Lotrel

• Combining benazepril with potassium supplements, potassium containing salt substitutes, and potassium conserving diuretics such as amiloride (Moduretic), spironolactone (Aldactone), and triamterene (Dyazide, Maxzide), can lead to dangerously high blood levels of potassium.
• 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, but the increased levels may lead to toxicity from lithium.
• 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, etc.), indomethacin (Indocin, Indocin-SR), and naproxen (Anaprox, Naprelan, Naprosyn, Aleve) may reduce the effects of ACE inhibitors. Combining ACE inhibitors with NSAIDs in patients who are elderly, volume-depleted (including those on diuretic therapy), or with poor kidney function may result in reduced kidney function, including kidney failure. These effects usually are reversible.
• Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and low blood pressure or hypotension) may occur when injectable gold (sodium aurothiomalate), used in the treatment of rheumatoid arthritis, is combined with ACE inhibitors.
• Amlodipine increases blood levels of simvastatin (Zocor). The dose of simvastatin should be limited to 20 mg daily when combined with amlodipine.

1. ACE inhibitors, including benazepril, can be harmful to the fetus and should not be taken by pregnant women.
2. Small amounts of benazepril are excreted in breast milk. It is not known whether amlodipine is excreted in breast milk. Lotrel or nursing should be discontinued.

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If more than 12 hours have passed since you missed your last dose, then skip the missed dose and take the next dose when you normally would.

Serious side effects have been reported with Lotrel including the following:

• serious allergic reactions that can be life threatening. Stop Lotrel and get emergency help right away if you get swelling of your face, eyelids, lips, tongue, or throat; have trouble swallowing; asthma, or other breathing problems. These allergic reactions are rare but happen more times in people who are African-American.
• low blood pressure (hypotension). Low blood pressure is most likely to happen if you also take water pills, are on a low salt diet, get dialysis treatments, have heart problems or get sick with vomiting or diarrhea. Lie down if you feel faint or dizzy.
• liver problems. Call your doctor if:
  • ​you have nausea
  • you feel more tired or weaker than usual
  • you have itching
  • your skin or eyes look yellow
  • you have pain in your upper right stomach
  • you have flu-like symptoms
• kidney problems. Some people will have changes on blood tests for kidney function and need a lower dose of Lotrel. Call your doctor if you get swelling in your feet, ankles, or hands or unexplained weight gain.
• more chest pain and heart attacks in people that already have severe heart problems. Get emergency help if you get worse chest pain or chest pain that does not go away.

Do not take Lotrel if you:

• are allergic to Lotrel or to any of its ingredients
• have diabetes and are also taking aliskiren
• have a history of angioedema, with or without previous ACE inhibitor treatment

Do not use 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 (hives or severe swelling of deep skin tissues sometimes caused by allergic reaction).

If you have diabetes, do not use amlodipine and benazepril together with any medication that contains aliskiren (Tekturna, Tekamlo).

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

Drinking alcohol with this medicine can cause side effects.

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

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

Many drugs can interact with amlodipine and benazepril. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

• lithium;

• probenecid;

• simvastatin (Zocor, Vytorin);

• a diuretic or "water pill";

• gold injections to treat arthritis;

• a shot for bee-sting allergy;

• heart or blood pressure medication;

• insulin or oral diabetes medicine;

• a potassium supplement (such as K-Dur, Klor-Con), or a salt substitute that contains potassium;

• 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

• a nonsteroidal anti-inflammatory drug (NSAID)--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. Give a list of all your medicines to any healthcare provider who treats you.

Amlodipine and benazepril is a combination of medicines that are used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Lowering blood pressure can reduce the risk of strokes and heart attacks.

Amlodipine is a calcium channel blocker (CCB). It affects the movement of calcium into the cells of the heart and blood vessels. This relaxes the blood vessels and lowers blood pressure. A lower blood pressure will increase the supply of blood and oxygen to the heart.

Benazepril is an angiotensin-converting enzyme (ACE) inhibitor. It works by blocking a substance in the body that causes the blood vessels to tighten. This relaxes the blood vessels and lowers blood pressure.

This medicine is available only with your doctor's prescription.

In addition to using this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You might have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, strokes, or kidney disease.

