Lotensin

[Benazepril]

Fetal/ Neonatal Morbidity and Mortality:

See WARNINGS, Fetal/ Neonatal Morbidity and Mortality.

Angioedema:

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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, sinusitus, urinary tract infection, infection, arthritis, impotence, alopecia, arthralgia, myalgia, asthenia, and sweating. Another potentially important adverse experience, eosinophilic pneumonitis, has been attributed to other ACE inhibitors.

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).

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