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Monopril

Generic Name: Fosinopril Sodium
Drug Category: ACE Inhibitor
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 6 years old for a maximum duration of 4 years.

Approved Uses

Indicated for:

Hypertension:

• The treatment of hypertension. They may be used alone or in combination with thiazide diuretics.

Heart Failure:

• Management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis.

Angioedema involving the extremities, face, lips, mucous membranes, tongue, glottis, or larynx has been reported in patients treated with ACE inhibitors.

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

Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death.

In using fosinopril sodium tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease.

In considering use of fosinopril sodium tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients.

Fosinopril sodium can cause symptomatic hypotension.

Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Closely monitor blood pressure, renal function and electrolytes in patients on fosinopril and other agents that affect the RAS.

Do not co-administer aliskiren with fosinopril in patients with diabetes. Avoid use of aliskiren with fosinopril in patients with renal impairment (GFR less than 60 mL/min).

Patients on diuretics, especially those with intravascular volume depletion, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with fosinopril sodium tablets.

Fosinopril sodium can attenuate potassium loss caused by thiazide diuretics. Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) or potassium supplements can increase the risk of hyperkalemia. Therefore, if concomitant use of such agents is indicated, they should be given with caution, and the patient’s serum potassium should be monitored frequently.

Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving ACE inhibitors during therapy with lithium.

Antacids may impair absorption of fosinopril. Therefore, if concomitant administration of these agents is indicated, dosing should be separated by 2 hours.

Nitritoid reactions (symptoms include facial flushing, nausea, vomiting, and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy including fosinopril sodium.

When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, fosinopril sodium tablets should be discontinued as soon as possible. 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.

Fosinopril sodium should not be administered to nursing mothers.

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Off-label Uses

• Use in patients under the age of 6. GoToSource 

• Dosage greater than 80 mg per day. GoToSource 

• Left ventricular hypertrophy. GoToSource 

• Pulmonary hypertension. GoToSource 

• Cardiorenal syndrome. GoToSource 

• Cocaine addiction. GoToSource 

• HIV-associated nephropathy. GoToSource

Adverse Events

Hypotension, cough and hyperkalemia (high potassium level). GoToSource

Cholestatic jaundice. GoToSource 

Pruritus (severe itching). GoToSource 

Pemphigus foliaceus (autoimmune skin condition). GoToSource

Intestinal angioedema. GoToSource

Birth defects. GoToSource

Litigation

Lawsuits filed for angioedema and birth defects. 

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated March 29, 2024