Patients on diuretics may occasionally experience an exaggerated fall in BP after initiation of therapy with this combination.

This possibility can be minimised by either discontinuing the diuretic or increasing the salt intake prior to initiation of treatment.

Indomethicin may reduce the antihypertensive effect of lisinopril.

Concomittant use of Lisinopril with potassium sparing supplements or potassium substituted salts may increase the risk of hyperkalemia.

Lisinopril attenuates potassioum loss caused by thiazide diuretics.

Increased serum lithium levels and lithium toxicity have been reported in patients receiving ACE inhibitors during therapy with lithium.

Monitor serum lithium levels while co-administering this FDC with lithium

Mild to moderate hypertension

The combination of amlodipine and lisonopril is generally well tolerated.

Angioneurotic edema has ben reported with ACE inhibitors.

In such cases the combination should be discontinued immediately.

Other side effects include nausea, headache, dizziness, cough, diarrhea, fatigue, rash, edema, flushing, palpitations, chest pain, asthenia, and dry mouth. Increase in blood urea, serum potassium and creatinine may occur.

Hypersenstivity to either component.

History of angioedema related to previous treatment with an ACE inhibitor.

Pregnancy

Special Precautions:

Hepatic impairment: Caution should be excercised when administering the combination in patients with severe hepatic impairment because of prolongation of elimination half-life.

Impaired renal function- The combination should be used with caution in patients with renal disease.

Congestive heart failure- This combination should be used with caution in presence of congestive heart failure. Hyperkalemia has been reported to occur with the use of lisinopril. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes melitus and the concomittant use of potassium sparing diuretics.

Lactation: Not known whether amlodipine or lisinopril is excreted in human milk. It is recommended that nursing be discontinued while this combination is administered.

Indication-

Mild to moderate hypertension

Dosage-

Tablet - FDC amlodipine 5mg + Lisinopril 5mg Usual initial dose is one tablet once daily. If the BP control is inadequate after a week or two, the dose may increased to two tablets a day.

Take with or without food

Pharmacology:

The fixed dose combination of amlodipine 5mg + l;isinopril 5mg is pharmcodynamically compatible and pharmcokinetically matching. Amlodipine is a dihydrophylline calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle.

It has a greater effect on vascular smooth muscle cells than on cardiac muscle cells and causes reduction in peripheral resistence and blood pressure. It is usually given as a once a day medication.

Lisinopril is a long acting ACE inhibitor which acts via preventing thre formation of angiotensin II , a powerful vasoconstrictor belonging to Renin-Angiotensin-Aldosterone axis. Maximal reductions in blood pressure are produced by lisinopril after about 4-6 hours and the duration of action lasts for 24 hours. It has a trough to peak ratio of 50%. It is also given as a once a day medication.

Combination of amlodipine and lisinopril:

The combination offers more improved BP control in a wide range of population. Combination therapy results in summation of results.

This facilitates the use of low doses of the individual agents and hence leads to attentuation of side effects. It is effective in high and low renin patients, diabetics, elderly and hyperlipidemia patients.

Combinations should be beneficial in conditions associated with low renin perfusion pressure. In diabetic nephropathy, combination excerts a better effect on proteinuria compared to drug alone. In atherosclerosis, the combination may prevent arterial lesion formation.

Amlodipine and lisinopril exert synergistic cardioprotective effects. In patients with insulin resistence, the combination has an additive favorable effect.

Pharmcokinetics:

Amlodipine and Lisinopril are pharmacokinetically compatible. Individual pharmacokinetic properties unchanged when administered in combination.

Concomittant food does not cause a significant reduction in its extent of absoption or alter time to peak plasma concentration

Concomittant food does not cause a significant reduction in its extent of absoption or alter time to peak plasma concentration.

Take with or without food

Not recommended