VALSARTAN AND HYDROCHLOROTHIAZIDE tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

זמין מ:

Bryant Ranch Prepack

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Valsartan and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National Hi

leaflet_short:

Valsartan and hydrochlorothiazide tablets, USP are available as non-scored tablets 320/25 mg Tablet - Purple, capsule-shaped, biconvex, film-coated tablets debossed with “349” on one side and “HH” on the other side. NDC: 71335-2200-1: 30 Tablets in a BOTTLE NDC: 71335-2200-2: 90 Tablets in a BOTTLE Store at 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP). Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

מצב אישור:

Abbreviated New Drug Application

עלון מידע

VALSARTAN AND HYDROCHLOROTHIAZIDE- VALSARTAN AND HYDROCHLOROTHIAZIDE
TABLET, FILM
COATED
Bryant Ranch Prepack
----------
PATIENT INFORMATION
FDA-Approved Patient Labeling
Valsartan and Hydrochlorothiazide Tablets, USP
(val sar’ tan and hye’’ droe klor’’ oh thye’ azide)
Read the Patient Information that comes with valsartan and
hydrochlorothiazide tablets 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 valsartan
and hydrochlorothiazide tablets, ask your doctor or pharmacist.
What is the most important information I should know about valsartan
and hydrochlorothiazide tablets?
Valsartan and hydrochlorothiazide tablets can cause harm or death to
an unborn baby. Talk to your
doctor about other ways to lower your blood pressure if you plan to
become pregnant. If you get pregnant
while taking valsartan and hydrochlorothiazide tablets, tell your
doctor right away.
What are valsartan and hydrochlorothiazide tablets?
Valsartan and hydrochlorothiazide tablets contain 2 prescription
medicines:
1. valsartan, an angiotensin receptor blocker (ARB)
2. hydrochlorothiazide (HCTZ), a water pill (diuretic)
Valsartan and hydrochlorothiazide tablets may be used to lower high
blood pressure (hypertension) in
adults-
•
when 1 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 1 medicine.
Valsartan and hydrochlorothiazide tablets have not been studied in
children under 18 years of age.
Who should not take valsartan and hydrochlorothiazide tablets?
Do not take valsartan and hydrochlorothiazide tablets if you:
•
are allergic to any of the ingredients in valsartan and
hydrochlorothiazide tablets. See the end of this
leaflet for a complete list of ingredients in valsartan and
hydrochlorothiazide tablets.
•
make less urine due to kidney p

מאפייני מוצר

VALSARTAN AND HYDROCHLOROTHIAZIDE- VALSARTAN AND
HYDROCHLOROTHIAZIDE TABLET, FILM COATED
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALSARTAN AND
HYDROCHLOROTHIAZIDE TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS, USP.
VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS, USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
INDICATIONS AND USAGE
Valsartan and hydrochlorothiazide tablets are the combination tablet
of valsartan, an angiotensin II
receptor blocker (ARB) and hydrochlorothiazide (HCTZ), a diuretic.
Valsartan and hydrochlorothiazide
tablets are indicated for the treatment of hypertension, to lower
blood pressure:
•
•
Lowering blood pressure reduces the risk of fatal and nonfatal
cardiovascular events, primarily strokes and
myocardial infarctions.
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets (valsartan/HCTZ mg): 80/12.5, 160/12.5, 160/25, 320/12.5,
320/25 (3)
CONTRAINDICATIONS
Anuria; Hypersensitivity to any sulfonamide-derived drugs or any
component; Do not coadminister
aliskiren with valsartan and hydrochlorothiazide tablets in patients
with diabetes (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
ADVERSE REACTIONS
The most common reasons for discontinuation of therapy with valsartan
and hydrochlorothiazide tablets
were headache and dizziness. The only adverse experience that occurred
in ≥ 2% of patients treated with
valsartan and hydrochlorothiazide tablets and at a higher incidence
than placebo was nasopharyngitis
(2.4% vs. 1.9%). (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SOLCO HEALTHCARE US,
LLC AT 1-866-257-
2597 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
WHEN PREGNANCY IS DETECTED, DISCONTINUE VALSARTAN AND
HYDROCHLOROTHIAZIDE
TABLETS AS SOON AS POSSIBLE. (5.1)
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN