method of administration
Posology
Adults and older people
A thin and even layer should be applied to the affected area of the skin, 1 to 2 times daily.
The same dose is used for adults and older people, as clinical evidence would indicate that no special dosage regimen is necessary in older people.
Paediatric population
Long term treatment, large amounts, and occlusion should be avoided.
Infants
Therapy should be limited to a maximum of seven days.
Method of administration
For cutaneous use on the scalp.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
This preparation is contraindicated in the presence of untreated viral, fungal, yeast or parasitic infections, tubercular or syphilitic lesions, peri-oral dermatitis, acne vulgaris and rosacea and in bacterial infections unless used in connection with appropriate chemotherapy.
4.4 Special warnings and precautions for use
Locoid should not be applied to the eyelids in view of the risk of glaucoma simplex or subcapsular cataract.
Keep away from the eyes.
As with all corticosteroids, application to the face, genitals, flexures and other areas of thin skin may cause skin atrophy and increased absorption and should be avoided. Hands must be washed after each application unless Locoid is used to treat the hands.
There is an increased risk of systemic and local adverse reactions in treatment of intertriginous areas, large areas of skin or, under occlusion, as well as with frequent dosing or treatment over a long period of time. Attention must be paid to the risks of systemic adverse reactions including adrenocortical suppression.
Due to the immunosuppressant and anti-inflammatory effect of corticosteroids, Locoid may be associated with increased susceptibility to skin infections, aggravation of existing infection, and activation of latent infection. As such, Locoid® is contraindicated against use on infected skin and should be used with particular caution at the site of previous or suspected infections.
In some patients with psoriasis, topical corticosteroids may cause rebound relapses following development of tolerance, risk of generalised pustular psoriasis and local and systemic toxicity due to impaired barrier function of the skin. Steroids may have a place in psoriasis of the scalp and chronic plaque psoriasis of the hands and feet. Careful patient supervision is important.
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
Paediatric population
Although generally regarded as safe, even for long-term administration in adults, there is a potential for adverse effects if over used in infancy. Extreme caution is required in dermatoses of infancy. In such patients courses of treatment should not normally exceed 7 days.
4.5 Interaction with other medicinal products and other forms of interaction No interaction studies have been performed.
4.6 Fertility, pregnancy and lactation
Pregnancy
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 17-butyrate (see section 5.3). 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 Locoid® should only be used when the potential benefit justifies the potential risk.
Breast-feeding
It is unknown whether hydrocortisone 17-butyrate/metabolites are present in maternal milk following topical application.
The use of Locoid during breastfeeding is not expected to affect breastfed infants since the systemic absorption of topically applied hydrocortisone 17-butyrate is low.
Locoid can be used during breastfeeding, but it is recommended to avoid applying Locoid directly on the breast.
Fertility
No animal or human data on Locoid and fertility is available.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
In clinical studies, cases of skin irritation and hypersensitivity were reported.
The most frequently reported adverse reactions post-marketing are hypersensitivity and skin reactions such as erythema, pruritus and skin infection.
Adverse reactions are listed by MedDRA System Organ Class.
Frequencies are defined as very rare (<1/10,000), rare (>1/10,000 to <1/1,000 ), uncommon (>1/1,000 to <1/100), common (> 1/100 to <1/10), very common (>1/10), and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
| System Organ Class | Rare >/10,000,<1/1000 | Very rare </10,000 | Not known (cannot be estimated from the available data) |
| Immune system disorders | Hypersensitivity | ||
| Endocrine disorders | Adrenal suppression | ||
| Eye disorders | Vision, blurred* | ||
| Skin and subcutaneous tissue disorders | Skin atrophy** Dermatitis*** Telangiectasia Skin striae Purpura Acne Perioral dermatitis Skin depigmentation | Pruritus Erythema Rash | |
| General disorders and administration site conditions | Rebound effect | Application site pain |
*See also section 4.4
**often irreversible, with thinning of the epidermis
***Dermatitis and eczema, including contact dermatitis
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
4.9 OverdoseExcessive use under occlusive dressings may produce adrenal suppression. No special procedures or antidote. Treat any adverse effects symptomatically.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Corticosteroid, ATC code: D07AB02
Hydrocortisone butyrate is a potent topical corticosteroid.
5.2 Pharmacokinetic properties
The topical activity has been demonstrated in vivo using the McKenzie-Stoughton test.
5.3 Preclinical safety data
5.3 Preclinical safety dataTopical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human foetus.
Theoretically, there is the possibility that if maternal systemic absorption occurred the infant’s adrenal function could be affected.
6.1 List of excipients
Isopropyl alcohol, glycerol (85%), Povidone K90, anhydrous citric acid, anhydrous sodium citrate, purified water.
6.2 Incompatibilities
None stated.
2 years
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
Plastic, dropper-necked screw cap vial.
Pack sizes: 30 ml and 100 ml.
Not all pack sizes may be marketed.
No special requirements.
6.6 Special precautions for disposal
6.6 Special precautions for disposalNo special requirements.
7 MARKETING AUTHORISATION HOLDER
LEO Pharma A/S
Industriparken 55
DK-2750 Ballerup
Denmark
8 MARKETING AUTHORISATION NUMBER(S)
PL 05293/0014
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION
Date of first authorisation: 28 September 1973
Date of latest renewal: 24 August 2010.