Keep out of reach of children.
Read the directions carefully before use.
For prescriptions only.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient:
Erythromycin base ................................... 0.4% (w/w)
Excipients q.s …………………………………… 10 g
Dermal gel.
Product description: A gel-formed, colorless to yellowish, fragrant preparation.
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Anti-infectives for treatment of acne. ATC code: D10AF02.
The pathogenesis of acne combines several factors:
- Seborrheic hypersecretion (dependent on androgens).
- Retention of sebum, by abnormal keratinization of infra-infundibulum of pilosebaceous follicle, leading to the formation of comedones and microcysts.
- Inflammatory reaction induced by saprophytic germs (Propionibacterium acnes, Staphylococcus epidermis, etc.) and certain irritant components of sebum, leading to the formation of inflammatory papules, pustules and nodules.
Erythromycin is an antibiotic from the macrolide group. Local treatment of acne is to be active on Propionibacterium acnes (some rare cases of resistance of this germ have however been reported).
This antibacterial activity is accompanied by an anti-inflammatory reaction.
SPECTRUM OF ANTIBACTERIAL ACTIVITY
Critical concentrations separate susceptible strains from intermediate susceptibility strains and the latter from resistant ones:
S <1 mg / l and R> 4 mg / l
The prevalence of acquired resistance may vary geographically and with time for selected species and local information of resistance is desirable, particularly when treating severe infections. These data can only provide guidance on the probabilities of the sensitivity of a bacterial strain to this antibiotic.
The table below reflects the rate of drug resistance for some bacterial species in France:
| Categories | Frequency of resistance acquired in France (> 10%) (extreme values) |
|
SUSCEPTIBLE SPECIES Gram-positive aerobes Bacillus Cereus Corynebacterium diphtheriae Enterococci Rhodococcus equi Staphylococcus methicillin-S Staphylococcus methicillin-R* Streptococcus B Non-group Streptococcus Streptococcus pneumoniae Streptococcus pyogenes Gram-negative aerobes Bordetella pertussis Branhamella catarrhalis Campylobacter Legionella Moraxella Anaerobes Actinomyces Bacteroides Eubacterium Mobiluncus Peptostreptococcus Porphyromonas Prevotella Propionibacterium acnes Others Borrelia burgdorferi Chlamydia Coxiella Leptospires Mycoplasma pneumoniae Treponema pallidum MODERATELY SUSCEPTIBLE SPECIES (in vitro of intermediate susceptibilities) Gram-negative aerobes Haemophilus Neisseria gonorrhoeae Anaerobes Clostridium perfringens Others Ureaplasma urealyticum RESISTANT SPECIES Gram-positive aerobes Corynebacterium jeikeium Nocardia asteroides Gram-negative aerobes Acinetobacter Enterobacteria Pseudomonas Anaerobes Fusobacterium Others Mycoplasma hominis |
50 - 70 % 70 - 80 % 30 - 40 % 35 - 70 % 16 - 31 %
30 - 60 % 30 - 40 %
|
* The frequency of methicillin resistance is approximately 30 to 50% of all staphylococci and is mainly found in hospitals.
Note: This spectrum corresponds to that of the systemic forms of erythromycin. With local pharmaceutical presentations, the concentrations obtained in situ are much higher than the plasma concentrations. Some uncertainties remain on the kinetics of the in situ concentrations, on the local physicochemical conditions that can modify the antibiotic activity and on the stability of the product in situ.
Not applicable.
Not applicable.
Pregnancy
Data from a large number of patients who were treated with erythromycin systemically during their pregnancy indicate to date an absence of side effects on pregnancy or on fetus and newborn health.
Erythromycin can be used during pregnancy if necessary.
Breastfeeding
Erythromycin is excreted in breast milk in very small amounts because systemic exposure of breastfeeding women after dermal administration to erythromycin is negligible. To date, no effects on the breastfed child have been reported.
Erythromycin can be used during breastfeeding.
Do not apply to breasts while breastfeeding.
Cross-resistance may happen when using other antibiotics, particularly macrolides, clindamycin and lincomycin.
Skin and subcutaneous tissue disorders.
Not known: acute generalized exanthematous pustulosis (AGEP).
A feeling of skin dryness may appear at the start of treatment. Exceptionally, skin irritation and erythema have been reported.
A few rare cases of skin intolerance have been reported; they usually disappear with continued treatment.
Please inform your doctor of all undesirable effects upon drug administration.
Not applicable.
Store in dry places, not exceeding 30oC, protect from light.
Avoid contact with mucous membranes and open wounds.
If applied to mucous membranes, eyes, mouth, nostrils or on an open wound, rinse thoroughly with warm water.
Avoid washing too frequently, particularly with alkaline soaps that promote the sebum production.
Avoid the use of perfumes, toilet waters, etc., throughout the therapy.
Do not swallow.
Keep out of reach of children.
As with other macrolides, severe and rare allergic reactions, including acute generalized exanthematous pustulosis (AGEP), have been reported. If an allergic reaction occurs, administration of the medicine should be discontinued and appropriate treatment initiated. Physicians should be informed of the possibility of recurrence of allergic symptoms when symptomatic treatment is discontinued .
Excipients
Propylene glycol: Propylene glycol may cause skin irritation. Do not use this medicine in babies less than 4 weeks old with open wounds or large areas of broken or damaged skin (such as burns) without talking to your doctor or pharmacist.
Local treatment of acne, particularly polymorphic acne with an inflammatory component (papulopustular).
Official recommendations for the proper use of antibacterials should be considered.
Hypersensitivity to erythromycin or to the macrolide and to any of the excipients mentioned in this medicine.
Posology
One to two daily applications for three months.
Pediatric population: Not applicable.
Method of administration
For external use.
Clean your face with a non-alkaline and low-detergent soap. Rinse thoroughly. When the skin is dry, apply a drop of MEDSKIN ERY on the face and massage gently to penetrate.
Or as directed by the physician.
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