NORVASC TABLET 10 mg

Land: Singapore

Språk: engelska

Källa: HSA (Health Sciences Authority)

Aktiva substanser:

AMLODIPINE BESYLATE

Tillgänglig från:

VIATRIS PRIVATE LIMITED

ATC-kod:

C08CA01

Dos:

10 mg

Läkemedelsform:

TABLET

Sammansättning:

AMLODIPINE BESYLATE 10 mg

Administreringssätt:

ORAL

Receptbelagda typ:

Prescription Only

Tillverkad av:

Pfizer Pharmaceuticals LLC (bulk product manufacturer)

Bemyndigande status:

ACTIVE

Tillstånd datum:

1990-12-28

Bipacksedel

 
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1 

                          NORVASC 
Amlodipine Besylate 

1. 
NAME OF THE MEDICINAL PRODUCT 

NORVASC 

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. 

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 (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. 

_ _

2 

_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 

Produktens egenskaper

NORVASC
Amlodipine Besylate
1.
NAME OF THE MEDICINAL PRODUCT
NORVASC
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.
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 (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 Artery Disease_
).
No dos