Prinivil

In general, lisinopril should not be taken with potassium supplements or diuretics that conserve potassium, for example, hydrochlorothiazide/triamterene (Dyazide), since blood potassium levels may rise to dangerous levels.

There have been reports of increased lithium (Eskalith, Lithobid) levels when lithium is used in combination with ACE inhibitors. The reason for this interaction is not known.

There have been reports that aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDS) such as ibuprofen (Advil, Children's Advil/Motrin, Medipren, Motrin, Nuprin, PediaCare Fever, and many others), indomethacin (Indocin, Indocin-SR), and naproxen (Anaprox, Naprelan, Naprosyn, Aleve) may reduce the effects of ACE inhibitors.

Nitritoid reactions (symptoms of facial flushing, nausea, vomiting and hypotension) may occur when injectable gold sodium aurothiomalate used in the treatment of rheumatoid arthritis, is combined with ACE inhibitors, including lisinopril.

Do not use lisinopril if you are pregnant. It could harm the unborn baby. Stop using this medication and tell your doctor right away if you become pregnant.

Drinking alcohol can further lower your blood pressure and may increase certain side effects of lisinopril.

Do not use salt substitutes or potassium supplements while taking lisinopril, 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 lisinopril. Drink plenty of water each day while you are taking this medication.

Prinivil may cause serious side effects. See "Precautions".

The most common side effects include:

• cough
• dizziness or lightheadedness
• headache
• nausea
• diarrhea
• vomiting
• body weakness
• upper respiratory infections (cold, flu)
• decrease in sexual ability (impotence, erectile dysfunction)
• rash
• excessive tiredness
• chest pain
• stomach pain
• extreme low blood pressure

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

Using this medicine while you are pregnant can harm your unborn baby and may even cause death. If you think you have become pregnant while using this medicine, tell your doctor right away. See "FDA Warning" and "Pregnancy Section".

This medicine may cause anaphylaxis and other serious types of allergic reactions. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

Prinivil may cause a serious side effect known as angioedema, a rapid swelling of deep layers of the skin. Stop taking Prinivil and call your doctor right away if you have symptoms suggesting angioedema (swelling of face, extremities, eyes, lips, tongue, difficulty in swallowing or breathing).

Prinivil may cause dizziness, lightheadedness, or fainting, especially when getting up from a lying or sitting position. Make sure you know how you react to the medicine before you drive, use machines, or do other things that could be dangerous if you are dizzy or not alert. 

Excessive sweating and dehydration can lead to a serious drop in blood pressure. Be sure to drink plenty of water during exercise and hot weather. Check with your doctor right away if you become sick while taking this medicine, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water or salt and may lead to low blood pressure. 

Check with your doctor if you have a fever, chills, or sore throat. These could be symptoms of an infection resulting from low white blood cells.

Hyperkalemia (high potassium in the blood) may occur while you are receiving Prinivil. Symptoms of hyperkalemia include: abdominal or stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, shortness of breath, or weakness or heaviness of the legs. Call your doctor right away if you have these symptoms. Do not use potassium supplements or salt substitutes containing potassium without first checking with your doctor.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, check with your doctor.

Keep all medical and laboratory appointments while taking Prinivil. It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

Call your doctor right away if you have severe stomach pain (with or without nausea or vomiting). This could be a symptom of intestinal angioedema.

Dizziness, lightheadedness, or fainting may also occur, especially when you get up from a lying or sitting position or if you have been taking a diuretic (water pill). Make sure you know how you react to the medicine before you drive, use machines, or do other things that could be dangerous if you are dizzy or not alert. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning.

Check with your doctor right away if you become sick while taking this medicine, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water or salt and may lead to low blood pressure. You can also lose water by sweating, so drink plenty of water during exercise or in hot weather.

Check with your doctor if you have a fever, chills, or sore throat. These could be symptoms of an infection resulting from low white blood cells.

Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have the following symptoms: abdominal or stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, shortness of breath, or weakness or heaviness of the legs. Do not use supplements or salt substitutes containing potassium without first checking with your doctor.

Check with your doctor right away if you have upper stomach pain, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, check with your doctor.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery.

This medicine may be less effective in black patients. Black patients also have an increased risk of angioedema (swelling of the hands, arms, face, mouth, or throat).

Do not take other medicines unless they have been discussed with your doctor. This includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Prinivil affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Have your blood pressure checked often. Talk with your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• If you are taking a salt substitute that has potassium, potassium-sparing diuretics, or potassium, talk with your doctor.
• If you are on a low-salt or salt-free diet, talk with your doctor.
• If you are taking lithium, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with this medicine.
• If you are taking Prinivil and have high blood pressure, talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
• Talk with your doctor before you drink alcohol.
• Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
• Tell your doctor if you have too much sweat, fluid loss, throwing up, or loose stools. This may lead to low blood pressure.
• This medicine may not work as well in black patients. Talk with the doctor.
• A very bad reaction called angioedema has happened with this medicine. Sometimes, this has been deadly. The chance of angioedema may be higher in black patients. Talk with the doctor.
• Low white blood cell counts have happened with captopril, a drug like this one. This may lead to more chance of getting an infection. Most of the time, this has happened in people with kidney problems, mainly if they have certain other health problems. Call your doctor right away if you have signs of infection like fever, chills, or sore throat. Talk with your doctor.
• If you are 65 or older, use Prinivil with care. You could have more side effects.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of a high potassium level like a heartbeat that does not feel normal; change in thinking clearly and with logic; feeling weak, lightheaded, or dizzy; feel like passing out; numbness or tingling; or shortness of breath.
• Very bad dizziness or passing out.
• Cough that does not go away.
• Very bad belly pain.
• Very upset stomach or throwing up.
• Chest pain or pressure.
• Trouble swallowing.
• Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Diuretics

Initiation of Prinivil in patients on diuretics may result in excessive reduction of blood pressure. The possibility of hypotensive effects with Prinivil can be minimized by either decreasing or discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with Prinivil. If this is not possible, reduce the starting dose of Prinivil [see Dosage and Administration (2.2) and Warnings and Precautions (5.4)].

