- Approval Id
- c18c852af65883fa
- Drug Name
- NORVASC TABLET 5 mg
- Product Name
- NORVASC TABLET 5 mg
- Approval Number
- SIN05277P
- Approval Date
- 1990-12-27
- Registrant
- VIATRIS PRIVATE LIMITED
- Licence Holder
- VIATRIS PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET
- Dosage
- 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_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
No dose adjustment of amlodipine is required upon concomitant administration of thiazide diuretics, beta-blockers, and ACE inhibitors.
_Use in the Elderly_
Normal dosage regimens are recommended. Amlodipine, used at similar doses in the elderly or younger patients, is equally well-tolerated.
_Use in Children_
Safety and effectiveness of amlodipine in children have not been established.
_Use in Patients with Impaired Hepatic Function_
See section 4.4. Special warnings and precautions for use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
_Use in Patients with Renal Failure_
Amlodipine may be used at normal doses in patients with renal failure. Changes in amlodipine plasma concentrations are not correlated with the degree of renal impairment. Amlodipine is not dialyzable.
- Route Of Administration
- ORAL
- Indication Info
- 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.
- Contraindications
- 4.3 Contraindications
Amlodipine is contraindicated in patients with a known hypersensitivity to dihydropyridines\* or any of the inert ingredients.
\\* Amlodipine is a dihydropyridine calcium channel blocker.
- Atc Code
- C08CA01
- Atc Item Name
- amlodipine
- Pharma Manufacturer Name
- VIATRIS PRIVATE LIMITED
- Company Detail Path
- /organization/viatris-private-limited
