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AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE- amlodipine valsartan and hydrochlorothiazide tablet, film coated


  1. Patient Information
  2. Pregnancy:
  3. Symptomatic Hypotension:
  4. Potassium Supplements:
  5. What Is The Most Important Information I Should Know About Amlodipine, Valsartan, Hydrochlorothiazide Tablets?
  6. Amlodipine, Valsartan, Hydrochlorothiazide Tablets Contain 3 Prescription Medicines:
  7. Who Should Not Take Amlodipine, Valsartan, Hydrochlorothiazide Tablets?
  8. Tell Your Doctor About All Of Your Medical Conditions, Including If You:
  9. Tell All Your Doctors And Dentist You Are Taking Amlodipine, Valsartan, Hydrochlorothiazide Tablets. This Is Especially Important If You:
  10. What Are The Possible Side Effects Of Amlodipine, Valsartan, Hydrochlorothiazide Tablets?
  11. How Should I Store Amlodipine, Valsartan, Hydrochlorothiazide Tablets?
  12. What Are The Ingredients In Amlodipine, Valsartan, Hydrochlorothiazide Tablets?
  13. What Is High Blood Pressure (hypertension)?
  14. Distributed By:
  15. Revised: 11/2018document Id:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information)

Pregnancy: 

Female patients of childbearing age should be told about the consequences of exposure to amlodipine, valsartan, hydrochlorothiazide tablets during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.

Symptomatic Hypotension: 

A patient receiving amlodipine, valsartan, hydrochlorothiazide tablets should be cautioned that lightheadedness can occur, especially during the first days of therapy, and that it should be reported to the prescribing physician. The patients should be told that if syncope occurs, amlodipine, valsartan, hydrochlorothiazide tablets should be discontinued until the physician has been consulted.

All patients should be cautioned that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope.

Potassium Supplements: 

A patient receiving amlodipine, valsartan, hydrochlorothiazide tablets should be told not to use potassium supplements or salt substitutes containing potassium without consulting the prescribing physician.

T2016-28
July 2015

Information for Patients

Patient Information

Amlodipine, Valsartan, Hydrochlorothiazide Tablets
(am-LOE-dih-peen, val-SAR-tan, hye-droe-klor-oh-THYE-ah-zide)

Read the Patient Information that comes with amlodipine, valsartan, 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 medical condition or treatment.

What Is The Most Important Information I Should Know About Amlodipine, Valsartan, Hydrochlorothiazide Tablets? 

Amlodipine, valsartan, 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 amlodipine, valsartan, hydrochlorothiazide tablets, tell your doctor right away.

Amlodipine, Valsartan, Hydrochlorothiazide Tablets Contain 3 Prescription Medicines: 

1.
amlodipine, a calcium channel blocker
2.
valsartan, an angiotensin receptor blocker, and
3.
hydrochlorothiazide, a diuretic (water pill)

Amlodipine, valsartan, hydrochlorothiazide tablets may be used to lower blood pressure in adults when 2 medicines to lower your high blood pressure are not enough.

Amlodipine, valsartan, hydrochlorothiazide tablets have not been studied in children under 18 years of age.

Who Should Not Take Amlodipine, Valsartan, Hydrochlorothiazide Tablets? 

Do not take amlodipine, valsartan, hydrochlorothiazide tablets if you have low or no urine output (anuria).

Tell Your Doctor About All Of Your Medical Conditions, Including If You: 

are pregnant or plan to become pregnant.
are breastfeeding or plan to breastfeed.Amlodipine, valsartan, hydrochlorothiazide tablets may pass into your milk. Do not breastfeed while you are taking amlodipine, valsartan, hydrochlorothiazide tablets.
are allergic to any of the ingredients in amlodipine, valsartan, hydrochlorothiazide tablets.

Take amlodipine, valsartan, hydrochlorothiazide tablets exactly as your doctor tells you.
Take amlodipine, valsartan, hydrochlorothiazide tablets one time each day.
Amlodipine, valsartan, hydrochlorothiazide tablets can be taken with or without food.
If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Just take the next dose at the regular time.
If you take too much amlodipine, valsartan, hydrochlorothiazide tablets, call your doctor or Poison Control Center, or go to the emergency room.

Tell All Your Doctors And Dentist You Are Taking Amlodipine, Valsartan, Hydrochlorothiazide Tablets. This Is Especially Important If You: 

are going to have surgery
go for kidney dialysis

What Are The Possible Side Effects Of Amlodipine, Valsartan, Hydrochlorothiazide Tablets? 

Amlodipine, valsartan, hydrochlorothiazide tablets may causeserious side effectsincluding:

harm to an unborn baby causing injury or death.
low blood pressure(hypotension). Low blood pressure is most likely to happen if you:
take water pills
are on a low salt diet
have heart problems
get dialysis treatments
get sick with vomiting or diarrhea
drink alcohol.

Lie down if you feel faint or dizzy. If you faint (lose consciousness), stop taking amlodipine, valsartan, hydrochlorothiazide tablets. Call your doctor right away.

