Many people starting Lotensin® (benazepril hydrochloride) Tablets do not have any side effects. However, the following side effects may occur as your body adjusts to Lotensin:
Dizziness
Lightheadedness
Drowsiness
Headache
You may also have a dry cough. If any of these side effects persist or worsen, tell your doctor immediately.
Tell your doctor immediately if any of these unlikely, but serious, side effects occur:
Fainting
Symptoms of high potassium level (muscle weakness, slow/irregular heartbeat)
Signs of infection (fever, chills, persistent sore throat)
Change in the amount of urine
Lotensin may rarely cause serious (and possibly fatal) liver problems. Tell your doctor right away if you notice any of the following symptoms:
Yellowing eyes/skin
Dark urine
Severe stomach/abdominal pain
Persistent nausea/vomiting
Urinating more or less than usual or not at all
Fever, chills, body aches, flu symptoms
Severe blistering, peeling, and red skin rash
Tired feeling, muscle weakness and pounding or uneven heartbeats
Chest pain
Swelling or rapid weight gain
A serious allergic reaction to Lotensin is rare. However, if you notice any symptoms of a serious allergic reaction including rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, severe stomach pain, or trouble breathing, get emergency medical help.
Lotensin may make you dizzy or drowsy. Do not drive or operate machinery, or do any activity that requires alertness until you are sure that you can perform such activities safely. Avoid alcoholic beverages.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. 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 sufficient fluids to avoid dehydration, unless your doctor tells you otherwise.
Before having surgery, tell your doctor or dentist about the products that you use (including Lotensin and all other prescription drugs, nonprescription drugs, and herbal products).
Lotensin may increase your potassium levels. Before using potassium, supplements or salt substitutes that contain potassium, consult with your doctor.
Older adults may be more sensitive to the side effects of Lotensin, including dizziness and increases in potassium levels.
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 Validus Pharmaceuticals LLC at 1-866-982-5438.
Lotensin is not recommended for use during pregnancy. It may harm an unborn baby.
Lotensin passes into breast milk. Consult your doctor before breast-feeding.
Drug Interactions:
Drug interactions may change how your medications work or increase your risk for serious side effects. Keep a list of all products that you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.
Some products that may interact with Lotensin include: aliskiren, lithium, and drugs that may increase potassium levels in the blood. Check the labels on all of your medicines, including over-the-counter drugs (such as cough and cold products, diet aids or NSAIDS such as ibuprofen or naproxen) because they may contain ingredients that could increase your blood pressure or worsen your heart failure.
Overdose:
Seek emergency medical attention or call the Poison Help Line at 1-800-222-1222 if you think you have taken too much Lotensin.
Symptoms of a Lotensin overdose may include hypotension: feeling extremely dizzy or light-headed, or fainting. If this occurs, contact your doctor immediately.
When pregnancy is detected, discontinue Lotensin as soon as possible.
Drugs that action directly on the rennin-angiotensin system can casuse injury and death to the developing fetus. See WARNINGS: Fetal Toxicity
CONTRAINDICATIONS
Individuals who are hypersensitive to Lotensin® (benazepril hydrochloride) Tablets or any other ACE-inhibitor should not take Lotensin.
Individuals who have a history of angioedema (swelling under the surface of the skin) should not take Lotensin.
WARNINGS
Anaphylactoid and Possibly Related Reactions
These reactions may begin within minutes or even seconds after exposure, and rapidly progress to cause airway constriction, skin and intestinal irritation, and altered heart rhythms. In severe cases, it can result in complete airway obstruction, shock and death. If this occurs, GET IMMEDIATE EMERGENCY HELP.
Head and Neck Angiodema
Swelling of the face, extremities, lips, tongue, glottis and larynx may occur. If any of these symptoms occur, Lotensin should be discontinued and appropriate therapy should be started immediately. When involvement of the tongue, glottis or larynx appears likely to cause airway obstruction, appropriate therapy such as epinephrine injection should be promptly administered.
Black individuals receiving ACE inhibitors have been reported to have a higher incidence of angioedema than nonblacks.
Intestinal Angiodema
Should you have abdominal pain (with or without vomiting) notify your doctor immediately.
Anaphylactoid Reactions when using anti-venom for Bee, Wasp Stings, etc.
Treatment with anti-sting venom (e.g., hymenoptera venom) may cause anaphylactoid reactions. Tell your doctor if you have an allergy that requires treatment with hymenoptera venom and get emergency help should an anaphylactoid reaction occur.
Anaphylactoid Reactions during Dialysis
Anaphylactoid reactions have been reported during dialysis. Should this occur, get immediate emergency help.
Hypotension
Lotension can cause symptomatic hypotension (low blood pressure). This is most likely to occur if you are on prolonged diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting.
Lotensin should be used cautiously in individuals with congestive heart failure with or without associated liver problems as it may cause excessive low blood pressure.
