Erythromycin solution for topical use

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

erythromycin

Available from:

Arpimed LLC

ATC code:

D10AF02

INN (International Name):

erythromycin

Dosage:

20mg/ml

Pharmaceutical form:

solution for topical use

Units in package:

30ml glass bottle

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-08-07

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
ERYTHROMYCIN
2% SOLUTION FOR TOPICAL USE
1.1 BRAND NAME –
Erythromycin
1.2 INTERNATIONAL NON-PROPERTY NAME –
Erythromycin
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains:
Active ingredient: erythromycin – 20 mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for topical use.
A transparent, odorless liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Erythromycin is indicated for use in the treatment of acne vulgaris.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
• ADULTS AND ADOLESCENTS
To be applied in a thin film to the affected area twice daily after
washing and
drying the skin.
Hands should be washed after application.
Patients should be advised that a therapeutic effect may not be seen
until after
6-8 weeks of treatment. Treatment may be continued for up to a maximum
of
6 months. If there has been no improvement after 6 to 8 weeks, or if
the
condition becomes worse, treatment should be discontinued.
Owing to the flammable nature of the product, Erythromycin solution
should be
kept away from open fire and flames and all sources of ignition,
including
smoking, during and immediately after use.
• PAEDIATRIC POPULATION
Safety and effectiveness of topical erythromycin in children under the
age of
12 have not been established.
• ELDERLY
There are no specific recommendations for use in the elderly.
• RENAL IMPAIRMENT
No dosage adjustment is necessary.
• HEPATIC IMPAIRMENT
No dosage adjustment is necessary.
4.3. CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Erythromycin should be used with caution in patients with a known
sensitivity or
allergy to any ingredients. Erythromycin contains propylene glycol
which may
cause skin irritation.
Concomitant topical acne therapy should be used with caution because a
cumulative irritancy effect may occur, especially with the use of
peeling, desquamating or
abrasive agents. I