Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET
**Posology** Posology and method of administration The usual starting dose is 5 mg daily. May if necessary be increased to 10 mg daily. It is not necessary to adjust the dose of amlodipine during co-administration of thiazides, beta-blockers or ACE inhibitors (angiotensin-converting enzymes). Normal dosage regimens are recommended. Amlodipine, used at similar doses in elderly and younger patients, is equally well tolerated. The efficacy and safety in children has not been investigated.
ORAL
Medical Information
**Indications** - Hypertension - Chronic Stable angina and/or Prizmetal/variant angina.
**Contraindications** Hypersensitivity to dihydropyridines (amlodipine, nifedipine, felodipine, isradipine). Or any of the excipients. Pregnancy (see Pregnancy and Lactation – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) Severe hypertension.
C08CA01
amlodipine
Manufacturer Information
TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
PT Actavis Indonesia
Active Ingredients
Documents
Package Inserts
ACTAPIN PI.pdf
Approved: October 8, 2020