ROACCUTANE CAPSULE 20 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

ISOTRETINOIN

Available from:

ROCHE SINGAPORE PTE. LTD.

ATC code:

D10BA01

Dosage:

20 mg

Pharmaceutical form:

CAPSULE, LIQUID FILLED

Composition:

ISOTRETINOIN 20 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Catalent Germany Eberbach GmbH

Authorization status:

ACTIVE

Authorization date:

1990-07-10

Patient Information leaflet

 
1

ROACCUTANE®

Isotretinoin 
_________________________________________________________________________
RETINOID FOR SYSTEMIC TREATMENT OF ACNE

COMPOSITION
_ _
_Active ingredient:_ isotretinoin; 13-cis retinoic acid. 

_Excipients:_ 
_ _
_Capsule filling:  _
Beeswax, yellow;  
Soya-bean oil, refined;  
Soya-bean oil, hydrogenated;  
Soya-bean oil, partially hydrogenated. 
_ _
_Capsule shell:  _
Gelatin;  
Glycerol 85%;  
Karion 83 containing sorbitol, mannitol, hydrogenated hydrolyzed
starch;  
Titanium dioxide (E171);  
Red iron oxide (E172). 
_Dry printing ink: _
Shellac, modified;  
Black iron oxide (E172); 
Propylene glycol. 

Capsules 10 mg and 20 mg.  

PROPERTIES AND EFFECTS 
_Mechanism of action _
Isotretinoin, the active ingredient of Roaccutane, is a synthetic stereoisomer of all-trans retinoic acid 
(tretinoin).The exact mechanism of action of Roaccutane has not yet been elucidated in detail, but it 
has  been  established  that  the  improvement  observed  in  the  clinical  picture  of  severe  acne  is 
associated with suppression of sebaceous gland activity and a histologically demonstrated reduction 
in the size of the sebaceous glands. Furthermore, a dermal anti-inflammatory effect of isotretinoin 
has been established. 

_Efficacy _
Hypercornification  of  the  epithelial  lining  of  the  pilosebaceous  unit  leads  to  shedding  of 
corneocytes  into  the  duct  and  blockage  by  keratin  and  excess  sebum.    This  is  followed  by 
formation  of  a  comedone  and,  eventually,  inflammatory  lesions.    Roaccutane  inhibits 
proliferation  of  sebocytes  and  appears  to  act  in  acne  by  re-setting  the  orderly  program  of 
differentiation.    Sebum  is  a  major  substrate  for  the  growth 

Summary of Product characteristics

CAP-ROA-2019 08-0
ROACCUTANE
®
Isotretinoin
CATEGORY
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Retinoid for systemic treatment of acne
ATC Code: D10BA01
1.2
TYPE OF DOSAGE FORM
_Capsules: soft_
: 10 mg and 20 mg
1.3
ROUTE OF ADMINISTRATION
Oral
1.4
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient:_
isotretinoin; 13-
_cis_
retinoic acid
_Excipients_
:
_Capsule filling:_
Beeswax, yellow; Soya-bean oil, refined; Soya-bean oil, hydrogenated;
Soya-bean oil,
partially hydrogenated.
_Capsule shell:_
Gelatin; Glycerol 85%; Karion 83 containing sorbitol, mannitol,
hydrogenated hydrolyzed
starch; Titanium dioxide (E171); Red iron oxide (E172).
_Dry printing ink:_
Shellac, modified; Black iron oxide (E172); Propylene glycol.
Capsules 10 mg
Capsules 20 mg
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
Roaccutane is indicated for the treatment of severe forms of acne
(nodulo-cystic forms) and
acne, which has failed to respond to other therapies.
Roaccutane should only be prescribed by physicians who are experienced
in the use of
systemic retinoids- preferably dermatologists- and understand the risk
of teratogenicity if
Roaccutane is used during pregnancy.
2.2
DOSAGE AND ADMINISTRATION
_Standard dosage_
The therapeutic response to Roaccutane and its adverse events are
dose-related and varies
between patients. This necessitates individual dosage adjustment
during therapy. Roaccutane
therapy should be started at a dose of 0.5 mg/kg daily. For most
patients the dose ranges
from 0.5-1.0 mg/kg per day. Patients with very severe disease or with
truncal acne may
require higher daily doses up to 2.0 mg/kg.
A cumulative dose of 120 mg/kg per treatment has been documented to
increase remission
rates and prevent relapse. The therapy duration in individual patients
therefore varies as a
function of the daily dose. Complete remission of the acne is often
achieved by a therapy
course of 16-24 weeks. In patients who show severe intolerance to the
recommended dose,
treatment may be continued at a lower do