AMLODIPINE BESYLATE TABLET 5MG

amlodipine besylate tablet

  • Product No.: AMC12097-01
  • Specification: 5mg 10x10tables
  • Trademark: Shinepharm
  • Support OEM/ODM: Yes
  • Delivery Time: 30~60 Days
  • Trade Term: FOB,CIF
  • Payment Term: T/T,L/C
  • Standard Available: CP,BP
  • Documents: GMP,COPP,CTD

Indications
HypertensionChronic stable angina pectorisVasospastic (Prinzmetal's) angina

Dosage and Administration

Usage: Tablet for oral administration.

Dosage:

1.Adults For both hypertension and angina the usual initial dose is 5 mg Istin once daily which may be increased to a maximum dose of 10 mg depending on the individual patient's response.

2.Elderly patientsNormal dosage regimens are recommended in the elderly

Patients with hepatic impairmentAmlodipine should be initiated at the lowest dose and titrated slowly in patients with severe hepatic impairment.

3.Paediatric populationThe recommended antihypertensive oral dose in paediatric patients ages 6-17 years is 2.5 mg once daily as a starting dose, up-titrated to 5 mg once daily if blood pressure goal is not achieved after 4 weeks.

Precautions & Warning:

Patients with cardiac failure: should be treated with caution.

Patients with hepatic impairmentSlow dose titration and careful monitoring may be required in patients with severe hepatic impairment.

Elderly patients:In the elderly increase of the dosage should take place with care

Patients with renal impairment: Amlodipine is not dialysable.

Contraindications

1. hypersensitivity to dihydropyridine derivatives, amlodipine or to any of the excipients

2. severe hypotension.

3.shock (including cardiogenic shock).

4. obstruction of the outflow tract of the left ventricle (e.g., high grade aortic stenosis).

5. haemodynamically unstable heart failure after acute myocardial infarction.

Adverse Reactions

Summary of the safety profile

The most commonly reported adverse reactions during treatment are somnolence, dizziness, headache, palpitations, flushing, abdominal pain, nausea, ankle swelling, oedema and fatigue.

Storage instructions:

Do not store above 25°C