4.1. Therapeutic indications

Betamethasone/neomycin skin preparations are indicated for the treatment of the following conditions where secondary bacterial infection is present, suspected, or likely to occur: eczema in adults and children (aged 2 years and over), including atopic and discoid eczema; prurigo nodularis; psoriasis (excluding widespread plaque psoriasis); neurodermatoses including lichen simplex and lichen planus; seborrhoeic dermatitis; contact sensitivity reactions; insect bite reactions; and anal and genital intertrigo.

4.2. Posology and method of administration

Posology

The cream is especially appropriate for moist or weeping surfaces, and the ointment is especially appropriate for dry, lichenified or scaly lesions, but this is not invariably so.

Adults

In adults, in the more resistant lesions, such as the thickened plaques of psoriasis on elbows and knees, the effects of this medicinal product can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response in such lesions, thereafter improvement can usually be maintained by regular application without occlusion.

Treatment should not be continued for more than 7 days without medical supervision.

Adults and children aged 2 years and over:

A small quantity should be applied to the affected area two or three times daily until improvement occurs. It may then be possible to maintain improvement by applying once a day, or even less often.

Betamethasone/neomycin skin preparations are suitable for use in children (2 years and over) at the same dose as adults. When used in children, courses should be limited to 5 days, if possible.

A possibility of increased absorption exists in very young children; thus this medicinal product is not recommended for use in neonates and infants younger than 2 years of age (see section 4.3 and section 4.4).

Dosage in renal impairment

Dosage should be reduced in patients with reduced renal function (see section 4.4).

Elderly

Betamethasone/neomycin skin preparations are suitable for use in the elderly. Caution should be exercised in cases where a decrease in renal function exists and significant systemic absorption of neomycin sulfate may occur (see section 4.4).

Method of administration

For topical administration.

4.3. Contraindications

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

- Rosacea.

- Acne vulgaris.

- Perioral dermatitis.

- Pruritus without inflammation

- Perianal and genital pruritus.

- Primary cutaneous viral infections (e.g. herpes simplex, chickenpox).

- Use is not indicated in treatment of primary infected skin lesions caused by infection with fungi or bacteria; primary or secondary infections due to yeast; or secondary infections due to Pseudomonas or Proteus species.

- Dermatoses in children under 2 years of age, including dermatitis and napkin eruptions. A possibility of increased absorption exists in very young children; thus, this medicinal product is not recommended for use in neonates and infants (up to 2 years). In neonates and infants, absorption by immature skin may be enhanced, and renal function may be immature.

- Preparations containing neomycin should not be used for the treatment of otitis externa when the ear drum is perforated, because of the risk of ototoxicity.

- Due to the known ototoxic and nephrotoxic potential of neomycin sulfate, the use of Betamethasone/Neomycin skin preparations in large quantities or on large areas for prolonged periods of time is not recommended in circumstances where significant systemic absorption may occur.

4.4. Special warnings and precautions for use

Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression

Manifestations of hypercortisolism (Cushing's syndrome) and reversible hypothalamic-pituitary-adrenal (HPA) axis suppression can occur in some individuals as a result of increased systemic absorption of topical corticosteroids. In this situation, topical steroids should be discontinued gradually under medical supervision because of the risk of adrenal insufficiency (see section 4.8 and section 4.9).

Infection

If infection persists, systemic chemotherapy is required.

Withdraw topical corticosteroid if there is a spread of infection.

Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and the skin should be cleansed before a fresh dressing is applied.

Application to the Face

Avoid prolonged application to the face. The face, more than other areas of the body, may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids. This must be borne in mind when treating such conditions as psoriasis, discoid lupus erythematosus and severe eczema.

Application to the Eyelids

If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as cataract and glaucoma might result from repeated exposure. If Betamethasone/Neomycin Ointment does enter the eye, the affected eye should be bathed in copious amounts of water.

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Chronic leg ulcers

Topical corticosteroids are sometimes used to treat the dermatitis around chronic leg ulcers. However, this use may be associated with a higher occurrence of local hypersensitivity reactions and an increased risk of local infection.

Paediatric population

In comparison with adults, children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects.

If used in childhood, or on the face, courses should be limited to five days and occlusion should not be used.

Use in Psoriasis

Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses, development of tolerance, risk of generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis careful patient supervision is important.

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.

Extended or recurrent application may increase the risk of contact sensitisation.

Extension of infection may occur due to the masking effect of the steroid.

Following significant systemic absorption, aminoglycosides such as neomycin can cause irreversible ototoxicity; and neomycin has nephrotoxic potential.

Renal impairment

In renal impairment the plasma clearance of neomycin is reduced (see Dosage in renal impairment, section 4.2).

Dilution

Products which contain antimicrobial agents should not be diluted.

Fire hazard in contact with dressings, clothing and bedding

Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

The label will state strong steroid.

4.5. Interaction with other medicinal products and other forms of interaction

Following significant systemic absorption, neomycin sulfate can intensify and prolong the respiratory depressant effects of neuromuscular blocking agents.

Co-administered drugs that can inhibit CYP3A4 (e.g. ritonavir, itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure. The extent to which this interaction is clinically relevant depends on the dose and route of administration of the corticosteroids and the potency of the CYP3A4 inhibitor.

4.6. Fertility, pregnancy and lactation

There is little information to demonstrate the possible effect of topically applied neomycin in pregnancy and lactation. However, neomycin present in maternal blood can cross the placenta and may give rise to a theoretical risk of foetal toxicity, thus use of this medicinal product is not recommended in pregnancy or lactation.

4.7. Effects on ability to drive and use machines

Betamethasone/neomycin skin preparations has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: 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), including isolated reports and not known (cannot be estimated from available data).

Post-marketing data

Infections and infestation

Very rare

Opportunistic infection

Immune system disorders

Very rare

Hypersensitivity, generalised rash

Endocrine Disorders

Very rare

Hypothalamic-pituitary adrenal (HPA) axis suppression

Cushingoid features (e.g. moon face, central obesity), delayed weight gain/growth retardation in children, osteoporosis, glaucoma, hyperglycaemia/glucosuria, cataract, hypertension, increased weight/obesity, decreased endogenous cortisol levels, alopecia, trichorrhexis

Skin and Subcutaneous Tissue Disorders

Common

Pruritus, local skin burning /skin pain

Very rare

Allergic contact dermatitis /dermatitis, erythema, rash, urticaria, pustular psoriasis, skin thinning* / skin atrophy*, skin wrinkling*, skin dryness*, striae*, telangiectasias*, pigmentation changes*, hypertrichosis, exacerbation of underlying symptoms

Not known

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)

General Disorders and Administration Site Conditions

Very rare

Application site irritation/pain

*Skin features secondary to local and/or systemic effects of hypothalamic-pituitary adrenal (HPA) axis suppression.

Eye disorders

Not known

Vision, blurred (see also section 4.4)

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 in the Google Play or Apple App Store.

4.9. Overdose

Acute overdosage is very unlikely to occur. However, in the case of chronic overdosage or misuse the features of Cushing's syndrome may appear and, in this situation, topical steroids should be discontinued gradually under medical supervision (see Section 4.4 Special Warnings and Precautions for use).

Also, consideration should be given to significant systemic absorption of neomycin sulfate (see 4.4 Special Warnings and Precautions for Use). If this is suspected, use of the product should be stopped and the patient's general status, hearing acuity, renal and neuromuscular functions should be monitored.

Blood levels of neomycin sulfate should also be determined. Haemodialysis may reduce the serum level of neomycin sulfate.