Generic Name: Moexipril Hydrochloride
Class: Angiotensin-Converting Enzyme Inhibitors
VA Class: CV800
Chemical Name: (3S-(2(R*(R*)),3R*))-2-(2-((1 - (Ethoxycarbonyl) - 3 - phenylpropyl)amino) - 1 - oxopropyl) - 1,2,3,4 - tetrahydro - 6,7 - dimethoxy - 3 - isoquinolinecarboxylic acid monohydrochloride
Molecular Formula: C27H34N2O7•ClH
CAS Number: 82586-52-5
May cause fetal and neonatal morbidity and mortality if used during pregnancy.1 110 111 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
If pregnancy is detected, discontinue as soon as possible.1 111
Introduction
Nonsulfhydryl ACE inhibitor.1
Uses for Univasc
Hypertension
Management of hypertension (alone or in combination with other classes of antihypertensive agents).1
One of several preferred initial therapies in hypertensive patients with heart failure, post-MI, high coronary disease risk, diabetes mellitus, chronic renal failure, and/or cerebrovascular disease.95
Can be used as monotherapy for initial management of uncomplicated hypertension;1 however, thiazide diuretics are preferred by JNC 7.95
CHF
Management of symptomatic CHF†, usually in conjunction with cardiac glycosides, diuretics, and β-adrenergic blocking agents.10 11 12 14 94 96
Diabetic Nephropathy
A first-line agent in the treatment of diabetic nephropathy† in hypertensive patients with diabetes mellitus.100 101 102
Univasc Dosage and Administration
General
Moexipril/hydrochlorothiazide fixed combination should not be used for initial treatment of hypertension.83
Administration
Oral Administration
Administer orally once or twice daily 1 hour before meals.1 3 18 83
Dosage
Available as moexipril hydrochloride; dosage expressed in terms of the salt.1 83
Adults
Hypertension
Oral
Initially, 7.5 mg once daily as monotherapy.1 3 5 18 95
In patients currently receiving diuretic therapy, discontinue diuretic, if possible, 2–3 days before initiating moexipril.1 8 9 10 11 12 13 14 37 46 May cautiously resume diuretic therapy if BP not controlled adequately with moexipril alone.1 28 29 30 39 If diuretic cannot be discontinued, increase sodium intake and give lower initial moexipril dose (3.75 mg) under close medical supervision.1 8 10 11 12 13 14 83 84
Usual dosage: 7.5–30 mg daily, given in 1 dose or 2 divided doses.1 83 95
If effectiveness diminishes toward end of dosing interval in patients treated once daily, consider increasing dosage or administering drug in 2 divided doses.1
Moexipril/Hydrochlorothiazide Combination Therapy
Oral
If BP is not adequately controlled by monotherapy with moexipril, can switch to the fixed-combination preparation containing moexipril hydrochloride 7.5 mg and hydrochlorothiazide 12.5 mg, moexipril hydrochloride 15 mg and hydrochlorothiazide 12.5 mg, or moexipril hydrochloride 15 mg and hydrochlorothiazide 25 mg.83 Adjust dosage of either or both drugs according to patient’s response.83
Prescribing Limits
Adults
Hypertension
Oral
Usually, maximum 30 mg daily.1 Dosages >60 mg daily have not been extensively evaluated in hypertensive patients.1 5
Special Populations
Renal Impairment
Hypertension
Oral
Initially, 3.75 mg once daily in patients with severe renal impairment (Clcr ≤40 mL/minute); titrate until BP is controlled or to maximum of 15 mg daily.1
Moexipril/hydrochlorothiazide fixed combination is not recommended in patients with severe renal impairment.83
Volume- and/or Salt-depleted Patients
Correct volume and/or salt depletion prior to initiation of therapy or initiate therapy under close medical supervision using lower initial dosage.1
Cautions for Univasc
Contraindications
Known hypersensitivity (e.g., history of angioedema) to moexipril or another ACE inhibitor.1 83
Warnings/Precautions
Warnings
Hypotension
Possible symptomatic hypotension, particularly in volume- and/or salt-depleted patients (e.g., those with restricted salt intake, treated with diuretics, undergoing dialysis, with nausea or vomiting, or with CHF).1 Risk of marked hypotension, sometimes associated with oliguria and azotemia, and rarely acute renal failure and death in patients with CHF with or without associated renal insufficiency.1
Hypotension may occur in patients undergoing surgery or during anesthesia with agents that produce hypotension; recommended treatment is fluid volume expansion.1
To minimize potential for hypotension, consider recent antihypertensive therapy, extent of BP elevation, sodium intake, fluid status, and other clinical conditions.1 May minimize potential for hypotension by withholding diuretic therapy and/or increasing sodium intake for 2–3 days prior to initiation of moexipril.1
