Moexipril Hydrochloride and Hydrochlorothiazide

×

Overview

What is Moexipril Hydrochloride and Hydrochlorothiazide?

Moexipril hydrochloride and hydrochlorothiazide tablets USP are a combination of an angiotensin-converting enzyme (ACE) inhibitor, moexipril hydrochloride, USP, and a diuretic, hydrochlorothiazide, USP. 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. It is chemically described as [3 -[2[ *( *)],3 *]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-3-isoquinolinecarboxylic acid, monohydrochloride. Moexipril hydrochloride, USP is a non-sulfhydryl containing precursor of the active ACE inhibitor moexiprilat and its structural formula is:

C H N O •HCl M.W. 535.04

Hydrochlorothiazide, USP 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. It is chemically described as 2 -1,2,4-benzothiadiazine-7-sulfonamide,6-chloro-3,4-dihydro-,1,1-dioxide. Hydrochlorothiazide, USP is a thiazide diuretic and its structural formula is:

C H ClN O S M.W. 297.75

Moexipril hydrochloride and hydrochlorothiazide tablets USP are available for oral administration in three strengths. The inactive ingredients in all strengths are lactose monohydrate, magnesium stearate, povidone, and sodium bicarbonate. The film coating in all strengths contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. In addition, the film coating for moexipril hydrochloride and hydrochlorothiazide tablets USP, 7.5 mg/12.5 mg contains FD&C Yellow # 5 Aluminum Lake and FD&C Yellow # 6 Aluminum Lake, and the film coating for moexipril hydrochloride and hydrochlorothiazide tablets USP, 15 mg/25 mg contains FD&C Red # 40 Aluminum Lake, FD&C Yellow # 5 Aluminum Lake, and FD&C Yellow # 6 Aluminum Lake.

What does Moexipril Hydrochloride and Hydrochlorothiazide look like?

What are the available doses of Moexipril Hydrochloride and Hydrochlorothiazide?

Sorry No records found.

What should I talk to my health care provider before I take Moexipril Hydrochloride and Hydrochlorothiazide?

Sorry No records found

How should I use Moexipril Hydrochloride and Hydrochlorothiazide?

Moexipril Hydrochloride and Hydrochlorothiazide Tablets USP are indicated for treatment of patients with hypertension.

In using Moexipril Hydrochloride and Hydrochlorothiazide Tablets USP, 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 and Hydrochlorothiazide Tablets USP do not have a similar risk (see , ). In addition, ACE inhibitors, for which adequate data are available, cause a higher rate of angioedema in black than in nonblack patients (see , ).

Moexipril and hydrochlorothiazide are effective treatments for hypertension. The recommended dosage range of moexipril is 7.5 to 30 mg daily, administered in a single or two divided doses one hour before meals, while hydrochlorothiazide is effective in a dosage of 12.5 to 50 mg daily.

The side effects (see ) of moexipril are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of moexipril and hydrochlorothiazide will be associated with both sets of dose-independent side effects, but regimens in which moexipril is combined with low doses of hydrochlorothiazide produce minimal effects on serum potassium. In moexipril hydrochloride/hydrochlorothiazide controlled clinical trials, the average change in serum potassium was near zero in subjects who received 3.75 mg/6.25 mg or 7.5 mg/12.5 mg, but subjects who received 15 mg/12.5 mg or 15 mg/25 mg experienced a mild decrease in serum potassium, similar to that experienced by subjects who received the same dose of hydrochlorothiazide monotherapy. To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.

What interacts with Moexipril Hydrochloride and Hydrochlorothiazide?

Moexipril hydrochloride and hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to any component of this product and in patients with a history of angioedema related to previous treatment with an ACE inhibitor. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. Hypersensitivity reactions are more likely to occur in patients with a history of allergy or bronchial asthma.

Do not coadminister aliskiren with moexipril hydrochloride/hydrochlorothiazide in patients with diabetes (see ).

What are the warnings of Moexipril Hydrochloride and Hydrochlorothiazide?

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 moexipril hydrochloride/hydrochlorothiazide, may be subject to a variety of adverse reactions, some of them serious.

