(and dosage form)
Each pledget contains 16 mg of erythromycin.
Alcohol contents per swab 66% v/v
A.20.1.6 Topical antibiotics
Erythromycin is a broad spectrum antibiotic produced from a strain of Streptomyces erythreus.
The exact mechanism by which erythromycin reduces lesions of acne vulgaris is not fully known. However, the effect appears to be due in part to the antibacterial activity of the drug.
ERYCETTE pledgets are indicated for the topical treatment of moderate acne vulgaris.
ERYCETTE is contra-indicated in those individuals who have shown hypersensitivity to any of its components.
The safe use of ERYCETTE pledgets during pregnancy or lactation has not been established.
Pseudomembranous colitis has been reported with nearly all antibacterial agents including erythromycin and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea subsequent to the administration of antibacterial agents.
Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of "antibiotic-associated colitis".
After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis.
Safety and effectiveness of this product in children have not been established.
DOSAGE AND DIRECTIONS FOR USE
The ERYCETTE pledget should be rubbed over the affected area twice a day after the skin has been washed thoroughly with warm water and soap and patted dry. Acne lesions on the face, neck, shoulder, chest and back may be treated in this manner. Additional pledgets may be used if needed. Each pledget should be used once and discarded.
This medication is for external use only. Avoid contact with eyes, nose, mouth and all mucous membranes. Do not use if sachets are damaged.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
The following local side-effects have been reported occasionally: peeling, dryness, itching, erythema, and oiliness. Irritation of the eyes and tenderness of the skin have also been reported with topical use of erythromycin. Generalised urticarial reactions, possibly related to the use of erythromycin, which required systemic steroid therapy, have been reported.
ERYCETTE pledgets are for topical use only and not for ophthalmic use. Concomitant topical acne therapy should be used with caution because a cumulative irritant effect may occur, especially with the use of peeling, desquamating or abrasive agents. Avoid contact with eyes and all mucous membranes.
The use of antimicrobial agents may be associated with overgrowth of the antibiotic-resistant organisms. If this occurs, discontinue use and take appropriate measures.
Each pledget foil pouch contains a moist, rectangular, thin, white polypropylene/polyester pad filled to contain 0,8 mL colourless solution.
ERYCETTE pledgets are available in boxes of 60 sachets.
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF THE APPLICANT
JANSSEN PHARMACEUTICA (PTY) LTD (Reg. No. 80/11122/07)
15th Road, Halfway House 1685
DATE OF PUBLICATION OF THIS PACKAGE INSERT
|7 July 1988.
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