CHEMICAL COMPOSITION:

Each film coated tablet contains:

Losardipin plus 5 /160/12.5: each F.C.Tablet contains Amlodipine 5 mg (equivalent to 6.94 mg Amlodipine besylate),Valsartan160 mg, Hydrochlorothiazide 12.5 mg.

Losardipin plus 10/160/12.5: each F.C.Tablet contains Amlodipine 10 mg (equivalent to 13.88 mg Amlodipine besylate),Valsartan 160 mg, Hydrochlorothiazide 12.5 mg.

Losardipin plus 5/160/25: each F.C.Tablet contains Amlodipine 5 mg (equivalent to 6.9 mg Amlodipine besylate),Valsartan 160 mg, Hydrochlorothiazide 25 mg.

MECHANISM OF ACTION:

The active ingredients of this drug target 3 separate mechanisms involved in blood pressure regulation. Amlodipine blocks the contractile effects of calcium on cardiac and vascular smooth muscle cells; valsartan blocks the vasoconstriction and sodium retaining effects of angiotensin II on cardiac, vascular smooth muscle, adrenal and renal cells; and hydrochlorothiazide directly promotes the excretion of sodium and chloride in the kidney leading to reductions in intravascular volume.

INDICATIONS:

This drug is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

This fixed combination drug is not indicated for the initial therapy of hypertension.

DOSAGE AND ADMINISTRATION:

Dose once-daily. The dosage may be increased after 2 weeks of therapy. The full blood pressure lowering effect was achieved 2 weeks after being on the maximal dose of Welvas Plus. The maximum recommended dose of this drug is 10/320/25 mg.

Add-on / Switch Therapy:

This drug may be used for patients not adequately controlled on any 2 of the following antihypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics.

A patient who experiences dose-limiting adverse reactions to an individual component while on any dual combination of the components of this drug may be switched to this drug containing a lower dose of that component to achieve similar blood pressure reductions.

Replacement Therapy

This drug may be substituted for the individually titrated components.

Use with Other Antihypertensive Drugs

This drug may be administered with other antihypertensive agents.

PACKAGE:

Losardipin plus 5 /160/12.5: 30 F.C.Tablets in 3 blisters.

Losardipin plus 10/160/12.5: 30 F.C.Tablets in 3 blisters.

 Losardipin plus 5/160/25: 30 F.C.Tablets in 3 blisters.