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:

Solco Healthcare US, LLC

INN (International Name):

VALSARTAN

Composition:

VALSARTAN 80 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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 High Bl

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°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).

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

VALSARTAN AND HYDROCHLOROTHIAZIDE- VALSARTAN AND HYDROCHLOROTHIAZIDE
TABLET, FILM
COATED
Solco Healthcare US, LLC
----------
PATIENT INFORMATION
Dispense with Patient Information available at:
www.solcohealthcare.com/DrugLabeling/valsartan-hctz-tablets.pdf
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 ingredi

Summary of Product characteristics

VALSARTAN AND HYDROCHLOROTHIAZIDE- VALSARTAN AND
HYDROCHLOROTHIAZIDE TABLET, FILM COATED
SOLCO HEALTHCARE US, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALSARTAN AND
HYDROCHLOROTHIAZIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION
FOR VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS.
VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS, 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 SYSTEM CAN