HYDROCORTISONE 1% w/w Ointment Ref.[7551] Active ingredients: Hydrocortisone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Pinewood Laboratories Limited, Trading as Pinewood Healthcare, Ballymacarbry, Clonmel, Co. Tipperary, Ireland

Contraindications

Bacterial (e.g. impetigo), viral (e.g. Herpes simplex) or fungal (e.g. candidal or dermatophyte) infections of the skin.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Use on the eyes and face, ano-genital region, broken or infected skin including cold sores, acne and athlete’s foot.

Special warnings and precautions for use

Remarks on indications

  1. 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.
  2. Topical corticosteroids are ineffective in granulomatous conditions and other inflammatory reactions involving the deeper regions of the dermis.
  3. Topical corticosteroids are not generally indicated in psoriasis excluding widespread plaque psoriasis provided that warnings are given.

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.

Although generally regarded as safe, even for long-term administration in adults, there is potential for overdosage in infants and children. Extreme caution is required in dermatoses of infancy especially napkin eruption where the napkin can act as an occlusive dressing and increase absorption. In infants and children, courses of treatment should therefore not normally exceed 7 days.

Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions, which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy, and a systemic administration of antimicrobial agents.

As with all corticosteroids, prolonged application to the face is undesirable.

Do not use under an occlusive dressing.

This medicinal product contains wool fat (lanolin), which may cause local skin reactions (e.g. contact dermatitis).

Interaction with other medicinal products and other forms of interaction

None known.

Pregnancy and lactation

Pregnancy

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.

Breastfeeding

There is no evidence against use in lactating women. However, caution should be exercised when Hydrocortisone Ointment is administered to nursing mothers. In this event, the product should not be applied to the chest area.

Effects on ability to drive and use machines

None known.

Undesirable effects

Hydrocortisone preparations are usually well tolerated, but if any signs of hypersensitivity appear, application should stop immediately.

Striae may occur especially in intertriginous areas.

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 Plat or Apple App Store.

Incompatibilities

None known.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.