Head and Neck Angioedema

Angioedema involving the face, extremities, lips, tongue, glottis, and/or larynx has been reported in patients treated with ACE inhibitors, including moexipril. Symptoms suggestive of angioedema or facial edema occurred in < 0.5% of moexipril-treated patients in placebo-controlled trials. None of the cases were considered life-threatening and all resolved either without treatment or with medication (antihistamines or glucocorticoids). One patient treated with hydrochlorothiazide alone experienced laryngeal edema. No instances of angioedema were reported in placebo-treated patients.

In cases of angioedema, treatment with moexipril hydrochloride/hydrochlorothiazide should be promptly discontinued and the patient carefully observed until the swelling disappears. In instances where swelling has been confined to the face and lips, the condition has generally resolved without treatment, although antihistamines have been useful in relieving symptoms.

Array

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

Moexipril hydrochloride/hydrochlorothiazide can cause symptomatic hypotension, although, as with other ACE inhibitors, this is unusual in uncomplicated hypertensive patients treated with moexipril hydrochloride/hydrochlorothiazide alone. Symptomatic hypotension is most likely to occur in patients who have been salt- and/or volume-depleted as a result of prolonged diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting. Volume- and/or salt-depletion should be corrected before initiating therapy with moexipril hydrochloride/hydrochlorothiazide (see ).

The thiazide component of moexipril hydrochloride and hydrochlorothiazide tablets may potentiate the action of other antihypertensive drugs, especially ganglionic or peripheral adrenergic-blocking drugs. The antihypertensive effects of the thiazide component may also be enhanced in the postsympathectomy patient.

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, moexipril hydrochloride/hydrochlorothiazide 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 hydrochloride/hydrochlorothiazide 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. Moexipril hydrochloride/hydrochlorothiazide treatment usually can be continued following restoration of blood pressure and volume.

Impaired Renal Function

Moexipril hydrochloride/hydrochlorothiazide should be used with caution in patients with severe renal disease. Thiazide diuretics may precipitate azotemia in such patients and the effects of repeated dosing may be cumulative.

As a consequence of inhibition of the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals. There is no clinical experience of moexipril hydrochloride/hydrochlorothiazide in the treatment of hypertension in patients with renal failure.

Some hypertensive patients with no apparent preexisting renal vascular disease have developed increases in blood urea nitrogen and serum creatinine, usually minor and transient, especially when moexipril has been given concomitantly with a thiazide diuretic. This is more likely to occur in patients with preexisting renal impairment. There may be a need for dose adjustment of moexipril hydrochloride/hydrochlorothiazide. (see ).

In hypertensive patients with severe congestive heart failure, whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with ACE inhibitors, including moexipril, may be associated with oliguria and/or progressive azotemia and, rarely, acute renal failure and/or death.

In hypertensive patients with unilateral or bilateral renal artery stenosis, increases in blood urea nitrogen and serum creatinine have been observed in some patients following ACE inhibitor therapy. These increases were almost always reversible upon discontinuation of the ACE inhibitor and/or diuretic therapy. In such patients, renal function should be monitored during the first few weeks of therapy.

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 moexipril, 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 moexipril are insufficient to show that moexipril does not cause agranulocytosis at rates similar to captopril.

Fetal Toxicity

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 events include skull hypoplasia, anuria, hypotension, renal failure and death. When pregnancy is detected, discontinue moexipril hydrochloride and hydrochlorothiazide tablets 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 moexipril hydrochloride and hydrochlorothiazide tablets, 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 moexipril hydrochloride and hydrochlorothiazide tablets for hypotension, oliguria, and hyperkalemia (see , ).

Intrauterine exposure to thiazide diuretics is associated with fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.

Reproduction studies with the combination of moexipril hydrochloride and hydrochlorothiazide (ratio 7.5:12.5) indicated that the combination possessed no teratogenic properties up to the lethal dose of 800 mg/kg/day in rats and up to the maternotoxic dose of 160 mg/kg/day in rabbits.

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.

