- Approval Id
- af2e7a8d0e4d2d87
- Drug Name
- AMLODANE 10 TABLET 10MG
- Product Name
- AMLODANE 10 TABLET 10MG
- Approval Number
- SIN16427P
- Approval Date
- 2022-02-11
- Registrant
- HALDANE PHARMACEUTICALS PTE. LTD.
- Licence Holder
- HALDANE PHARMACEUTICALS PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET
- Dosage
- **DOSAGE AND 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.
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 “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
- **INDICATIONS & USES:**
**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
- **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
- HALDANE PHARMACEUTICALS PTE. LTD.
- Company Detail Path
- /organization/2d216c1fd8f30117/haldane-pharmaceuticals-pte-ltd
