BENZAMYCIN TOPICAL GEL

Nchi: Israeli

Lugha: Kiingereza

Chanzo: Ministry of Health

Viambatanisho vya kazi:

BENZOYL PEROXIDE; ERYTHROMYCIN

Inapatikana kutoka:

PERRIGO ISRAEL AGENCIES LTD

ATC kanuni:

D10AE51

Dawa fomu:

GEL

Tungo:

BENZOYL PEROXIDE 87.125 MG/G; ERYTHROMYCIN 0.8 G

Njia ya uendeshaji:

TOPICAL

Dawa ya aina:

Required

Viwandani na:

VALEANT CANADA LP/VALEANT CANADA S.E.C, CANADA

Kundi la matibabu:

BENZOYL PEROXIDE, COMBINATIONS

Eneo la matibabu:

BENZOYL PEROXIDE, COMBINATIONS

Matibabu dalili:

For topical treatment of acne vulgaris.

Idhini ya tarehe:

2011-07-31

Taarifa za kipeperushi

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
BENZAMYCIN TOPICAL GEL
Each gram contains 30 mg (3%) erythromycin and 50 mg (5%) benzoyl
peroxide.
For the list of inactive ingredients – see section 6 in the leaflet.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have further questions, refer to the doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if it seems to you that their medical
condition is similar.
This medicine is intended for adults and children over the age of 12
years.
1. WHAT IS THE MEDICINE INTENDED FOR?
For topical treatment of acne vulgaris.
THERAPEUTIC GROUP:
Erythromycin – macrolide antibiotic.
Benzoyl peroxide – an antibacterial and keratolytic (an ingredient
that
causes separation and loosening of the outer layer of the skin).
2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF:
you are sensitive (allergic) to the active ingredients erythromycin
and
benzoyl peroxide or to any of the additional ingredients contained
in the medicine.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE:
∙ Do not use the gel on damaged or inflamed skin or on open wounds.
∙ Do not use the gel if the skin is particularly sensitive, e.g., if
you
are suffering from sensitivities, irritation or peeling left from a
previous skin treatment, or if you are suffering from burns (until
skin healing).
∙ Mild tingling and/or redness may occur at the start of treatment.
If worsening irritation or dryness occurs, stop the treatment and
consult a doctor.
∙ The medicine may bleach hair and colored fabrics.
∙ Avoid, as much as possible, exposure to the sun (or to UV
radiation).
If you must be exposed to the sun, make sure to have appropriate
protection (long clothes, hat, sunscreens, etc.) and use the medicine
in the evening.
∙ Avoid contact with the

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Benzamycin
Topical Gel
2.
QUALITATIVE AND QUANTITATIVE
COMPOSITION
The active substances are Erythromycin 3 % w/w & benzoyl peroxide 5%
w/w (after reconstitution)
For a full list of excipients, see section 14.1.
3.
PHARMACEUTICAL FORM
Gel.
_1T_
For Dermatological Us e Only. Not for Ophthalmic Use
_0T1T_
.
_1_
_T_
Reconstitute Before Dispensing
_1T_
.
4.
DESCRIPT ION
Benzamycin Topical Gel contains erythromycin [(3R*, 4S*, 5S*, 6R*,
7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-
[(2,6-Dideoxy-3-
_4T_
_C_
_4T_
-methyl-3-
_4T_
_O_
_4T_
-methyl-α-L-
_4T_
_ribo_
_4T_
-hexopyranosyl)-oxy]-14-ethyl-7,12,13-trihydroxy-
3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-
_4T_
_xylo_
_4T_
-
hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione]. Erythromycin is a
macrolide antibiotic produced from a
strain of
_0T_
_0T4T_
_Saccharopolyspora erythraea_
_0T4T_
_0T_
(formerly
_0T_
_0T4T_
_Streptomyces erythreus_
_4T_
). It is a base and readily forms salts
with acids.
Chemically erythromycin is C
_5T_
37
_5T_
H
_5T_
67
_5T_
NO
_5T_
13
_5T_
. It has the following structural formula:
Erythromycin has the molecular weight of 733.94. It is a white
crystalline powder and has a solubility of
approximately 1 mg/mL in water and is soluble in alcohol at 25°C.
Benzamycin Topical Gel also contains
benzoyl peroxide for topical use. Benzoyl peroxide is an antibacterial
and keratolytic agent.
Chemically benzoyl peroxide is C
_5T_
14
_5T_
H
_5T_
10
_5T_
O
_5_
_T_
4
_5T_
. It has the following structural formula:
Benzoyl peroxide has the molecular weight of 242.23. It is a white
granular powder and is sparingly soluble in
water and alcohol and soluble in acetone, chloroform and ether.
Each gram of Benzamycin Topical Gel contains, as dispensed, 30 mg (3%)
of erythromycin and 50 mg (5%) of
benzoyl peroxide.
5.
CLINICAL PHARMACOLOGY
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 t