Benazepril - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS Anaphylactoid reactions, including angioedema .

Myocardial infarction or increased angina in patients with obstructive coronary artery disease .

Assess for hypotension and hyperkalemia ( 5.4 , 5.8 ).

Titrate slowly in patients with impaired hepatic or severely impaired renal function ( 5.6 , 5.7 ).

5.1 Fetal Toxicity Amlodipine and benazepril hydrochloride can cause fetal harm when administered to a pregnant woman.

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.

Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.

Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death.

When pregnancy is detected, discontinue amlodipine and benazepril hydrochloride capsule as soon as possible [see Use in Specific Populations ].

5.2 Angioedema and Anaphylactoid Reactions Head and Neck Angioedema Angioedema of the face, extremities, lips, tongue, glottis, and larynx has been reported in patients treated with benazepril.

This may occur at any time during treatment.

Angioedema associated with edema of the larynx, tongue, or glottis can compromise the airway and be fatal.

If laryngeal stridor or angioedema of the face, tongue, or glottis occurs, discontinue treatment with amlodipine and benazepril hydrochloride capsule and treat immediately.

When involvement of the tongue, glottis, or larynx appears likely to cause airway obstruction, appropriate therapy, e.g., administer subcutaneous epinephrine injection 1:1000 (0.3 to 0.5 mL), promptly [ see Adverse Reactions ].

Patients with a history of angioedema may be at increased risk for angioedema while receiving amlodipine and benazepril hydrochloride capsules.

Black patients receiving ACE inhibitors have a higher incidence of angioedema compared to nonblacks.

Patients receiving coadministration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema [see Drug Interactions ].

Intestinal Angioedema Intestinal angioedema has been reported in patients treated with ACE inhibitors.

These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal.

The angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE inhibitor.

Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain.

Anaphylactoid Reactions During Desensitization Two patients undergoing desensitizing treatment with hymenoptera (wasp sting) venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions.

Anaphylactoid Reactions During Membrane Exposure Anaphylactoid reactions have been reported in patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor.

Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption.

5.3 Increased Angina and/or Myocardial Infarction Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease.