This information is intended for use by health professionals

1. Name of the medicinal product

DITHROCREAM™

2. Qualitative and quantitative composition

Dithranol 0.1%, 0.25%, 0.5%, 1.0% or 2.0% w/w.

3. Pharmaceutical form

Yellow aqueous cream.

4. Clinical particulars
4.1 Therapeutic indications

For the topical treatment of subacute and chronic psoriasis including psoriasis of the scalp.

4.2 Posology and method of administration

Dithranol therapy customarily involves titrating the concentration applied to skin to suit individual patient's circumstances. Dithrocream is, therefore, available in five strengths. The different packs are colour coded as follows:

0.1%

pale blue

0.25%

red

0.5%

purple

1.0%

brown

2.0%

yellow

For adults and the elderly: It is important to determine each patient's optimal treatment strength, as too high a strength may induce a burning sensation. Where the response to Dithrocream has not previously been established, always commence with Dithrocream 0.1%, continuing for at least one week and then, if necessary, increase to the 0.25% followed by the 0.5%, the 1.0% and finally the 2.0% strength. The aim should be to build up gradually over approximately 4 weeks to the highest tolerated strength to produce the optimum therapeutic effect. This optimum concentration will depend upon such factors as the thickness and location of the psoriatic plaques, as well as the variation between individual patients in their reaction to dithranol.

Dithrocream should be applied sparingly, and only to the affected areas, once every 24 hours, at any convenient time of the day or evening. Rub the cream gently and carefully into the skin until completely absorbed. For use on the scalp, first comb the hair to remove scalar debris and, after suitably parting, rub the cream well into the affected areas. Remove by washing off the skin or scalp, usually no more than one hour after application (Short Contact Therapy). Alternatively, it may be applied at night before retiring and washed off in the morning.

Treatment should be continued until the skin is entirely clear, i.e. when there is nothing to feel with the fingers and the texture is normal. By gradually increasing the strength of cream applied, it should be possible to clear psoriasis patches within 4 to 6 weeks.

For children No additional special precautions necessary. However, use cautiously as described above for adults and the elderly, with regular supervision.

4.3 Contraindications

Not to be used on the face, or for acute or pustular psoriasis.

Not to be used in cases of sensitivity to any of the ingredients.

4.4 Special warnings and precautions for use

Dithrocream 0.5%, Dithrocream 1.0% and Dithrocream 2.0% should only be used for those patients who have failed to respond to lower strengths of dithranol. Dithrocream 1.0% and 2.0% should normally only be applied for 'short contact' periods.

Dithrocream 0.5%, Dithrocream 1.0% and Dithrocream 2.0% should always be used under medical supervision.

It is most important to avoid applying an excessive amount of the cream, which may cause unnecessary soiling and staining of the clothing and/or bed linen. After each period of treatment, a bath/shower should be taken to remove any residual cream. To prevent the possibility of discolouration, particularly where Dithrocream 1.0% or 2.0% has been used, always rinse the bath/shower with hot water immediately after washing/showering and then use a suitable cleanser to remove any deposit on the surface of the bath/shower.

After use on the scalp, a shampoo may be used to remove the Dithrocream residue. Great care must be taken when washing out the shampoo (which may contain some Dithrocream residue), to ensure that it does not get into the eyes or on the face. This is particularly important when the higher strengths of Dithrocream have been used.

Although a feeling of warmth at the application site is normal, if this amounts to a burning sensation, or if the lesions spread, treatment should be stopped at once, and the dosage re-evaluated by a doctor.

Dithrocream is not normally recommended for use on areas of folded skin such as the groin and beneath the breasts. Do not use high strengths on these sites.

Keep away from the eyes and mucous membranes.

Always wash the hands after use.

As long term use of topical corticosteroids is known to destabilise psoriasis, and withdrawal may give rise to a rebound phenomenon, an interval of at least one week should be allowed between the discontinuance of such steroids and the commencement of Dithrocream therapy. A suitably bland emollient may usefully be applied in the intervening period.

The excipients, chlorocresol and cetostearyl alcohol may on rare occasions give rise to allergic or local skin reactions (eg. contact dermatitis) in sensitive people.

Contact with fabrics, plastics and other materials may cause permanent staining and should be avoided.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Pregnancy and lactation

Although there is no experimental evidence to support the safety of the drug in pregnancy or during lactation, no adverse effects have been reported.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Some skin irritation and/or a feeling of warmth at the site of application is normally associated with dithranol therapy. Dithrocream applied at too high a strength or left in contact with the skin for too long may induce a burning sensation.

Dithrocream may cause temporary staining of the skin and/or hair.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal products 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.

4.9 Overdose

Dithranol is a cathartic (laxative) and if accidentally swallowed, it should be removed by gastric lavage and supportive treatment given.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Dithranol has been used in the treatment of sub-acute and chronic psoriasis for over 70 years and, during that time, it has become established as a safe and effective form of therapy. Its precise mode of action is still to be confirmed, although it has been shown to inhibit DNA replication, cellular respiration and key cellular enzymes eg glucose-6-phosphate dehydrogenase.

Because dithranol causes staining and irritation, it is now widely used in short contact therapy where the preparation is washed off the skin after periods of one hour or less. For this purpose, Dithrocream is particularly suitable, as it is convenient to apply and washes off easily in a bath or shower.

5.2 Pharmacokinetic properties

The traditional formulations of dithranol are based on soft paraffin from which it is effectively released into the skin. In Dithrocream, during manufacture, the oily paraffin phase of the cream is heated until the dithranol entirely dissolves so that, on cooling, it is retained solely within the paraffin phase and does not spread into the aqueous phase. After application of Dithrocream to the skin, the water is lost through absorption and evaporation, leaving the oily phase which then acts in the same way as a dithranol ointment. However, since the cream may be rubbed into the skin more effectively than the ointment, it is convenient to apply and, owing to the presence of the emulsifying components, is easier to wash off.

The availability of the dithranol has now been confirmed in numerous publications detailing the results of clinical trials.

5.3 Preclinical safety data

No special information.

6. Pharmaceutical particulars
6.1 List of excipients

White Soft Paraffin; Cetostearyl Alcohol; Salicylic Acid; Ascorbic Acid; Sodium Laurilsulfate; Chlorocresol; Purified Water.

Dithrocream 2.0% also contains Liquid Paraffin.

6.2 Incompatibilities

None known.

6.3 Shelf life

48 months.

6.4 Special precautions for storage

Do not store above 25°C. Replace cap tightly after use.

6.5 Nature and contents of container

All strengths of Dithrocream are supplied in collapsible tubes containing 50 g. These are supplied as original packs (OP).

6.6 Special precautions for disposal and other handling

Not applicable.

7. Marketing authorisation holder

Dermal Laboratories

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK.

8. Marketing authorisation number(s)

Dithrocream 0.1%

00173/0029

Dithrocream 0.25%

00173/0028

Dithrocream 0.5%

00173/0027

Dithrocream 1.0%

00173/0039

Dithrocream 2.0%

00173/0045

9. Date of first authorisation/renewal of the authorisation

31 July 2008.

10. Date of revision of the text

October 2014.