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Lotensin

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Lotensin

Lotensin Side Effects Center

Pharmacy Editor: Charles Patrick Davis, MD, PhD

Lotensin (benazepril hydrochloride) is an angiotensin-converting enzyme inhibitor used to treat patients with hypertension. The drug is available in the generic form termed benazepril hydrochloride. Common side effects are dizziness, cough, nausea and drowsiness or lightheadedness; do not use when operating vehicles or machinery.

Lotensin is supplied as tablets containing strengths of 5, 10, 20, and 40 mg of benazepril hydrochloride for oral administration. The usual starting dose is 10 mg per day. Serious side effects include fainting, changes in urine output, blistering red skin rash, unusually tired, skin easily bruised or bleeds or the person may develop serious flu-like symptoms. Lotensin should not be used in pregnant females as it may damage the fetus. The drug has been found in breast milk so use in breast feeding women must be weighed against the possible harm to the infant. Lotensin is not recommended for children under 6 years old. However, doses of Lotensin between 0.1 and 0.6 mg/kg once daily have been studied, and doses greater than 0.1 mg/kg were shown to reduce blood pressure. Consequently, the recommended starting dose of Lotensin in children 6 years and older is 0.2 mg/kg once per day as monotherapy. Doses above 0.6 mg/kg have not been studied in children 6 years and older.

Our Lotensin 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.

Lotensin 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 to benazepril if you are African-American.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • little or no urinating;
  • swelling or rapid weight gain;
  • fever, chills, body aches, flu symptoms;
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • jaundice (yellowing of the skin or eyes);
  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling); or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • cough;
  • headache;
  • dizziness, drowsiness, tired feeling;
  • anxiety, sleep problems (insomnia);
  • flushing (warmth, redness, or tingly feeling);
  • nausea, vomiting, constipation; or
  • mild skin itching or rash.

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 Lotensin (Benazepril) »

What is Patient Information Overview?

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

Lotensin Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness, lightheadedness, drowsiness, or headache may occur as your body adjusts to the medication. Dry cough may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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 unlikely but serious side effects occur: fainting, symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat), signs of infection (such as fever, chills, persistent sore throat), change in the amount of urine.

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

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 Lotensin (Benazepril)»

What is Prescribing information?

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

Lotensin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Lotensin has been evaluated for safety in over 6000 patients with hypertension; over 700 of these patients were treated for at least one year. The overall incidence of reported adverse events was comparable in Lotensin and placebo patients.

The reported side effects were generally mild and transient, and there was no relation between side effects and age, duration of therapy, or total dosage within the range of 2 to 80 mg. Discontinuation of therapy because of a side effect was required in approximately 5% of U.S. patients treated with Lotensin and in 3% of patients treated with placebo.

The most common reasons for discontinuation were headache (0.6%) and cough (0.5%) (see PRECAUTIONS, Cough).

The side effects considered possibly or probably related to study drug that occurred in U.S. placebo-controlled trials in more than 1% of patients treated with Lotensin are shown below.

PATIENTS IN U.S. PLACEBO-CONTROLLED STUDIES

  LOTENSIN
(N=964)
PLACEBO
(N=496)
N % N %
Headache
60
6.2
21
4.2
Dizziness
35
3.6
12
2.4
Fatigue
23
2.4
11
2.2
Somnolence
15
1.6
2
0.4
Postural Dizziness
14
1.5
1
0.2
Nausea
13
1.3
5
1.0
Cough
12
1.2
5
1.0

Other adverse experiences reported in controlled clinical trials(in less than 1% of benazepril patients), and rarer events seen in post-marketing experience, include the following (in some, a causal relationship to drug use is uncertain):

Cardiovascular

Symptomatic hypotension was seen in 0.3% of patients, postural hypotension in 0.4%, and syncope in 0.1%; these reactions led to discontinuation of therapy in 4 patients who had received benazepril monotherapy and in 9 patients who had received benazepril with hydrochlorothiazide (see PRECAUTIONS and WARNINGS). Other reports included angina pectoris, palpitations, and peripheral edema.

