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AVALIDE- irbesartan and hydrochlorothiazide tablet, film coated


  1. Patient Information
  2. Revised: 7/2018document Id:

Patient Information 

Pregnancy

Tell female patients of childbearing age about the consequences of exposure to AVALIDE during pregnancy. Discuss treatment options with women planning to become pregnant. Ask patients to report pregnancies to their physician as soon as possible.

Symptomatic Hypotension

Tell patients using AVALIDE that they may feel lightheaded, especially during the first days of use. Tell patients to inform their physician if they feel lightheaded or faint. Tell the patient, if fainting occurs, stop using AVALIDE and contact the prescribing doctor.

Tell patients using AVALIDE that getting dehydrated can lower their blood pressure too much and lead to lightheadedness and possible fainting. Dehydration may occur with excessive sweating, diarrhea, or vomiting and with not drinking enough liquids.

Potassium Supplements

Advise patients not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider[seeDrug Interactions (7.3)].

Acute Myopia and Secondary Angle-Closure Glaucoma

Advise patients to discontinue AVALIDE and seek immediate medical attention if they experience symptoms of Acute Myopia or Secondary Angle-Closure Glaucoma[seeWarnings and Precautions (5.8)].

sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY

2018 sanofi-aventis U.S. LLC

PRINCIPAL DISPLAY PANEL - 150/12.5 mg Tablet Bottle Label

30 Tablets
NDC 0024-5855-30

Avalide
(irbesartan-
hydrochlorothiazide)
Tablets
150/12.5 mg

Rx only
SANOFI

PRINCIPAL DISPLAY PANEL - 150/12.5 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 300/12.5 mg Tablet Bottle Label

30 Tablets
NDC 0024-5856-30

Avalide
(irbesartan-
hydrochlorothiazide)
Tablets
300/12.5 mg

Rx only
SANOFI

PRINCIPAL DISPLAY PANEL - 300/12.5 mg Tablet Bottle Label
AVALIDE
irbesartan and hydrochlorothiazide tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0024-5855
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IRBESARTAN(UNII: J0E2756Z7N) (IRBESARTAN - UNII:J0E2756Z7N)IRBESARTAN150 mg
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)HYDROCHLOROTHIAZIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
CARNAUBA WAX(UNII: R12CBM0EIZ)
Product Characteristics
ColorORANGE (peach)Scoreno score
ShapeOVAL (biconvex)Size13mm
FlavorImprint Codeheart;2875
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0024-5855-3030 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2013
2NDC:0024-5855-9090 in 1 BOTTLE; Type 0: Not a Combination Product01/01/201312/31/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02075801/01/2013
AVALIDE
irbesartan and hydrochlorothiazide tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0024-5856
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IRBESARTAN(UNII: J0E2756Z7N) (IRBESARTAN - UNII:J0E2756Z7N)IRBESARTAN300 mg
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)HYDROCHLOROTHIAZIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
CARNAUBA WAX(UNII: R12CBM0EIZ)
Product Characteristics
ColorORANGE (peach)Scoreno score
ShapeOVAL (biconvex)Size16mm
FlavorImprint Codeheart;2876
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0024-5856-3030 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2013
2NDC:0024-5856-9090 in 1 BOTTLE; Type 0: Not a Combination Product01/01/201308/31/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02075801/01/2013
Labeler -Sanofi-Aventis U.S. LLC (824676584)
Establishment
NameAddressID/FEIBusiness Operations
Sanofi Winthrop Industrie763683216ANALYSIS(0024-5855, 0024-5856) , LABEL(0024-5855, 0024-5856) , MANUFACTURE(0024-5855, 0024-5856) , PACK(0024-5855, 0024-5856)
Establishment
NameAddressID/FEIBusiness Operations
Sanofi Winthrop Industrie571879985LABEL(0024-5855, 0024-5856) , PACK(0024-5855, 0024-5856)
Establishment
NameAddressID/FEIBusiness Operations
Sanofi Chimie262699775ANALYSIS(0024-5855, 0024-5856) , API MANUFACTURE(0024-5855, 0024-5856)
Establishment
NameAddressID/FEIBusiness Operations
Chinoin Pharmaceutical and Chemical Works Private Co., Ltd.643939754ANALYSIS(0024-5855, 0024-5856) , API MANUFACTURE(0024-5855, 0024-5856)
Establishment
NameAddressID/FEIBusiness Operations
Eurofins Lancaster Laboratories, Inc069777290ANALYSIS(0024-5855, 0024-5856)
Establishment
NameAddressID/FEIBusiness Operations
CAMBREX PROFARMACO MILANO S.R.L.438051401ANALYSIS(0024-5855, 0024-5856) , API MANUFACTURE(0024-5855, 0024-5856)

Revised: 7/2018document Id: 

b25b88be-e51a-4170-bc22-3aafaa1767d6Set id: 0d91895e-c869-4b33-9b83-d55c1ad6317eVersion: 11Effective Time: 20180731Sanofi-Aventis U.S. LLC



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