Uses
Hypertension
Management of hypertension (alone or in combination with other classes of antihypertensive agents).
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.
Can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.
CHF
Management of symptomatic CHF†, usually in conjunction with cardiac glycosides, diuretics, and β-adrenergic blocking agents.
Diabetic Nephropathy
A first-line agent in the treatment of diabetic nephropathy† in hypertensive patients with diabetes mellitus.
Dosage and Administration
General
Administration
Oral Administration
Administer orally once or twice daily 1 hour before meals.
Dosage
Available as moexipril hydrochloride; dosage expressed in terms of the salt.
Adults
Hypertension
Oral
Initially, 7.5 mg once daily as monotherapy.
In patients currently receiving diuretic therapy, discontinue diuretic, if possible, 2–3 days before initiating moexipril. May cautiously resume diuretic therapy if BP not controlled adequately with moexipril alone. If diuretic cannot be discontinued, increase sodium intake and give lower initial moexipril dose (3.75 mg) under close medical supervision.
Usual dosage: 7.5–30 mg daily, given in 1 dose or 2 divided doses.
If effectiveness diminishes toward end of dosing interval in patients treated once daily, consider increasing dosage or administering drug in 2 divided doses.
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. Adjust dosage of either or both drugs according to patient's response.
Prescribing Limits
Adults
Hypertension
Oral
Usually, maximum 30 mg daily. Dosages >60 mg daily have not been extensively evaluated in hypertensive patients.
Special Populations
Dosage in 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.
Moexipril/hydrochlorothiazide fixed combination is not recommended in patients with severe renal impairment.
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.
Cautions
Contraindications
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). 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.
Hypotension may occur in patients undergoing surgery or during anesthesia with agents that produce hypotension; recommended treatment is fluid volume expansion.
To minimize potential for hypotension, consider recent antihypertensive therapy, extent of BP elevation, sodium intake, fluid status, and other clinical conditions. May minimize potential for hypotension by withholding diuretic therapy and/or increasing sodium intake for 2–3 days prior to initiation of moexipril.
Transient hypotension is not a contraindication to additional doses; may reinstate therapy cautiously after BP is stabilized (e.g., with volume expansion).
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.
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.
Consider monitoring leukocytes in patients with collagen vascular disease, especially if renal impairment exists.
Fetal/Neonatal Morbidity and Mortality
Possible fetal and neonatal morbidity and mortality when used during pregnancy. (See Boxed Warning.) Such potential risks occur throughout pregnancy, especially during the second and third trimesters.
Also may increase the risk of major congenital malformations when administered during the first trimester of pregnancy.
Discontinue as soon as possible when pregnancy is detected, unless continued use is considered lifesaving. Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy.
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.
If jaundice or marked elevation of liver enzymes occurs, discontinue drug and monitor patient.
Sensitivity Reactions
Anaphylactoid reactions and/or angioedema possible; if associated with laryngeal edema, may be fatal. Immediate medical intervention (e.g., epinephrine) for involvement of tongue, glottis, or larynx. Intestinal angioedema possible; consider in differential diagnosis of patients who develop abdominal pain.
Anaphylactoid reactions reported in patients receiving ACE inhibitors while undergoing LDL apheresis with dextran sulfate absorption or following initiation of hemodialysis that utilized high-flux membrane.
Life-threatening anaphylactoid reactions reported in at least 2 patients receiving ACE inhibitors while undergoing desensitization treatment with hymenoptera venom.
Contraindicated in patients with a history of angioedema associated with ACE inhibitors.
General Precautions
Renal Effects
Transient increases in BUN and Scr possible, especially in patients with preexisting renal impairment or those receiving concomitant diuretic therapy. 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.
Possible oliguria, progressive azotemia, and, rarely, acute renal failure and/or death in patients with severe CHF.
Closely monitor renal function following initiation of therapy in such patients. Some patients may require dosage reduction or discontinuance of ACE inhibitor or diuretic and/or adequate sodium repletion.
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). (See Specific Drugs under Interactions.)
Monitor serum potassium concentration carefully in these patients.
Cough
Persistent and nonproductive cough; resolves after drug discontinuance.
Use of Fixed Combinations
When used in fixed combination with hydrochlorothiazide, consider the cautions, precautions, and contraindications associated with hydrochlorothiazide.
Specific Populations
Pregnancy
Category C (1st trimester); Category D (2nd and 3rd trimesters). (See Fetal/Neonatal Morbidity and Mortality under Cautions and see Boxed Warning.)
Lactation
Not known whether moexipril is distributed into milk. Caution advised if used in nursing women.
Pediatric Use
Safety and efficacy not established.
Geriatric Use
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults. Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.
Renal Impairment
Systemic exposure to moexipril and moexiprilat may be increased. Initial dosage adjustment recommended in patients with severe renal impairment. (See Renal Impairment under Dosage and Administration.)
Moexipril/hydrochlorothiazide fixed combination is not recommended in patients with severe renal impairment.
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. Use in combination with a diuretic.
Higher incidence of angioedema reported with ACE inhibitors in blacks compared with other races.
Common Adverse Effects
Cough, dizziness, diarrhea, flu syndrome, fatigue, pharyngitis, flushing, rash, myalgia.
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