Moexipril HCl Hydrochlorothiazide Tablets

Uniretic® (moexipril hydrochloride/hydrochlorothiazide) is a combination of an angiotensinconverting enzyme (ACE) inhibitor, moexipril hydrochloride, and a diuretic, hydrochlorothiazide. Moexipril hydrochloride is a fine white to off-white powder. It is soluble (about 10% weight-tovolume) in distilled water at room temperature. It has the empirical formula C27H34N2O7·HCl and a molecular weight of 535.04. It is chemically described as [3S-[2[R*(R*)],3R*]]-2-[2-[[1(Ethoxycarbonyl)-3-phenyl-propyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-3isoquino-linecarboxylic acid, monohydrochloride. Moexipril hydrochloride is a non-sulfhydryl containing precursor of the active ACE inhibitor moexiprilat and its structural formula is:

Hydrochlorothiazide is a white, or practically white, crystalline powder. It is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine and in dimethylformamide. Hydrochlorothiazide has the empirical formula C7H8CIN3O4S2 and a molecular weight of 297.75. It is chemically described as 2H-1,2,4-Benzothiadiazine-7-sulfonamide,6-chloro-3,4-dihydro-,1,1dioxide. Hydrochlorothiazide is a thiazide diuretic and its structural formula is:

Uniretic® is available for oral administration in three tablet strengths. The inactive ingredients in all strengths are lactose, magnesium oxide, crospovidone, magnesium stearate and gelatin. The film coating in all strengths contains hydroxypropyl cellulose, hypromellose, polyethylene glycol 6000, magnesium stearate and titanium dioxide. In addition, the film coating for uniretic® 7.5 mg / 12.5 mg and uniretic® 15 mg / 25 mg contains ferric oxide.

Uniretic® is indicated for treatment of patients with hypertension. This fixed combination is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION).

In using uniretic®, 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 uniretic® does not have a similar risk (see WARNINGS, Neutropenia/ Agranulocytosis). In addition, ACE inhibitors, for which adequate data are available, cause a higher rate of angioedema in black than in nonblack patients (see WARNINGS, Angioedema).

Patients should be advised to take uniretic® one hour before a meal (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).

Angioedema, including laryngeal edema, may occur with treatment with ACE inhibitors, usually occurring early in therapy (within the first month). Patients should be so advised and told to report immediately any signs or symptoms suggesting angioedema (swelling of the face, extremities, eyes, lips, tongue, difficulty in breathing) and to take no more drug until they have consulted with the prescribing physician.

Patients should be cautioned that lightheadedness can occur with uniretic®, especially during the first few days of therapy. If fainting occurs, the patient should stop taking uniretic® and consult the prescribing physician.

All patients should be cautioned that excessive perspiration and dehydration may lead to an excessive fall in blood pressure because of reduction in fluid volume. Other causes of volume depletion such as vomiting or diarrhea may also lead to a fall in blood pressure; patients should be advised to consult their physician if they develop these conditions.

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

Patients should be told to report promptly any indication of infection (e.g., sore throat, fever) that could be a sign of neutropenia.

Female patients of childbearing age should be told about the consequences of exposure to uniretic® during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.

Do not use this medication if you are allergic to hydrochlorothiazide or moexipril, or if you are unable to urinate.

You should not use this medication if you are allergic to other ACE inhibitor, such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), ramipril (Altace), or trandolapril (Mavik).

To make sure you can safely take hydrochlorothiazide and moexipril, tell your doctor if you have any of these other conditions:

• kidney disease (or if you are on dialysis);
• liver disease;
• glaucoma;
• congestive heart failure;
• gout;
• lupus;
• diabetes; or
• an allergy to sulfa drugs or penicillin.

FDA pregnancy category D. Do not use this medication if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. Moexipril can cause birth defects. Use effective birth control while taking hydrochlorothiazide and moexipril.

Hydrochlorothiazide can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.