Trimovate

1. Name Of The Medicinal Product

Trimovate Cream

Trimovate

Clobetasone Butyrate

2. Qualitative And Quantitative Composition

Trimovate Cream is a yellow water-miscible cream containing clobetasone butyrate 0.05% w/w, oxytetracycline 3.0% w/w as calcium oxytetracycline and nystatin 100,000 units per gram.

3. Pharmaceutical Form

Cream for topical administration.

4. Clinical Particulars

4.1 Therapeutic Indications

Clobetasone butyrate is a topically active corticosteroid which provides an exceptional combination of activity and safety. Topical formulations have been shown to be more effective in the treatment of eczemas than 1% hydrocortisone, yet to have little effect on hypothalamic-pituitary-adrenal function.

The combination of the topically active antibiotics, nystatin and oxytetracycline, provides a broad spectrum of antibacterial and anticandidal activity against many of the organisms associated with infected dermatoses. Trimovate is indicated for the treatment and management of steroid responsive dermatoses where candidal or bacterial infection is present, suspected or likely to occur and the use of a more potent topical corticosteroid is not required. These include infected eczemas, intertrigo, napkin rash, anogenital pruritius and seborrhoeic dermatitis.

4.2 Posology And Method Of Administration

Apply to the affected area up to four times a day.

Suitable for treating infants, children and adults.

4.3 Contraindications

Primary cutaneous infections caused by viruses (e.g. herpes simplex, chickenpox) fungi and bacteria. Secondary infections due to dermatophytes, Pseudomonas or Proteus species.

Hypersensitivity to the preparation.

4.4 Special Warnings And Precautions For Use

Although generally regarded as safe, even for long term administration in adults, there is a potential for overdosage, and in children this may result in adrenal suppression. Extreme caution is required in dermatoses in such patients and treatment should not normally exceed seven days. In infants, the napkin may act as an occlusive dressing, and increase absorption.

If infection persists, systemic chemotherapy is likely to be required: Any spread of infection requires withdrawal of topical corticosteroid therapy. 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. Do not continue for more than seven days in the absence of clinical improvement, since occult extension of infection may occur due to the masking effect of the steroid.

As with all corticosteroids, prolonged application to the face is undesirable. If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as glaucoma might result.

Trimovate may cause slight staining of hair, skin or fabric, but this can be removed by washing. The application may be covered with a non-occlusive dressing to protect clothing.

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

Products which contain antimicrobial agents should not be diluted.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None reported.

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 fetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human fetus.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Local hypersensitivity reactions such as erythema, rash, pruritus, urticaria, local skin burning and allergic contact dermatitis may occur at the site of application and may resemble symptoms of the condition under treatment..

In the unlikely event of signs of hypersensitivity appearing, application should be stopped immediately.

If large areas of the body were to be treated with Trimovate, it is possible that some patients would absorb sufficient steroid to cause transient adrenal suppression despite the low degree of systemic activity associated with clobetasone butyrate.

Local atrophic changes could possibly occur in situations where moisture increases absorption of clobetasone butyrate, but only after prolonged use.

There are reports of pigmentation changes and hypertrichosis with topical steroids. Exacerbation of underlying symptoms may occur with extensive use.

4.9 Overdose

Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse the features of hypercortisolism may appear.

In this situation topical steroids should be reduced or discontinued gradually under medical supervision because of the risk of adrenal insufficiency

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Clobetasone butyrate is a topically active corticosteroid.

Clobetasone butyrate is less potent than other available corticosteroid preparations and has been shown not to suppress the hypothalamo-pituitary-adrenal axis in patients treated for psoriasis or eczema. Pharmacological studies in man and animals have shown that clobetasone butyrate has a relatively high level of topical activity accompanied by a low level of systemic activity.

The use of nystatin in the local treatment of candidal infections of the skin and of the tetracyclines in localised bacterial infections is well known. Nystatin is included in Trimovate at the standard concentration recommended by the British Pharmaceutical codex for the topical preparation nystatin ointment (100,000 units/g) and oxytetracycline calcium is included at a concentration to give approximately the same level of activity as recommended for Oxytetracycline Ointment BPC (3.0% w/w).

The principle action of the preparation is based on the anti-inflammatory activity of the corticosteroid. The broad spectrum antibacterial and anti-candidal activity provided by the combination of oxytetracycline and nystatin allow this effect to be utilised in the treatment of conditions which are or are likely to become infected.

5.2 Pharmacokinetic Properties

Trimovate has been shown to have a satisfactory pharmacokinetic profile by many years of successful clinical experience.

5.3 Preclinical Safety Data

No additional data of relevance.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Titanium dioxide, glyceryl monostearate, cetostearyl alcohol, soft paraffin white, polyoxyl 40 stearate, dimeticone 20, glycerol, chlorocresol, sodium metabisulphite, sodium acid phosphate, disodium hydrogen phosphate anhydrous, purified water.

6.2 Incompatibilities

None reported.

6.3 Shelf Life

18 months.

6.4 Special Precautions For Storage

Store below 25C.

6.5 Nature And Contents Of Container

Collapsible latex banded aluminium tube, internally coated with epoxy resin based lacquer with polypropylene cap.

6.6 Special Precautions For Disposal And Other Handling

None stated.

Administrative Data

7. Marketing Authorisation Holder

Glaxo Wellcome UK Ltd trading as GlaxoSmithKline UK,

Stockley Park West,

Uxbridge, Middlesex.

UB11 1BT.

8. Marketing Authorisation Number(S)

PL 10949/0040

9. Date Of First Authorisation/Renewal Of The Authorisation

29 May 2002

10. Date Of Revision Of The Text

14 February 2007

11. Legal Category

POM.