Fosinopril

Fosinopril is a prescription medication used to treat high blood pressure and congestive heart failure. Fosinopril belongs to a group of drugs called angiotensin converting enzyme (ACE) inhibitors, which relax blood vessels to lower blood pressure and make the heart more efficient.

Fosinopril is a prescription medication used to treat high blood pressure and congestive heart failure.

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

Fosinopril may be found in some form under the following brand names:

• Monopril

Serious side effects have been reported. See “Drug Precautions” section.

Common side effects include:

• dizziness
• cough
• nausea
• vomiting
• diarrhea
• fatigue
• headhache
• sore throat

This is not a complete list of fosinopril side effects. Ask your doctor or pharmacist for more information.

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• potassium-sparing diuretics such as:
  • spironolactone (Aldactone)
  • triamterene (Dyrenium)
  • amiloride (Midamor)
• other diuretics such as:
  • furosemide (Lasix)
  • hydrochlorothiazide
  • torsemide (Demadex)
• antacids such as Maalox or Mylanta
• aliskiren (Tekturna)
• angiotensin receptor blockers such as candesartan (Atacand), losartan (Cozaar), and telmisartan (Micardis, Twynsta)
• aspirin and other NSAIDs (non-steroidal anti-inflammatory drugs) such as:
  • celecoxib (Celebrex)
  • diclofenac (Cambia, Cataflam, Flector, Voltaren, Zipsor and others)
  • etodolac (Lodine)
  • ibuprofen (Advil, Motrin, Nuprin)
  • indomethacin (Indocin, Indocin SR)
  • ketoprofen (Orudis, Actron, Oruvail)
  • ketorolac (Toradol)
  • meloxicam (Mobic)
  • nabumetone (Relafen)
  • naproxen (Naprosyn)
  • naproxen sodium (Aleve, Anaprox, Naprelan)
  • oxaprozin (Daypro)
  • piroxicam (Feldene)
• lithium (Eskalith, Lithobid)
• potassium supplements
• injectable gold (sodium aurothiomalate)

This is not a complete list of fosinopril drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with fosinopril including:

• Hypotension. Excessive perspiration and dehydration may lead to an excessive fall in blood pressure (hypotension). Vomiting or diarrhea may also lead to a fall in blood pressure.
• Decline in kidney function. Your doctor may need to perform tests to determine the stability of the function of your kidneys, especially in patients who already have kidney dysfunction.
• Hyperkalemia. fosinopril may lead to increased levels of potassium, which could lead to side effects such as heart arrhythmias (irregular heartbeat) and nausea.
• Cough: Persistent dry cough has been reported with all ACE inhibitors, and will resolve after discontinuation of therapy.
• Valvular Stenosis. Those with aortic stenosis (stiffening of the main artery that carries blood away from the heart) might be at risk of decreased blood flow to the rest of the body.
• Angioedema. Tell your healthcare profession right away if you have signs or symptoms of angioedema, which include:
  • swelling of face, eyes, lips, tongue, larynx and extremities
  • difficulty in swallowing or breathing
  • hoarseness (having difficulty making sounds when trying to speak)
• Neutropenia. Report any sign of infection such as sore throat or fever, which may be a sign of neutropenia (a decreased amount of white blood cells).
• Edema: report any sign of edema (increase in swelling of the arms or legs), which may be a sign of declining kidney function.
• Heart failure patients. Caution is advised against rapid increases in exercise or physical activity for those who are being treated for heart failure.
• Intestinal Angioedema. Intestinal angioedema (swelling within the gut) has been reported in patients treated with ACE inhibitors. Report signs and symptoms of intestinal angioedema, including abdominal (stomach-area) pain, with or without nausea or vomiting.
• Liver failure. This is a rare occurrence. Nevertheless, report any signs or symptoms of hepatic failure, including:
  • yellowing of the skin or eyes
  • nausea
  • vomiting
  • fatigue
  • itching

Fosinopril can cause dizziness. Do not drive or operate heavy machinery until you know how fosinopril affects you.

Do not take fosinopril if you are hypersensitive to this product. Signs of a hypersensitivity reaction include:

• chest pain
• swelling of the face, eyes, lips, tongue, arms, or legs
• difficulty breathing or swallowing
• fainting
• rash

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of fosinopril, salt substitutes containing potassium should be avoided.

Before taking fosinopril, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have a history of angioedema (swelling under the skin)
• have diabetes (high blood sugar) and you are taking aliskiren (Tekturna; also in Amturnide, Tekamlo, Tekturna HCT). Your doctor will probably tell you not to take fosinopril if you have diabetes and you are also taking aliskiren.
• have or have ever had heart or kidney disease or diabetes
• have liver disease
• are having surgery, including dental surgery. Inform the doctor or dentist that you are taking fosinopril.
• are using salt substitutes containing potassium. If your doctor prescribes a low-salt or low-sodium diet, follow these instructions carefully.
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. Fosinopril is usually not recommended for use during pregnancy. See "FDA Warning" section.

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.

Fosinopril falls into 2 categories, C and D. The FDA places fosinopril in category C for the first trimester and category D for the second and third trimesters. It has been shown that use of fosinopril in pregnant women caused some babies to be born with problems. More specifically, it has been shown that use of drugs like fosinopril during the second and third trimesters of pregnancy harms the unborn baby’s kidneys and even increases the risk of death to the unborn baby. A more recent study showed that there may, in fact, also be an increased risk to the fetus if it is exposed to fosinopril during the first trimester, although the results of the study have not been confirmed.

However, in some situations the benefit of using this medication may be greater than the risk of harm to the baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Fosinopril has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from fosinopril, a choice should be made whether to stop nursing or to stop use of this medication. Determining the importance of the drug to the mother should be considered.

• Take fosinopril exactly as prescribed.
• Fosinopril comes in tablet form and is usually taken once daily.
• It can be taken with or without food.
• If fosinopril bothers your stomach, try taking it with food.
• If you take antacids, take them 2 hours before or after fosinopril.
• This medication should be taken at around the same time each day.
• If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of fosinopril at the same time.

Take fosinopril exactly as prescribed. Follow the directions on your prescription label carefully.

The recommended starting dose is usually 10 mg once daily. Your healthcare provider may increase your dose if necessary to achieve the desired blood pressure response. The usual recommended dosing range is between 20 mg and 40 mg a day.

Based on how your body responds to the medication and side effects you experience your healthcare provider may decide to increase or decrease your dose. The dose you receive is also based on the following factors:

• your age
• the medical condition you are being treated for
• other medical conditions you may have 
• other medications you are taking including diuretics

If you take too much fosinopril call your healthcare provider or poison control center, or seek emergency medical attention right away.

• Store at room temperature between 15°C - 30°C (59°F - 86°F).
• Keep this and all medications out of the reach of children.

USE IN PREGNANCY

When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, fosinopril sodium tablets should be discontinued as soon as possible.