Exforge HCT (Amlodipine Besylate / Hydrochlorothiazide / Valsartan) - Indications and Dosage

1 INDICATIONS AND USAGE

Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) is indicated for the treatment of hypertension.

This fixed combination drug is not indicated for the initial therapy of hypertension [see Dosage and Administration (2)].

2 DOSAGE AND ADMINISTRATION

2.1 General Considerations

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

Exforge HCT may be administered with or without food.

No initial dosage adjustment is required for elderly patients.

Renal impairment : The usual regimens of therapy with Exforge HCT may be followed if the patient's creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so avoid use of Exforge HCT [see Impaired Renal Function ].

Hepatic impairment: Avoid Exforge HCT in patients with severe hepatic impairment. In patients with lesser degrees of hepatic impairment, monitor for worsening of hepatic or renal function and adverse reactions [see Impaired Hepatic Function (5.4)].

2.2 Add-on / Switch Therapy

Exforge HCT may be used for patients not adequately controlled on any two 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 Exforge HCT may be switched to Exforge HCT containing a lower dose of that component to achieve similar blood pressure reductions.

2.3 Replacement Therapy

Exforge HCT may be substituted for the individually titrated components.

3 DOSAGE FORMS AND STRENGTHS

• 5 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets — White, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing "NVR" on one side and "VCL" on the other side.
  
• 10 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets — Pale yellow, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing "NVR" on one side and "VDL" on the other side.
  
• 5 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets — Yellow, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing "NVR" on one side and "VEL" on the other side.
  
• 10 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets — Brown-yellow, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing "NVR" on one side and "VHL" on the other side.
  
• 10 mg amlodipine /320 mg valsartan /25 mg hydrochlorothiazide Tablets — Brown-yellow, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing "NVR" on one side and "VFL" on the other side.

16 HOW SUPPLIED/STORAGE AND HANDLING

Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) is available as film-coated tablets containing amlodipine besylate equivalent to 5 mg or 10 mg of amlodipine free-base with valsartan 160 mg or 320 mg and hydrochlorothiazide 12.5 mg or 25 mg, providing for the following available combinations: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg and 10/320/25 mg. All strengths are packaged in bottles of 30 and 90 tablets.

5 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets – White, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing "NVR" on one side and "VCL" on the other side.

      Bottles of 30                NDC 0078-0559-15

      Bottles of 90                NDC 0078-0559-34

10 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets – Pale yellow, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing "NVR" on one side and "VDL" on the other side.

      Bottles of 30                NDC 0078-0561-15

      Bottles of 90                NDC 0078-0561-34

5 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets – Yellow, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing "NVR" on one side and "VEL" on the other side.

      Bottles of 30                NDC 0078-0560-15

      Bottles of 90                NDC 0078-0560-34

10 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets – Brown-yellow, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing "NVR" on one side and "VHL" on the other side.

      Bottles of 30                NDC 0078-0562-15

      Bottles of 90                NDC 0078-0562-34

10 mg amlodipine /320 mg valsartan /25 mg hydrochlorothiazide Tablets – Brown-yellow, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing "NVR" on one side and "VFL" on the other side.

      Bottles of 30                NDC 0078-0563-15

      Bottles of 90                NDC 0078-0563-34

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

[see USP controlled room temperature.]

Protect from moisture.

Dispense in tight container (USP).