Monopril

DRUG DESCRIPTION

MONOPRIL® (fosinopril sodium tablets) is the sodium salt of fosinopril, the ester prodrug of an angiotensin-converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin-converting enzyme. Fosinopril sodium is designated chemically as: L-proline, 4-cyclohexyl-1-[[[2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl)phosphinyl]acetyl]-, sodium salt, trans-.

Fosinopril sodium is a white to off-white crystalline powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane.

Its structural formula is:

MONOPRIL®
  (fosinopril sodium) Structural Formula Illustration

Its empirical formula is C30H45NNaO7P, and its molecular weight is 585.65.

MONOPRIL (fosinopril sodium) is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: lactose, microcrystalline cellulose, crospovidone, povidone, and sodium stearyl fumarate.

What are the possible side effects of fosinopril (Monopril)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • feeling light-headed, fainting;
  • urinating less than usual, or not at all;
  • fever, chills, body aches, flu symptoms;
  • severe blistering, peeling, and red skin rash;
  • pale skin, easy bruising or bleeding, unusual weakness;
  • ...

Read All Potential Side Effects and See Pictures of Monopril »

What are the precautions when taking fosinopril sodium (Monopril)?

Before taking fosinopril, tell your doctor or pharmacist if you are allergic to it; or to other ACE inhibitors (such as benazepril); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: history of an allergic reaction which included swelling of the face/lips/tongue/throat (angioedema), blood filtering procedures (such as LDL apheresis, dialysis), high level of potassium in the blood, collagen vascular disease (such as lupus, scleroderma).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are...

Read All Potential Precautions of Monopril »


Monopril Consumer (continued)

SIDE EFFECTS: Dizziness or lightheadedness may occur as your body adjusts to the medication. Dry cough may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: fainting, muscle weakness, signs of infection (such as fever, chills, persistent sore throat), change in the amount of urine.

This drug may rarely cause serious (possibly fatal) liver problems. Tell your doctor right away if you notice any of the following rare but serious side effects: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking fosinopril, tell your doctor or pharmacist if you are allergic to it; or to other ACE inhibitors (such as benazepril); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: history of an allergic reaction which included swelling of the face/lips/tongue/throat (angioedema), blood filtering procedures (such as LDL apheresis, dialysis), high level of potassium in the blood, collagen vascular disease (such as lupus, scleroderma).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Too much sweating, diarrhea, or vomiting may cause loss of too much body water (dehydration) and increase your risk of lightheadedness. Report prolonged diarrhea or vomiting to your doctor. Be sure to drink enough fluids to prevent dehydration unless your doctor directs you otherwise.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This product may increase your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.

Older adults may be more sensitive to the effects of this product, especially dizziness.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details. (See also Warning section.)

This medication passes into breast milk. Consult your doctor before breast-feeding.


Monopril Patient Information Including Side Effects

Brand Names: Monopril

Generic Name: fosinopril (Pronunciation: foe SIN oh pril)

  • What is fosinopril (Monopril)?
  • What are the possible side effects of fosinopril (Monopril)?
  • What is the most important information I should know about fosinopril (Monopril)?
  • What should I discuss with my healthcare provider before taking fosinopril (Monopril)?
  • How should I take fosinopril (Monopril)?
  • What happens if I miss a dose (Monopril)?
  • What happens if I overdose (Monopril)?
  • What should I avoid while taking fosinopril (Monopril)?
  • What other drugs will affect fosinopril (Monopril)?
  • Where can I get more information?

What is fosinopril (Monopril)?

Fosinopril is in a group of drugs called ACE inhibitors. ACE stands for angiotensin converting enzyme.

Fosinopril is used to treat high blood pressure (hypertension) or heart failure.

Fosinopril may also be used for other purposes not listed in this medication guide.

What are the possible side effects of fosinopril (Monopril)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • feeling light-headed, fainting;
  • urinating less than usual, or not at all;
  • fever, chills, body aches, flu symptoms;
  • severe blistering, peeling, and red skin rash;
  • pale skin, easy bruising or bleeding, unusual weakness;
  • pounding or uneven heartbeats;
  • slow heart rate, weak pulse, muscle weakness, tingly feeling;
  • jaundice (yellowing of the skin or eyes);
  • chest pain; or
  • swelling, rapid weight gain.

Less serious side effects may include:

  • cough;
  • muscle or joint pain;
  • dizziness, headache, tired feeling;
  • runny or stuffy nose;
  • nausea, vomiting, diarrhea; or
  • mild skin itching or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about fosinopril (Monopril)?

Do not use this medication without telling your doctor if you are pregnant or planning a pregnancy. Fosinopril could cause birth defects in the baby if you take the medication during pregnancy. Use an effective form of birth control. Stop using this medication and tell your doctor right away if you become pregnant during treatment.

Avoid taking an antacid within 2 hours before or after you take fosinopril.

Avoid drinking alcohol. It can further lower your blood pressure and may increase some of the side effects of fosinopril.

Do not use salt substitutes or potassium supplements while taking fosinopril, unless your doctor has told you to.

Vomiting, diarrhea, or heavy sweating can cause you to become dehydrated. This can lead to very low blood pressure, electrolyte disorders, or kidney failure while you are taking fosinopril. Drink plenty of water daily while you are taking this medication.

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