LODOTRA MODIFIED-RELEASE TABLETS 5mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Prednisone

Available from:

MUNDIPHARMA PHARMACEUTICALS PTE. LTD.

ATC code:

H02AB07

Dosage:

5.00mg/tablet

Pharmaceutical form:

TABLET, DELAYED RELEASE

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Aenova France SAS

Authorization date:

2014-02-28

Patient Information leaflet

_LODOTRA_
®
 Modified-release tablets 
NAME OF THE MEDICINAL PRODUCT 
_LODOTRA_
®
 Modified-release tablets 1mg 
_LODOTRA_
®
 Modified-release tablets 2mg 
_LODOTRA_
®
 Modified-release tablets 5mg 

QUALITATIVE AND QUANTITATIVE COMPOSITION

_LODOTRA_
®
 Modified-release tablets 1mg: 
Each modified-release tablet contains 1 mg of prednisone.  
It also contains 40.7 mg of lactose as an excipient. 
_LODOTRA_
® 
Modified-release tablets 2mg: 
Each modified-release tablet contains 2 mg of prednisone.  
It also contains 39.7 mg of lactose as an excipient. 
_LODOTRA_
® 
Modified-release tablets 5mg: 
Each modified-release tablet contains 5 mg of prednisone.  
It also contains 36.9 mg of lactose as an excipient. 
For a full list of excipients, see section on _Pharmaceutical
Particulars_. 
PHARMACEUTICAL FORM

Modified-release tablet 
_LODOTRA_
®
 Modified-release tablets 1mg:  
Pale yellowish-white, cylindrical modified-release tablet with
“NP1” embossed on one 
side.  
_LODOTRA_
® 
Modified-release tablets 2mg: 
Yellowish-white, cylindrical modified-release tablet with “NP2”
embossed on one side.  
_LODOTRA_
® 
Modified-release tablets 5mg:  
Light yellow, cylindrical modified-release tablet with “NP5”
embossed on one side.  

CLINICAL PARTICULARS 
THERAPEUTIC INDICATIONS 
_LODOTRA_
® 
Modified-release tablet is indicated for the treatment of moderate to
severe, 
active rheumatoid arthritis in adults particularly when accompanied
by morning 
stiffness. 
POSOLOGY AND METHOD OF ADMINISTRATION

The appropriate dose depends on the severity of the condition and
the individual 
response of the patient. In general, for the initiation of the
therapy 5 mg to 10 mg 
prednisone is recommended. In certain cases, a higher initial dose
might be required 
(e.g. 15 or 20 mg prednisone). Depending on the clinical symptoms and
the patient’s 
response, the initial dose can be reduced in steps to a lower
maintenance dose. 
When changing over from the