If hypotension occurs, you should lie down, and if necessary, be treated with intravenous saline infusion.
Fetal Toxicity
Pregnancy Category D
The use of Lotensin during the second and third trimesters of pregnancy reduces fetal kidney function and increases the chance of fetal and neonatal morbidity and death. Amniotic fluid may be decreased which is associated with fetal lung hypoplasia and skeletal deformaties. When pregnancy is detected, discontinue Lotensin as soon as possible and seek appropriate management of maternal hypertension during pregnancy. In the unusual case where there is no alternative but to use Lotensin during pregnancy, you should understand the potential risk to the fetus. Serial ultrasounds should be performed to assess the intra-amniotic environment. If a decrease in amniotic fluid is detected, Lotensin should be discontinued immediately, unless it is considered lifesaving for the mother. However, you should be aware that a decrease in amniotic fluid may not be detectable and could result on sustained irreversible injury to the fetus.
Hepatic Failure
Should you develop jaundice or marked elevations of hepatic (liver) enzymes, you should stop taking Lotensin immediately and your doctor should conduct the appropriate follow-up.
PRECAUTIONS
General
Impaired Renal Function:
Changes in renal (kidney) function may occur in some individuals. Individuals with severe congestive heart failure who are treated with Lotensin may experience decreased urine output and/or progressively high levels of nitrogen-containing compounds in the blood (such as urea, creatinine, or other various body waste compounds). Rarely, acute renal failure and/or death has been reported. In some instances, an increase in nitrogen-containing compounds in the blood may be reversible when Lotensin therapy is stopped. If you have a history of renal artery stenosis, your doctor should monitor your renal function, particularly during the first few weeks of therapy.
Hyperkalemia:
Risk factors associated with the development of hyperkalemia (high levels of serum potassium) with the use of Lotensin include: renal insufficiency, diabetes mellitus, potassium supplements, and/or potassium-containing salt substitutes and the concomitant use of potassium-sparing diuretics.
Cough:
Persistent nonproductive cough has been reported with the use of Lotensin. Discontinuing Lotensin will resolve the cough.
Surgery/Anesthesia:
Some anesthetics used during surgery may produce a hypotensive reaction. If this occurs with patients on Lotensin, it can be corrected by volume expansion.
Pregnancy:
Exposure to Lotensin during pregnancy can cause severe harm to an unborn fetus (See warnings: Fetal Toxicity).
Angiodema:
Angioedema can occur at any time in patients taking Lotensin. If this occurs, seek immediate emergency help.
Symptomatic hypotension:
Lightheadedness should be reported to your doctor. If fainting occurs, Lotensin therapy should be discontinued until the prescribing doctor has been consulted.
Hyperkalemia:
Individuals on Lotensin thrapy should not use potassium supplements or salt substitutes containing potassium without consulting their prescribing doctor.
Neutropenia:
Any indication of infection (sore throat, fever) should be immediately reported to the prescribing doctor.
Drug Interactions
Potassium Supplements and Potassium-Sparing Diuretics: Use of potassium supplements and potassium-sparing diuretics during Lotensin therapy may affect potassium levels.
Lithium: Increased serum lithium and symptoms of lithium toxicity have been reported in patients receiving ACE inhibitors during lithium therapy.
Dual Blockade of the Renin-Angiotension System (RAS): Blood pressure, renal function and electrolytes should be monitored periodically in patients on Lotensin and other agents that affect the RAS due to increased risks of hypertension, hyperkalemia, and changes in renal function (including acute renal failure).
NSAIDS and Cox-2 selective agents: Administration of NSAIDS, including selective Cox-2 inhibitors, with ACE inhibitors may result in generally reversible loss of renal function and renal failure and these patients should be monitored periodically. The antihypertensive effect of benazepril and hydrochlorothiazide may be attenuated by NSAIDS.
Gold: Nitroid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and ACE inhibitor therapy.
Anti-diabetic Therapy: In rare cases, diabetic individuals taking Lotensin with insulin or anti-diabetic medications may develop hypoglycemia and should be monitored.
Use in Special Populations
Nursing Mothers:
Because of the unknown effects of benazepril in infants, a decision should be made whether to discontinue nursing the infant, or to discontinue Lotensin, taking into account the benefit/risk of using the drug to the mother.
Geriatric Use:
A limited amount of data suggests that it may be useful to monitor kidney function in elderly patients.
Pediatric Use:
Lotensin is approved for pediatric patients 7 to 16 years of age. Lotensin is generally well-tolerated and adverse effects are similar to those in adults. Lotensin is not recommended for patients less than 6 years of age.
Adverse Reactions
The most common reasons for discontinuation of therapy with Lotensin were headache, dizziness, sleepiness, postural dizziness. 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.
To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals, LLC at — VALIDUS (1-866-982-5438) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