Get emergency help if you get worse chest pain or chest pain that does not go away.
kidney problems.Kidney problems may become worse in people that already have kidney disease. Some people will have changes in blood tests for kidney function and may need a lower dose of amlodipine, valsartan, hydrochlorothiazide tablets. Call your doctor if you have swelling in your feet, ankles, or hands, or unexplained weight gain. If you have heart failure, your doctor should check your kidney function before prescribing amlodipine, valsartan, hydrochlorothiazide tablets.
laboratory blood test changes in people with heart failure. Some people with heart failure who take valsartan, one of the medicines in amlodipine, valsartan, hydrochlorothiazide tablets, have changes in blood tests including increased potassium and decreased kidney function.
allergic reactions
skin rash.Call your doctor right away if you get an unusual skin rash.
eye problems.One of the medicines in amlodipine, valsartan, hydrochlorothiazide tablets can cause eye problems that may lead to vision loss. Symptoms of eye problems can happen within hours to weeks of starting amlodipine, valsartan, hydrochlorothiazide tablets. Tell your doctor right away if you have:
decrease in vision
eye pain

Themost commonside effects of amlodipine, valsartan, hydrochlorothiazide tablets include:

dizziness
swelling (edema) of the hands, ankles, or feet
headache
indigestion
tiredness
muscle spasms
back pain
nausea

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of amlodipine, valsartan, hydrochlorothiazide tablets. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How Should I Store Amlodipine, Valsartan, Hydrochlorothiazide Tablets? 

Store amlodipine, valsartan, hydrochlorothiazide tablets at room temperature between 59 F to 86 F (15 C to 30 C).
Keep amlodipine, valsartan, hydrochlorothiazide tablets dry (protect it from moisture).

Keep amlodipine, valsartan, hydrochlorothiazide tablets and all medicines out of the reach of children.

General Information about amlodipine, valsartan, hydrochlorothiazide tablets

Medicines are sometimes prescribed for conditions that are not mentioned in the patient information leaflet. Do not use amlodipine, valsartan, hydrochlorothiazide tablets for a condition for which it was not prescribed. Do not give amlodipine, valsartan, hydrochlorothiazide tablets to other people, even if they have the same symptoms that you have. It may harm them.

This patient information leaflet summarizes the most important information about amlodipine, valsartan, hydrochlorothiazide tablets. If you would like more information about amlodipine, valsartan, hydrochlorothiazide tablets, talk with your doctor. You can ask your doctor or pharmacist for information about amlodipine, valsartan, hydrochlorothiazide tablets that is written for health professionals.

What Are The Ingredients In Amlodipine, Valsartan, Hydrochlorothiazide Tablets? 

Active ingredients: amlodipine besylate, valsartan, hydrochlorothiazide

The inactive ingredients of all strengths of the tablets are crospovidone, magnesium stearate, microcrystalline cellulose, and colloidal anhydrous silica. The film coating contains hypromellose, talc, macrogol 4000, and may contain titanium dioxide or yellow and red iron oxides.

What Is High Blood Pressure (hypertension)? 

Blood pressure is the force of blood in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too much. Amlodipine, valsartan, hydrochlorothiazide tablets can help your blood vessels relax so your blood pressure is lower. Medicines that lower blood pressure lower your chance of having a stroke or heart attack.

High blood pressure makes the heart work harder to pump blood throughout the body and causes damage to blood vessels. If high blood pressure is not treated, it can lead to stroke, heart attack, heart failure, kidney failure, and vision problems.

Distributed By: 

Sandoz Inc.

Princeton, NJ 08540

T2016-28/T2016-29
July 2015/July 2015

PRINCIPAL DISPLAY PANEL

Package Label 5 mg / 160 mg / 12.5 mg

NDC 0781-5756-31 Rx Only

Amlodipine, Valsartan, Hydrochlorothiazide Tablets

5 mg* / 160 mg / 12.5 mg

*each tablet contains 6.9 mg of amlodipine besylate

30 Tablets

Sandoz

PRINCIPAL DISPLAY PANEL Package Label     5 mg / 160 mg / 12.5 mg Rx Only  NDC 0781-5756-31 AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE TABLETS  (amlodipine, valsartan, hydrochlorothiazide) 5 mg* / 160 mg / 12.5 mg *each tablet contains 6.9 mg of amlodipine besylate 30 Tablets

PRINCIPAL DISPLAY PANEL

Package Label - 10 mg* / 160 mg / 12.5 mg

NDC 0781-5760-31 Rx Only

Amlodipine, Valsartan, Hydrochlorothiazide Tablets

10 mg* / 160 mg / 12.5 mg

*each tablet contains 13.9 mg of amlodipine besylate

30 Tablets

Sandoz

PRINCIPAL DISPLAY PANEL Package Label     10 mg / 160 mg / 12.5 mg Rx Only  NDC 0781-5760-31 AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE TABLETS 10 mg* / 160 mg / 12.5 mg *each tablet contains 13.9 mg of amlodipine besylate 30 Tablets

