VALSARTAN AND HYDROCHLOROTHIAZIDE- valsartan and hydrochlorothiazide tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

VALSARTAN

Composition:

VALSARTAN 160 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 High Blood Pressure Education Progra

Product summary:

Valsartan and hydrochlorothiazide tablets, USP are available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg, and 320/25 mg. Strengths are available as follows. 80/12.5 mg Tablet - Purple, capsule-shaped, biconvex, film-coated tablets debossed with “345” on one side and “HH” on the other side. Bottles of 30 ........................................................................................NDC 43547-311-03 Bottles of 90 ........................................................................................NDC 43547-311-09 Bottles of 500.......................................................................................NDC 43547-311-50 160/12.5 mg Tablet - Pink, capsule-shaped, biconvex, film-coated tablets debossed with “347” on one side and “HH” on the other side. Bottles of 30 .........................................................................................NDC 43547-312-03 Bottles of 90 .........................................................................................NDC 43547-312-09 Bottles of 500........................................................................................NDC 43547-312-50 160/25 mg Tablet - Purple, capsule-shaped, biconvex, film-coated tablets debossed with “346” on one side and “HH” on the other side. Bottles of 30 .........................................................................................NDC 43547-313-03 Bottles of 90 .........................................................................................NDC 43547-313-09 Bottles of 500........................................................................................NDC 43547-313-50 320/12.5 mg Tablet - Pink, capsule-shaped, biconvex, film-coated tablets debossed with “351” on one side and “HH” on the other side. Bottles of 30 .........................................................................................NDC 43547-314-03 Bottles of 90 .........................................................................................NDC 43547-314-09 Bottles of 500........................................................................................NDC 43547-314-50 320/25 mg Tablet - Purple, capsule-shaped, biconvex, film-coated tablets debossed with “349” on one side and “HH” on the other side. Bottles of 30 ..........................................................................................NDC 43547-315-03 Bottles of 90 ..........................................................................................NDC 43547-315-09 Bottles of 500 ........................................................................................NDC 43547-315-50 Store at 20-25 o C (68-77 o F); excursions permitted to 15-30 o C (59-86 o F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

REMEDYREPACK INC.
----------
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 problems.
•
are allergic to medicines that contain sulfonamides.
What should I tell my doct

Summary of Product characteristics

VALSARTAN AND HYDROCHLOROTHIAZIDE- VALSARTAN AND HYDROCHLOROTHIAZIDE
TABLET,
FILM COATED
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALSARTAN AND
HYDROCHLOROTHIAZIDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR VALSARTAN AND
HYDROCHLOROTHIAZIDE.
VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
TABLET, FILM COATED
FOR ORAL USE.
INITIAL U.S. APPROVAL: 1998
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE VALSARTAN AND
HYDROCHLOROTHIAZIDE TABLETS AS SOON AS
POSSIBLE. (5.1)
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THE DEVELOPING
FETUS. (5.1)
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:
In patients not adequately controlled with monotherapy ( 1)
As initial therapy in patients likely to need multiple drugs to
achieve their blood pressure goals ( 1)
Lowering blood pressure reduces the risk of fatal and nonfatal
cardiovascular events, primarily strokes and myocardial
infarctions .
DOSAGE AND ADMINISTRATION
Dose once daily. Titrate as needed to a maximum dose of 320/25mg ( 2)
May be used as add-on/switch therapy for patients not adequately
controlled on any of the components (valsartan or
HCTZ) ( 2)
May be substituted for titrated components ( 2.3)
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
Hypotension: Correct volume depletion prior to