Biforge

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Biforge Product Information Leaflets
Brand Name:
Biforge
Generic Name:
Amlodipine (as besylate) + Valsartan

DESCRIPTION:

Biforge is a fixed combination of amlodipine and valsartan. Valsartan is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT receptor subtype. Valsartan is an angiotensin II receptor antagonist (ARB).

COMPOSITION:

Biforge 5/160mg Tablets: Each film coated tablet contains: Amlodipine (as besylate) U.S.P. 5 mg Valsartan U.S.P. 160 mg Biforge 10/160mg Tablets: Each film coated tablet contains: Amlodipine (as besylate) U.S.P. 10 mg Valsartan U.S.P. 160 mg

INDICATIONS:

Biforge (amlodipine and valsartan) 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. Biforge (amlodipine and valsartan) may be used in patients whose blood pressure is not adequately controlled on either monotherapy. Biforge (amlodipine and valsartan) may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of Biforge (amlodipine and 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 Biforge (amlodipine and valsartan).

DOSAGE & ADMINISTRATION:

General Considerations Dose once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 10/320 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. It 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 Biforge (amlodipine and valsartan). A patient who experiences dose-limiting adverse reactions on either component alone may be switched to Biforge (amlodipine and valsartan) containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to Biforge (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 10/320 mg. Replacement Therapy For convenience, patients receiving amlodipine and valsartan from separate tablets may instead wish to receive tablets of Biforge (amlodipine and valsartan) containing the same component doses. Initial Therapy A patient may be initiated on Biforge (amlodipine and valsartan) if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose is Biforge 5/160 mg once daily in patients who are not volume-depleted.

CONTRAINDICATIONS:

Do not use in patients with known hypersensitivity to any component. Do not co-administer aliskiren with Biforge (amlodipine and valsartan) in patients with diabetes.

PRESENTATION:

Biforge 5/160mg Tablets: Alu. Alu. blister pack of 2x7's Biforge 10/160mg Tablets: Alu. Alu. blister pack of 2x7's

Patients should consult with their physician before taking any medicine.