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Locoid Scalp Lotion

Last Updated on eMC 13-Apr-2015 View changes  | Astellas Pharma Ltd Contact details

1. Name of the medicinal product

Locoid Scalp Lotion

2. Qualitative and quantitative composition

Locoid Scalp Lotion contains 0.1% w/v 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. The product is recommended for clinical use in the treatment of scalp conditions responsive to topical corticosteroids e.g. eczema, dermatitis and psoriasis.

Topical corticosteroids are not generally indicated in psoriasis but may be 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

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 should be avoided where possible.

Infants

Therapy should be limited if possible to a maximum of seven days.

Method of administration

For cutaneous use on the scalp.

Dosage: To be applied evenly and sparingly no more than twice daily

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 or fungal 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

As with all corticosteroids, application to the face, flexures and other areas of thin skin may cause skin atrophy and increased absorption and should be avoided.

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 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.

Infants

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.

Keep away from eyes.

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. Studies in animals have shown reproductive toxicity (see section 5.3).

Breast-feeding

Hydrocortisone butyrate/metabolites are excreted in human milk, but at therapeutic doses of Locoid Scalp Lotion no effects on the breast-fed newborns/infants are anticipated.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Tabulated list of adverse reactions

System Organ Class

Rare

>/10,000,<1/1000

Very rare

</10,000

Not known

Immune system disorders

  

Hypersensitivity

Endocrine disorders

 

Adrenal suppression

 

Skin and subcutaneous tissue disorders

Skin atrophy, often irreversible, with thinning of the epidermis

Telangiectasia

Skin striae

Pustular acne

Perioral dermatitis

Rebound effect

Skin depigmentation

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.

4.9 Overdose

Excessive use under occlusive dressings may produce adrenal suppression. No special procedures or antidote. Treat any adverse effects symptomatically.

5. Pharmacological properties
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

Topical 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. Pharmaceutical particulars
6.1 List of excipients

Isopropyl alcohol, glycerol (85%), Povidone K90, anhydrous citric acid, anhydrous sodium citrate, purified water.

6.2 Incompatibilities

None stated.

6.3 Shelf life

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.

6.6 Special precautions for disposal and other handling

No special requirements.

7. Marketing authorisation holder

Astellas Pharma Ltd.

2000 Hillswood Drive

Chertsey

Surrey

KT16 0RS

United Kingdom

8. Marketing authorisation number(s)

PL 00166/0060R

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation: 28 September 1973

Date of latest renewal: 24 August 2010

10. Date of revision of the text

25 March 2015

Company contact details

Astellas Pharma Ltd

Company image
Address

2000 Hillswood Drive, Chertsey, Surrey, KT16 0RS, UK

Fax

+44 (0) 203 379 8820

Medical Information e-mail
Telephone

+44 (0) 203 379 8700

Medical Information Direct Line

0800 783 5018

Stock Availability

+44 (0) 203 379 8721

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Active ingredients

hydrocortisone butyrate

Legal categories

POM - Prescription Only Medicine

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