Impaired Hepatic Function

Moexipril hydrochloride/hydrochlorothiazide should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. In patients with mild to moderate cirrhosis given single 15 mg doses of moexipril, the C of moexipril was increased by about 50% and the AUC increased by about 120%, while the C for moexiprilat was decreased by about 50% and the AUC increased by almost 300%. No formal pharmacokinetic studies have been carried out with moexipril hydrochloride/hydrochlorothiazide in hypertensive patients with impaired liver function.

Systemic Lupus Erythematosus

Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.

Acute Myopia and Secondary Angle-Closure Glaucoma

Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

What are the precautions of Moexipril Hydrochloride and Hydrochlorothiazide?

General

Serum Electrolyte Imbalances

In clinical trials with moexipril monotherapy, persistent hyperkalemia (serum potassium above 5.4 mEq/L) occurred in approximately 1.3% of hypertensive patients receiving moexipril. Risk factors for the development of hyperkalemia with ACE inhibitors include renal insufficiency, diabetes mellitus, and the concomitant use of potassium-sparing diuretics, potassium supplements, and/or potassium-containing salt substitutes.

Treatment with thiazide diuretics has been associated with hypokalemia, hyponatremia, and hypochloremic alkalosis. These disturbances sometimes manifest as one or more of the following: dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, nausea, and vomiting. Hypokalemia has also been reported to sensitize or exaggerate the response of the heart to the toxic effects of digitalis. The risk of hypokalemia is greatest in patients with cirrhosis of the liver, in patients experiencing a brisk diuresis, in patients who are receiving inadequate oral intake of electrolytes, and in patients receiving concomitant therapy with corticosteroids or ACTH.

The opposite effects of moexipril and hydrochlorothiazide on serum potassium will approximately counterbalance each other in many patients, so that little net effect upon serum potassium will be seen. Initial and periodic determinations of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals.

Chloride deficits generally are mild and require specific treatment only under extraordinary circumstances (e.g., in liver disease or renal disease). Dilutional hyponatremia may occur in edematous patients; appropriate therapy is water restriction rather than administration of salt, except in rare instances when the hyponatremia is life-threatening. In actual salt depletion, appropriate replacement is the therapy of choice.

Calcium excretion is reduced by thiazides. In a few patients on prolonged thiazide therapy, pathological changes in the parathyroid gland have been seen, with hypercalcemia and hypophosphatemia. More serious complications of hyperparathyroidism (renal lithiasis, bone resorption, and peptic ulceration) have not been seen. Thiazides enhance urinary excretion of magnesium and hypomagnesemia may result.

Other Metabolic Disturbances

Thiazide diuretics may reduce glucose tolerance and may raise serum levels of cholesterol, triglycerides, and uric acid. These effects are usually minor, but frank gout or overt diabetes may be precipitated in susceptible patients.

Surgery/Anesthesia

In patients undergoing major surgery or during anesthesia with agents that produce hypotension, moexipril may block the effects of compensatory renin release. If hypotension occurs in this setting and is considered to be due to this mechanism, it can be corrected by volume expansion.

Cough

Presumably due to the inhibition of the degradation of endogenous bradykinin, persistent nonproductive cough has been reported with all ACE inhibitors, always resolving after discontinuation of therapy. ACE inhibitor-induced cough should be considered in the differential diagnosis of cough. In placebo-controlled trials with moexipril hydrochloride/hydrochlorothiazide, cough was present in 3% of moexipril hydrochloride/hydrochlorothiazide patients and 1% of patients given placebo.

Information for Patients

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Food

Patients should be advised to take moexipril hydrochloride/hydrochlorothiazide one hour before a meal (see and ).

Angioedema

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.

Symptomatic Hypotension

Patients should be cautioned that lightheadedness can occur with moexipril hydrochloride/hydrochlorothiazide, especially during the first few days of therapy. If fainting occurs, the patient should stop taking moexipril hydrochloride/hydrochlorothiazide 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.

Hyperkalemia

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

Neutropenia

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

Pregnancy

Female patients of childbearing age should be told about the consequences of exposure to moexipril hydrochloride and hydrochlorothiazide tablets 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.

