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Univasc

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Overview

What is Univasc?

univasc (moexipril hydrochloride), the hydrochloride salt of moexipril, has the empirical formula C H N O •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 is a fine white to off-white powder. It is soluble (about 10% weight-to-volume) in distilled water at room temperature.

univasc is supplied as scored, 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, magnesium oxide, crospovidone, magnesium stearate and gelatin. The film coating contains hydroxypropyl cellulose, hypromellose, polyethylene glycol 6000, magnesium stearate, titanium dioxide, and ferric oxide.



What does Univasc look like?



What are the available doses of Univasc?

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What should I talk to my health care provider before I take Univasc?

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How should I use Univasc?

univasc is indicated for treatment of patients with hypertension. It may be used alone or in combination with thiazide diuretics.

In using univasc , 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 univasc does not have a similar risk (see ).

In considering use of univasc , 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 , Angioedema).

The recommended initial dose of univasc in patients not receiving diuretics is 7.5 mg, one hour prior to meals, once daily. Dosage should be adjusted according to blood pressure response. The antihypertensive effect of univasc may diminish towards the end of the dosing interval. Blood pressure should, therefore, be measured just prior to dosing to determine whether satisfactory blood pressure control is obtained. If control is not adequate, increased dose or divided dosing can be tried. The recommended dose range is 7.5 to 30 mg daily, administered in one or two divided doses one hour before meals. Total daily doses above 60 mg a day have not been studied in hypertensive patients.

In patients who are currently being treated with a diuretic, symptomatic hypotension may occasionally occur following the initial dose of univasc . The diuretic should, if possible, be discontinued for 2 to 3 days before therapy with univasc is begun, to reduce the likelihood of hypotension (see ). If the patient's blood pressure is not controlled with univasc alone, diuretic therapy may then be reinstituted. If diuretic therapy cannot be discontinued, an initial dose of 3.75 mg of univasc should be used with medical supervision until blood pressure has stabilized (see and ).


What interacts with Univasc?

univasc is 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 univasc in patients with diabetes (see ).



What are the warnings of Univasc?

Anaphylactoid and Possibly Related Reactions

Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors, including univasc , may be subject to a variety of adverse reactions, some of them serious.

Head and Neck Angioedema

Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors, including univasc , may be subject to a variety of adverse reactions, some of them serious.

Intestinal Angioedema

Intestinal angioedema has been reported in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal. The angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE inhibitor. Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain.

Anaphylactoid Reactions During Desensitization

Two patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions. In the same patients, these reactions did not occur when ACE inhibitors were temporarily withheld, but they reappeared when the ACE inhibitors were inadvertently readministered.

Anaphylactoid Reactions During Membrane Exposure

Anaphylactoid reactions have been reported in patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption.

Hypotension

univasc can cause symptomatic hypotension, although, as with other ACE inhibitors, this is unusual in uncomplicated hypertensive patients treated with univasc alone. Symptomatic hypotension was seen in 0.5% of patients given moexipril and led to discontinuation of therapy in about 0.25%. Symptomatic hypotension is most likely to occur in patients who have been salt- and volume-depleted as a result of prolonged diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting. Volume- and salt-depletion should be corrected and, in general, diuretics stopped, before initiating therapy with univasc (see , and ).

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. In these patients, univasc therapy should be started under close medical supervision, and patients should be followed closely for the first two weeks of treatment and whenever the dose of moexipril or an accompanying diuretic is increased. Care in avoiding hypotension should also be taken in patients with ischemic heart disease, aortic stenosis, or cerebrovascular disease, in whom an excessive decrease in blood pressure could result in a myocardial infarction or a cerebrovascular accident.

If hypotension occurs, the patient should be placed in a supine position and, if necessary, treated with an intravenous infusion of normal saline. univasc treatment usually can be continued following restoration of blood pressure and volume.

Neutropenia/Agranulocytosis

Another ACE inhibitor, captopril, has been shown to cause agranulocytosis and bone marrow depression, rarely in patients with uncomplicated hypertension, but more frequently in hypertensive patients with renal impairment, especially if they also have a collagen-vascular disease such as systemic lupus erythematosus or scleroderma. Although there were no instances of severe neutropenia (absolute neutrophil count <500/mm ) among patients given univasc , as with other ACE inhibitors, monitoring of white blood cell counts should be considered for patients who have collagen-vascular disease, especially if the disease is associated with impaired renal function. Available data from clinical trials of univasc are insufficient to show that univasc does not cause agranulocytosis at rates similar to captopril.

Fetal Toxicity

Pregnancy Category D

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 effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue univasc as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus.

In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue univasc , unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of exposure to univasc for hypotension, oliguria, and hyperkalemia. (see ).

No embryotoxic, fetotoxic, or teratogenic effects were seen in rats or in rabbits treated with up to 90.9 and 0.7 times, respectively, the Maximum Recommended Human Dose (MRHD) on a mg/m basis.

Hepatic Failure

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. Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up.


What are the precautions of Univasc?

General

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Carcinogenesis, Mutagenesis, Impairment of Fertility

No evidence of carcinogenicity was detected in long-term studies in mice and rats at doses up to 14 or 27.3 times the Maximum Recommended Human Dose (MRHD) on a mg/m basis.

No mutagenicity was detected in the Ames test and microbial reverse mutation assay, with and without metabolic activation, or in an nucleus anomaly test. However, increased chromosomal aberration frequency in Chinese hamster ovary cells was detected under metabolic activation conditions at a 20-hour harvest time.

