Capoten

Capoten is a prescription medication used to treat high blood pressure, congestive heart failure, a condition called Left Ventricular Dysfunction, and diabetic nephropathy. If taken after a heart attack, Capoten can also help improve survival and lower the risk of developing congestive heart failure.

Capoten 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.

This medication comes in tablet form and is taken 2 to 3 times a day. It should be taken without food or at least one hour before a meal or snack.

Common side effects of Capoten include rash, cough, and loss of taste. Capoten can cause dizziness. Do not drive or operate heavy machinery until you know how this medication affects you.

Capoten is a prescription medication used to:

• to treat high blood pressure
• to treat congestive heart failure
• to treat diabetic nephropathy
• to improve survival and lower the risk of developing congestive heart failure after a heart attack

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

• Par Pharmaceutical, Inc.

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

Common side effects are rash, itching, cough, metallic or loss of taste, skin flushing, stomach pain, nausea, vomiting, diarrhea, anorexia, constipation, dizziness, headache, weakness, fatigue, insomnia, and dry mouth.

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

Serious side effects have been reported with Capoten 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. Capoten 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 professional 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

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

Do not take Capoten 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 Capoten, salt substitutes containing potassium should be avoided.

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

• 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 Capoten if you have diabetes and you are also taking aliskiren.
• have or have ever had heart or kidney disease or diabetes
• are having surgery, including dental surgery. Inform the doctor or dentist that you are taking Capoten.
• are using salt substitutes containing potassium. If your doctor prescribes a low-salt or low-sodium diet, follow these instructions carefully.
• 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.

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.

Capoten falls into category D. It has been shown that use of Capoten in pregnant women caused some babies to be born with problems. More specifically, it has been shown that use of drugs like Capoten 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. However, in some serious 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.

Capoten has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Capoten, 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 Capoten exactly as prescribed.

Capoten comes in tablet form and is given either 2 or 3 times a day, at least 1 hour before a meal. It should be taken without food or at least one hour before a meal or snack.

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 Capoten at the same time.

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

The starting dose of Capoten is 25 mg twice a day or three times a day. If the goal reduction of blood pressure has not been reached after one or two weeks, the dose may be titrated to 50 mg twice a day or three times a day.

The dose of Capoten in hypertension usually is maxed at 50 mg three times a day. If the blood pressure has not been satisfactorily controlled after one to two weeks at this dose, (and the patient is not already receiving a diuretic), a dose of diuretic (such as hydrochlorothiazide, 25 mg daily), may be added by your doctor. This diuretic dose may be increased every one to two weeks until its maximum effective dose is reached.

If you take too much Capoten call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Capoten is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Do not store above 30º C (86º F).
• Keep bottles tightly closed to protect from moisture.
• Keep this and all medicines out of the reach of children.

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