Drug Interactions

Potassium Supplements and Potassium-Sparing Diuretics

As noted above (Serum Electrolyte Imbalances), the net effect of moexipril hydrochloride/hydrochlorothiazide may be to elevate a patient’s serum potassium, to reduce it, or to leave it unchanged. Potassium-sparing diuretics (spironolactone, amiloride, triamterene) or potassium supplements can increase the risk of hyperkalemia. If concomitant use of such agents is indicated, they should be given with caution, and the patient’s serum potassium should be monitored.

Oral Anticoagulants

Interaction studies with warfarin failed to identify any clinically important effect of moexipril monotherapy on the serum concentrations of the anticoagulant or on its anticoagulant effect.

Lithium

Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving ACE inhibitors during therapy with lithium. Because renal clearance of lithium is reduced by thiazides, the risk of lithium toxicity is presumably raised further when, as in therapy with moexipril hydrochloride/hydrochlorothiazide, a thiazide diuretic is coadministered with the ACE inhibitor. These drugs should be coadministered with caution, and frequent monitoring of serum lithium levels is recommended.

Gold

Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy including moexipril hydrochloride/hydrochlorothiazide.

Alcohol, Barbiturates, or Narcotics

Potentiation of orthostatic hypotension may occur in patients on thiazide diuretic therapy with concomitant use of alcohol, barbiturates, or narcotics.

Antidiabetic Agents

Use of thiazide diuretics concomitantly with antidiabetic agents (oral agents and insulin) may require dosage adjustment of the antidiabetic agent. Moexipril has been used in clinical trials concomitantly with oral hypoglycemic agents and there was no evidence of any clinically important adverse interactions.

Cholestyramine and Colestipol Resins

Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85% and 43%, respectively.

Corticosteroids, ACTH

Use of thiazide diuretics concomitantly with corticosteroids or ACTH may intensify electrolyte depletion, particularly hypokalemia.

Pressor Amines

Thiazide diuretics may decrease arterial responsiveness to pressor amines (e.g., norepinephrine), but not enough to preclude effectiveness of the pressor agent for therapeutic use.

Skeletal Muscle Relaxants, Nondepolarizing

Thiazide diuretics may increase the responsiveness to tubocurarine.

Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including moexipril, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving moexipril and NSAID therapy.

The antihypertensive effect of ACE inhibitors and hydrochlorothiazide, as well as the diuretic and natriuretic effects of hydrochlorothiazide, may be attenuated by NSAIDs.

Dual Blockade of the Renin-Angiotensin System (RAS)

Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Closely monitor blood pressure, renal function and electrolytes in patients on moexipril hydrochloride/hydrochlorothiazide and other agents that affect the RAS.

Do not coadminister aliskiren with moexipril hydrochloride/hydrochlorothiazide in patients with diabetes. Avoid use of aliskiren with moexipril hydrochloride/hydrochlorothiazide in patients with renal impairment (GFR < 60 mL/min).

Other Agents

No clinically important pharmacokinetic interactions occurred when moexipril was administered concomitantly with digoxin or cimetidine.

Moexipril has been used in clinical trials concomitantly with calcium-channel-blocking agents, diuretics, H blockers, digoxin, and cholesterol-lowering agents There was no evidence of clinically important adverse interactions. In general, ACE inhibitors have less than additive effects with beta-adrenergic blockers, presumably because both work by inhibiting the renin-angiotensin system.

Coadministration of propantheline or guanabenz increased the absorption of hydrochlorothiazide.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Moexipril Hydrochloride

No evidence of carcinogenicity was detected in long-term studies when moexipril was administered to 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 (CHO) 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.

