INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ILOTYCIN T.S. (Solution)

SCHEDULING STATUS:
Schedule 4

PROPRIETARY NAME
(and dosage form):

ILOTYCIN T.S. (Solution)

COMPOSITION:
Each mL of ILOTYCIN T.S. (erythromycin topical solution) contains 20 mg of
erythromycin base. The alcohol 95% content is 70% v/v.

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.6 Topical Antibiotics

PHARMACOLOGICAL ACTION:
Erythromycin is a broad spectrum antibiotic produced from a strain ofStreptomyces erythraeus and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids.
Erythromycin inhibits bacterial protein synthesis without affecting nucleic acid synthesis.

INDICATIONS:
ILOTYCIN T.S. is indicated for the treatment of the following grades of acne vulgaris (primary grades II and III) in which comedones, papules and pustules predominate. This preparation is not recommended for deep, cystic nodular varieties (acne conglobata).

CONTRA-INDICATIONS:
This drug is contra-indicated in patients with a history of hypersensitivity to erythromycin.

WARNINGS:
Usage in pregnancy: The safety of this preparation in pregnant women has not been established.

DOSAGE AND DIRECTIONS FOR USE:
ILOTYCIN T.S. should be applied to the affected area twice a day after the skin is thoroughly washed with warm water and soap. Apply ILOTYCIN T.S. over entire facial area using the "Dab-O-Matic" applicator. Acne lesions on the neck, shoulder, chest and back may also be treated in this manner.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The use of antimicrobial agents may be associated with the overgrowth of antibiotic-resistant organisms; in such a case, antibiotic administration should be stopped and appropriate measures taken.
As with any other medicament intended for topical use, there is always the possibility that primary irritation or allergic contact dermatitis will develop in certain individuals. However, previous experience with ointment preparations of ILOTYCIN indicates that such occurrences are rare, and the incidence with this formulation is less than 1%.
ILOTYCIN T.S. is for external use only. It should not be used in the eyes. Do not let the solution get into the eyes.

IDENTIFICATION:
ILOTYCIN T.S. (Solution) is a clear, colourless, alcoholic solution.

PRESENTATION:
ILOTYCIN T.S. (Solution) is supplied in bottles containing 50 mL.

STORAGE INSTRUCTIONS:
Store at 15-25°C in tightly closed containers.
Keep out of reach of children.

REGISTRATION NUMBER:
M/20.1.6/80

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Quatromed Limited
10 Lindley Street
Bethlehem
Free State

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
21 July 1980

Pro-Print PPI062.0

Updated on this site: December 1999

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996,1997,1998