Prinivil

[lisinopril]

Warnings & Precautions
WARNINGS

Angioedema

Angioedema has been reported in patients treated with PRINIVIL ® (lisinopril tablets, Merck Frosst Std.). This may occur at any time during treatment. Angioedema associated with laryngeal edema and/ or shock may be fatal.

If angioedema occurs, PRINIVIL ® should be promptly discontinued and the patient should be observed until the swelling subsides. Where swelling is confined to the face, lips and mouth the condition will usually resolve without further treatment, although antihistamines may be useful in relieving symptoms. These patients should be followed carefully until the swelling has resolved.

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However, where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, emergency therapy should be administered promptly when indicated. This includes giving subcutaneous adrenaline (0.5 mL 1: 1000), and/ or maintaining a patent airway. The patient should be under close medical supervision until complete and sustained symptom resolution has occurred. The incidence of angioedema during ACE inhibitor therapy has been reported to be higher in black than in non-black patients.

Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor (see CONTRAINDICATIONS).

Hypotension

Symptomatic hypotension has occurred after administration of PRINIVIL ® , usually after the first or second dose or when the dose was increased. It is more likely to occur in patients who are volume depleted by diuretic therapy, dietary salt restriction, dialysis, diarrhea, vomiting, or possibly in patients with renin-dependent renovascular hypertension (see DOSAGE AND ADMINISTRATION). In patients with severe congestive heart failure, with or without associated renal insufficiency, excessive hypotension has been observed and may be associated with oliguria and/ or progressive azotemia, and rarely with acute renal failure and/ or death.

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