Hydrochlorothiazide

Under the auspices of the National Toxicology Program, rats and mice received hydrochlorothiazide in their feed for two years, at doses up to 600 mg/kg/day in mice and up to 100 mg/kg/day in rats. These studies uncovered no evidence of a carcinogenic potential of hydrochlorothiazide in rats or female mice, but there was equivocal evidence of hepatocarcinogenicity in male mice. Hydrochlorothiazide was not genotoxic in assays using strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 of (the Ames test); in the CHO test for chromosomal aberrations; or in assays using mouse germinal cell chromosomes, Chinese hamster bone marrow chromosomes; and the sex-linked recessive lethal trait gene. Positive test results were obtained in the CHO Sister Chromatid Exchange (clastogenicity) test and in the Mouse Lymphoma Cell (mutagenicity) assays, using concentrations of hydrochlorothiazide of 43 to 1300 mcg/mL. Positive test results were also obtained in the nondisjunction assay, using an unspecified concentration of hydrochlorothiazide.

Hydrochlorothiazide had no adverse effects on the fertility of mice and rats of either sex in studies wherein these species were exposed, via their diets, to doses up to 100 and 4 mg/kg/day, respectively, prior to mating and throughout gestation.

Nursing Mothers

It is not known whether moexipril or moexiprilat is excreted in human milk. Thiazides are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from hydrochlorothiazide and the unknown effects of moexipril or moexiprilat in infants, a decision should be made whether to discontinue nursing or to discontinue moexipril hydrochloride/hydrochlorothiazide, taking into account the importance of the drug to the mother.

Pediatric Use

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 moexipril hydrochloride/hydrochlorothiazide in pediatric patients have not been established.

Geriatric Use

Of the patients who received moexipril hydrochloride/hydrochlorothiazide in controlled clinical studies, 24% were 65 years of age or older. No overall differences in effectiveness or safety were observed between these patients and younger patients. In elderly patients receiving moexipril, plasma levels of drug are slightly higher and renal clearance is reduced when compared to younger patients, but these effects did not have detectable consequences. Hydrochlorothiazide is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

What are the side effects of Moexipril Hydrochloride and Hydrochlorothiazide?

Moexipril hydrochloride/hydrochlorothiazide has been evaluated for safety in more than 1140 patients with hypertension with more than 120 treated for more than one year. Moexipril hydrochloride/hydrochlorothiazide has not demonstrated a potential for causing adverse experiences different from those previously associated with other ACE inhibitor/diuretic combinations. The overall incidence of reported adverse events was slightly less in patients treated with moexipril hydrochloride/hydrochlorothiazide than patients treated with placebo.

Adverse experiences were usually mild and transient, and there was no relationship between adverse experiences and gender, race, age, or total daily dosage (except for serum potassium decreases at 50 mg hydrochlorothiazide) within the moexipril/hydrochlorothiazide dosage range of 3.75 mg/3.125 mg to 30 mg/50 mg. Discontinuation of therapy due to adverse experiences was required in 5.3% of patients treated with moexipril hydrochloride/hydrochlorothiazide and in 8.4% of patients treated with placebo. The most common reasons for discontinuation of therapy with moexipril hydrochloride/hydrochlorothiazide were cough (0.5%) and dizziness (0.5%).

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/hydrochlorothiazide and that were at least as frequent in the moexipril hydrochloride/hydrochlorothiazide group as in the placebo group are shown in the following table.

Other adverse experiences occurring in more than 1% of patients treated with moexipril hydrochloride/hydrochlorothiazide in controlled or uncontrolled trials, some of which were of uncertain drug relationship, listed in decreasing frequency include: upper respiratory infection, headache, pain, flu syndrome, pharyngitis, hyperuricemia, diarrhea, back pain, rhinitis, sinusitis, abnormal ECG, infection, abdominal pain, chest pain, dyspepsia, hyperglycemia, hypokalemia, rash, vertigo, nausea, hypertonia, increased SGPT, urinary tract infection, impotence, peripheral edema, pyuria, bronchitis, and fever. See and for discussion of anaphylactoid reactions, angioedema, hypotension, neutropenia/agranulocytosis, fetal/neonatal morbidity and mortality, serum electrolyte imbalances, and cough.

The following adverse experiences, some of which are of uncertain drug relationship, were reported in moexipril hydrochloride/hydrochlorothiazide controlled or uncontrolled clinical trials in less than 1% of patients or have been attributed to other ACE inhibitors. Within each organ system, adverse experiences are listed in decreasing frequency.

