Aphamea Brochure
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Cardio-Vascular Drugs
Each tablet contains
Amlodipine besylate equivalent to 5 mg Amlodipine.
Amlodipine is indicated for the treatment of these cases alone or in combination with other drugs:
- Hypertension.
- Coronary Artery Disease (CAD).
- Chronic Stable Angina.
- Vasospastic Angina (Prinzmetal’s or Variant Angina).
- Angiographically Documented CAD.
Adults: The usual initial antihypertensive oral dose of Amlodipine is 5 mg once daily with a maximum dose of 10 mg once daily.Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding Amlodipine to other antihypertensive therapy.
Adjust dosage according to each patient’s need. In general, titration should proceed over 7 to 14 days so that the physician can fully assess the patient’s response to each dose level. Titration may proceed more rapidly, however, if clinically warranted, provided the patient is assessed frequently.
Angina: The recommended dose for chronic stable or vasospastic angina of Amlodipine is 5 to 10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg for adequate effect.
coronary artery disease :The recommended dose range for patients with coronary artery disease is 5 to 10 mg once daily. In clinical studies, the majority of patients required 10 mg.
Children: The effective antihypertensive oral dose in pediatric patient’s ages 6 to 17 years is 2.5 mg to 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients.
Effect of Amlodipine on blood pressure in patients less than 6 years of age is not known.
Geriatric :
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing
range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients have decreased clearance of amlodipine with a resulting increase of AUC of approximately 40–60%, and a lower initial dose may be required .
Hypotension: Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely.
Increased Angina or Myocardial Infarction : Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of Amlodipine ,particularly in patients with severe obstructive coronary artery disease.
Beta-Blocker Withdrawal : Amlodipine is not a beta-blocker and therefore gives no protection against the dangers of abrupt beta blocker withdrawal; any such withdrawal should be by gradual reduction of the dose of beta-blocker.
Patients with Hepatic Failure: Because Amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t1/2) is 56 hours in patients with impaired hepatic function, titrate slowly when administering Amlodipine to patients with severe hepatic impairment.