Transient hypotension is not a contraindication to additional doses; may reinstate therapy cautiously after BP is stabilized (e.g., with volume expansion).1
Initiate therapy in patients with CHF (with or without associated renal insufficiency) under close medical supervision; monitor closely for first 2 weeks following initiation of moexipril or any increase in moexipril or diuretic dosage.1
Hematologic Effects
Neutropenia and agranulocytosis reported with captopril; risk of neutropenia appears to depend principally on degree of renal impairment and presence of collagen vascular disease (e.g., systemic lupus erythematosus, scleroderma); risk with moexipril is unknown.1 83
Consider monitoring leukocytes in patients with collagen vascular disease, especially if renal impairment exists.1 83
Fetal/Neonatal Morbidity and Mortality
Possible fetal and neonatal morbidity and mortality when used during pregnancy.1 111 (See Boxed Warning.) Such potential risks occur throughout pregnancy, especially during the second and third trimesters.111
Also may increase the risk of major congenital malformations when administered during the first trimester of pregnancy.110 111
Discontinue as soon as possible when pregnancy is detected, unless continued use is considered lifesaving.1 110 111 Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy.75
Hepatic Effects
Clinical syndrome that usually is manifested initially by cholestatic jaundice and may progress to fulminant hepatic necrosis (occasionally fatal) reported rarely with ACE inhibitors.1
If jaundice or marked elevation of liver enzymes occurs, discontinue drug and monitor patient.1
Sensitivity Reactions
Anaphylactoid reactions and/or angioedema possible; if associated with laryngeal edema, may be fatal.1 83 Immediate medical intervention (e.g., epinephrine) for involvement of tongue, glottis, or larynx.1 83 Intestinal angioedema possible; consider in differential diagnosis of patients who develop abdominal pain.1 83
Anaphylactoid reactions reported in patients receiving ACE inhibitors while undergoing LDL apheresis with dextran sulfate absorption1 51 52 83 or following initiation of hemodialysis that utilized high-flux membrane.1 47 48 49 83
Life-threatening anaphylactoid reactions reported in at least 2 patients receiving ACE inhibitors while undergoing desensitization treatment with hymenoptera venom.1 83
Contraindicated in patients with a history of angioedema associated with ACE inhibitors.1 83
General Precautions
Renal Effects
Transient increases in BUN and Scr possible, especially in patients with preexisting renal impairment or those receiving concomitant diuretic therapy.1 83 Possible increases in BUN and Scr in patients with unilateral or bilateral renal artery stenosis; generally reversible following discontinuance of ACE inhibitors and/or diuretic.1 83
Possible oliguria, progressive azotemia, and, rarely, acute renal failure and/or death in patients with severe CHF.1 83
Closely monitor renal function following initiation of therapy in such patients.1 83 Some patients may require dosage reduction or discontinuance of ACE inhibitor or diuretic and/or adequate sodium repletion.1 83
Hyperkalemia
Possible hyperkalemia, especially in patients with renal impairment or diabetes mellitus and those receiving drugs that can increase serum potassium concentration (e.g., potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes).1 (See Specific Drugs under Interactions.)
Monitor serum potassium concentration carefully in these patients.1
Cough
Persistent and nonproductive cough; resolves after drug discontinuance.1
Use of Fixed Combinations
When used in fixed combination with hydrochlorothiazide, consider the cautions, precautions, and contraindications associated with hydrochlorothiazide.83
Specific Populations
Pregnancy
Category C (1st trimester); Category D (2nd and 3rd trimesters).1 (See Fetal/Neonatal Morbidity and Mortality under Cautions and see Boxed Warning.)
Lactation
Not known whether moexipril is distributed into milk.1 Caution advised if used in nursing women.1
Pediatric Use
Safety and efficacy not established.1
Geriatric Use
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.1 Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.1
Renal Impairment
Systemic exposure to moexipril and moexiprilat may be increased.1 Initial dosage adjustment recommended in patients with severe renal impairment.1 (See Renal Impairment under Dosage and Administration.)
