Univasc

Univasc is a prescription medication used to treat high blood pressure. Univasc 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 once or twice daily. It should be taken one hour before a meal.

Common side effects of Univasc include cough, diarrhea, and flu-like symptoms. Univasc may cause dizziness. Do not drive or operate heavy machinery until you know how this medication affects you.

Univasc 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.

• UCB, Inc.

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

Common side effects include:

• dizziness
• cough
• diarrhea
• flu-like symptoms
• fatigue
• sore throat
• flushing of face and neck (warmth and redness)
• rash
• muscle aches

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

Serious side effects have been reported with Univasc 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. Univasc 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

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

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

Before taking Univasc , 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 moexipril 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 moexipril.
• 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. moexipril 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.

Univasc falls into category D. It has been shown that use of Univasc in pregnant women caused some babies to be born with problems. More specifically, it has been shown that use of drugs like Univasc 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 moexipril during the first trimester.

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.

It is not known whether Univasc crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Univasc.

• Take Univasc exactly as prescribed.
• Univasc comes in tablet form and is taken once or twice daily.
• Take Univasc on an empty stomach - one hour before a meal.
• 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 Univasc at the same time.

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

The recommended starting dose of Univasc is usually 7.5 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 7.5 mg and 30 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 Univasc call your healthcare provider or poison control center, or seek emergency medical attention right away.

Store, tightly closed, at controlled room temperature 20° to 25°C (68° to 77°F).

Keep this and all medications out of the reach of children.

WARNING: FETAL TOXICITY

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