ISOTREXIN GEL

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

ERYTHROMYCIN

Available from:

GLAXOSMITHKLINE PTE LTD

ATC code:

D10AF52

Dosage:

2% w/w

Pharmaceutical form:

GEL

Administration route:

TOPICAL

Prescription type:

Prescription Only

Manufactured by:

STIEFEL LABORATORIES PTE LTD

Authorization date:

1999-08-05

Patient Information leaflet

ISOTREXIN
TM
 GEL 
FORMULATIONS AND STRENGTHS  
Topical gel containing erythromycin 2.0% w/w (20
_ _
mg/g) and isotretinoin 0.05% w/w 
(0.5
_ _
mg/g). 
A pale yellow gel. 
EXCIPIENTS  
Hydroxypropylcellulose 
Butylated hydroxytoluene (BHT) 
Anhydrous ethanol 
CLINICAL INFORMATION 
INDICATIONS 
ISOTREXIN GEL is indicated for the
topical treatment of mild to moderate acne vulgaris and 
is effective in treating both inflammatory and
non-inflammatory lesions. 
DOSAGE AND ADMINISTRATION 
ISOTREXIN GEL is for topical use only. 
ADULTS AND ADOLESCENTS 
Wash the skin gently with a mild cleanser and dry
fully. Apply ISOTREXIN GEL in a thin 
film over the entire affected area once or twice daily.
 Avoid close proximity to eyes, lips, 
and other mucous membranes. Hands should
be washed after application.  
8 weeks of treatment may be required before
a therapeutic effect is observed. The efficacy 
and safety of erythromycin/isotretinoin has not been
studied beyond 12 weeks in acne 
vulgaris clinical trials. The prescriber should evaluate the benefit
of continuing treatment 
beyond 12 weeks of uninterrupted use,
taking account of an increased risk of antimicrobial 
resistance. 
Patients should be advised that excessive application will not
improve efficacy, but may 
increase the risk of skin irritation.  
If undue irritation (redness, peeling, or discomfort) occurs,
patients may use a moisturiser as 
needed and should reduce frequency of application or
temporarily interrupt treatment. The 
normal frequency of application should be resumed once the
irritation subsides. Treatment 
should be discontinued if the irritation persists.
 Efficacy has not been established for less 
than once daily dosing frequencies.  
Due to the flammable nature of ISOTREXIN GEL, patients should
avoid smoking or being 
near an open flame during application and immediately after use. 
CHILDREN 
The safety a