EDARBI TABLET 40MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Azilsartan medoxomil potassium 42.68mg eqv Azilsartan medoxomil

Available from:

TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

ATC code:

C09CA09

Dosage:

40mg

Pharmaceutical form:

TABLET

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Takeda Pharmaceutical Company Limited (Osaka Plant)

Authorization date:

2014-03-06

Patient Information leaflet

FULL PRESCRIBING INFORMATION 

EDARBI (AZILSARTAN MEDOXOMIL) TABLETS 40 MG AND 80 MG. 

1.  INDICATIONS AND USAGE 

Edarbi is indicated for the treatment of essential hypertension
in adult. 
Edarbi may be used alone or in combination with
other antihypertensive agents. 

2.  DOSAGE AND ADMINISTRATION 

2.1 RECOMMENDED DOSE 
The recommended starting dose is 40 mg once daily. The
dose may be 
increased to a maximum of 80 mg once
daily for patients whose blood pressure 
is not adequately controlled at the lower dose. 

Near-maximal antihypertensive
effect is evident at 2 weeks, with maximal effects 
attained by 4 weeks. 

If blood pressure is not adequately controlled with
Edarbi alone, additional blood 
pressure reduction can be achieved when Edarbi is co-administered with
other 
antihypertensive medicinal products, including diuretics (such as chlorthalidone 
and hydrochlorothiazide) and calcium channel blockers.  

Edarbi may be taken with
or without food _[see Clinical Pharmacology (11.3)]_. 

2.2 HANDLING INSTRUCTIONS 

Protect from light and moisture. 
Do not repackage: dispense and store in original container 

2.3 SPECIAL POPULATIONS 

No initial dose adjustment is recommended
for elderly patients, patients with mild 
to- moderate renal impairment, or mild- to- moderate
hepatic dysfunction. There 
is no experience of use of Edarbi in hypertensive patients with
severe renal 
impairment, end stage
renal disease or with severe hepatic impairment _[see Use_ 
_in Specific Populations (8.0) and
Clinical Pharmacology (11.3)]._ 

3.  DOSAGE FORMS AND STRENGTHS 

Edarbi is supplied as white to nearly white round tablets in the
following dosage 
strengths: 
•  40 mg tablets - debossed “ASL” on one side and
“40” on the other 
•  80 mg tablets - debossed “ASL” on one side and
“80” o