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Products

Silkaderm, 0.05 % solution

Drug formLiquid (for external use)

ATC categoryAgents for topical use. Dermatology

ATC subcategoryAgents for acne treatment

Brand nameSilkaderm

Generic nameTretinoin

Composition

Each ml contains:

active ingredient: tretinoin – 0.5 mg;
excipients: a-tocopheryl acetate(vitamin E), propylene glycol, ethanol 96%.

Pharmacological group and ATC code
Dermatologicaldrug, retinoid; D10AD01.

Pharmacology

Tretinoin is a retinoid and is the acid form of vitamin A.

Tretinoin is used primarily in the topical treatment of acne vulgaris when comedones, papules, and pustules predominate. It appears to stimulate mitosis and turnover of follicular epithelial cells and reduce their cohesiveness thereby facilitating the extrusion of existing comedones and preventing the formation of new ones. It also appears to have a thinning effect on the stratum corneum.

Pharmacokinetics
Absorption does not seem to occur to any great extent with topical use.

Uses
Silkaderm is used primarily in the topical treatment of acne vulgaris when comedones, papules, and pustules predominate.

Silkaderm is also used for the treatment of mottled hyperpigmentation, roughness, and fine wrinkling of photodamaged skin.

Dosage and administration
Silkaderm is applied topically to the skin. Patients should be instructed carefully in proper use of the drug, including associated precautions.

The skin should be cleansed to remove excessive oiliness and dried 15 to 30 minutes before applying tretinoin lightly, once or twice daily according to response and irritation; some patients may require less frequent applications. Other topical preparations (including skin moisturisers) should not be applied at the same time as tretinoin is applied, and caution is required if other local irritants are used concurrently. There may be apparent exacerbations of the acne during early treatment and a therapeutic response may not be evident for 6 to 8 weeks. When the condition has resolved maintenance therapy should be less frequent.

For the treatment of mottled hyperpigmentation, roughness, and fine wrinkling of photodamaged skin: it is applied once daily at night. Effects may not be seen until about 6 months after starting treatment.

Contraindications
Silkaderm is contra-indicated in pregnancy in breast-feeding mothers; women of child-bearing age must use effective contraception (oral progestogen-only contraceptives not considered effective). Silkaderm is contra-indicated in personal or familial history of cutaneous epithelioma.

Adverse effects

Tretinoin is a skin irritant. Topical application may cause transitory stinging and a feeling of warmth and in normal use it produces some erythema and peeling similar to that of mild sunburn. Sensitive individuals may experience oedema, blistering, and crusting of the skin. Excessive application can cause severe erythema, peeling, and discomfort with no increase in efficacy. Photosensitivity may occur. Temporary hypopigmentation and hyperpigmentation have been reported.

Precautions

Silkaderm should be avoided in severe acne involving large areas.

Contact with eyes, nostrils, mouth and mucous membranes, eczematous, broken or sunburned skin should be avoided. Silkaderm should be used with caution in sensitive areas such as the neck, and accumulation in angles of the nose should be avoided.

Exposure to UV light (including sunlight, solariums) should be avoided; if sun exposure is unavoidable, an appropriate sunscreen or protective clothing should be used. Use of Silkaderm with abrasive cleaners, comedogenic or astringent cosmetics should be avoided. Allow peeling (e.g. resulting from use of benzoyl peroxide) to subside before using a Silkaderm; alternating a preparation that causes peeling with a topical retinoid may give rise to contact dermatitis (reduce frequency of Silkaderm application).

Pediatric Precautions
Safety and efficacy of Silkaderm in pediatric patients younger than 18 years of age have not been established.

Geriatric Precautions
Safety and efficacy of Silkaderm in adults older than 50 years of age have not been established.

Drug interactions

Concomitant use of Silkaderm with other topical medications (especially those containing keratolytic agents such as sulfur, resorcinol, benzoyl peroxide, or salicylic acid) should be undertaken with caution because of the possibility of interactions. In patients who have used keratolytic agents, sufficient time should elapse for the effects of these drugs to subside before initiating Silkaderm therapy. Patients receiving Silkaderm therapy should not wash their faces more frequently than 2 or 3 times daily, using a mild, bland soap. Medicated or drying soaps and abrasive soaps and cleansers generally should not be used. Use of topical preparations with high concentrations of alcohol, menthol, spices, or lime such as shaving lotions, astringents, and perfume should be avoided, since they may cause stinging of treated skin, especially during initial therapy. Patients also should avoid the use of irritating cosmetics (e.g., toners, peeling [desquamating] agents), permanent wave solutions, electrolysis, or hair depilatories during topical Silkaderm therapy. Non-medicated cosmetics may be used by patients receiving Silkaderm therapy, but the areas to be treated should be cleansed thoroughly before Silkaderm is applied; medicated cosmetics should not be used.

Identification

A transparent, yellow liquid.

Presentation

30 ml of solution is filled into amber glass bottles (inside package).
The bottles are packed and inserted with the leaflet into cardboard boxes (outer package).

Expiry date

3 years. Do not use after the expiration date.

Prescription status

To be dispensed without prescription.

Storage conditions

Store at a room temperature, in a dry place, out of the reach of children. Protect from light.