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Logo STIEMYCIN Topical solution

SCHEDULING STATUS
S4

PROPRIETARY NAME
(and dosage form)

STIEMYCIN Topical solution

COMPOSITION
Stiemycin contains per 100 mL : 2g
erythromycin base

PHARMACOLOGICAL CLASSIFICATION
A13.12 Acne preparations.

PHARMACOLOGICAL ACTION
Erythromycin is a macrolide antibiotic. It interferes with bacterial protein synthesis by binding to the 50S subunit of ribosomes of sensitive organisms. Although the mechanism of action of Stiemycin in reducing inflammatory lesions of acne vulgaris has not been conclusively shown, it is presumably due to its antibiotic action on sensitive bacteria, and in reducing follicular porphyrin fluorescence and free fatty acid levels of skin lipids.

INDICATIONS
Stiemycin is indicated for the topical treatment of moderate acne vulgaris.

CONTRA-INDICATIONS
Patients with known hypersensitivity to erythromycin or other macrolide antibiotics or propylene glycol should not use Stiemycin.

In the event of irritation, stop using Stiemycin and consult your doctor.

WARNING
Avoid contact with eyes and other mucous membranes. This product is for external use only. Safety in pregnancy has not been established.

DOSAGE AND DIRECTIONS FOR USE
Apply Stiemycin, using the applicator on the bottle to the effected area twice daily after washing with soap and water.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Dryness, pruritus, erythema, desquamation and burning sensation have been reported.

Concomitant topical acne therapy should be used with caution because a cumulative irritant effect may occur, specially with the use of abrasive agents. The use of topical antimicrobial agents has been associated with the overgrowth of antibiotic-resistant organisms on the skin. Should this occur, administration should be discontinued and appropriate measures taken.

KNOWN SYMPTOMS OF OVERDOSAGE AND PRECAUTIONS OF ITS TREATMENT
In cases of accidental oral ingestion, treatment is symptomatic and supportive.

IDENTIFICATION
Clear, colourless, ethanolic solution.

PRESENTATION
Amber glass bottle of 25 mL capacity, fitted with a Dab-o-matic applicator neck plug and a polypropylene cap. The bottle is labelled with a self-adhesive label and presented in a carton with a package leaflet.

STORAGE INSTRUCTIONS
Store below 25°C. Keep out of reach of children. Avoid naked flame.

REGISTRATION NUMBER
X/13.12/275

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Stiefel Laboratories SA (Pty) Limited
20 Julbert Road, Benrose
Johannesburg 2094

DATE OF PUBLICATION
April 1991

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