VALSARTAN AND HYDROCHLOROTHIAZIDE- valsartan and hydrochlorothiazide tablet, film coated 
DirectRX

----------

VALSARTAN AND HYDROCHLOROTHIAZIDE

INDICATIONS & USAGE SECTION

DOSAGE & ADMINISTRATION SECTION

DOSAGE FORMS & STRENGTHS SECTION

80 mg/12.5 mg are light orange, oval shaped, film-coated tablets with VH1 on one side and > on the other.

160 mg/12.5 mg are dark red, oval shaped, film-coated tablets with VH2 on one side and > on the other.

160 mg/25 mg are brown, oval shaped, film-coated tablets with VH3 on one side and > on the other.

320 mg/12.5 mg are pink, oval shaped, film-coated tablets with VH4 on one side and > on the other.

320 mg/25 mg are yellow, oval shaped, film-coated tablets with VH5 on one side and > on the other.

CONTRAINDICATIONS SECTION

Valsartan and hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to any component of this product.

Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.

Do not coadminister aliskiren with valsartan and hydrochlorothiazide tablets in patients with diabetes [see Drug Interactions (7)].

WARNINGS AND PRECAUTIONS SECTION

ADVERSE REACTIONS SECTION

DRUG INTERACTIONS SECTION

USE IN SPECIFIC POPULATIONS SECTION

OVERDOSAGE SECTION

Valsartan – Hydrochlorothiazide: Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. Depressed level of consciousness, circulatory collapse and shock have been reported. If symptomatic hypotension should occur, supportive treatment should be instituted.

Valsartan is not removed from the plasma by dialysis.

The degree to which hydrochlorothiazide is removed by hemodialysis has not been established. The most common signs and symptoms observed in patients are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.

In rats and marmosets, single oral doses of valsartan up to 1524 and 762 mg/kg in combination with hydrochlorothiazide at doses up to 476 and 238 mg/kg, respectively, were very well tolerated without any treatment-related effects. These no adverse effect doses in rats and marmosets, respectively, represent 46.5 and 23 times the maximum recommended human dose (MRHD) of valsartan and 188 and 113 times the MRHD of hydrochlorothiazide on a mg/m2 basis. (Calculations assume an oral dose of 320 mg/day valsartan in combination with 25 mg/day hydrochlorothiazide and a 60 kg patient.)

Valsartan: Valsartan was without grossly observable adverse effects at single oral doses up to 2000 mg/kg in rats and up to 1000 mg/kg in marmosets, except for salivation and diarrhea in the rat and vomiting in the marmoset at the highest dose (60 and 31 times, respectively, the maximum recommended human dose on a mg/m2 basis). (Calculations assume an oral dose of 320 mg/day and a 60 kg patient.)

Hydrochlorothiazide: The oral LD50 of hydrochlorothiazide is greater than 10 g/kg in both mice and rats, which represents 2027 and 4054 times, respectively, the maximum recommended human dose on a mg/m2 basis. (Calculations assume an oral dose of 25 mg/day and a 60 kg patient.)

DESCRIPTION SECTION

CLINICAL PHARMACOLOGY SECTION

NONCLINICAL TOXICOLOGY SECTION

CLINICAL STUDIES SECTION

PATIENT MEDICATION INFORMATION SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

VALSARTAN AND HYDROCHLOROTHIAZIDE 
valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-634(NDC:0591-2315)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I) VALSARTAN80 mg
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
Colororange (Light orange) Scoreno score
ShapeOVAL (oval shaped) Size10mm
FlavorImprint Code VH1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-634-3030 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2015
2NDC:61919-634-9090 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09151901/01/2015
Labeler - DirectRX (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DirectRX079254320repack(61919-634)

Revised: 11/2015
Document Id: 09fbfdf9-5951-4633-8df8-40515546fb4b
Set id: 9ea4336c-6450-419e-8185-0072c07bba76
Version: 2
Effective Time: 20151110
 
DirectRX