Amlodipine
Visa No.: VD-35752-22
Product: Amlodipine 5 mg Cap
API: Amlodipine
Product Category: Cardiovascular & Metabolism
Version approved leaflet: 527/QĐ-QLD_09/09/2022_178BS
INDICATIONS
Hypertension
Chronic stable angina
Vasospastic angina (Prinzmetal’s angina)
DOSAGE AND ADMINISTRATION
Dosage
Adults
For hypertension and angina, the usual initial dose is 5 mg once daily. The dose may be increased to a maximum of 10 mg once daily, depending on inpidual patient response.
In hypertensive patients, amlodipine may be used alone or in combination with thiazide diuretics, alpha-blockers, beta-blockers, or angiotensin-converting enzyme (ACE) inhibitors. In patients with angina, amlodipine may be used as monotherapy or in combination with other antianginal agents, including nitrates and/or beta-blockers.
Dose adjustment is not required when amlodipine is used in combination with thiazide diuretics, alpha-blockers, beta-blockers, or ACE inhibitors.
Special populations
Elderly patients
Amlodipine is similarly well tolerated in elderly and younger patients. The usual dosage regimen is recommended; however, caution is advised when increasing the dose.
Patients with hepatic impairment
Dose recommendations have not been established in patients with mild to moderate hepatic impairment; therefore, dose selection should be cautious and treatment should be initiated at the lower end of the dosing range. The pharmacokinetics of amlodipine have not been studied in patients with severe hepatic impairment. Treatment should be initiated at the lowest dose and titrated slowly
Patients with renal impairment
Changes in amlodipine plasma concentrations are not correlated with the degree of renal impairment; therefore, the usual dose is recommended.
Amlodipine is not dialysable.
Children and adolescents
Children aged 6–17 years with hypertension The recommended initial oral dose is 2.5 mg once daily. The dose may be increased to 5 mg once daily if blood pressure control is not achieved after 4 weeks. Doses above 5 mg daily have not been studied in paediatric patients.
Children under 6 years of age
No data are available.
Method of administration
For oral use.
CONTRAINDICATIONS
Amlodipine is contraindicated in patients with:
Hypersensitivity to dihydropyridines, amlodipine, or any excipients
Severe hypotension
Shock (including cardiogenic shock)
Obstruction of the left ventricular outflow tract (e.g. high-grade aortic stenosis)
- Haemodynamically unstable heart failure following acute myocardial infarction
WARNINGS AND PRECAUTIONS
This medicine is for prescription use only.
Read the instructions for use carefully before use.
If further information is required, consult a physician or pharmacist.
Keep out of reach of children.
