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Lotrel

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Lotrel

Lotrel

Lotrel Side Effects Center

Medical Author: Charles Patrick Davis, MD, PhD

Lotrel (amlodipine besylate and benazepril hydrochloride) is a combination of amlodipine besylate and benazepril hydrochloride that is used for treatment of hypertension that is resistant to treatment by either amilodipine or benzapril alone. A generic form is available and is named amlodipine/benazepril. This combination drug is used usually after one of the drugs has failed to control the patient's hypertension. The most common side effects are cough, headache, and edema.

Lotrel (amlodipine/benazepril) capsules are available in the following combinations: 2.5/10 mg, 5/10 mg, 5/20 mg, 5/40 mg, 10/20 mg, and 10/40 mg. Initial treatments usually begin with the 2.5/10 mg tablet once a day. Patients taking diuretics may have instances of low blood pressure and hypokalemia. This drug may also increase lithium to toxic levels, so patients on lithium need levels examined if placed on Lotrel. Because of potential fetal injury or damage, pregnant females should not take this drug. Patients with severe renal disease (creatinine clearance <30 ml/min) should not use this medication. Other more serious side effects include a rash, chest pain, yellow skin and angioedema. Angioedema, if severe, can cause tongue and larynx swelling that inhibits or blocks the airway; this emergency condition needs immediate treatment. Lotrel is not approved for use in the pediatric population.

Our Lotrel Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Lotrel in Detail - Patient Information: Side Effects

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:

  • trouble swallowing;
  • chest pain;
  • feeling like you might pass out;
  • urinating more or less than usual, or not at all;
  • swelling, rapid weight gain;
  • fever, chills, sore throat, body aches, flu symptoms; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • cough;
  • dizziness, headache;
  • sleep problems (insomnia);
  • flushing (warmth, redness, or tingling under your skin);
  • diarrhea, constipation;
  • muscle pain; or
  • loss of interest in sex.

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.

Read the entire detailed patient monograph for Lotrel (Amlodipine Besylate and Benazepril HCl) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Lotrel Overview - Patient Information: Side Effects

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, symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat), 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.

Some people who already have severe heart disease may rarely develop worsening chest pain or a heart attack after starting this medication or increasing the dose. Get medical help right away if you experience: worsening chest pain, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating).

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.

Read the entire patient information overview for Lotrel (Amlodipine Besylate and Benazepril HCl)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Lotrel FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Lotrel has been evaluated for safety in over 2,991 patients with hypertension; over 500 of these patients were treated for at least 6 months, and over 400 were treated for more than 1 year.

In a pooled analysis of 5 placebo-controlled trials involving Lotrel doses up to 5/20, the reported side effects were generally mild and transient, and there was no relationship between side effects and age, sex, race, or duration of therapy. Discontinuation of therapy due to side effects was required in approximately 4% of patients treated with Lotrel and in 3% of patients treated with placebo.

The most common reasons for discontinuation of therapy with Lotrel in these studies were cough and edema (including angioedema).

The peripheral edema associated with amlodipine use is dose-dependent. When benazepril is added to a regimen of amlodipine, the incidence of edema is substantially reduced.

The addition of benazepril to a regimen of amlodipine should not be expected to provide additional antihypertensive effect in African-Americans. However, all patient groups benefit from the reduction in amlodipine-induced edema.

The side effects considered possibly or probably related to study drug that occurred in these trials in more than 1% of patients treated with Lotrel are shown in the table below. Cough was the only adverse event with at least possible relationship to treatment that was more common on Lotrel (3.3%) than on placebo (0.2%).

PERCENT INCIDENCE IN U.S. PLACEBO-CONTROLLED TRIALS

  Benazepril/ Amlodipine Benazepril Amlodipine Placebo
N=760 N=554 N=475 N=408
Cough
3.3
1.8
0.4
0.2
Headache
2.2
3.8
2.9
5.6
Dizziness
1.3
1.6
2.3
1.5
Edema*
2.1
0.9
5.1
2.2
*Edema refers to all edema, such as dependent edema, angioedema, facial edema.

The incidence of edema was greater in patients treated with amlodipine monotherapy (5.1%) than in patients treated with Lotrel (2.1%) or placebo (2.2%).

Other side effects considered possibly or probably related to study drug that occurred in U.S. placebo-controlled trials of patients treated with Lotrel or in postmarketing experience were the following:

Body as a Whole: Asthenia and fatigue.

CNS: Insomnia, nervousness, anxiety, tremor, and decreased libido.

Dermatologic: Flushing, hot flashes, rash, skin nodule, and dermatitis.

Digestive: Dry mouth, nausea, abdominal pain, constipation, diarrhea, dyspepsia, and esophagitis.

Hematologic: Neutropenia

Metabolic and Nutritional: Hypokalemia.

Musculoskeletal: Back pain, musculoskeletal pain, cramps, and muscle cramps.

Respiratory: Pharyngitis.

Urogenital: Sexual problems such as impotence, and polyuria. Monotherapies of benazepril and amlodipine have been evaluated for safety in clinical trials in over 6,000 and 11,000 patients, respectively. The observed adverse reactions to the monotherapies in these trials were similar to those seen in trials of Lotrel.

Post-marketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

In postmarketing experience with benazepril, there have been rare reports of Stevens-Johnson syndrome, pancreatitis, hemolytic anemia, pemphigus, and thrombocytopenia. Gingival hyperplasia, tachycardia, jaundice, and hepatic enzyme elevations (mostly consistent with cholestasis severe enough to require hospitalization) have been reported in association with use of amlodipine. Other potentially important adverse experiences attributed to other ACE inhibitors and calcium channel blockers include: eosinophilic pneumonitis (ACE inhibitors) and gynecomastia (CCBs). Other infrequently reported events included chest pain, ventricular extrasystole, gout, neuritis, tinnitus, alopecia, upper respiratory tract infection, palpitations and somnolence.

Read the entire FDA prescribing information for Lotrel (Amlodipine Besylate and Benazepril HCl) »

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Lotrel - User Reviews

Lotrel User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Lotrel sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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