Exforge (Amlodipine Besylate / Valsartan) - Indications and Dosage

INDICATIONS AND USAGE

Exforge^® (amlodipine and valsartan) is indicated for the treatment of hypertension.   

This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION).

DOSAGE AND ADMINISTRATION

Amlodipine is an effective treatment of hypertension in once daily doses of 2.5 mg-10 mg while valsartan is effective in doses of 80 mg-320 mg. In clinical trials with Exforge^® (amlodipine and valsartan) using amlodipine doses of 5 mg-10 mg and valsartan doses of 160 mg-320 mg, the antihypertensive effects increased with increasing doses.

The hazards (see WARNINGS) of valsartan are generally independent of dose; those of amlodipine are a mixture of dose-dependent phenomena (primarily peripheral edema) and dose-independent phenomena, the former much more common than the latter. Therapy with any combination of amlodipine and valsartan will thus be associated with both sets of dose-independent hazards. 

A patient who experiences dose-limiting adverse reactions on either component alone may be switched to Exforge containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to Exforge should be subsequently evaluated and if blood pressure remains uncontrolled after 3-4 weeks of therapy, the dose may be titrated up to a maximum of 10/320 mg. 

To minimize dose-independent hazards, it is usually appropriate to begin therapy with Exforge only after a patient has failed to achieve the desired antihypertensive effect with one or the other monotherapy.

Dose Titration Guided by Clinical Effect

A patient whose blood pressure is not adequately controlled with amlodipine (or another DHP CCB) alone or with valsartan (or another ARB) alone may be switched to combination therapy with Exforge.

Replacement Therapy

For convenience, patients receiving amlodipine and valsartan from separate tablets may instead wish to receive tablets of Exforge containing the same component doses.

HOW SUPPLIED

Exforge^® (amlodipine and valsartan) is available as tablets containing amlodipine besylate equivalent to 5 mg, or 10 mg of amlodipine free-base with valsartan 160 mg or 320 mg, providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg and 10/320 mg.

All strengths are packaged in bottles of 30 and 90 count, and unit dose blister packages.

5/160 mg Tablets  - dark yellow, ovaloid shaped, film coated tablet with beveled edge, debossed with “NVR” on one side and “ECE” on the other side.  

      Bottles of 30                               NDC # 0078-0488-15

      Bottles of 90                               NDC # 0078-0488-34

      Unit Dose 100 tablets (10 X 10 tablets blister cards)      NDC # 0078-0488-35

10/160 mg Tablets  - light yellow, ovaloid shaped, film coated tablet with beveled edge, debossed with “NVR” on one side and “UIC” on the other side.

      Bottles of 30                               NDC # 0078-0489-15

      Bottles of 90                               NDC # 0078-0489-34

      Unit Dose 100 tablets (10 X 10 tablets blister cards)      NDC # 0078-0489-35

5/320 mg Tablets  - very dark yellow, ovaloid shaped, film coated tablet with beveled edge, debossed with “NVR” on one side and “CSF” on the other side.

      Bottles of 30                               NDC # 0078-0490-15

      Bottles of 90                               NDC # 0078-0490-34

      Unit Dose 100 tablets (10 X 10 tablets blister cards)      NDC # 0078-0490-35

10/320 mg Tablets  - dark yellow, ovaloid shaped, film coated tablet with beveled edge, debossed with “NVR” on one side and “LUF” on the other side.

      Bottles of 30                               NDC # 0078-0491-15

      Bottles of 90                               NDC # 0078-0491-34

      Unit Dose 100 tablets (10 X 10 tablets blister cards)      NDC # 0078-0491-35

Storage

Store at 25^oC (77^oF); excursions permitted to 15-30^oC (59-86^oF). [See USP Controlled Room Temperature.] Protect from moisture.

*Norvasc^® is a registered trademark of Pfizer, Inc.

**Viagra^® is a registered trademark of Pfizer, Inc.

Distributed by:

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936

©Novartis

April 2007