Reproduction studies have been performed in rabbits at oral doses up to 0.7 times the MRHD on a mg/m basis, and in rats up to 90.9 times the MRHD on a mg/m basis. No indication of impaired fertility, reproductive toxicity, or teratogenicity was observed.

Nursing Mothers

It is not known whether univasc is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when univasc is given to a nursing mother.

Pediatric Use

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If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function.



Safety and effectiveness of univasc in pediatric patients have not been established.

Geriatric Use

Clinical studies of univasc did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.


What are the side effects of Univasc?

univasc has 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 univasc 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 univasc and in 1.8% of patients treated with placebo. The most common reasons for discontinuation in patients treated with univasc 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 univasc alone and that were at least as frequent in the univasc group as in the placebo group are shown in the following table:

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 and 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:

Renal:

Gastrointestinal:

Respiratory:

Urogenital:

Dermatologic:

Neurological and Psychiatric:

Other:

ADVERSE EVENTS IN PLACEBO-CONTROLLED STUDIES
ADVERSE EVENTUNIVASC (N=674) PLACEBO (N=226)
N (%)N (%)
Cough Increased41 (6.1)5 (2.2)
Dizziness29 (4.3)5 (2.2)
Diarrhea21 (3.1)5 (2.2)
Flu Syndrome21 (3.1)0 (0)
Fatigue16 (2.4)4 (1.8)
Pharyngitis12 (1.8)2 (0.9)
Flushing11 (1.6)0 (0)
Rash11 (1.6)2 (0.9)
Myalgia9 (1.3)0 (0)





What should I look out for while using Univasc?

univasc is 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 univasc in patients with diabetes (see ).


What might happen if I take too much Univasc?

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.


How should I store and handle Univasc?

Store at 25°C (77°F) with excursions permitted between 15–30°C (59–86°F) [see USP Controlled Room Temperature].All regulations concerning handling of pressure vessels must be followed.Protect the cylinders from shocks, falls, oxidizing and flammable materials, moisture, and sources of heat or ignition.Store at 25°C (77°F) with excursions permitted between 15–30°C (59–86°F) [see USP Controlled Room Temperature].All regulations concerning handling of pressure vessels must be followed.Protect the cylinders from shocks, falls, oxidizing and flammable materials, moisture, and sources of heat or ignition.Store at 25°C (77°F) with excursions permitted between 15–30°C (59–86°F) [see USP Controlled Room Temperature].All regulations concerning handling of pressure vessels must be followed.Protect the cylinders from shocks, falls, oxidizing and flammable materials, moisture, and sources of heat or ignition.univasc (moexipril hydrochloride) 7.5 mg 707SP7.5univasc (moexipril hydrochloride) 15 mg 715SP15Store, tightly closed, at controlled room temperature 20° to 25°C (68° to 77°F). Protect from excessive moisture.If product package is subdivided, dispense in tight containers as described in USP-NF.univasc (moexipril hydrochloride) 7.5 mg 707SP7.5univasc (moexipril hydrochloride) 15 mg 715SP15Store, tightly closed, at controlled room temperature 20° to 25°C (68° to 77°F). Protect from excessive moisture.If product package is subdivided, dispense in tight containers as described in USP-NF.univasc (moexipril hydrochloride) 7.5 mg 707SP7.5univasc (moexipril hydrochloride) 15 mg 715SP15Store, tightly closed, at controlled room temperature 20° to 25°C (68° to 77°F). Protect from excessive moisture.If product package is subdivided, dispense in tight containers as described in USP-NF.univasc (moexipril hydrochloride) 7.5 mg 707SP7.5univasc (moexipril hydrochloride) 15 mg 715SP15Store, tightly closed, at controlled room temperature 20° to 25°C (68° to 77°F). Protect from excessive moisture.If product package is subdivided, dispense in tight containers as described in USP-NF.univasc (moexipril hydrochloride) 7.5 mg 707SP7.5univasc (moexipril hydrochloride) 15 mg 715SP15Store, tightly closed, at controlled room temperature 20° to 25°C (68° to 77°F). Protect from excessive moisture.If product package is subdivided, dispense in tight containers as described in USP-NF.univasc (moexipril hydrochloride) 7.5 mg 707SP7.5univasc (moexipril hydrochloride) 15 mg 715SP15Store, tightly closed, at controlled room temperature 20° to 25°C (68° to 77°F). Protect from excessive moisture.If product package is subdivided, dispense in tight containers as described in USP-NF.univasc (moexipril hydrochloride) 7.5 mg 707SP7.5univasc (moexipril hydrochloride) 15 mg 715SP15Store, tightly closed, at controlled room temperature 20° to 25°C (68° to 77°F). Protect from excessive moisture.If product package is subdivided, dispense in tight containers as described in USP-NF.univasc (moexipril hydrochloride) 7.5 mg 707SP7.5univasc (moexipril hydrochloride) 15 mg 715SP15Store, tightly closed, at controlled room temperature 20° to 25°C (68° to 77°F). Protect from excessive moisture.If product package is subdivided, dispense in tight containers as described in USP-NF.univasc (moexipril hydrochloride) 7.5 mg 707SP7.5univasc (moexipril hydrochloride) 15 mg 715SP15Store, tightly closed, at controlled room temperature 20° to 25°C (68° to 77°F). Protect from excessive moisture.If product package is subdivided, dispense in tight containers as described in USP-NF.univasc (moexipril hydrochloride) 7.5 mg 707SP7.5univasc (moexipril hydrochloride) 15 mg 715SP15Store, tightly closed, at controlled room temperature 20° to 25°C (68° to 77°F). Protect from excessive moisture.If product package is subdivided, dispense in tight containers as described in USP-NF.