(and dosage form):
1 g Skinoren Gel contains 0,15 g (15% m/m) micronised azelaic acid and 0,001 g (0,1% m/m) benzoic acid as a preservative.
A. 13.12 Acne preparations.
The antimicrobial action of azelaic acid and a direct influence on follicular hyperkeratosis are assumed to be the basis for the therapeutic efficacy of Skinoren Gel in acne.
Clinically, a significant reduction in the colonisation density of Propionibacterium acnes and a significant reduction in the fraction of free fatty acids in the skin surface lipids is observed.
In vitro and in vivo, azelaic acid inhibits the proliferation of keratinocytes and normalises the disturbed terminal epidermal differentiation processes in acne. In the rabbit ear model azelaic acid accelerates the comedolysis of tetradecane-induced comedones.
Azelaic acid penetrates into all layers of the skin after topical application of the gel. Penetration is faster into damaged skin than into intact skin. A total of 3,6% of the dose applied is absorbed percutaneously after a single topical application of 1 g azelaic acid (5 g Skinoren Acne Cream). Clinical investigations in acne patients indicated similar absorption rates of azelaic acid from Skinoren Gel and cream.
A portion of the azelaic acid absorbed through the skin is excreted in unchanged form with the urine. The remaining portion is broken down by beta-oxidation into dicarboxylic acids with shorter chain length (C7, C5) which have likewise been found in the urine.
Mild to moderate acne vulgaris.
Hypersensitivity to any ingredient of the gel, in particular propylene glycol.
For external use only.
Care must be taken to prevent Skinoren Gel from coming into contact with the eyes. If it does, the eyes should immediately be rinsed with copious amounts of water.
Safety and efficacy of the use of Skinoren Gel on children has not been established.
DOSAGE AND DIRECTIONS FOR USE
Before Skinoren Gel is applied, the skin should be thoroughly cleaned with plain water, and dried. A mild skin-cleansing agent may be used.
Skinoren Gel should be applied sparingly to the affected skin areas twice a day (morning and evening) and rubbed gently into the skin. Approximately 0,5 g (= 2,5 cm) of gel is sufficient for the entire facial area.
It is important to use Skinoren Gel continuously over the entire period of treatment.
In the event of intolerable irritation of the skin (see Side effects), the amount of gel per application should be reduced or the frequency of use of Skinoren Gel should be reduced to once a day until the irritation ceases. If required, the treatment should be temporarily interrupted for a few days.
The duration of use of Skinoren Gel can vary from person to person and also depends on the severity of the acne. In general, a distinct improvement becomes apparent within 4 weeks. To obtain the best results, however, Skinoren Gel should be used over several months.
SIDE EFFECTS AND SPECIAL PRECAUTIONS
Skin and subcutaneous tissue disorders
Local skin irritation may occur usually at the start of treatment. Common undesirable effects (in descending order of frequency) include burning/stinging sensations, itching, reddening, skin dryness and scaling. Contact dermatitis and folliculitis are uncommon. In the majority of cases, the symptoms are mild and generally regress in the course of treatment.
Pregnancy and lactation
Embryotoxicity and teratogenicity studies in animals have not produced any evidence for a risk on use during pregnancy.
The amount of azelaic acid potentially transferred per day to the baby with the breast milk is negligible and should not imply any risk, particularly when the extremely low toxicity is considered.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Animal experimental studies into acute toxicity do not indicate that any risk of acute intoxication is to be expected following a single dermal or oral overdosage.
White to yellowish white opaque hydrogel.
Standard tubes with membrane closures and screw caps (tube material aluminium, internal coating done with epoxide, end seal band made of polyamide-based compound, external coating made of polyester, screw cap made of high density polyethylene) containing 5, 30 or 50 g.
Keep well closed. Store below 25°C. Keep out of reach of children.
NAME AND BUSINESS ADDRESS OF THE APPLICANT
Schering (Pty) Ltd
(Reg No: 1964/009072/07)
106 Sixteenth Road
P O Box 5278
Halfway House 1685
DATE OF PUBLICATION OF THIS PACKAGE INSERT
20 September 2002
SCHERING (PTY) LTD
(Reg No: 1964/009072/07)
Schering AG Germany
Updated on this site: January 2005
Source: Pharmaceutical Industry
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