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Drug DescriptionSide Effects & Drug InteractionsWarnings & Precautions
Clinical PharmacologyOverdosage & ContraindicationsIndications & DosagePatient Info

Monopril

[Fosinopril]


Overdosage & Contraindications
CONTRAINDICATIONS

MONOPRIL (fosinopril sodium tablets) is contraindicated in patients who are hypersensitive to this product or to any other angiotensin-converting enzyme inhibitor (e. g., a patient who has experienced angioedema with any other ACE inhibitor therapy).

WARNINGS Anaphylactoid and Possibly Related Reactions

Text Continues Below



Presumably because angiotensin-converting enzyme inhibitors affect the metabo-lism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including MONOPRIL) may be subject to a variety of adverse reactions, some of them serious.

Head and Neck Angioedema:

Angioedema involving the extremities, face, lips, mucous membranes, tongue, glottis or larynx has been reported in patients treat-ed with ACE inhibitors. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. If laryngeal stridor or angioedema of the face, lips, mucous membranes, tongue, glottis or extremities occurs, treatment with MONOPRIL should be discontinued and appropriate therapy instituted immediately. Where there is involvement of the tongue, glottis, or larynx, likely to cause airway obstruction, appropriate therapy, e. g., subcutaneous epinephrine solu-tion 1: 1000 (0.3 mL to 0.5 mL) should be promptly administered (see PRECAU-TIONS: Information for Patients and ADVERSE REACTIONS).

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 diag-nosed 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 pre-senting with abdominal pain.

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