Renal

Of hypertensive patients with no apparent preexisting renal disease, about 2% have sustained increases in serum creatinine to at least 150% of their baseline values while receiving Lotensin, but most of these increases have disappeared despite continuing treatment. A much smaller fraction of these patients (less than 0.1%) developed simultaneous (usually transient) increases in blood urea nitrogen and serum creatinine.

Angioedema

Angioedema has been reported in patients receiving ACE inhibitors. During clinical trials in hypertensive patients with benazepril, 0.5% of patients experienced edema of the lips or face without other manifestations of angioedema. Angioedema associated with laryngeal edema and/or shock may be fatal. If angioedema of the face, extremities, lips, tongue, or glottis and/or larynx occurs, treatment with Lotensin should be discontinued and appropriate therapy instituted immediately (see WARNINGS).

Dermatologic

Stevens-Johnson syndrome, pemphigus, apparent hypersensitivity reactions (manifested by dermatitis, pruritus, or rash), photosensitivity, and flushing.

Gastrointestinal

Pancreatitis, constipation, gastritis, vomiting, and melena.

Hematologic

Thrombocytopenia and hemolytic anemia.

Neurologic and Psychiatric

Anxiety, decreased libido, hypertonia, insomnia, nervousness, and paresthesia.

Other

Asthma, bronchitis, dyspnea, sinusitis, urinary tract infection, frequent urination, infection, arthritis, impotence, alopecia, arthralgia, myalgia, asthenia, and sweating.

Another potentially important adverse experience, eosinophilic pneumonitis, has been attributed to other ACE inhibitors.

The following adverse events of unknown frequency have been reported during post-marketing use of benazepril: small bowel angioedema, anaphylactoid reactions, hyperkalemia, agranulocytosis, and neutropenia.

Pediatric Patients: The adverse experience profile for pediatric patients appears to be similar to that seen in adult patients. Infants below the age of 1 year should not be given ACE inhibitors due to concerns over possible effects on kidney development.

The long-term effects of benazepril on growth and development have not been studied.

Clinical Laboratory Test Findings

Creatinine and Blood Urea Nitrogen

Of hypertensive patients with no apparent preexisting renal disease, about 2% have sustained increases in serum creatinine to at least 150% of their baseline values while receiving Lotensin, but most of these increases have disappeared despite continuing treatment. A much smaller fraction of these patients (less than 0.1%) developed simultaneous (usually transient) increases in blood urea nitrogen and serum creatinine. None of these increases required discontinuation of treatment. Increases in these laboratory values are more likely to occur in patients with renal insufficiency or those pretreated with a diuretic and, based on experience with other ACE inhibitors, would be expected to be especially likely in patients with renal artery stenosis (see PRECAUTIONS, General).

Potassium

Since benazepril decreases aldosterone secretion, elevation of serum potassium can occur. Potassium supplements and potassium-sparing diuretics should be given with caution, and the patient's serum potassium should be monitored frequently (see PRECAUTIONS).

Hemoglobin

Decreases in hemoglobin (a low value and a decrease of 5 g/dL) were rare, occurring in only 1 of 2,014 patients receiving Lotensin alone and in 1 of 1,357 patients receiving Lotensin plus a diuretic. No U.S. patients discontinued treatment because of decreases in hemoglobin.

Other (causal relationships unknown)

Clinically important changes in standard laboratory tests were rarely associated with Lotensin administration. Elevations of uric acid, blood glucose, serum bilirubin, and liver enzymes (see WARNINGS) have been reported, as have scattered incidents of hyponatremia, electrocardiographic changes, leukopenia, eosinophilia, and proteinuria. In U.S. trials, less than 0.5% of patients discontinued treatment because of laboratory abnormalities.

Read the entire FDA prescribing information for Lotensin (Benazepril) »

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Lotensin - User Reviews

Lotensin 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 Lotensin 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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