NORVASC ODT (ORODISPERSIBLE TABLET) 5MG

Țară: Singapore

Limbă: engleză

Sursă: HSA (Health Sciences Authority)

Ingredient activ:

Amlodipine Besylate 6.93mg eqv amlodipine

Disponibil de la:

PFIZER PFE PRIVATE LIMITED

Codul ATC:

C08CA01

Dozare:

5mg

Forma farmaceutică:

TABLET, ORALLY DISINTEGRATING

Compoziție:

Amlodipine Besylate 6.93mg eqv amlodipine 5mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

Prescription Only

Produs de:

AUROBINDO PHARMA LIMITED

Statutul autorizaţiei:

ACTIVE

Data de autorizare:

2014-02-07

Prospect

LPD Reference: NORODT-SIN-0414/0 
Date of last revision: 15 Apr 2014 
COUNTRY: Singapore 
Reference document: CDS
Version8.0, effective date: 20 Apr 2013 

_ _
NORODT-SIN-0414/0 
Date of last revision: 15 Apr 2014 

1 

                         PFIZER 

                       NORVASC ODT 
Amlodipine Besylate 

1. 
NAME OF THE MEDICINAL PRODUCT 

NORVASC ODT 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Active ingredient: amlodipine besylate. 

The tablets contain amlodipine besylate equivalent to 5 and
10 mg amlodipine. 

3. 
PHARMACEUTICAL FORM 

Tablets, Orally Disintegrating 

4. 
CLINICAL PARTICULARS 

4.1 
Therapeutic indications 

HYPERTENSION 

Amlodipine is indicated for the first line treatment of
hypertension and can be used as the sole 
agent to control blood pressure in the majority of patients.
Patients not adequately controlled on 
a single antihypertensive agent may benefit from the addition of
amlodipine, which has been 
used in combination with a thiazide diuretic, alpha blockers, beta
adrenoceptor blocking agent, 
or an angiotensin-converting enzyme inhibitor. 

CORONARY ARTERY DISEASE (CAD) 
_ _
_ _
_Chronic Stable Angina _

Amlodipine is indicated for the symptomatic treatment
of chronic stable angina.Amlodipine 
may be used alone or in combination with other antianginal
drugs. 

_Vasospastic_ _Angina (Prinzmetal's or variant angina)_ 

Amlodipine is indicated for the treatment of confirmed or suspected
vasospastic angina. 
Amlodipine may be used as monotherapy, or in combination with other
antianginal drugs. 

LPD Reference: NORODT-SIN-0414/0 
Date of last revision: 15 Apr 2014 
COUNTRY: Singapore 
Reference document: CDS
Version8.0

Caracteristicilor produsului

NORVASC ODT
Amlodipine Besylate
1.
NAME OF THE MEDICINAL PRODUCT
NORVASC ODT
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: amlodipine besylate.
The tablets contain amlodipine besylate equivalent to 5 mg and 10 mg
amlodipine.
3.
PHARMACEUTICAL FORM
Tablets, Orodispersible
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
HYPERTENSION
Amlodipine is indicated for the first-line treatment of hypertension
and can be used as the
sole agent to control blood pressure in the majority of patients.
Patients not adequately
controlled on a single anti-hypertensive agent may benefit from the
addition of amlodipine,
which has been used in combination with a thiazide diuretic, alpha
blockers, beta
adrenoceptor blocking agent, or an angiotensin-converting enzyme (ACE)
inhibitor.
CORONARY ARTERY DISEASE
_Chronic Stable Angina _
Amlodipine is indicated for the symptomatic treatment of chronic
stable angina. Amlodipine
may be used alone or in combination with other antianginal drugs.
_Vasospastic_
_Angina (Prinzmetal’s or Variant Angina)_
Amlodipine is indicated for the treatment of confirmed or suspected
vasospastic angina.
Amlodipine may be used as monotherapy, or in combination with other
antianginal drugs.
_Angiographically Documented Coronary Artery Disease _
In patients with recently documented coronary artery disease (CAD) by
angiography and
without heart failure or an ejection fraction <40%, amlodipine is
indicated to reduce the risk
of hospitalization due to angina and to reduce the risk of a coronary
revascularization
procedure.
4.2
Posology and method of administration
For both hypertension and angina, the usual initial dose is 5 mg
amlodipine once daily,
which may be increased to a maximum dose of 10 mg depending on the
individual patient’s
response.
For patients with coronary artery disease, the recommended dosage
range is 5 mg to 10 mg
once daily. In clinical studies, the majority of patients required 10
mg once daily (see section
5.1. Pharmacodynamic properties -
_Use in Patients with Coronary A