DITHROCREAM Cream Ref.[27607] Active ingredients: Dithranol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: Diomed Developments Ltd, T/A Dermal Laboratories, Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR

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.

4.9. Overdose

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

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

50 g and 100 g membrane-sealed, epoxy resin-coated aluminium collapsible tubes with high density polyethylene white spiked screw caps, supplied as original packs (OP).

6.6. Special precautions for disposal and other handling

Not applicable.

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