- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
- 11. Legal category
1. Name of the medicinal product
LOCOID SCALP LOTION
2. Qualitative and quantitative composition
Contains 0.1% w/v hydrocortisone butyrate.For excipients, see 6.1
3. Pharmaceutical form
Cutaneous solution.Clear, colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
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 special precautions for use.
4.2 Posology and method of administration
For topical application to the scalp.Dosage: To be applied evenly and sparingly no more than twice dailyAdults and the Elderly: The same dose is used for adults and the elderly, as clinical evidence would indicate that no special dosage regimen is necessary in the elderly.Children: Long term treatment should be avoided where possible.Infants: Therapy should be limited if possible to a maximum of seven days.
Hypersensitivity to hydrocortisone or to any of the ingredients of the lotion.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
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.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.Keep away from eyes.
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
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. 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.The use of topical corticosteroids during lactation is unlikely to present a hazard to infants being breast-fed.
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
|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|
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
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
No preclinical safety data have been generated.
6. Pharmaceutical particulars
6.1 List of excipients
Isopropyl alcohol, glycerol (85%), Povidone K90, anhydrous citric acid, anhydrous sodium citrate, purified water.
6.3 Shelf life
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.
6.6 Special precautions for disposal and other handling
No special requirements.
7. Marketing authorisation holder
Astellas Pharma Ltd.2000 Hillswood DriveChertseySurreyKT16 0RSUnited Kingdom
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
First authorised 28 September 1973; renewed 19 December 2003.
10. Date of revision of the text
17 September 2012
11. Legal category
Astellas Pharma Ltd
2000 Hillswood Drive, Chertsey, Surrey, KT16 0RS, UK
+44 (0) 203 379 8820
Medical Information e-mail
+44 (0) 203 379 8700
Medical Information Direct Line
0800 783 5018
+44 (0) 203 379 8721