e initial dose of amlodipine was 5 mg for 2 weeks with forced titration to 10 mg for 2 weeks, followed by the optional addition of HCTZ 12.5 mg for 4 weeks. At the primary endpoint of 4 weeks, the treatment difference between amlodipine/valsartan and amlodipine was 6.6/3.9 mmHg.
16HOW SUPPLIED/STORAGE AND HANDLING
Exforge is available as non-scored 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.
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 54868-5997-0
Bottles of 90
NDC 54868-5997-1
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 54868-5804-0
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 54868-5996-0
Bottles of 90
NDC 54868-5996-1
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 54868-5983-0
Bottles of 90
NDC 54868-5983-1
Store at 25oC (77oF); excursions permitted to 15-30oC (59-86oF). [See USP Controlled Room Temperature.]Protect from moisture.
17PATIENT COUNSELING INFORMATION
Information for Patients
Pregnancy: Female patients of childbearing age should be told that use of drugs like valsartan that act on the renin-angiotensin system 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 who become pregnant should notify their physicians as soon as possible.
T2011-68
FDA-APPROVED PATIENT LABELING
PATIENT INFORMATION
EXFORGE (X-phorj)
(amlodipine and valsartan)
Tablets
Read the Patient Information that comes with EXFORGE 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. If you have any questions about EXFORGE, ask your doctor or pharmacist.
What is the most important information I should know about EXFORGE?
If you become pregnant, stop taking EXFORGE and call your doctor right away. EXFORGE can harm an unborn baby causing injury and even death. If you plan to become pregnant, talk to your doctor about other treatment options to lower your blood pressure before taking EXFORGE.
What is EXFORGE?
EXFORGE contains two prescription medicines:
amlodipine, a calcium channel blocker
valsartan, an angiotensin receptor blocker (ARB).
EXFORGE may be used to lower high blood pressure (hypertension) in adults
when one medicine to lower your high blood pressure is not enough
as the first medicine to lower high blood pressure if your doctor decides you are likely to need more than one medicine.
EXFORGE has not been studied in children under 18 years of age.
What should I tell my doctor before ta |
