Monopril HCT

Name: Monopril HCT

What happens if i miss a dose (monopril hct)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What should i avoid while taking hydrochlorothiazide and fosinopril (monopril hct)?

Avoid taking an antacid within 2 hours before or after you take hydrochlorothiazide and fosinopril. Antacids can make it harder for your body to absorb fosinopril.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol, which can increase some of the side effects of hydrochlorothiazide and fosinopril.

Avoid the regular use of salt substitutes in your diet, and do not take potassium supplements while taking hydrochlorothiazide and fosinopril, unless your doctor has told you to.

  • ACE Inhibitors

Uses of Monopril HCT

Monopril HCT is a prescription medication used to treat high blood pressure.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. 

Monopril HCT and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Monopril HCT falls into category D. When pregnancy is detected, discontinue Monopril HCT as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the unborn baby.

Monopril HCT Usage

  • Take Monopril HCT exactly as prescribed. 
  • Monopril HCT comes in a tablet form and is taken by mouth once daily with or without food. 

Monopril HCT Dosage

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

  • your blood pressure
  • previous medications used and the doses tried
  • how you respond to this medication
  • your other medical conditions

The dosing of Monopril HCT is based off its two components: fosinopril and hydrochlorothiazide. Fosinopril is a successful treatment of high blood pressure in once-daily doses of 10–80 mg, while hydrochlorothiazide is successful in doses of 12.5–50 mg per day.  

Monopril HCT FDA Warning

WARNING: FETAL TOXICITY 

• When pregnancy is detected, discontinue Monopril HCT as soon as possible. 
• Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

How should I take Monopril HCT (hydrochlorothiazide and fosinopril)?

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking hydrochlorothiazide and fosinopril. This can lead to very low blood pressure, electrolyte disorders, or kidney failure.

Your blood pressure will need to be checked often. Your blood and urine may also be tested if you have been vomiting or are dehydrated. Visit your doctor regularly.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

If you need surgery, tell the surgeon ahead of time that you are using hydrochlorothiazide and fosinopril. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

How is Monopril-HCT Supplied

MONOPRIL®-HCT (fosinopril sodium-hydrochlorothiazide tablets) is available in two different strengths. Dosage strengths of both components, tablet characteristics, and available quantities/packaging are identified below.

Monopril-HCT 10/12.5 Monopril-HCT 20/12.5
Fosinopril 10 mg 20 mg
Hydrochlorothiazide 12.5 mg 12.5 mg
Shape round round
Color peach peach
Debossed “1492” “1493” on one side; bisect bar on the other side
Bottle of 100 NDC 0087-1492-01 NDC 0087-1493-01

Storage

Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closed.

PRODUCT OF ITALY

Bristol-Myers Squibb Company
Princeton, NJ 08543 USA

Rev June 2008

-----------------------------------------
REPRESENTATIVE PACKAGING

See How Supplied section for a complete list of available packages of Monopril-HCT.

100 Tablets
NDC 0087-1492-01
MONOPRIL®-HCT
10/12.5 mg
(fosinopril sodium-hydrochlorothiazide tablets)
Rx only
Bristol-Myers Squibb Company

Monopril-HCT 
fosinopril sodium and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0087-1492
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
fosinopril sodium (fosinopril) fosinopril sodium 10 mg
hydrochlorothiazide (hydrochlorothiazide) hydrochlorothiazide 12.5 mg
Inactive Ingredients
Ingredient Name Strength
lactose  
croscarmellose sodium  
povidone  
sodium stearyl fumarate  
ferric oxide  
Product Characteristics
Color ORANGE (peach) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 1492
Contains     
Packaging
# Item Code Package Description
1 NDC:0087-1492-01 100 TABLET (100 TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020286 06/01/2009 09/30/2010
Monopril-HCT 
fosinopril sodium and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0087-1493
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
fosinopril sodium (fosinopril) fosinopril sodium 20 mg
hydrochlorothiazide (hydrochlorothiazide) hydrochlorothiazide 12.5 mg
Inactive Ingredients
Ingredient Name Strength
lactose  
croscarmellose sodium  
povidone  
sodium stearyl fumarate  
ferric oxide  
Product Characteristics
Color ORANGE (peach) Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code 1493
Contains     
Packaging
# Item Code Package Description
1 NDC:0087-1493-01 100 TABLET (100 TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020286 06/01/2009 01/31/2011
Labeler - Bristol-Myers Squibb Company (938368834)
Revised: 08/2008   Bristol-Myers Squibb Company
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