Lotrel contains a combination of amlodipine and benazepril. Amlodipine is a calcium channel blocker. Amlodipine relaxes (widens) blood vessels and improves blood flow.

Benazepril is an ACE inhibitor. ACE stands for angiotensin converting enzyme. Benazepril also widens blood vessels and also prevents the body from retaining water.

Lotrel is used to treat high blood pressure (hypertension).

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

Do not use Lotrel if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away.

You should not use this medicine if you have ever had angioedema. Do not take this medicine within 36 hours before or after taking medicine that contains sacubitril (such as Entresto).

If you have diabetes, do not use Lotrel together with any medication that contains aliskiren (a blood pressure medicine).

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 Lotrel, which can lead to severely low blood pressure or a serious electrolyte imbalance.

Before taking this medicine

You should not use Lotrel if you are allergic to amlodipine or benazepril, or if:

• you have had angioedema (hives or severe swelling of deep skin tissues sometimes caused by allergic reaction);

• you have diabetes and are taking a medication called aliskiren;

• you recently took a heart medicine called sacubitril; or

• you are allergic to any other ACE inhibitor, such as captopril, enalapril, lisinopril, moexipril, benazepril, quinapril, ramipril, Accupril, Prinivil, Mavik, Vasotec, and many others.

Do not take Lotrel within 36 hours before or after taking medicine that contains sacubitril (such as Entresto).

If you have diabetes, do not use Lotrel together with any medication that contains aliskiren (a blood pressure medicine).

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

Tell your doctor if you have ever had:

• heart disease or congestive heart failure;

• high levels of potassium in your blood (hyperkalemia);

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

• liver disease; or

• if you are on a low-salt diet.

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

You should not breast-feed while you are using Lotrel unless instructed by your doctor.

Take Lotrel exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take Lotrel with or without food. Take the medicine at the same time each day.

Vomiting, diarrhea, or heavy sweating can cause you to become dehydrated. Drink plenty of water each day while you are taking this medicine.

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

If you need surgery, tell your surgeon you currently use this medicine. You may need to stop for a short time.

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 Lotrel. This can lead to very low blood pressure, electrolyte disorders, or kidney failure.

Keep using Lotrel as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Hypertension:

Initial dose: amlodipine 2.5 mg-benazepril 10 mg orally once a day
Maintenance dose: amlodipine 2.5 to 10 mg-benazepril 10 to 40 mg orally once a day
Maximum dose: Amlodipine: 10 mg/day; Benazepril 80 mg/day

Comments:
-May increase dose after 2 weeks as needed to achieve blood pressure goal.
-Adding benazepril to amlodipine should not be expected to provide additional blood pressure reduction in African Americans.

You should not use Lotrel if you are allergic to amlodipine or benazepril, or if:

• you have had angioedema (hives or severe swelling of deep skin tissues sometimes caused by allergic reaction);

• you have diabetes and are taking a medication called aliskiren;

• you recently took a heart medicine called sacubitril; or

• you are allergic to any other ACE inhibitor, such as captopril, enalapril, lisinopril, moexipril, benazepril, quinapril, ramipril, Accupril, Prinivil, Mavik, Vasotec, and many others.

Do not take Lotrel within 36 hours before or after taking medicine that contains sacubitril (such as Entresto).

If you have diabetes, do not use Lotrel together with any medication that contains aliskiren (a blood pressure medicine).

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

Tell your doctor if you have ever had:

• heart disease or congestive heart failure;

• high levels of potassium in your blood (hyperkalemia);

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

• liver disease; or

• if you are on a low-salt diet.

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

You should not breast-feed while you are using Lotrel unless instructed by your doctor.

Take the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Drinking alcohol with this medicine can cause side effects.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

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

Get emergency medical help if you have signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat. You may be more likely to have an allergic reaction if you are African-American.

Some side effects may not occur until after you have used the medicine for several months.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• swelling in your hands or feet, rapid weight gain;

• new or worsened chest pain;

• fever, chills, sore throat, body aches, flu symptoms;

• high potassium--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement; or

• liver problems--nausea, stomach pain (upper right side), itching, unusual tiredness, flu-like symptoms, dark urine, jaundice (yellowing of the skin or eyes).

Common Lotrel side effects may include:

• cough;

• dizziness; or

• swelling in your hands or feet.

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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can affect Lotrel, especially:

• lithium;

• probenecid;

• simvastatin;

• a diuretic or "water pill";

• gold injections to treat arthritis;

• heart or blood pressure medication;

• insulin or oral diabetes medicine;

• an antibiotic--clarithromycin, telithromycin;

• antifungal medicine--itraconazole, ketoconazole;

• antiviral medicine to treat HIV/AIDS--indinavir, ritonavir, and others;

• medicine to prevent organ transplant rejection--cyclosporine, everolimus, sirolimus, tacrolimus, temsirolimus; or

• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete and many other drugs can interact with amlodipine and benazepril. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.