Lotrel

DRUG DESCRIPTION

Lotrel is a combination of amlodipine besylate and benazepril hydrochloride.

Benazepril hydrochloride is a white to off-white crystalline powder, soluble ( > 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is

Benazepril hydrochloride Structural Formula Illustration

Its empirical formula is C24H28N2O5•HCl, and its molecular weight is 460.96.

Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group.

Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is

Its empirical formula is C20H25ClN2O5•C6H6O3S, and its molecular weight is 567.1.

Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker.

Lotrel capsules are formulated in six different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5/10 mg, 5/10 mg, 5/20 mg, 5/40 mg, 10/20 mg and 10/40 mg.

The inactive ingredients of the capsules are calcium phosphate, cellulose compounds, colloidal silicon dioxide, crospovidone, gelatin, hydrogenated castor oil (not present in 5/40 mg or 10/40 mg strengths), iron oxides, lactose, magnesium stearate, polysorbate 80, silicon dioxide, sodium lauryl sulfate, sodium starch (potato) glycolate, starch (corn), talc, and titanium dioxide.

What are the possible side effects of amlodipine and benazepril (Lotrel)?

Get emergency medical help if you have any of these 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 of amlodipine and benazepril may not occur until after you have been using the medication for several months.

Call your doctor at once if you have any of these serious side effects:

  • feeling light-headed, fainting;
  • ...

Read All Potential Side Effects and See Pictures of Lotrel »

What are the precautions when taking amlodipine besylate and benazepril hcl (Lotrel)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to amlodipine or benazepril; or to other dihydropyridine calcium channel blockers (such as nisoldipine, nifedipine); or to other ACE inhibitors (such as captopril, lisinopril); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: history of an allergic reaction which included swelling of the face/lips/tongue/throat (angioedema), blood filtering procedures (such as LDL apheresis, dialysis), liver disease, a certain structural heart problem (aortic stenosis), collagen vascular...

Read All Potential Precautions of Lotrel »


Lotrel Consumer (continued)

SIDE EFFECTS: Dizziness or light-headedness may occur as your body adjusts to the medication. Dry cough or swelling hands/ankles/feet may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these serious side effects occur: fainting, fast/irregular/pounding heartbeat, muscle weakness, change in the amount of urine, signs of infection (such as fever, chills, persistent sore throat).

This drug may rarely cause serious (possibly fatal) liver problems. Tell your doctor right away if you notice any of the following serious side effects: yellowing eyes or skin, dark urine, severe stomach/abdominal pain, persistent nausea.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to amlodipine or benazepril; or to other dihydropyridine calcium channel blockers (such as nisoldipine, nifedipine); or to other ACE inhibitors (such as captopril, lisinopril); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: history of an allergic reaction which included swelling of the face/lips/tongue/throat (angioedema), blood filtering procedures (such as LDL apheresis, dialysis), liver disease, a certain structural heart problem (aortic stenosis), collagen vascular disease (such as lupus, scleroderma).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Too much sweating, diarrhea, or vomiting may cause loss of too much body water (dehydration) and increase your risk of lightheadedness. Report prolonged diarrhea or vomiting to your doctor. Be sure to drink enough fluids to prevent dehydration unless your doctor directs you otherwise.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This product may increase your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.

Older adults may be more sensitive to the effects of this product, especially dizziness.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details. (See also Warning section.)

Benazepril passes into breast milk. It is unknown if amlodipine passes into breast milk. Consult your doctor before breast-feeding.


Lotrel Patient Information Including Side Effects

Brand Names: Lotrel

Generic Name: amlodipine and benazepril (Pronunciation: am LOE di peen and ben AY ze pril)

  • What is amlodipine and benazepril (Lotrel)?
  • What are the possible side effects of amlodipine and benazepril (Lotrel)?
  • What is the most important information I should know about amlodipine and benazepril (Lotrel)?
  • What should I discuss with my healthcare provider before taking amlodipine and benazepril (Lotrel)?
  • How should I take amlodipine and benazepril (Lotrel)?
  • What happens if I miss a dose (Lotrel)?
  • What happens if I overdose (Lotrel)?
  • What should I avoid while taking amlodipine and benazepril (Lotrel)?
  • What other drugs will affect amlodipine and benazepril (Lotrel)?
  • Where can I get more information?

What is amlodipine and benazepril (Lotrel)?

Amlodipine is in a group of drugs called calcium channel blockers. Amlodipine relaxes (widens) blood vessels and improves blood flow.

Benazepril is in a group of drugs called ACE inhibitors. ACE stands for angiotensin converting enzyme. Benazepril also widens blood vessels and also prevents the body from retaining water.

Amlodipine and benazepril is used to treat high blood pressure (hypertension). It is usually given after other blood pressure medications have been tried without successful treatment.

Amlodipine and benazepril may also be used for other purposes not listed in this medication guide.

What are the possible side effects of amlodipine and benazepril (Lotrel)?

Get emergency medical help if you have any of these 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 of amlodipine and benazepril may not occur until after you have been using the medication for several months.

Call your doctor at once if you have any of these serious side effects:

  • feeling light-headed, fainting;
  • urinating more or less than usual, or not at all;
  • fever, chills, body aches, flu symptoms;
  • pale skin, easy bruising or bleeding;
  • severe blistering, peeling, and red skin rash;
  • tired feeling, muscle weakness, and pounding or uneven heartbeats;
  • chest pain;
  • swelling, rapid weight gain; or
  • jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • cough;
  • nausea, vomiting;
  • diarrhea, constipation; or
  • dizziness, headache.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about amlodipine and benazepril (Lotrel)?

Do not use this medication without telling your doctor if you are pregnant or planning a pregnancy. Amlodipine and benazepril could cause birth defects in the baby if you take the medication during pregnancy. Use an effective form of birth control. Stop using this medication and tell your doctor right away if you become pregnant during treatment.

Amlodipine and benazepril can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Some side effects of amlodipine and benazepril may not occur until after you have been using the medication for several months.

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 amlodipine and benazepril. Drink 6 to 8 full glasses of water daily while you are taking this medication.

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