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Uniretic

Generic Name: Moexipril HCl/Hydrochlorothiazide
Drug Category: ACE Inhibitor/Thiazide Diuretic
Litigation Alert Level: Medium
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 2 years.

Approved Uses

Indicated for treatment of patients with hypertension. This fixed combination is not indicated for the initial therapy of hypertension.

Patients should be advised to take moexipril hydrochloride/hydrochlorothiazide one hour before a meal.

Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. Hypersensitivity reactions are more likely to occur in patients with a history of allergy or bronchial asthma.

Do not co-administer aliskiren with moexipril hydrochloride/hydrochlorothiazide in patients with diabetes.

Avoid use of aliskiren with moexipril hydrochloride/hydrochlorothiazide in patients with renal impairment (GFR < 60 mL/min).

In using Moexipril Hydrochloride and Hydrochlorothiazide Tablets USP, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that Moexipril Hydrochloride and Hydrochlorothiazide Tablets USP do not have a similar risk.

Angioedema involving the face, extremities, lips, tongue, glottis, and/or larynx has been reported in patients treated with ACE inhibitors, including moexipril. Intestinal angioedema has been reported in patients treated with ACE inhibitors. Intestinal angioedema has been reported in patients treated with ACE inhibitors. 

Moexipril hydrochloride/hydrochlorothiazide can cause symptomatic hypotension, although, as with other ACE inhibitors, this is unusual in uncomplicated hypertensive patients treated with moexipril hydrochloride/hydrochlorothiazide alone.

In patients with congestive heart failure, with or without associated renal insufficiency, ACE inhibitor therapy may cause excessive hypotension, which may be associated with oliguria or progressive azotemia, and rarely, with acute renal failure and death.

Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.

Presumably due to the inhibition of the degradation of endogenous bradykinin, persistent nonproductive cough has been reported with all ACE inhibitors, always resolving after discontinuation of therapy.

Risk factors for the development of hyperkalemia with ACE inhibitors include renal insufficiency, diabetes mellitus, and the concomitant use of potassium-sparing diuretics, potassium supplements, and/or potassium-containing salt substitutes.

Treatment with thiazide diuretics has been associated with hypokalemia, hyponatremia, and hypochloremic alkalosis.

Thiazide diuretics may reduce glucose tolerance and may raise serum levels of cholesterol, triglycerides, and uric acid. These effects are usually minor, but frank gout or overt diabetes may be precipitated in susceptible patients.

Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation.

Moexipril hydrochloride/hydrochlorothiazide should be used with caution in patients with severe renal disease. Thiazide diuretics may precipitate azotemia in such patients and the effects of repeated dosing may be cumulative.

Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and sometimes death. The mechanism of this syndrome is not understood.

Two patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions.

Patients should be told not to use potassium supplements or salt substitutes containing potassium without consulting their physician.

The thiazide component of moexipril hydrochloride and hydrochlorothiazide tablets may potentiate the action of other antihypertensive drugs, especially ganglionic or peripheral adrenergic-blocking drugs. The antihypertensive effects of the thiazide component may also be enhanced in the post-sympathectomy patient.

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

Potentiation of orthostatic hypotension may occur in patients on thiazide diuretic therapy with concomitant use of alcohol, barbiturates, or narcotics.

Use of thiazide diuretics concomitantly with corticosteroids or ACTH may intensify electrolyte depletion, particularly hypokalemia.

Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85% and 43%, respectively.

Thiazide diuretics may increase the responsiveness to tubocurarine.

The antihypertensive effect of ACE inhibitors and hydrochlorothiazide, as well as the diuretic and natriuretic effects of hydrochlorothiazide, may be attenuated by NSAIDs.

Co-administration of propantheline or guanabenz increased the absorption of hydrochlorothiazide.

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 events include skull hypoplasia, anuria, hypotension, renal failure and death. When pregnancy is detected, discontinue moexipril hydrochloride and hydrochlorothiazide tablets as soon as possible.

Intrauterine exposure to thiazide diuretics is associated with fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.

It is not known whether moexipril or moexiprilat is excreted in human milk. Thiazides are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from hydrochlorothiazide and the unknown effects of moexipril or moexiprilat in infants, a decision should be made whether to discontinue nursing or to discontinue moexipril hydrochloride and hydrochlorothiazide tablets, taking into account the importance of the drug to the mother.

GoToSource

Off-label Uses

• Use in patients under the age of 18. GoToSource

• Initial therapy of hypertension. GoToSource

• Left ventricular hypertrophy. GoToSource

• Proteinuric nephropathy. GoToSource

Adverse Events

Fatigue, headache, dizziness and cough. GoToSource

Hypotension (low blood pressure). GoToSource

Drug-induced lupus erythematosus (autoimmune disorder). GoToSource

Acute angle-closure glaucoma (sudden increase in eye pressure). GoToSource

Hyperkalemia (elevated potassium in the blood) and neutropenia (low level of neutrophils a type of white blood cell). GoToSource 

Acute cholestatic hepatitis, impaired glucose tolerance, pancreatitis (inflammation of pancreas) and increased plasma levels of low-density lipoprotein cholesterol, total cholesterol and total triglycerides. GoToSource

Aplastic anemia (bone marrow not producing blood cells), sialadenitis (inflammation of salivary glands), agranulocytosis (low number of granulocytes, a type of white blood cell), leukopenia (low white blood cell count), thrombocytopenia (low blood platelet count), urticaria (hives) erythema multiforme, exfoliative dermatitis (severe skin reactions), azotemia (elevated BUN indicating kidney damage), hyponatremia (low blood sodium level) and hypomagnesemia (low blood magnesium level). GoToSource

QT prolongation and drug-induced torsades de pointes. GoToSource

Angioedema (swelling in deep layers of skin). GoToSource

Litigation

Lawsuits filed for arrhythmias and sudden death. 

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 28, 2024