Boots derma care hydrocortisone 1%

Overdose

POM: Acute overdosage is very unlikely to occur. In the case of chronic overdosage or misuse the features of hypercorticism may appear and in this situation, topical steroids should be discontinued.

P: No special precautions or antidotes are likely to be needed.

Shelf life

36 months.

Contraindications

POM: Should not be used if allergic to any of the ingredients or on untreated, infected lesions, ulcerative conditions, rosacea, peri-oral dermatitis or acne.

P: The product should not be used if allergic to any of the ingredients or on the eyes or face, the ano-genital area or on broken or infected skin including impetigo, cold sores, acne or athlete's foot.

Incompatibilities

Not applicable.

List of excipients

White soft paraffin.

Pharmaceutical form

Ointment

Undesirable effects

POM: The product is usually well tolerated, but if hypersensitivity occurs use of the product should be discontinued.

Epidermal thinning, telangectasia and striae may occur in areas of high absorption such as skin folds, the face and the nappy area and where occlusive dressings are used. Sufficient systemic absorption may occur at these sites to produce features of suppression of the HPA (hypothalamo-pituitary-adrenal) axis after prolonged treatment.

P: Hydrocortisone Ointment 1% is usually well tolerated but if hypersensitivity occurs discontinue use.

Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included.

Therapeutic indications

POM: For the treatment of mild to moderate inflammatory skin disorders such as eczema, including atopic, infantile, discoid and stasis eczema; seborrhoeic dermatitis, intertrigo, otitis externa, contact dermatitis, neurodermatitis flexural psoriasis and lichen simplex.

P: For the relief of irritant contact dermatitis, allergic contact dermatitis, insect bite reactions and mild to moderate eczema.

Pharmacodynamic properties

Hydrocortisone is a corticosteroid which has antiinflammatory activity.

Pharmacokinetic properties

Following topical application to most areas of normal skin, only minimal amounts of the drug reach the dermis and subsequently the systemic circulation. Absorption may be markedly increased when the skin has lost its keratin layer and can be increased by inflammation or diseases of the epidermal barrier. Hydrocortisone is absorbed to a greater degree from the scrotum, axilla, eyelid, face and scalp than from the forearm, knee, elbow, palm and sole.

Date of revision of the text

May 2010

Name of the medicinal product

Boots Derma Care Hydrocortisone 1% Ointment

Marketing authorisation holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

Trading as: BCM

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

P: 15 gram internally lacquered, collapsible, aluminium tubes with polypropylene caps. The tubes are packed into cartons.

POM: 15, 30 and 50 gram internally lacquered, collapsible, aluminium tubes with polypropylene caps. The tubes are packed into cartons.

Marketing authorisation number(s)

PL 00014/0364.

Boots Derma Care Hydrocortisone 1% price

We have no data on the cost of the drug.
However, we will provide data for each active ingredient

Qualitative and quantitative composition

Active ingredient

% w/w

Hydrocortisone Ph Eur

1.0

Special warnings and precautions for use

POM: Avoid prolonged, continuous use, particularly in children and especially on the face, as adrenal suppression may occur.

P: Medical advice should be sought if the condition does not improve.

Effects on ability to drive and use machines

P and POM: No adverse effects known.

Dosage (Posology) and method of administration

POM: For adults and children: Apply sparingly twice a day.

P: For adults, the elderly and children over 10 years of age: Apply sparingly to a small area, once or twice a day, for a maximum of 7 days.

Children under 10 years of age: Not recommended except under medical supervision.

For topical application.

Special precautions for disposal and other handling

Not applicable.

Date of first authorisation/renewal of the authorisation

14 April 1987 / 17 June 1997