Fucidin H Ointment

1. Name Of The Medicinal Product

Fucidin^® H Ointment

2. Qualitative And Quantitative Composition

Fucidin^® H Ointment contains Sodium Fusidate Ph. Eur. 2% and Hydrocortisone Acetate Ph.Eur. 1%.

3. Pharmaceutical Form

Ointment for topical administration.

4. Clinical Particulars

4.1 Therapeutic Indications

Fucidin^® H Ointment is indicated in eczema and dermatitis with secondary bacterial infections, including atopic eczema, primary irritant dermatitis and allergic and seborrhoeic dermatitis where the organisms responsible are known to be or believed to be sensitive to fusidic acid.

4.2 Posology And Method Of Administration

Adults and Children: Uncovered lesions – a small quantity should be applied to the affected area twice daily until a satisfactory response is obtained. A single treatment course should not normally exceed 2 weeks.

Covered lesions - less frequent applications may be adequate.

4.3 Contraindications

Hypersensitivity to fusidic acid and its salts. As with other topical corticosteroid preparations, Fucidin^® H Ointment is contra-indicated in primary bacterial, viral and fungal skin infections, skin manifestations in relation to tuberculosis or syphilis, perioral dermatitis and rosacea.

4.4 Special Warnings And Precautions For Use

Fucidin^® H Ointment should not be used in or near the eye as sodium fusidate causes conjunctival irritation.

Bacterial resistance has been reported to occur with the use of fusidic acid applied topically. As with all topical antibiotics, extended or recurrent application may increase the risk of contact sensitisation and the development of antibiotic resistance.

Steroid-antibiotic combinations should not be continued for more than 7 days in the absence of any clinical improvement since in this situation occult extension of the infection may occur due to the masking of the steroid. Similarly, steroids may also mask hypersensitivity reactions.

As Fucidin^® H Ointment contains a corticosteroid it is not recommended in the following conditions: atrophic skin, cutaneous ulcer, acne vulgaris, fragile skin veins and perianal and genital pruritus. Contact with open wounds and mucous membranes should be avoided. As with all corticosteroids, prolonged use on the face should be avoided.

In infants and children, long-term continuous topical therapy with corticosteroids should be avoided. Adrenal suppression can occur even without occlusion.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

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. Animal studies and many years of clinical experience have suggested that fusidic acid is devoid of teratogenic effect. There is evidence to suggest that when given systemically, fusidic acid can penetrate the placental barrier. The use of topical Fucidin^® in pregnancy requires that the potential benefits be weighed against the possible hazards to the foetus.

Safety in nursing mothers has not been established.

When fusidic acid (as the sodium salt) has been given systemically, levels have been detected in breast milk, but with topical use the possible amount of drug present is unlikely to affect the infant.

4.7 Effects On Ability To Drive And Use Machines

Not known.

4.8 Undesirable Effects

Very common > 1/10

Common > 1/100 and < 1/10

Uncommon > 1/1,000 and < 1/100

Rare > 1/10,000 and < 1/1,000

Very rare < 1/10,000

The most frequently reported undesirable effects on Fucidin^® H are various symptoms of application site irritation. Allergic reactions have been reported.

Based on clinical data for Fucidin^® H approximately 5% of patients can be expected to experience an undesirable effect. Pruritus, skin irritation, skin rash, worsening of eczema, transient stinging and burning sensation were uncommon.

Although it has not been observed in the clinical studies for Fucidin^® H, topical use of steroids may result in skin atrophy, telangiectasia or skin striae, especially during prolonged application.

As with all other corticosteroids folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation and systemic activity, although rare, may occur.

Based on post-marketing data the total 'reporting rate' of undesirable effect is very rare being approximately 1:1,000,000 treatment courses.

The undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported.

•Skin and subcutaneous tissue disorders

Pruritus

Skin irritation

Skin burning sensation

Skin stinging sensation

Rash

Eczema aggravated

•Immune system disorders

Allergic reaction

4.9 Overdose

Acute overdosage is very unlikely to occur. However, chronic overdosage or misuse may result in increased risk of topical or systemic side effects.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Fucidin^® H Ointment combines the potent topical antibacterial action of fusidic acid with the anti-inflammatory and antipruritic effects of hydrocortisone. Concentrations of 0.03 - 0.12 microgram fusidic acid per ml inhibit nearly all strains of staphylococcus aureus. Topical application of fusidic acid is also effective against streptococci, corynebacteria, neisseria and certain clostridia.

5.2 Pharmacokinetic Properties

There are no data which define the pharmacokinetics of Fucidin^® H Ointment following topical administration in man.

However, in vitro studies show that fusidic acid can penetrate intact human skin. The degree of penetration depends on factors such as the duration of exposure to fusidic acid and the condition of the skin. Fusidic acid is excreted mainly in the bile with little excreted in the urine.

Hydrocortisone is absorbed following topical administration. The degree of absorption is dependent on various factors including skin condition and site of application. Absorbed hydrocortisone is extensively metabolised and rapidly eliminated in the urine.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Cetyl alcohol, lanolin, white soft paraffin, liquid paraffin.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Aluminium tubes of 30 gram and 60 gram.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

LEO Laboratories Limited

Longwick Road

Princes Risborough

Bucks

HP27 9RR

8. Marketing Authorisation Number(S)

PL 0043/5012R

9. Date Of First Authorisation/Renewal Of The Authorisation

24 October 1986 / 24 October 1991

10. Date Of Revision Of The Text

October 2005

11. Legal Category

POM