SOLARAZE ® Diclofenac

SOLARAZE ® is a drug based on Diclofenac sodium

THERAPEUTIC GROUP: Other dermatological preparations

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications SOLARAZE ® Diclofenac

SOLARAZE ® is used in the treatment of actinic keratosis.

Mechanism of action SOLARAZE ® Diclofenac

Actinic keratosis, also called solar keratosis, is a dermatological pathology characterized by the presence of patches of the maximum size of one cm, scaly, yellowish, rough and sometimes surrounding telangiectasias.

The pathogenesis, not yet fully known, sees ultraviolet radiation as the main cause, so that the sites in which these lesions are observed are those chronically exposed to the sun, such as the face, scalp, cheeks, face, hands and ears.

One of the potential therapeutic applications for this precancerous disease, although not yet supported by clear and defined molecular mechanisms, involves the topical use of non-steroidal anti-inflammatory drugs and more precisely of 3% diclofenac, which proved effective in reducing the progression and incidence of complications.

The main therapeutic mechanism of diclofenac, also in this case, is determined by the inhibitory action exerted on cyclooxygenases, and by the relative reduction of prostaglandin concentrations involved in the pathogenesis of actinic keratosis.

Studies carried out and clinical efficacy

1. THE MOLECULAR MECHANISMS OF DICLOFENAC IN ATTINIC KERATOSIS

Br J Dermatol. 2007 May; 156 Suppl 3: 25-33.

Study that seeks to clarify the molecular mechanisms underlying the therapeutic activity of non-steroidal anti-inflammatory drugs in the treatment of actinic keratosis. In addition to the anti-inflammatory action, this active ingredient appears to carry out a direct apoptotic action against hyperplastic keratinocytes.

2. DICLOFENAC AND PHOTOTOSSICITY

Eur J Dermatol. 2006 Jul-Aug; 16 (4): 385-90.

Work demonstrating that the application of 3% diclofenac in hyaluronate together with that of sun filters does not induce phototoxic or photosensitizing reactions. This is very important given the role of UV in the pathogenesis of actinic keratosis.

3. SOLARAZE ® And contact dermatitis

Contact Dermatitis. 2004 Oct; 51 (4): 215-6.

Study demonstrating the allergenic power of some excipients present in SOLARAZE. Unfortunately this reaction, characterized by the presence of contact dermatitis, significantly limits the topical use of diclofenac, reducing its therapeutic efficacy.

Method of use and dosage

SOLARAZE ®

Topical gel with 3% diclofenac sodium (equal to 30 mg of active ingredient per gram of gel)

The therapeutic treatment of solar keratoses involves taking 3% diclofenac twice a day for at least 30 days, applying a sufficient amount of gel to cover the affected area.

To favor absorption it is necessary to gently massage the part, avoiding to damage the scales.

Treatment should be supervised by your doctor

Warnings SOLARAZE ® Diclofenac

Treatment with SOLARAZE ® should be supervised by your doctor, so that the latter can assess the effectiveness and safety of the therapy put in place.

The patient should avoid contact of the drug with the eyes, mucous membranes and any injured areas, in order to minimize the systemic absorption of the active ingredient and the appearance of side effects.

It is also useful for the patient not to be exposed to the sun during the treatment.

The presence in SOLARAZE of excipients such as benzyl alcohol and sodium hyaluronate could increase the risk of allergic reactions especially in atopic patients.

PREGNANCY AND BREASTFEEDING

The absence of studies related to the side effects of topical diclofenac on fetal health and those known to be associated with oral intake, also extend the contraindications to pregnancy and the subsequent breastfeeding period.

Interactions

The reduced systemic absorption that is observed following the topical application of diclofenac, allows to dramatically limit the possible drug interactions with other active ingredients, making the use of SOLARAZE ® as safe.

Contraindications SOLARAZE ® Diclofenac

The use of SOLARAZE ® is contraindicated in patients who are hypersensitive to the active ingredient or to one of its excipients, as well as to salicylates and any other type of non-steroidal anti-inflammatory drug.

Undesirable effects - Side effects

Topical administration of SOLARAZE ® may be associated with the appearance of local reactions such as hives, skin rash, conjunctivitis and contact dermatitis.

Only rarely have clinically relevant side effects been observed, for which it was necessary to discontinue therapy.