Storage: Store in a cool place.
Shelf Life: 36 months from the date of manufacture.
Precaution: Keep out of reach of children.
Presentation: Strip of 10 tablets

Indications:  Amlodipine is indicated in the treatment of hypertension and myocardial ischemia associated with angina pectoris. 
Dosage & Administration: 
1.Hypertension: In the treatment of hypertension, the usual initial dose is 5-mg Amlodipine orally, once daily which may be increased to a maximum dose of 10-mg once daily.  Dosage should be adjusted according to each patient's need.  Generally, titration should proceed over 7 to 14 days to fully assess the patient's response to each level of dosage. Titration may proceed more rapidly, however, if clinically warranted, provided the patient is assessed frequently.  Small, fragile or elderly individuals/patients with Hepatic insufficiency may be started on 2.5- mg once daily. Can be considered when Amlodipine is used as a Combination Therapy. 
2.Angina:  The recommended dose for chronic stable or vasospastic Angina is 5 to 10- mg. Most patients will require 10- mg for adequate effect.  Co-administration with other Antihypertensive and/or anti-anginal drugs:  Amlodipine has been safely administered with Thiazides, ACE inhibitors, beta-blockers, long-acting nitrates, and/or sublingual nitro-glycerine.  An initial dose of 2.5-mg is recommended when adding Amlodipine to other Antihypertensive agents.  Caution should be taken with dose selection for an elderly patient starting at the low end of the dosing range, due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in these patients.  Since elderly patients have decreased clearance of Amlodipine with a resulting increase of AUC of approximately 40-60%, it is therefore recommended to lower the initial dose 2.5-mg. 
Use in patients with hepatic impairment:  Amlodipine is extensively metabolized by the liver; clearance is reduced, and the plasma elimination half-life (t1/2) is prolonged (56 hours) in patients with impaired 1/2 hepatic function. Therefore, treatment should be started at a lower dose of 2.5- mg once daily in these patients and caution should be exercised while administering Amlodipine to patients with severe hepatic impairment. 
Use in patients with renal impairment: The pharmacokinetics of Amlodipine are not significantly influenced by renal impairment. Therefore, no dosage adjustment is required in patients with renal failure. 
Use in Children:  Safety and efficacy of Amlodipine in children has not yet been established. 
Contraindications:  Patients with known sensitivity to Amlodipine.  Pregnancy and lactation 

Amlodipine is a long acting, Dihydropyridine Calcium Channel Blocker. Amlodipine selectively inhibits calcium influx across cell membranes in cardiac and vascular smooth muscle - with a greater effect on vascular smooth muscle. 
Hypertension:  Amlodipine is a peripheral arteriolar vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure. 
Exertional Angina:  In patients with exertional angina, Amlodipine reduces the total peripheral resistance (afterload) against which the heart works, thus reducing myocardial oxygen demand, at any given level of exercise. 
Vasospastic Angina:  Amlodipine has been demonstrated to block constriction and restore blood flow in coronary arteries and arterioles in response to calcium, potassium epinephrine, serotonin, and thromboxane. 
An analogy in experimental 2 animal models and in human coronary vessels in vitro. This inhibition of coronary spasm is responsible for the effectiveness of Amlodipine in vasospastic (Prinzmetal's or variant) angina. 
Pharmacokinetic Profile:  After oral administration of therapeutic doses of Amlodipine, peak plasma concentrations are achieved between 6 and 12 hours.  Absolute bioavailability is approximately between 60-90%.  Amlodipine is highly (90%) bound to plasma proteins.  Amlodipine is extensively (about 90%) converted to inactive metabolites via hepatic metabolism with 10% of the parent compound and 60% of the metabolites excreted in the urine.  Steady state plasma levels of Amlodipine are reached after 7 to 8 days of consequent daily dosing. It has a terminal elimination half-life of 30-50 hours.  In patients with moderate to severe heart failure, 40-60% increase in AUC is observed.

Increased Angina and/or Myocardial Infarction  Rarely, patients, particularly those with severe obstructive coronary artery disease, have reported increased frequency, duration and/or severity of Angina or acute myocardial infarction.  Use in Patients with Congestive Heart Failure  In general, Calcium Channel Blockers (CCBs) should be used with caution in patients with heart failure. However, no evidence of adverse effect on survival or cardiac morbidity was reported when Amlodipine was administered to patients with heart failure who were maintained on stable doses of ACE inhibitor, digoxin, and diuretics.  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 managed with gradual reduction of the dose of beta-blocker.  General  Since the vasodilation induced by Amlodipine is gradual in the onset, acute hypotension has rarely been reported after oral administration of Amlodipine. Nonetheless, caution should be exercised when administering Amlodipine with any other peripheral vasodilator, particularly in patients with severe aortic stenosis.