Moexipril/hydrochlorothiazide fixed combination is not recommended in patients with severe renal impairment.83
Blacks
BP reduction may be smaller in black patients compared with nonblack patients; however, no apparent population difference during combined therapy with ACE inhibitor and thiazide diuretic.25 83 92 93 95 108 109 Use in combination with a diuretic.25 83 86 95
Higher incidence of angioedema reported with ACE inhibitors in blacks compared with other races.1
Common Adverse Effects
Cough, dizziness, diarrhea, flu syndrome, fatigue, pharyngitis, flushing, rash, myalgia.1
Interactions for Univasc
Specific Drugs
Drug | Interaction | Comments |
|---|---|---|
Anticoagulants, oral | Clinically important interaction not observed1 | |
Cimetidine | Clinically important interaction not observed1 | |
Digoxin | Clinically important interaction not observed1 | |
Diuretics | Increased hypotensive effect1 | If possible, discontinue diuretic before initiating moexipril1 (see Dosage under Dosage and Administration) |
Diuretic, potassium-sparing (amiloride, spironolactone, triamterene) | Enhanced hyperkalemic effect1 | Use with caution; monitor serum potassium concentrations frequently1 |
Lithium | Increased serum lithium concentrations; possible toxicity1 | Use with caution; monitor serum lithium concentration frequently1 |
Potassium supplements or potassium-containing salt substitutes. | Enhanced hyperkalemic effect1 | Use with caution; monitor serum potassium concentrations frequently1 |
Univasc Pharmacokinetics
Absorption
Bioavailability
About 13% of oral dose is absorbed.1 Peak plasma concentration of moexiprilat is achieved within about 1.5 hours.1
Onset
Following a single oral dose, antihypertensive effects are observed within about 1 hour with peak BP reduction at 3–6 hours.1
During chronic therapy, maximum antihypertensive effect with any dose is achieved after 4 weeks.1
Duration
Antihypertensive effect of a single dose persists for about 24 hours.1
Food
Food reduces peak plasma concentration of moexipril; administer 1 hour before meals.1
Special Populations
In patients with cirrhosis, peak plasma concentration and AUC of moexipril following a single oral dose were increased, while peak plasma concentration of moexiprilat was decreased and AUC of moexiprilat was increased.1
In patients with renal impairment, increased moexipril and moexiprilat concentrations.1
Distribution
Extent
Not known whether distributed into milk.1
Plasma Protein Binding
Moexiprilat: 50%.1
Elimination
Metabolism
Metabolized in the liver, principally to an active metabolite, moexiprilat.1
Elimination Route
Following oral administration, eliminated in feces (53%), principally as moexiprilat, and to a lesser extent in urine (13%).1
Following IV administration, eliminated principally in urine, as moexiprilat (40%) and moexipril (26%), and to lesser extent in feces (about 20%, mainly as moexiprilat).1
Half-life
Moexiprilat: 12 hours.1
Special Populations
In patients with renal impairment (Clcr 10–40 mL/minute), threefold to fourfold increase in moexiprilat half-life.1
Stability
Storage
Oral
Tablets
Tight containers at 15–30°C.1
ActionsActions
Prodrug; not pharmacologically active until hydrolyzed in the liver to moexiprilat.1
Suppresses the renin-angiotensin-aldosterone system.1
Advice to Patients
Risk of angioedema, anaphylactoid reactions, or other sensitivity reactions.1 Importance of reporting sensitivity reactions (e.g., edema of face, eyes, lips, tongue, or extremities; hoarseness; swallowing or breathing with difficulty) immediately to clinician and of discontinuing the drug.1
Importance of reporting signs of infection (e.g., sore throat, fever).1
Risk of hypotension.1 Importance of informing clinicians promptly if lightheadedness or fainting occurs.1
Importance of adequate fluid intake; risk of volume depletion with excessive perspiration, dehydration, vomiting, or diarrhea.1
Risks of use during pregnancy.1 110 111 (See Boxed Warning.)
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs (including salt substitutes containing potassium).1
Importance of taking moexipril 1 hour before meals.1
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1
Importance of advising patients of other important precautionary information.1 (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets, film-coated | 7.5 mg* | Moexipril Hydrochloride Tablets | Teva |
Univasc (scored) | Schwarz | |||
15 mg* | Moexipril Hydrochloride Tablets | Teva | ||
Univasc (scored) | Schwarz |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets, film-coated | 7.5 mg with Hydrochlorothiazide 12.5 mg | Uniretic (scored) | Schwarz |
15 mg with Hydrochlorothiazide 12.5 mg | Uniretic (scored) | Schwarz | ||
15 mg with Hydrochlorothiazide 25 mg | Uniretic (scored) | Schwarz |
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Moexipril HCl 15MG Tablets (WATSON LABS): 30/$41.99 or 90/$109.98
Moexipril HCl 7.5MG Tablets (WATSON LABS): 30/$40.99 or 90/$100.97
Moexipril-Hydrochlorothiazide 15-12.5MG Tablets (WATSON LABS): 100/$109.98 or 300/$315.96
Moexipril-Hydrochlorothiazide 15-25MG Tablets (WATSON LABS): 30/$36.99 or 90/$89.97
Moexipril-Hydrochlorothiazide 7.5-12.5MG Tablets (TEVA PHARMACEUTICALS USA): 30/$37.99 or 90/$95.97
Uniretic 15-12.5MG Tablets (SCHWARZ PHARMA): 30/$84.99 or 90/$228.98
Uniretic 15-25MG Tablets (SCHWARZ PHARMA): 30/$84.99 or 90/$228.98
Uniretic 7.5-12.5MG Tablets (SCHWARZ PHARMA): 30/$84.99 or 90/$231.97
Univasc 15MG Tablets (SCHWARZ PHARMA): 30/$91.99 or 90/$244.97
Univasc 7.5MG Tablets (SCHWARZ PHARMA): 30/$61.99 or 90/$164.97
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions April 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
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