PRINCIPAL DISPLAY PANEL

Package Label - 5 mg / 160 mg / 25 mg

NDC 0781-5771-31 Rx Only

Amlodipine, Valsartan, Hydrochlorothiazide Tablets

5 mg* / 160 mg / 25 mg

*each tablet contains 6.9 mg of amlodipine besylate

30 Tablets

Sandoz

PRINCIPAL DISPLAY PANEL Package Label     5 mg / 160 mg / 25 mg Rx Only  NDC 0781-5771-31 AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE TABLETS 5 mg* / 160 mg / 25 mg *each tablet contains 6.9 mg of amlodipine besylate 30 Tablets

PRINCIPAL DISPLAY PANEL

Package Label - 10 mg* / 160 mg / 25 mg

NDC 0781-5787-31 Rx Only

Amlodipine, Valsartan, Hydrochlorothiazide Tablets

10 mg* / 160 mg / 25 mg

*each tablet contains 13.9 mg of amlodipine besylate

30 Tablets

Sandoz

PRINCIPAL DISPLAY PANEL Package Label     10 mg / 160 mg / 25 mg Rx Only  NDC 0781-5787-31 AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE TABLETS 10 mg* / 160 mg / 25 mg *each tablet contains 13.9 mg of amlodipine besylate 30 Tablets

PRINCIPAL DISPLAY PANEL

Package Label - 10 mg* / 320 mg / 25 mg

NDC 0781-5794-31 Rx Only

Amlodipine, Valsartan, Hydrochlorothiazide Tablets

10 mg* / 320 mg / 25 mg

*each tablet contains 13.9 mg of amlodipine besylate

30 Tablets

Sandoz

PRINCIPAL DISPLAY PANEL Package Label     10 mg / 320 mg / 25 mg Rx Only  NDC 0781-5794-31 AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE TABLETS 10 mg* / 320 mg / 25 mg *each tablet contains 13.9 mg of amlodipine besylate 30 Tablets
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE
amlodipine valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0781-5756
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE(UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)AMLODIPINE5 mg
VALSARTAN(UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)VALSARTAN160 mg
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)HYDROCHLOROTHIAZIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
ColorWHITE (white)Scoreno score
ShapeOVAL (ovaloid, biconvex tablets with beveled edge)Size15mm
FlavorImprint CodeNVR;VCL
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0781-5756-3130 in 1 BOTTLE; Type 0: Not a Combination Product12/01/201405/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02231412/01/201405/31/2021
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE
amlodipine valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0781-5760
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE(UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)AMLODIPINE10 mg
VALSARTAN(UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)VALSARTAN160 mg
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)HYDROCHLOROTHIAZIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
ColorYELLOW (pale yellow)Scoreno score
ShapeOVAL (ovaloid, biconvex tablets with beveled edge)Size15mm
FlavorImprint CodeNVR;VDL
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0781-5760-3130 in 1 BOTTLE; Type 0: Not a Combination Product12/01/201405/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02231412/01/201405/31/2021
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE
amlodipine valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0781-5771
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE(UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)AMLODIPINE5 mg
VALSARTAN(UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)VALSARTAN160 mg
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)HYDROCHLOROTHIAZIDE25 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
ColorYELLOW (yellow)Scoreno score
ShapeOVAL (ovaloid, biconvex tablets with beveled edge)Size15mm
FlavorImprint CodeNVR;VEL
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0781-5771-3130 in 1 BOTTLE; Type 0: Not a Combination Product12/01/201405/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02231412/01/201405/31/2021
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE
amlodipine valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0781-5787
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE(UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)AMLODIPINE10 mg
VALSARTAN(UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)VALSARTAN160 mg
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)HYDROCHLOROTHIAZIDE25 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
ColorBROWN (brown-yellow)Scoreno score
ShapeOVAL (ovaloid, biconvex tablets with beveled edge)Size15mm
FlavorImprint CodeNVR;VHL
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0781-5787-3130 in 1 BOTTLE; Type 0: Not a Combination Product12/01/201405/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02231412/01/201405/31/2021
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE
amlodipine valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0781-5794
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE(UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)AMLODIPINE10 mg
VALSARTAN(UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)VALSARTAN320 mg
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)HYDROCHLOROTHIAZIDE25 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
ColorBROWN (brown-yellow)Scoreno score
ShapeOVAL (ovaloid, biconvex tablets with beveled edge)Size19mm
FlavorImprint CodeNVR;VFL
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0781-5794-3130 in 1 BOTTLE; Type 0: Not a Combination Product12/01/201405/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02231412/01/201405/31/2021
Labeler -Sandoz Inc (110342024)

Revised: 11/2018document Id: 

07a597a4-a78e-4558-adda-335d316400a2Set id: dd311bf0-c5c8-4f0b-9f8f-e855bb32a71eVersion: 3Effective Time: 20181120Sandoz Inc



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