Cardiovascular:

Dermatologic:

Gastrointestinal:

Hematologic:

Metabolic:

Neurologic/Psychiatric

Renal:

Respiratory:

Urogenital:

Other:

Monotherapy with moexipril has been evaluated for safety in over 3000 patients. In clinical trials, the observed adverse experiences with moexipril were similar to those seen in the moexipril hydrochloride/hydrochlorothiazide trials.

**Adverse Events in Placebo-Controlled Trials**
Cough	15	(3)	2	(1)
Dizziness	7	(1.4)	2	(1)
Fatigue	5	(1)	1	(0.5)

Hydrochlorothiazide

The following adverse reactions have been reported with hydrochlorothiazide and, within each organ system, are listed by decreasing severity.

Cardiovascular:

Array

Neurologic/Psychiatric:

Musculoskeletal:

Hematologic:

Metabolic:

Hypersensitivity:

Clinical Laboratory Test Findings

Serum Electrolytes

See , .

Creatinine and Blood Urea Nitrogen

As with other ACE inhibitors, minor increases in blood urea nitrogen or serum creatinine, reversible upon discontinuation of therapy, were observed in less than 1% of patients with essential hypertension who were treated with moexipril hydrochloride/hydrochlorothiazide. Increases are more likely to occur in patients with compromised renal function (see , ).

Other (Causal Relationship Unknown)

Clinically important changes in standard laboratory tests were rarely associated with moexipril hydrochloride/hydrochlorothiazide administration. To report SUSPECTED ADVERSE REACTIONS contact AvKARE, Inc. at 1-855-361-3993; email ; or FDA at 1-800-FDA-1088 or .

What should I look out for while using Moexipril Hydrochloride and Hydrochlorothiazide?

Moexipril hydrochloride and hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to any component of this product and in patients with a history of angioedema related to previous treatment with an ACE inhibitor. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. Hypersensitivity reactions are more likely to occur in patients with a history of allergy or bronchial asthma.

Do not coadminister aliskiren with moexipril hydrochloride/hydrochlorothiazide in patients with diabetes (see ).

What might happen if I take too much Moexipril Hydrochloride and Hydrochlorothiazide?

No specific information is available on the treatment of overdosage with moexipril hydrochloride/hydrochlorothiazide. Treatment should be symptomatic and supportive. Therapy with moexipril hydrochloride/hydrochlorothiazide should be discontinued and the patient observed closely. Suggested measures include induction of emesis and/or gastric lavage and correction of dehydration, electrolyte imbalance and hypotension by established procedures.

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. The oral LD of hydrochlorothiazide is greater than 10 g/kg in mice and rats. For the combination of moexipril hydrochloride and hydrochlorothiazide (ratio 7.5:12.5), the approximate LD was around 10 g/kg for mice and above 10 g/kg for rats. Addition of hydrochlorothiazide to moexipril hydrochloride did not increase the acute toxicity due to moexipril hydrochloride.

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. The most common signs and symptoms observed with an overdose of hydrochlorothiazide have been those of dehydration and electrolyte depletion (hypokalemia, hypochloremia, hyponatremia). If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.

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 Moexipril Hydrochloride and Hydrochlorothiazide?

