Indications and Usage
Moexipril hydrochloride tablets are indicated for treatment of patients with hypertension. It may be used alone or in combination with thiazide diuretics.
In using moexipril hydrochloride tablets, 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 tablets do not have a similar risk (see WARNINGS).
In considering use of moexipril hydrochloride 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 (see WARNINGS, Angioedema).
Dosage and Administration
Contraindications
Moexipril hydrochloride tablets are contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an ACE inhibitor.
Do not co-administer aliskiren with moexipril hydrochloride tablets in patients with diabetes (see PRECAUTIONS, Drug Interactions).
Adverse Reactions
Moexipril hydrochloride tablets have been evaluated for safety in more than 2500 patients with hypertension; more than 250 of these patients were treated for approximately one year. The overall incidence of reported adverse events was only slightly greater in patients treated with moexipril hydrochloride tablets than patients treated with placebo.
Reported adverse experiences were usually mild and transient, and there were no differences in adverse reaction rates related to gender, race, age, duration of therapy, or total daily dosage within the range of 3.75 mg to 60 mg. Discontinuation of therapy because of adverse experiences was required in 3.4% of patients treated with moexipril hydrochloride tablets and in 1.8% of patients treated with placebo. The most common reasons for discontinuation in patients treated with moexipril hydrochloride tablets were cough (0.7%) and dizziness (0.4%).
All adverse experiences considered at least possibly related to treatment that occurred at any dose in placebo-controlled trials of once-daily dosing in more than 1% of patients treated with moexipril hydrochloride tablets alone and that were at least as frequent in the moexipril hydrochloride tablets group as in the placebo group are shown in the following table:
ADVERSE EVENTS IN PLACEBO-CONTROLLED STUDIES
|
ADVERSE EVENT |
MOEXIPRIL HYDROCHLORIDE TABLETS (N=674) |
PLACEBO (N=226) |
|
N (%) |
N (%) |
|
|
Cough Increased |
41 (6.1) |
5 (2.2) |
|
Dizziness |
29 (4.3) |
5 (2.2) |
|
Diarrhea |
21 (3.1) |
5 (2.2) |
|
Flu Syndrome |
21 (3.1) |
0 (0) |
|
Fatigue |
16 (2.4) |
4 (1.8) |
|
Pharyngitis |
12 (1.8) |
2 (0.9) |
|
Flushing |
11 (1.6) |
0 (0) |
|
Rash |
11 (1.6) |
2 (0.9) |
|
Myalgia |
9 (1.3) |
0 (0) |
Other adverse events occurring in more than 1% of patients on moexipril that were at least as frequent on placebo include: headache, upper respiratory infection, pain, rhinitis, dyspepsia, nausea, peripheral edema, sinusitis, chest pain, and urinary frequency. See WARNINGS and PRECAUTIONS for discussion of anaphylactoid reactions, angioedema, hypotension, neutropenia/agranulocytosis, second and third trimester fetal/neonatal morbidity and mortality, hyperkalemia, and cough.
Other potentially important adverse experiences reported in controlled or uncontrolled clinical trials in less than 1% of moexipril patients or that have been attributed to other ACE inhibitors include the following:
Cardiovascular:Symptomatic hypotension, postural hypotension, or syncope were seen in 9/1750 (0.51%) patients; these reactions led to discontinuation of therapy in controlled trials in 3/1254 (0.24%) patients who had received moexipril hydrochloride tablets monotherapy and in 1/344 (0.3%) patients who had received moexipril hydrochloride tablets with hydrochlorothiazide (see PRECAUTIONSand WARNINGS). Other adverse events included angina/myocardial infarction, palpitations, rhythm disturbances, and cerebrovascular accident.
Renal:Of hypertensive patients with no apparent preexisting renal disease, 1% of patients receiving moexipril hydrochloride tablets alone and 2% of patients receiving moexipril hydrochloride tablets with hydrochlorothiazide experienced increases in serum creatinine to at least 140% of their baseline values (see PRECAUTIONSand DOSAGE AND ADMINISTRATION).
Gastrointestinal:Abdominal pain, constipation, vomiting, appetite/weight change, dry mouth, pancreatitis, hepatitis.
Respiratory:Bronchospasm, dyspnea, eosinophilic pneumonitis.
Urogenital:Renal insufficiency, oliguria.
Dermatologic:Apparent hypersensitivity reactions manifested by urticaria, rash, pemphigus, pruritus, photosensitivity, alopecia.
Neurological and Psychiatric:Drowsiness, sleep disturbances, nervousness, mood changes, anxiety.
Other:Angioedema (see WARNINGS), taste disturbances, tinnitus, sweating, malaise, arthralgia, hemolytic anemia.
Overdosage
Human overdoses of moexipril have not been reported. In case reports of overdoses with other ACE inhibitors, hypotension has been the principal adverse effect noted. Single oral doses of 2 g/kg moexipril were associated with significant lethality in mice. Rats, however, tolerated single oral doses of up to 3 g/kg.
No data are available to suggest that physiological maneuvers (e.g., maneuvers to change the pH of the urine) would accelerate elimination of moexipril and its metabolites. The dialyzability of moexipril is not known.
Angiotensin II could presumably serve as a specific antagonist-antidote in the setting of moexipril overdose, but angiotensin II is essentially unavailable outside of research facilities. Because the hypotensive effect of moexipril is achieved through vasodilation and effective hypovolemia, it is reasonable to treat moexipril overdose by infusion of normal saline solution. In addition, renal function and serum potassium should be monitored.
Description
Moexipril Hydrochloride, USP, the hydrochloride salt of moexipril, has the empirical formula C 27H 34N 2O 7•HCl and a molecular weight of 535.04. It is chemically described as [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. It is a non-sulfhydryl containing precursor of the active angiotensin-converting enzyme (ACE) inhibitor moexiprilat and its structural formula is:
Moexipril Hydrochloride, USP is a fine white to off-white powder. It is soluble (about 10% weight-to-volume) in distilled water at room temperature.
Moexipril Hydrochloride Tablets, USP are supplied as scored, film-coated tablets containing 7.5 mg and 15 mg of moexipril hydrochloride for oral administration. In addition to the active ingredient, moexipril hydrochloride, the tablet core contains the following inactive ingredients: lactose monohydrate, crospovidone, magnesium oxide, povidone, colloidal silicon dioxide, and magnesium stearate. The film-coating contains hypromellose, polyethylene glycol, titanium dioxide, iron oxide red and iron oxide yellow.
"Image Description"Clinical Pharmacology
How Supplied / Storage and Handling
Moexipril Hydrochloride, USP 7.5 mgtablets are light beige, round, film-coated scored tablets, debossed with “
C” above and “
E” below the score on one side and “
266” on other side.
They are supplied as follows:
Bottles of 90 NDC 62135-967-90
Moexipril Hydrochloride, USP 15 mgtablets are dark beige, round, film-coated scored tablets, debossed with “
C” above and “
E” below the score on one side and “
267” on other side.
They are supplied as follows:
Bottles of 90 NDC 62135-969-90
Store, tightly closed, at 20° to 25°C (68° to 77°F). Excursions permitted between 15° and 30°C (59° and 86°F) [See USP Controlled Room Temperature]. Protect from excessive moisture.
If product package is subdivided, dispense in tight containers as described in USP-NF.
Manufactured for:
Chartwell RX, LLC.
Congers, NY 10920
L72585
Rev. 03/2025