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Logo SKINOREN ACNE CREAM

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

SKINOREN ACNE CREAM
Anti-acne agent

COMPOSITION
1 g cream contains micronised
azelaic acid (1,7-heptanedicarboxylic acid) 0,2 g (20%). The cream contains benzoic acid 0,2% w/w as a preservative.

PHARMACOLOGICAL CLASSIFICATION
A. 13.12 Acne preparations.

PHARMACOLOGICAL ACTION
The antimicrobial property of azelaic acid and a direct influence on follicular hyperkeratosis are assumed to be the basis for the therapeutic efficacy of Skinoren Acne Cream in acne.
Azelaic acid exerts an antibacterial effect on Propionibacterium acnes and causes a significant reduction of the colonisation density of Propionibacterium acnes. A significant reduction of the fraction of free fatty acids in the skin surface lipids also occurs.
In animal experiments azelaic acid inhibits the proliferation of cultivated keratinocytes (suppression of DNA synthesis) and accelerates the comedolysis of tetradecane-induced comedones. After treatment with Skinoren Acne Cream ultrastructural changes in particular of the keratohyaline granules and of filaggrin, an important factor in keratinisation occurred. These findings suggest that, under clinical conditions, Skinoren Acne Cream affects the keratinocytes and the pattern of keratinisation.
The amount of azelaic acid recovered in the viable epidermis and the corium increased with the time of exposure and was approximately 9,5% of the applied dose after 24 hours. Following topical application of 1 g azelaic acid (5 g Skinoren Acne Cream) to human volunteers 2,2% (+ 0,7%) of the dose was excreted as unchanged substance in the urine within 72 hours.

INDICATIONS
Topical treatment of mild to moderate acne vulgaris.

CONTRA-INDICATIONS
Hypersensitivity to Skinoren Acne Cream (propylene glycol).
Safety in pregnancy and lactation has not been established.

DOSAGE AND DIRECTIONS FOR USE
For external use only.
Before Skinoren Acne Cream is applied, the skin must be thoroughly cleansed with clear water or, if necessary, with a mild cleansing agent.
In general, Skinoren Acne Cream should be applied in adequate amounts to the affected areas of the skin twice a day (mornings and evenings) and should be rubbed in well. The amount of Skinoren Acne Cream to be applied will depend on the size of the affected area. As a guide, a daily dose of 2 g (1 g per application) will be sufficient for the treatment of the entire facial area (1 g = 4 cm cream). If other areas of acne, in addition to the face, require treatment, for example the chest and back, a daily dose of 10 g of cream should not, in general, be exceeded.
Patients with sensitive skin are advised to use Skinoren Acne Cream only once a day (in the evening) during the first week of treatment and then to continue it with two applications per day. If marked irritative reactions persist, the frequency of use should be reduced to one application per day until the symptoms of irritation regress, or the treatment should be interrupted temporarily.
The duration of use of Skinoren Acne Cream can vary from person to person and also depends on the severity of the acne. In general, a distinct improvement of the condition becomes apparent after about 4 weeks. To obtain the best results, Skinoren Acne Cream should be used regularly. Safety and efficacy have not been proven for more than 6 months.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Skinoren Acne Cream lacks the potential for bleaching hair and clothes.
Local skin irritation (eg reddening or scaling, itching and burning) may occur, usually at the start of treatment, but it usually regresses in the course of treatment.
Photosensitivity reactions have been reported.
Care must be taken that Skinoren Acne Cream does not come into contact with the eyes. If it does, the eyes should immediately be thoroughly rinsed with copious amounts of water.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Findings from animal experiments show that vomiting is possible on accidental ingestion of largish amounts. However, no organotoxic changes are likely.

IDENTIFICATION
White to slightly yellowish opaque cream.

PRESENTATION
Tubes of 30 g.

STORAGE INSTRUCTIONS
Store below 30°C. For shelf-life please refer to the imprint on the pack. Keep out of reach of children.

REGISTRATION NUMBER
W/13.12/228

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Schering (Pty) Ltd
(Reg No: 1964/009072/07)
106 Sixteenth Road
Randjespark
Midrand        1685
P O Box 5278
Halfway House        1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT
30 September 1992

SCHERING (PTY) LTD
(Reg No: 1964/009072/07)
Subsidiary of
Schering AG        Germany

Updated on this site: April 2003
Current: January 2005
Source: Pharmaceutical Industry

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