Moexipril Hydrochloride and Hydrochlorothiazide Tablets USP are available as follows:7.5 mg/12.5 mg: Yellow, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5213”. They are available in bottles of 100 tablets. (NDC 42291-576-01)15 mg/12.5 mg: White, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5214”. They are available in bottles of 100 tablets. (NDC 42291-577-01)15 mg/25 mg: Yellow, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5215”. They are available in bottles of 100 tablets. (NDC 42291-578-01)Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from excessive moisture.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 08/15 AV 03/17 (P) Moexipril Hydrochloride and Hydrochlorothiazide Tablets USP are available as follows:7.5 mg/12.5 mg: Yellow, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5213”. They are available in bottles of 100 tablets. (NDC 42291-576-01)15 mg/12.5 mg: White, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5214”. They are available in bottles of 100 tablets. (NDC 42291-577-01)15 mg/25 mg: Yellow, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5215”. They are available in bottles of 100 tablets. (NDC 42291-578-01)Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from excessive moisture.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 08/15 AV 03/17 (P) Moexipril Hydrochloride and Hydrochlorothiazide Tablets USP are available as follows:7.5 mg/12.5 mg: Yellow, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5213”. They are available in bottles of 100 tablets. (NDC 42291-576-01)15 mg/12.5 mg: White, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5214”. They are available in bottles of 100 tablets. (NDC 42291-577-01)15 mg/25 mg: Yellow, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5215”. They are available in bottles of 100 tablets. (NDC 42291-578-01)Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from excessive moisture.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 08/15 AV 03/17 (P) Moexipril Hydrochloride and Hydrochlorothiazide Tablets USP are available as follows:7.5 mg/12.5 mg: Yellow, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5213”. They are available in bottles of 100 tablets. (NDC 42291-576-01)15 mg/12.5 mg: White, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5214”. They are available in bottles of 100 tablets. (NDC 42291-577-01)15 mg/25 mg: Yellow, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5215”. They are available in bottles of 100 tablets. (NDC 42291-578-01)Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from excessive moisture.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 08/15 AV 03/17 (P) Moexipril Hydrochloride and Hydrochlorothiazide Tablets USP are available as follows:7.5 mg/12.5 mg: Yellow, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5213”. They are available in bottles of 100 tablets. (NDC 42291-576-01)15 mg/12.5 mg: White, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5214”. They are available in bottles of 100 tablets. (NDC 42291-577-01)15 mg/25 mg: Yellow, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5215”. They are available in bottles of 100 tablets. (NDC 42291-578-01)Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from excessive moisture.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 08/15 AV 03/17 (P) Moexipril Hydrochloride and Hydrochlorothiazide Tablets USP are available as follows:7.5 mg/12.5 mg: Yellow, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5213”. They are available in bottles of 100 tablets. (NDC 42291-576-01)15 mg/12.5 mg: White, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5214”. They are available in bottles of 100 tablets. (NDC 42291-577-01)15 mg/25 mg: Yellow, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5215”. They are available in bottles of 100 tablets. (NDC 42291-578-01)Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from excessive moisture.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 08/15 AV 03/17 (P) Moexipril Hydrochloride and Hydrochlorothiazide Tablets USP are available as follows:7.5 mg/12.5 mg: Yellow, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5213”. They are available in bottles of 100 tablets. (NDC 42291-576-01)15 mg/12.5 mg: White, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5214”. They are available in bottles of 100 tablets. (NDC 42291-577-01)15 mg/25 mg: Yellow, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5215”. They are available in bottles of 100 tablets. (NDC 42291-578-01)Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from excessive moisture.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 08/15 AV 03/17 (P) Moexipril Hydrochloride and Hydrochlorothiazide Tablets USP are available as follows:7.5 mg/12.5 mg: Yellow, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5213”. They are available in bottles of 100 tablets. (NDC 42291-576-01)15 mg/12.5 mg: White, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5214”. They are available in bottles of 100 tablets. (NDC 42291-577-01)15 mg/25 mg: Yellow, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5215”. They are available in bottles of 100 tablets. (NDC 42291-578-01)Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from excessive moisture.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 08/15 AV 03/17 (P) Moexipril Hydrochloride and Hydrochlorothiazide Tablets USP are available as follows:7.5 mg/12.5 mg: Yellow, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5213”. They are available in bottles of 100 tablets. (NDC 42291-576-01)15 mg/12.5 mg: White, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5214”. They are available in bottles of 100 tablets. (NDC 42291-577-01)15 mg/25 mg: Yellow, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5215”. They are available in bottles of 100 tablets. (NDC 42291-578-01)Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from excessive moisture.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 08/15 AV 03/17 (P) Moexipril Hydrochloride and Hydrochlorothiazide Tablets USP are available as follows:7.5 mg/12.5 mg: Yellow, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5213”. They are available in bottles of 100 tablets. (NDC 42291-576-01)15 mg/12.5 mg: White, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5214”. They are available in bottles of 100 tablets. (NDC 42291-577-01)15 mg/25 mg: Yellow, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5215”. They are available in bottles of 100 tablets. (NDC 42291-578-01)Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from excessive moisture.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 08/15 AV 03/17 (P) Moexipril Hydrochloride and Hydrochlorothiazide Tablets USP are available as follows:7.5 mg/12.5 mg: Yellow, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5213”. They are available in bottles of 100 tablets. (NDC 42291-576-01)15 mg/12.5 mg: White, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5214”. They are available in bottles of 100 tablets. (NDC 42291-577-01)15 mg/25 mg: Yellow, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5215”. They are available in bottles of 100 tablets. (NDC 42291-578-01)Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from excessive moisture.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 08/15 AV 03/17 (P)