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

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For high blood pressure:
    • Adults—At first, one capsule containing amlodipine 2.5 milligrams (mg) and benazepril 10 mg once a day. Your doctor may adjust the dose as needed. However, the dose is usually not more than amlodipine 10 mg and benazepril 40 mg per day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If more than 12 hours have passed since you missed your last dose, then skip the missed dose and take the next dose when you normally would.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• Tell all of your health care providers that you take Lotrel. This includes your doctors, nurses, pharmacists, and dentists.
• It may take a few weeks to see the full effect.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine 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 are allergic to tartrazine, talk with your doctor. Some products have tartrazine.
• 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.
• It is rare, but worse chest pain and heart attack can happen after Lotrel is first started or after the dose is raised. The risk may be greater in people who have very bad heart blood vessel disease. 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.
• 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.
• 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.
• A very bad reaction called angioedema has happened with Lotrel. Sometimes, this has been deadly. The chance of angioedema may be higher in black patients. Talk with the doctor.
• If you are 65 or older, use this medicine with care. You could have more side effects.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Cough.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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 also take medicine that contains sacubitril (such as Entresto); or

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

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

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

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

• 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.

Amlodipine and benazepril can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using Lotrel.

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.

Applies to amlodipine / benazepril: oral capsule

General

The most common side effects were cough, headache, dizziness, and edema.[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness
Frequency not reported: Tremor

Amlodipine:
Common (1% to 10%): Headache, dizziness
Postmarketing reports: Dysgeusia, hypoesthesia, paresthesia, syncope, peripheral neuropathy, hypertonia

Benazepril:
Common (1% to 10%): Headache, dizziness
Postmarketing reports: Paresthesia, dysgeusia[Ref]

Respiratory

Common (1% to 10%): Cough
Frequency not reported: Pharyngitis

Amlodipine:
Uncommon (0.1% to 1%): Cough
Postmarketing reports: Rhinitis

Benazepril:
Common (1% to 10%): Cough[Ref]

Other

Common (1% to 10%): Edema
Frequency not reported: Asthenia, fatigue

Amlodipine:
Common (1% to 10%): Edema
Postmarketing reports: Malaise

Benazepril:
Uncommon (0.1% to 1%): Edema[Ref]

Amlodipine-induced peripheral edema is dose dependent. Benazepril reduces the incidence of edema when added to amlodipine.[Ref]

Genitourinary

Frequency not reported: Impotence, polyuria

Amlodipine:
Postmarketing reports: Micturition disorder, nocturia, erectile dysfunction[Ref]

Gastrointestinal

Frequency not reported: Dry mouth, nausea, abdominal pain, constipation, diarrhea, dyspepsia, esophagitis

Amlodipine:
Postmarketing reports: Gingival hyperplasia, gastritis[Ref]

Musculoskeletal

Frequency not reported: Back pain, musculoskeletal pain, cramps, muscle cramps

Amlodipine:
Postmarketing reports: Muscle spasms, arthralgia

Benazepril:
Postmarketing reports: Arthralgia, arthritis, myalgia[Ref]

Dermatologic

Frequency not reported: Rash, skin nodule, dermatitis

Amlodipine:
Postmarketing reports: Hyperhidrosis, pruritus, skin discoloration, urticaria, erythema multiform

Benazepril:
Postmarketing reports: Stevens-Johnson syndrome, pemphigus, pruritus, photosensitivity reaction[Ref]

Psychiatric

Frequency not reported: Insomnia, nervousness, anxiety, libido decreased[Ref]

Cardiovascular

Frequency not reported: Flushing, hot flashes

Amlodipine:
Postmarketing reports: Tachycardia, hypotension, vasculitis

Benazepril:
Postmarketing reports: Orthostatic symptoms, hypotension, angina pectoris, arrhythmia[Ref]

Ocular

Amlodipine:
Postmarketing reports: Visual impairment, diplopia

Benazepril:
Postmarketing reports: Impaired vision[Ref]

Metabolic

Frequency not reported: Hypokalemia

Amlodipine:
Postmarketing reports: Hyperglycemia, weight decrease or gain[Ref]

Immunologic

Amlodipine:
Postmarketing reports: Allergic reaction[Ref]

Renal

Benazepril
Postmarketing reports: Serum creatinine increased, BUN increased, renal impairment[Ref]

Hematologic

Frequency not reported: Neutropenia

Amlodipine:
Postmarketing reports: Leucocytopenia

Benazepril:
Postmarketing reports: Hemolytic anemia, thrombocytopenia, agranulocytosis, neutropenia[Ref]

Hepatic

Amlodipine:
Postmarketing reports: Jaundice, hepatic enzyme elevations

Benazepril:
Postmarketing reports: Pancreatitis[Ref]

Some side effects of Lotrel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.