E-SOL GEL

Država: Malezija

Jezik: angleščina

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktivna sestavina:

ERYTHROMYCIN; TRETINOIN

Dostopno od:

THE ZYFAS MEDICAL CO.,

INN (mednarodno ime):

ERYTHROMYCIN; TRETINOIN

Enote v paketu:

10 gm

Izdeluje:

DaeHwa Pharmaceutical Co.Ltd

Navodilo za uporabo

_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
E-SOL GEL
Erythromycin 4%, Tretinoin 0.025%
1
WHAT IS IN THIS LEAFLET
1. What E-SOL GEL is used for
2. How E-SOL GEL works
3. Before you use E-SOL GEL
4. How to use E-SOL GEL
5. While you are using it
6. Side effects
7. Storage and disposal of E-SOL
GEL
8. Product description
9. Manufacturer and Product
Registration Holder
10. Date of revision
WHAT E-SOL GEL IS USED FOR
Treatment of acne.
HOW E-SOL GEL WORKS
E-sol is a gel contains Erythromycin
and Tretinoin as active ingredients.
Erythromycin is an antibiotic which
kills the germs found in acne and
reduces the inflammation of your
skin. Tretinoin is an agent which
modifies abnormal skin cell
renewal.
BEFORE YOU USE E-SOL GEL
-_ When you must not apply it _
- If you are allergic to any
components in E-SOL GEL
- If you have a type of skin cancer
known as epithelioma or have
family history of it.
- if your skin is sunburnt
- if you are using any other
medication on your skin which may
lead to skin irritation e.g. an
exfoliator
- if you are suffering from acute
eczema, rosacea (a skin disease
which affects the face and is
characterized by redness, pimples
and peeling) or acute inflammatory
conditions of the skin, especially
around the mouth.
- if you are pregnant
- if you are planning a pregnancy
_-Before you start to apply it _
- For external use only. Excessive
use should be avoided.
- Exposure to excessive sunlight,
including sunlamps, should be
avoided while using the preparation,
or a suitably effective sunscreen
should be employed.
- Cosmetics may be used, but the
areas to be treated should be
cleansed thoroughly before the
medication is applied.
- Do not use E-sol Gel if you are
pregnant or thinking of becoming
pregnant. Your doctor can give you
more information.
_- Apply other medicines _
E-Sol gel should not be used
concomitantly with other skin
medications particularly those
containing keratolytic agents, as this
may exacerbate any skin irritation
that is present.
HOW TO USE E-SOL GEL
_-How much to apply

Lastnosti izdelka

E-SOL GEL
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Erythromycin ……………………. 4 % w/w
Tretinoin…………………………..0.025%ww
PRODUCT DESCRIPTION
Homogeneous opaque gel
PHARMACODYNAMICS / PHARMACOKINETICS
●Pharmacodynamics
Erythromycin is a macrolide antibiotic with bacteriostatic action on
all pathogens involved in
the development of acne. When applied topically it also effects a
reduction in the concentration
of skin surface lipids and shows a direct anti-inflammatory effect.
The retinoid tretinoin acts
topically as keratolytic agent by markedly increasing cell turnover in
the cornified epithelium
including epithelium of the follicular ducts and comedones. In the
first instance, skin irritation,
erythema and increased vascularization occur followed by thickening
and desquamation of the
epithelium. The renewal time of the cornified epithelium is therefore
shortened.
●Pharmacokinetics
Percutaneous absorption or erythromycin is negligible following
topical application of E-Sol
Gel for several to large areas of skin .After topical application, up
to 6% of the applied dose of
tretinoin is recovered in the urine within 50-60 hours, indicating
some absorption. The ratio of
renal to biliary excretion is approximately 1:3, therefore the maximum
likely total absorption
is 24%
INDICATION
E-Sol Gel is indicated for topical application in the treatment of all
forms of acne, both non-
inflammatory forms with comedones and inflammatory forms with papules
and pustules
particularly those associated with a very oily skin.
RECOMMENDED DOSAGE AND ADMINISTRATION
The dosage is the same for all ages. The duration of use depends on
the condition of the skin and
should not exceed 12 weeks.
E-Sol gel should be applied once a day, in the evening, to the skin
where acne lesions appear,
using enough to cover the entire affected area lightly. Application
may cause a transient feeling
of warmth or slight stinging. In cases where it has been necessary to
temporarily discontinue
therapy or reduce the frequency of appl