IMPORTANT SAFETY INFORMATION
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Lotensin® (benazepril hydrochloride) Tablets
WARNING: FETAL TOXICITY
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
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.
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.
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.
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.
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.
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.
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.
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.
Persistent nonproductive cough has been reported with the use of Lotensin. Discontinuing Lotensin will resolve the cough.
Some anesthetics used during surgery may produce a hypotensive reaction. If this occurs with patients on Lotensin, it can be corrected by volume expansion.
Exposure to Lotensin during pregnancy can cause severe harm to an unborn fetus (See warnings: Fetal Toxicity).
Angioedema can occur at any time in patients taking Lotensin. If this occurs, seek immediate emergency help.
Lightheadedness should be reported to your doctor. If fainting occurs, Lotensin therapy should be discontinued until the prescribing doctor has been consulted.
Individuals on Lotensin thrapy should not use potassium supplements or salt substitutes containing potassium without consulting their prescribing doctor.
Any indication of infection (sore throat, fever) should be immediately reported to the prescribing doctor.
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
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.
A limited amount of data suggests that it may be useful to monitor kidney function in elderly patients.
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.
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