Hydrocortisone has topical anti-inflammatory activity of value in the treatment of
irritant dermatitis, contact allergic dermatitis, insect bite reactions and mild to
moderate eczema.

Hydrocortisone has topical anti-inflammatory activity of value in the treatment of a
wide variety of dermatological conditions, including the following: eczema and
dermatitis of all types including atopic eczema, photodermatitis, intertrigo, primary
irritant and allergic dermatitis, prurigo nodularis, seborrhoeic dermatitis and insect
bite reactions.

Use sparingly over a small area once/twice a day for a maximum period of one week.
If the condition has not improved, or worsens, consult your doctor.
This product should not be recommended for use on children under 10 years of age
without medical advice.

Apply, once to four times daily gradually increasing the intervals between
applications as the condition improves. Treatment may then be reduced to two to three
times a week or when symptoms recur. Gentle massage assists penetration.

Bacterial (e.g. impetigo), viral (e.g. Herpes simplex) or fungal (e.g. candidal or dermatophyte) infections of the skin. Hypersensitivity to any of the ingredients. Additional contraindications for P supply: Use on the eyes and face, Ano-genital region, Broken or infected skin including cold sores, acne and athlete's foot.

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 generalized
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.
Topical steroid withdrawal syndrome:
Long term continuous or inappropriate use of topical steroids can result in the
development of rebound flares after stopping treatment (topical steroid withdrawal
syndrome). A severe form of rebound flare can develop which takes the form of a
dermatitis with intense redness, stinging and burning that can spread beyond the initial
treatment area. It is more likely to occur when delicate skin sites such as the face and
flexures are treated. Should there be a reoccurrence of the condition within days to
weeks after successful treatment a withdrawal reaction should be suspected.
Reapplication should be with caution and specialist advise is recommended in these
cases or other treatment options should be considered.

None known.

Pregnancy Category C

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

None known.

Hydrocortisone preparations are usually well tolerated, but if any signs of hypersensitivity appear, application should stop immediately. Striae may occur especially in intertriginous areas.

Serious systemic effects of pituitary suppression and hypercorticism may occur if
significant systemic absorption occurs. This is likely if applied frequently or over

prolonged periods or over a large areas or over moist and /or denuded areas or if an
occlusive dressing is present. Systemic absorption is more likely when used over
intertriginous areas. Children are particularly at risk and in these patients,
Hydrocortisone Cream should only be used twice daily for a maximum of ten days
over a body surface area not exceeding 10% and without an occlusive dressing.
Vision, blurred (see also section 4.4) (uncommon)
Skin and Subcutaneous Tissue Disorders Not known (cannot be estimated from
available data): Withdrawal reactions - redness of the skin which may extend to areas
beyond the initial affected area, burning or stinging sensation, itch, skin peeling,
oozing pustules (see section 4.4).

To report any side effect(s): For Saudi Arabia: • The National Pharmacovigilance and Drug Safety Centre (NPC) • SFDA call center: 19999 • E-mail: npc.drug@sfda.gov.sa • Website: https://ade.sfda.gov.sa For UAE • Pharmacovigilance & Medical Device section • P.O.Box: 1853 • Tel: 80011111 • Email: pv@mohap.gov.ae • Drug Department Ministry of Health & Prevention, Dubai, UAE. For Oman • Department of Pharmacovigilance & Drug Information • Directorate General of Pharmaceutical Affairs & Drug Control • Ministry of Health, Sultanate of Oman • Phone Nos. 22357687 / 22357686 • Fax: 22358489 • Email: dg-padc@moh.gov.om • Website: www.moh.gov.om

 

Not applicable.
 

Hydrocortisone is an anti-inflammatory steroid. Its anti-inflammatory action is due to
reduction in the vascular component of the inflammatory response and reduction in
the formation of inflammatory fluid and cellular exudates. The granulation reaction is
also decreased due to the inhibition effect of Hydrocortisone on connective tissue.
Stabilisation of most cell granules and lysomal membranes decreases the mediators
involved in inflammatory response and reduces release of enzymes in prostaglandin
synthesis. The vasoconstrictor action of Hydrocortisone may also contribute to its
anti-inflammatory activity.

Absorption: Topically applied steroids are absorbed to a significant extent only if
applied to broken skin, to very large areas, or under occlusive dressings.
Distribution: Corticosteroids are rapidly distributed to all body tissues. They cross the
placenta and may be excreted in small amounts in breast milk
Metabolism: Hydrocortisone is metabolised mainly in the liver, but also the kidney,
to various degraded and hydrogenated forms such as tetrahydrocortisone.
Elimination: Hydrocortisone is excreted in the urine, mostly conjugated as
glucuronides. Only very small amounts of unchanged hydrocortisone are excreted.

Adverse effects of Hydrocortisone are due to its effects on electrolyte balance,
metabolism and particularly adrenal suppression. Topical use of Hydrocortisone has
only rarely been associated with systemic side effects.

Excipients
Chloresol BP
Macrogol BP
Cetomacrogol Emulsifying Wax BP
White Soft Paraffin
Liquid Paraffin E.P.

Purified Water BP

Not Applicable.

48 Months (4 Years). The in-use shelf-life is 30 days after first opening.

Store below 30°C

A smooth white uniform cream with very few agglomerates in 10g, 15g and 30g
Aluminum Tube

No special precautions required.