CHEMICAL COMPOSITION:

Losardipin 5/80: Each F.C.Tablet contains Amlodipine 5 mg (equivalent to 6.94 mg Amlodipine besylate), Valsartan 80 mg.

Losardipin 5/160: Each F.C.Tablet contains Amlodipine 5 mg (equivalent to 6.94 mg Amlodipine besylate), Valsartan 160 mg.

Losardipin 10/160: Each F.C.Tablet contains Amlodipine 10 mg (equivalent to 13.88 mg Amlodipine besylate), Valsartan 160 mg.

Mechanism of action:

Amlodipine:

Amlodipine is a dihydropyridine calcium channel blocker that inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Serum calcium concentration is not affected by Amlodipine.

Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.

Valsartan:

Valsartan blocks the vasoconstrictor and aldosterone secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for angiotensin II synthesis. Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and angiotensin II circulating levels do not overcome the effect of valsartan on blood pressure.

INDICATIONS:

Amlodipine/valsartan is indicated for the treatment of hypertension. This drug may be used:

• In patients whose blood pressure is not adequately controlled on either monotherapy.
• As initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

The choice of Amlodipine/valsartan as initial therapy for hypertension should be based on an assessment of potential benefits and risks including whether the patient is likely to tolerate the lowest dose of Amlodipine/ valsartan. Patients with stage 2 hypertension (moderate or severe) are at a relatively higher risk for cardiovascular events, kidney failure and vision problems, so prompt treatment is clinically relevant.

The decision to use this combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal and the incremental likelihood of achieving goal with a combination compared to monotherapy.

DOSAGE AND ADMINISTRATION:

General considerations:

Dose once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one (Amlodipine and Valsartan) 10 mg / 320 mg tablet once daily as needed to control blood pressure. The majority of the antihypertensive effect is attained within 2 weeks after initiation of therapy or a change in dose. It may be administered with or without food, and may be administered with other antihypertensive agents.

Add-on Therapy:

A patient whose blood pressure is not adequately controlled with amlodipine (or another dihydropyridine calcium-channel blocker) alone or with valsartan (or another angiotensin II receptor blocker) alone may be switched to combination therapy with (Amlodipine and Valsartan). The clinical response to (Amlodipine and Valsartan) should be subsequently evaluated and if blood pressure remains uncontrolled after 3 to 4 weeks of therapy, the dose may be titrated up to a maximum of (Amlodipine and Valsartan) 10 mg / 320 mg.

Initial Therapy

A patient may be initiated on (Amlodipine and Valsartan) if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose is 5/160 mg once daily in patients who are not volume-depleted.

Package:

Losardipin 5/80: A pack of 30 F.C.T.

Losardipin 5/160: A pack of 30 F.C.T.

Losardipin 10/160: A pack of 30 F.C.T.