Prinivil attenuates potassium loss caused by thiazide-type diuretics. Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) can increase the risk of hyperkalemia. Therefore, if concomitant use of such agents is indicated, monitor the patient's serum potassium frequently.

Antidiabetics

Concomitant administration of Prinivil and antidiabetic medicines (insulins, oral hypoglycemic agents) may cause an increased blood-glucose-lowering effect with risk of hypoglycemia.

Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including lisinopril, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving lisinopril and NSAID therapy.

The antihypertensive effect of ACE inhibitors, including lisinopril, may be attenuated by NSAIDs.

Dual Blockade of the Renin-Angiotensin System (RAS)

Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or direct renin inhibitors (such as aliskiren) is associated with increased risks of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy.

The Veterans Affairs Nephropathy in Diabetes (VA NEPHRON-D) trial enrolled 1448 patients with type 2 diabetes, elevated urinary-albumin-to-creatinine ratio, and decreased estimated glomerular filtration rate (GFR 30 to 89.9 ml/min), randomized them to lisinopril or placebo on a background of losartan therapy and followed them for a median of 2.2 years. Patients receiving the combination of losartan and lisinopril did not obtain any additional benefit compared to monotherapy for the combined endpoint of decline in GFR, end stage renal disease, or death, but experienced an increased incidence of hyperkalemia and acute kidney injury compared with the monotherapy group.

In general, avoid combined use of RAS inhibitors. Monitor blood pressure, renal function and electrolytes in patients on Prinivil and other agents that affect the RAS.

Do not coadminister aliskiren with Prinivil in patients with diabetes. Avoid use of aliskiren with Prinivil in patients with renal impairment (GFR <60 ml/min).

Lithium

Lithium toxicity has been reported in patients receiving lithium concomitantly with drugs, which cause elimination of sodium, including ACE inhibitors. Lithium toxicity was usually reversible upon discontinuation of lithium and the ACE inhibitor. Monitor serum lithium levels during concurrent use.

Gold

Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy including Prinivil.

Mammalian Target of Rapamycin (mTOR) Inhibitors

Patients taking concomitant mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema [see Warnings and Precautions (5.2)].

NOTE: This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.

Pregnancy: Tell female patients of childbearing age about the consequences of exposure to Prinivil during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible.

Angioedema: Angioedema, including laryngeal edema, may occur at any time during treatment with angiotensin converting enzyme inhibitors, including Prinivil. Tell patients to report immediately any signs or symptoms suggesting angioedema (swelling of face, extremities, eyes, lips, tongue, difficulty in swallowing or breathing) and to take no more drug until they have consulted with the prescribing physician.

Symptomatic Hypotension: Tell patients to report light-headedness especially during the first few days of therapy. If actual syncope occurs, tell the patient to discontinue the drug until they have consulted with the prescribing physician.

Tell patients that excessive perspiration and dehydration may lead to an excessive fall in blood pressure because of reduction in fluid volume. Other causes of volume depletion such as vomiting or diarrhea may also lead to a fall in blood pressure; advise patients accordingly.

Hyperkalemia: Tell patients not to use salt substitutes containing potassium without consulting their physician.

Hypoglycemia: Tell diabetic patients treated with oral antidiabetic agents or insulin starting an ACE inhibitor to monitor for hypoglycemia closely, especially during the first month of combined use [see Drug Interactions (7.2)].

Leukopenia/Neutropenia: Tell patients to report promptly any indication of infection (e.g., sore throat, fever), which may be a sign of leukopenia/neutropenia.

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You should not use Prinivil if you are allergic to lisinopril, or if:

• you have a history of angioedema;

• you also take medicine that contains sacubatril (such as Entresto); or

• if you are allergic to any other ACE inhibitor, such as benazepril, captopril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, or trandolapril.

If you have diabetes, do not use Prinivil together with any medication that contains aliskiren (such as Tekturna or Tekamlo).

You may also need to avoid taking Prinivil with aliskiren if you have kidney disease.

You should not use Prinivil if you have hereditary angioedema.

To make sure Prinivil is safe for you, tell your doctor if you have:

• kidney disease (or if you are on dialysis);

• liver disease;

• diabetes; or

• high levels of potassium in your blood.

Do not use Prinivil if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away. Prinivil can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control while taking Prinivil.

It is not known whether lisinopril passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using lisinopril.

Take Prinivil exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Drink plenty of water each day while you are taking this medicine.

Prinivil can be taken with or without food.

Your blood pressure will need to be checked often, and you may need frequent blood tests.

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 this medicine. This can lead to very low blood pressure, electrolyte disorders, or kidney failure while you are taking Prinivil.

If you need surgery, tell the surgeon ahead of time that you are using Prinivil.

If you are being treated for high blood pressure, keep using this medication 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.

Store at room temperature away from moisture and heat.