r pack of 30) NDC 0078-0315-15
160/25 mgTablet- Brown orange, ovaloid with slightly convex faces debossed NVR on one side and HXH on the other side.
Bottles of 90 NDC 0078-0383-34
Bottles of 7,000 NDC 0078-0383-17
Unit Dose (blister pack) NDC 0078-0383-06
Box of 100 (strips of 10)
Unit Dose (blister pack of 30) NDC 0078-0383-15
320/12.5mg Tablet- Pink, ovaloid with beveled edge, debossed NVR on one side and HIL on the other side.
Bottles of 90 NDC 0078-0471-34
Bottles of 3,500 NDC 0078-0471-11
Unit Dose (blister pack) NDC 0078-0471-06
Box of 100 (strips of 10)
Unit Dose (blister pack of 30) NDC 0078-0471-15
320/25 mgTablet- Yellow, ovaloid with beveled edge, debossed NVR on one side and CTI on the other side.
Bottles of 90 NDC 0078-0472-34
Bottles of 3,500 NDC 0078-0472-11
Unit Dose (blister pack) NDC 0078-0472-06
Box of 100 (strips of 10)
Unit Dose (blister pack of 30) NDC 0078-0472-15
Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].
Protect from moisture.
Dispense in tight container (USP).
17 PATIENT COUNSELING INFORMATION
17.1 Information for Patients
Pregnancy: Female patients of childbearing age should be told that use of drugs like DiovanHCTthat 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 DiovanHCT who become pregnant should notify their physician as soon as possible.
Symptomatic Hypotension: A patient receiving DiovanHCT 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, DiovanHCT 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 DiovanHCT should be told not to use potassium supplements or salt substitutes containing potassium without consulting the prescribing physician.
17.2 FDA-Approved Patient LabelingPATIENT INFORMATION
DIOVANHCT (DYE’-o-van HCT)
(valsartan and hydrochlorothiazide)
Tablets
Read the Patient Information that comes with DIOVANHCT 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 condition and treatment. If you have any questions about DIOVANHCT, ask your doctor or pharmacist.
What is the most important information I should know about DIOVANHCT?
If you become pregnant, stop taking DIOVANHCT and call your doctor right away. DIOVANHCT 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 high blood pressure before taking DIOVANHCT.
What is DIOVANHCT?
DIOVANHCT contains two prescription medicines:
valsartan, an angiotensin receptor blocker (ARB)
hydrochlorothiazide (HCTZ), a water pill (diuretic)
DIOVANHCT may be used to lower high blood pressure (hyp |
