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Lotrel

Last reviewed on RxList: 8/10/2020
Lotrel Side Effects Center

What Is Lotrel?

Lotrel (amlodipine besylate and benazepril hydrochloride) is a combination of an angiotensin-converting enzyme (ACE) inhibitor and a calcium channel blocker used for treatment of high blood pressure (hypertension) that is resistant to treatment by either amilodipine or benzapril alone. Lotrel is used usually after one of the other drugs has failed to control the patient's hypertension. Lotrel is available in generic form.

What Are Side Effects of Lotrel?

Common side effects of Lotrel include:

  • cough,
  • dizziness,
  • lightheadedness,
  • headache, and
  • swelling of the hands/ankles/feet.

Serious side effects of Lotrel include:

  • rash,
  • new or worsened chest pain,
  • yellowing skin or eyes (jaundice),
  • nausea,
  • upper stomach pain,
  • itching,
  • unusual weakness or tired feeling,
  • rapid weight gain,
  • fever,
  • chills,
  • sore throat,
  • body aches,
  • flu symptoms,
  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling), or
  • angioedema (swelling). Angioedema, if severe, can cause tongue and larynx swelling that inhibits or blocks the airway; this emergency condition needs immediate treatment.

Dosage for Lotrel

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.

What Drugs, Substances, or Supplements Interact with Lotrel?

Lotrel may interact with salt substitutes or potassium supplements, alcohol, gold injections, shots for bee-sting allergy, lithium, simvastatin, nonsteroidal anti-inflammatory drugs (NSAIDs), or diuretics (water pills). Tell your doctor all medications and supplements you use.

Lotrel During Pregnancy and Breastfeeding

Amlodipine and benazepril can pass into breast milk and may harm a nursing baby. Breastfeeding while using Lotrel is not recommended. Lotrel is not approved for use in the pediatric population.

Additional Information

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.

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Lotrel Consumer Information

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 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.

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

QUESTION

Salt and sodium are the same. See Answer
Lotrel Professional Information

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/ AmlodipineBenazeprilAmlodipinePlacebo
N=760N=554N=475N=408
Cough 3.31.80.40.2
Headache2.23.82.95.6
Dizziness1.31.62.31.5
Edema*2.10.95.12.2
*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, dyspepsia, and esophagitis.

Hematologic: Neutropenia

Musculoskeletal: cramps, and muscle cramps.

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.

Postmarketing 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, thrombocytopenia, paresthesia, dysgeusia, orthostatic symptoms and hypotension, angina pectoris and arrhythmia, pruritus, photosensitivity reaction, arthralgia, arthritis, myalgia, blood urea nitrogen (BUN) increase, serum creatinine increase, renal impairment, vision impairment, agranulocytosis, neutropenia.

Rare reports in association with use of amlodipine: gingival hyperplasia, tachycardia, jaundice, and hepatic enzyme elevations (mostly consistent with cholestasis severe enough to require hospitalization), leukocytopenia, allergic reaction, hyperglycemia, dysgeusia, hypoesthesia, paresthesia, syncope, peripheral neuropathy, hypertonia, visual impairment, diplopia, hypotension, vasculitis, rhinitis, gastritis, hyperhidrosis, pruritus, skin discoloration, urticaria, erythema multiform, muscle spasms, arthralgia, micturition disorder, nocturia, erectile dysfunction, malaise, weight decrease or gain.

Other potentially important adverse experiences attributed to other ACE inhibitors and calcium channel blockers include: eosinophilic pneumonitis (ACE inhibitors) and gynecomastia (CCBs).

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

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