Figure 2: Mean Sitting Diastolic Blood Pressure by Treatment and Week

Figure 3: Mean Sitting Systolic Blood Pressure by Treatment and Week

A subgroup of 283patients was studied with ambulatory blood pressure monitoring. The blood pressure lowering effect in the triple therapy group was maintained throughout the 24-hour period (see Figure 4 and Figure 5).

Figure 4: Mean Ambulatory Diastolic Blood Pressure at Endpoint by Treatment and Hour

Figure 5: Mean Ambulatory Systolic Blood Pressure at Endpoint by Treatment and Hour
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: 10/320/25 mg. Strengths are packaged in bottles of 30 tablets.
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 54868-6123-0
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).
Relabeling of "Additional Barcode" by:
Physicians Total Care, Inc.
Tulsa, OK 74146
17 PATIENT COUNSELING INFORMATION
Pregnancy: Female patients of childbearing age should be told that use of drugs like Exforge HCT that act on the renin-angiotensin system during pregnancy can cause serious problems in the fetus and infant including: low blood pressure, poor development of skull bones, kidney failure and death. Discuss other treatment options with female patients planning to become pregnant. Women using Exforge HCT who become pregnant should notify their physician as soon as possible.
Symptomatic Hypotension: A patient receiving Exforge HCT should be cautioned that lightheadedness can occur, especially during the first days of therapy, and that it should be reported to the prescribing physician. The patients should be told that if syncope occurs, Exforge HCT should be discontinued until the physician has been consulted.
All patients should be cautioned that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope.
Potassium Supplements: A patient receiving Exforge HCT should be told not to use potassium supplements or salt substitutes containing potassium without consulting the prescribing physician.
17.1 Information for Patients
Patient Information
Exforge HCT (X-phorj HCT)
(amlodipine and valsartan and hydrochlorothiazide) Tablets
Read the Patient Information that comes with EXFORGE HCT before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or treatment.
What is the most important information I should know about EXFORGE HCT?
If you become pregnant while taking EXFORGE HCT, stop taking EXFORGE HCT and call your doctor right away. EXFORGE HCT can harm an unb