×

Clinical Information

Chemical Structure

No Image found

Clinical Pharmacology

Non-Clinical Toxicology

Moexipril hydrochloride and hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to any component of this product and in patients with a history of angioedema related to previous treatment with an ACE inhibitor. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. Hypersensitivity reactions are more likely to occur in patients with a history of allergy or bronchial asthma.

Do not coadminister aliskiren with moexipril hydrochloride/hydrochlorothiazide in patients with diabetes (see ).

Moexipril hydrochloride/hydrochlorothiazide has been evaluated for safety in more than 1140 patients with hypertension with more than 120 treated for more than one year. Moexipril hydrochloride/hydrochlorothiazide has not demonstrated a potential for causing adverse experiences different from those previously associated with other ACE inhibitor/diuretic combinations. The overall incidence of reported adverse events was slightly less in patients treated with moexipril hydrochloride/hydrochlorothiazide than patients treated with placebo.

Adverse experiences were usually mild and transient, and there was no relationship between adverse experiences and gender, race, age, or total daily dosage (except for serum potassium decreases at 50 mg hydrochlorothiazide) within the moexipril/hydrochlorothiazide dosage range of 3.75 mg/3.125 mg to 30 mg/50 mg. Discontinuation of therapy due to adverse experiences was required in 5.3% of patients treated with moexipril hydrochloride/hydrochlorothiazide and in 8.4% of patients treated with placebo. The most common reasons for discontinuation of therapy with moexipril hydrochloride/hydrochlorothiazide were cough (0.5%) and dizziness (0.5%).

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/hydrochlorothiazide and that were at least as frequent in the moexipril hydrochloride/hydrochlorothiazide group as in the placebo group are shown in the following table.

Other adverse experiences occurring in more than 1% of patients treated with moexipril hydrochloride/hydrochlorothiazide in controlled or uncontrolled trials, some of which were of uncertain drug relationship, listed in decreasing frequency include: upper respiratory infection, headache, pain, flu syndrome, pharyngitis, hyperuricemia, diarrhea, back pain, rhinitis, sinusitis, abnormal ECG, infection, abdominal pain, chest pain, dyspepsia, hyperglycemia, hypokalemia, rash, vertigo, nausea, hypertonia, increased SGPT, urinary tract infection, impotence, peripheral edema, pyuria, bronchitis, and fever. See and for discussion of anaphylactoid reactions, angioedema, hypotension, neutropenia/agranulocytosis, fetal/neonatal morbidity and mortality, serum electrolyte imbalances, and cough.

The following adverse experiences, some of which are of uncertain drug relationship, were reported in moexipril hydrochloride/hydrochlorothiazide controlled or uncontrolled clinical trials in less than 1% of patients or have been attributed to other ACE inhibitors. Within each organ system, adverse experiences are listed in decreasing frequency.

Cardiovascular:

Dermatologic:

Gastrointestinal:

Hematologic:

Metabolic:

Neurologic/Psychiatric

Renal:

Respiratory:

Urogenital:

Other:

Monotherapy with moexipril has been evaluated for safety in over 3000 patients. In clinical trials, the observed adverse experiences with moexipril were similar to those seen in the moexipril hydrochloride/hydrochlorothiazide trials.

×

Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

×

Review

×

Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

×

Tips

×

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

Disclaimer: