Captopril and Hydrochlorothiazide

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Overview

What is Captopril and Hydrochlorothiazide?

Captopril and hydrochlorothiazide tablets, USP for oral administration combines two antihypertensive agents: captopril and hydrochlorothiazide. Catopril, the first of a new class of antihypertensive agents, is a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Hydrochlorothiazide is a benzothiadiazide (thiazide) diuretic-antihypertensive.

Captopril, USP is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate.

Hydrochlorothiazide, USP is a white crystalline powder slightly soluble in water but freely soluble in sodium hydroxide solution.

Captopril is designated chemically as 1-[(2S)-3-Mercapto-2-methylpropionyl]-L-proline; Hydrochlorothiazide is 6-Chloro-3,4-dihydro-2-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Their structural formulas are:

Captopril and Hydrochlorothiazide Tablets, USP are available for oral administration in four combinations of captopril with hydrochlorothiazide: 25 mg with 15 mg, 25 mg with 25 mg, 50 mg with 15 mg, and 50 mg with 25 mg. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium lauryl sulfate. The 25 mg/25 mg and 50 mg/25 mg tablets also contain the coloring agent FD&C Yellow #6 Aluminum Lake.

What does Captopril and Hydrochlorothiazide look like?

What are the available doses of Captopril and Hydrochlorothiazide?

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

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How should I use Captopril and Hydrochlorothiazide?

Captopril and Hydrochlorothiazide tablets are indicated for the treatment of hypertension. The blood pressure lowering effects of captopril and thiazides are approximately additive.

This fixed combination drug may be used as initial therapy or substituted for previously titrated doses of the individual components.

When captopril and hydrochlorothiazide are given together it may not be necessary to administer captopril in divided doses to attain blood pressure control at trough (before the next dose). Also, with such a combination, a daily dose of 15 mg of hydrochlorothiazide may be adequate.

Treatment may, therefore, be initiated with Captopril and Hydrochlorothiazide tablets 25 mg/15 mg once daily. Subsequent titration should be with additional doses of the components (captopril, hydrochlorothiazide) as single agents or as Captopril and Hydrochlorothiazide tablets 50 mg/15 mg, 25 mg/25 mg, or 50 mg/25 mg (see ).

In using Captopril and Hydrochlorothiazide, consideration should be given to the risk of neutropenia/agranulocytosis (see ).

Captopril and Hydrochlorothiazide may be used for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, Captopril and Hydrochlorothiazide should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to other drug combinations.

ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see ).

DOSAGE MUST BE INDIVIDUALIZED ACCORDING TO PATIENT'S RESPONSE.

Captopril and Hydrochlorothiazide tablets may be substituted for the previously titrated individual components.

Alternatively, therapy may be instituted with a single tablet of Captopril and Hydrochlorothiazide 25 mg/15 mg taken once daily. For patients insufficiently responsive to the initial dose, additional captopril or hydrochlorothiazide may be added as individual components or by using Captopril and Hydrochlorothiazide tablets 50 mg/15 mg, 25 mg/25 mg or 50 mg/25 mg, or divided doses may be used.

Because the full effect of a given dose may not be attained for 6 to 8 weeks, dosage adjustments should generally be made at 6 week intervals, unless the clinical situation demands more rapid adjustment.

In general, daily doses of captopril should not exceed 150 mg and of hydrochlorothiazide should not exceed 50 mg.

Captopril and Hydrochlorothiazide tablets should be taken one hour before meals.

What interacts with Captopril and Hydrochlorothiazide?

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What are the warnings of Captopril and Hydrochlorothiazide?

Captopril

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

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Total urinary proteins greater than 1 g per day were seen in about 0.7 percent of patients receiving captopril. About 90 percent of affected patients had evidence of prior renal disease or received relatively high doses of captopril (in excess of 150 mg/day), or both. The nephrotic syndrome occurred in about one-fifth of proteinuric patients. In most cases, proteinuria subsided or cleared within six months whether or not captopril was continued. Parameters of renal function, such as BUN and creatinine, were seldom altered in the patients with proteinuria.

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Excessive hypotension was rarely seen in hypertensive patients but is a possible consequence of captopril use in salt/volume depleted persons (such as those treated vigorously with diuretics), patients with heart failure or those patients undergoing renal dialysis. (See .)

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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.

Hydrochlorothiazide

Thiazides should be used with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function.

Thiazides 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.

Sensitivity reactions may occur in patients with or without a history of allergy or bronchial asthma.

The possibility of exacerbation or activation of systemic lupus erythematosus has been reported.

In general, lithium should not be given with diuretics (see ).

What are the precautions of Captopril and Hydrochlorothiazide?

General

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Recent clinical observations have shown an association of hypersensitivity-like (anaphylactoid) reactions during hemodialysis with high-flux dialysis membranes (e.g., AN69) in patients receiving ACE inhibitors as medication. In these patients, consideration should be given to using a different type of dialysis membrane or a different class of medication. (See ).

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Information for Patients

Patients should be advised to immediately report to their physician any signs or symptoms suggesting angioedema (e.g., swelling of face, eyes, lips, tongue, larynx and extremities; difficulty in swallowing or breathing; hoarseness) and to discontinue therapy. (See .)

Patients should be told to report promptly any indication of infection (e.g., sore throat, fever), which may be a sign of neutropenia, or of progressive edema which might be related to proteinuria and nephrotic syndrome.

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 with the physician.

Patients should be advised not to use potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes without consulting their physician. (See and ; .)

Patients should be warned against interruption or discontinuation of medication unless instructed by the physician.

Heart failure patients on captopril therapy should be cautioned against rapid increases in physical activity.

Patients should be informed that Captopril and Hydrochlorothiazide tablets should be taken one hour before meals (see ).

Pregnancy

Female patients of childbearing age should be told about the consequences of second- and third-trimester exposure to ACE inhibitors, and they should also be told that these consequences do not appear to have resulted from intrauterine ACE-inhibitor exposure that has been limited to the first trimester. These patients should be asked to report pregnancies to their physicians as soon as possible.

Laboratory Tests

Serum electrolyte levels should be regularly monitored (see and ; ).

Drug Interactions

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Drug/Laboratory Test Interactions

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Captopril may cause a false-positive urine test for acetone.

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Hydrochlorothiazide may cause diagnostic interference of the bentiromide test.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity and fertility studies have not been conducted with captopril and hydrochlorothiazide tablets, however, in animals they have been conducted with the individual components as noted below. Mutagenecity studies indicate that captopril in a 2:1 combination with hydrochlorothiazide was not mutagenic or clastogenic, with or without metabolic activation, in the following assays: 1) Ames reverse-mutation in ; 2) forward mutation study in ; 3) mitotic gene conversion test in ; and 4) sister-chromatid-exchange study in human lymphocytes.

In a cytogenetics study using human lymphocytes, there were no increases in chromosomal abnormalities without metabolic activation, nor with metabolic activation at 28 hours post-treatment. A statistically significant increase was found at 22 hours with metabolic activation at the three concentrations tested (captopril/hydrochlorothiazide in a 2:1 combination at 5, 25, 50 mcg/mL total weight); however, there was no dose response, and the difference is probably attributable to the unusual absence of any abnormalities in the negative-control cultures in this test.

In an oral micronucleus study in mice, the captopril/hydrochlorothiazide combination (2:1 mixture at 2500 mg/kg total weight) was not genotoxic.

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Animal Toxicology

Chronic oral toxicity studies were conducted in rats (2 years), dogs (47 weeks; 1 year), mice (2 years), and monkeys (1 year). Significant drug-related toxicity included effects on hematopoiesis, renal toxicity, erosion/ulceration of the stomach, and variation of retinal blood vessels.

Reductions in hemoglobin and/or hematocrit values were seen in mice, rats, and monkeys at doses 50 to 150 times the maximum recommended human dose (MRHD). Anemia, leukopenia, thrombocytopenia, and bone marrow suppression occurred in dogs at doses 8 to 30 times MRHD. The reductions in hemoglobin and hematocrit values in rats and mice were only significant at 1 year and returned to normal with continued dosing by the end of the study. Marked anemia was seen at all dose levels (8 to 30 times MRHD) in dogs, whereas moderate to marked leukopenia was noted only at 15 and 30 times MRHD and thrombocytopenia at 30 times MRHD. The anemia could be reversed upon discontinuation of dosing. Bone marrow suppression occurred to a varying degree, being associated only with dogs that died or were sacrificed in a moribund condition in the 1 year study. However, in the 47-week study at a dose 30 times MRHD, bone marrow suppression was found to be reversible upon continued drug administration.

Captopril caused hyperplasia of the juxtaglomerular apparatus of the kidneys at doses 7 to 200 times the MRHD in rats and mice, at 20 to 60 times MRHD in monkeys, and at 30 times the MRHD in dogs.

Gastric erosions/ulcerations were increased in incidence at 20 and 200 times MRHD in male rats and at 30 and 65 times MRHD in dogs and monkeys, respectively. Rabbits developed gastric and intestinal ulcers when given oral doses approximately 30 times MRHD for only five to seven days.

In the two-year rat study, irreversible and progressive variations in the caliber of retinal vessels (focal sacculations and constrictions) occurred at all dose levels (7 to 200 times MRHD) in a dose-related fashion. The effect was first observed in the 88th week of dosing, with a progressively increased incidence thereafter, even after cessation of dosing.

Pregnancy Categories C (first trimester) and D (second and third trimesters)

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Pregnancy–Nonteratogenic Effects

Thiazides cross the placental barrier and appear in cord blood. The use of thiazides in pregnant women requires that the anticipated benefit be weighed against possible hazards to the fetus. These hazards include fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions which have occurred in the adult.

Nursing Mothers

Both captopril and hydrochlorothiazide are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from both drugs, a decision should be made whether to discontinue nursing or to discontinue therapy taking into account the importance of Captopril and Hydrochlorothiazide to the mother. (See .)

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. There is limited experience reported in the literature with the use of captopril in the pediatric population; dosage, on a weight basis, was generally reported to be comparable to or less than that used in adults.

Infants, especially newborns, may be more susceptible to the adverse hemodynamic effects of captopril. Excessive, prolonged and unpredictable decreases in blood pressure and associated complications, including oliguria and seizures, have been reported.

Captopril and Hydrochlorothiazide should be used in pediatric patients only if other measures for controlling blood pressure have not been effective.

What are the side effects of Captopril and Hydrochlorothiazide?

Captopril

Reported incidences are based on clinical trials involving approximately 7000 patients.

Renal

Each of the following has been reported in approximately 1 to 2 of 1000 patients and are of uncertain relationship to drug use: renal insufficiency, renal failure, nephrotic syndrome, polyuria, oliguria, and urinary frequency.

Hematologic

Dermatologic

Flushing or pallor has been reported in 2 to 5 of 1000 patients.

Cardiovascular

Tachycardia, chest pain, and palpitations have each been observed in approximately 1 of 100 patients.

Angina pectoris, myocardial infarction, Raynaud's syndrome, and congestive heart failure have each occurred in 2 to 3 of 1000 patients.

Dysgeusia

Angioedema

Cough

The following have been reported in about 0.5 to 2 percent of patients but did not appear at increased frequency compared to placebo or other treatments used in controlled trials: gastric irritation, abdominal pain, nausea, vomiting, diarrhea, anorexia, constipation, aphthous ulcers, peptic ulcer, dizziness, headache, malaise, fatigue, insomnia, dry mouth, dyspnea, alopecia, paresthesias.

Other clinical adverse effects reported since the drug was marketed are listed below by body system. In this setting, an incidence or causal relationship cannot be accurately determined.

Body as a Whole:

General:

Cardiovascular:

Dermatologic:

Gastrointestinal:

Hematologic:

Hepatobiliary:

Metabolic:

Musculoskeletal:

Nervous/Psychiatric:

Respiratory:

Special Senses:

Urogenital:

As with other ACE inhibitors, a syndrome has been reported which may include: fever, myalgia, arthralgia, interstitial nephritis, vasculitis, rash or other dermatologic manifestations, eosinophilia and an elevated ESR.

Fetal/Neonatal Morbidity and Mortality

See .

Hydrochlorothiazide

Altered Laboratory Findings

What should I look out for while using Captopril and Hydrochlorothiazide?

What might happen if I take too much Captopril and Hydrochlorothiazide?

How should I store and handle Captopril and Hydrochlorothiazide?

Dispense in a well-closed container as defined in the USP.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a well-closed container as defined in the USP.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Captopril and Hydrochlorothiazide Tablets, USP 25 mg/15 mg are supplied as white, round, quadrisected, biconvex tablets containing 25 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with on one side and is quadrisected on the reverse side. They are available as follows:NDC 0378-0081-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 25 mg/25 mg are supplied as peach, round, quadrisected, biconvex, tablets containing 25 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with on one side and is quadrisected on the reverse side. They are available as follows:NDC 0378-0083-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 50 mg/15 mg are supplied as white, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with on one side and is partially bisected on both sides. They are available as follows:NDC 0378-0084-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 50 mg/25 mg are supplied as peach, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with on one side and is partially bisected on both sides. They are available as follows:NDC 0378-0086-01bottles of 100 tabletsDispense in a tight, light-resisitant container as defined in the USP using a child-resistant closure.Keep container tightly closed.Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from moisture.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED MARCH 2006CPHZ:R7Captopril and Hydrochlorothiazide Tablets, USP 25 mg/15 mg are supplied as white, round, quadrisected, biconvex tablets containing 25 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with on one side and is quadrisected on the reverse side. They are available as follows:NDC 0378-0081-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 25 mg/25 mg are supplied as peach, round, quadrisected, biconvex, tablets containing 25 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with on one side and is quadrisected on the reverse side. They are available as follows:NDC 0378-0083-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 50 mg/15 mg are supplied as white, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with on one side and is partially bisected on both sides. They are available as follows:NDC 0378-0084-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 50 mg/25 mg are supplied as peach, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with on one side and is partially bisected on both sides. They are available as follows:NDC 0378-0086-01bottles of 100 tabletsDispense in a tight, light-resisitant container as defined in the USP using a child-resistant closure.Keep container tightly closed.Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from moisture.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED MARCH 2006CPHZ:R7Captopril and Hydrochlorothiazide Tablets, USP 25 mg/15 mg are supplied as white, round, quadrisected, biconvex tablets containing 25 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with on one side and is quadrisected on the reverse side. They are available as follows:NDC 0378-0081-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 25 mg/25 mg are supplied as peach, round, quadrisected, biconvex, tablets containing 25 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with on one side and is quadrisected on the reverse side. They are available as follows:NDC 0378-0083-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 50 mg/15 mg are supplied as white, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with on one side and is partially bisected on both sides. They are available as follows:NDC 0378-0084-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 50 mg/25 mg are supplied as peach, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with on one side and is partially bisected on both sides. They are available as follows:NDC 0378-0086-01bottles of 100 tabletsDispense in a tight, light-resisitant container as defined in the USP using a child-resistant closure.Keep container tightly closed.Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from moisture.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED MARCH 2006CPHZ:R7Captopril and Hydrochlorothiazide Tablets, USP 25 mg/15 mg are supplied as white, round, quadrisected, biconvex tablets containing 25 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with on one side and is quadrisected on the reverse side. They are available as follows:NDC 0378-0081-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 25 mg/25 mg are supplied as peach, round, quadrisected, biconvex, tablets containing 25 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with on one side and is quadrisected on the reverse side. They are available as follows:NDC 0378-0083-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 50 mg/15 mg are supplied as white, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with on one side and is partially bisected on both sides. They are available as follows:NDC 0378-0084-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 50 mg/25 mg are supplied as peach, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with on one side and is partially bisected on both sides. They are available as follows:NDC 0378-0086-01bottles of 100 tabletsDispense in a tight, light-resisitant container as defined in the USP using a child-resistant closure.Keep container tightly closed.Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from moisture.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED MARCH 2006CPHZ:R7Captopril and Hydrochlorothiazide Tablets, USP 25 mg/15 mg are supplied as white, round, quadrisected, biconvex tablets containing 25 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with on one side and is quadrisected on the reverse side. They are available as follows:NDC 0378-0081-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 25 mg/25 mg are supplied as peach, round, quadrisected, biconvex, tablets containing 25 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with on one side and is quadrisected on the reverse side. They are available as follows:NDC 0378-0083-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 50 mg/15 mg are supplied as white, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with on one side and is partially bisected on both sides. They are available as follows:NDC 0378-0084-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 50 mg/25 mg are supplied as peach, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with on one side and is partially bisected on both sides. They are available as follows:NDC 0378-0086-01bottles of 100 tabletsDispense in a tight, light-resisitant container as defined in the USP using a child-resistant closure.Keep container tightly closed.Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from moisture.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED MARCH 2006CPHZ:R7Captopril and Hydrochlorothiazide Tablets, USP 25 mg/15 mg are supplied as white, round, quadrisected, biconvex tablets containing 25 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with on one side and is quadrisected on the reverse side. They are available as follows:NDC 0378-0081-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 25 mg/25 mg are supplied as peach, round, quadrisected, biconvex, tablets containing 25 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with on one side and is quadrisected on the reverse side. They are available as follows:NDC 0378-0083-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 50 mg/15 mg are supplied as white, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with on one side and is partially bisected on both sides. They are available as follows:NDC 0378-0084-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 50 mg/25 mg are supplied as peach, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with on one side and is partially bisected on both sides. They are available as follows:NDC 0378-0086-01bottles of 100 tabletsDispense in a tight, light-resisitant container as defined in the USP using a child-resistant closure.Keep container tightly closed.Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from moisture.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED MARCH 2006CPHZ:R7Captopril and Hydrochlorothiazide Tablets, USP 25 mg/15 mg are supplied as white, round, quadrisected, biconvex tablets containing 25 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with on one side and is quadrisected on the reverse side. They are available as follows:NDC 0378-0081-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 25 mg/25 mg are supplied as peach, round, quadrisected, biconvex, tablets containing 25 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with on one side and is quadrisected on the reverse side. They are available as follows:NDC 0378-0083-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 50 mg/15 mg are supplied as white, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with on one side and is partially bisected on both sides. They are available as follows:NDC 0378-0084-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 50 mg/25 mg are supplied as peach, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with on one side and is partially bisected on both sides. They are available as follows:NDC 0378-0086-01bottles of 100 tabletsDispense in a tight, light-resisitant container as defined in the USP using a child-resistant closure.Keep container tightly closed.Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from moisture.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED MARCH 2006CPHZ:R7Captopril and Hydrochlorothiazide Tablets, USP 25 mg/15 mg are supplied as white, round, quadrisected, biconvex tablets containing 25 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with on one side and is quadrisected on the reverse side. They are available as follows:NDC 0378-0081-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 25 mg/25 mg are supplied as peach, round, quadrisected, biconvex, tablets containing 25 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with on one side and is quadrisected on the reverse side. They are available as follows:NDC 0378-0083-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 50 mg/15 mg are supplied as white, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with on one side and is partially bisected on both sides. They are available as follows:NDC 0378-0084-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 50 mg/25 mg are supplied as peach, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with on one side and is partially bisected on both sides. They are available as follows:NDC 0378-0086-01bottles of 100 tabletsDispense in a tight, light-resisitant container as defined in the USP using a child-resistant closure.Keep container tightly closed.Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from moisture.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED MARCH 2006CPHZ:R7Captopril and Hydrochlorothiazide Tablets, USP 25 mg/15 mg are supplied as white, round, quadrisected, biconvex tablets containing 25 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with on one side and is quadrisected on the reverse side. They are available as follows:NDC 0378-0081-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 25 mg/25 mg are supplied as peach, round, quadrisected, biconvex, tablets containing 25 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with on one side and is quadrisected on the reverse side. They are available as follows:NDC 0378-0083-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 50 mg/15 mg are supplied as white, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with on one side and is partially bisected on both sides. They are available as follows:NDC 0378-0084-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 50 mg/25 mg are supplied as peach, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with on one side and is partially bisected on both sides. They are available as follows:NDC 0378-0086-01bottles of 100 tabletsDispense in a tight, light-resisitant container as defined in the USP using a child-resistant closure.Keep container tightly closed.Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from moisture.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED MARCH 2006CPHZ:R7Captopril and Hydrochlorothiazide Tablets, USP 25 mg/15 mg are supplied as white, round, quadrisected, biconvex tablets containing 25 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with on one side and is quadrisected on the reverse side. They are available as follows:NDC 0378-0081-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 25 mg/25 mg are supplied as peach, round, quadrisected, biconvex, tablets containing 25 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with on one side and is quadrisected on the reverse side. They are available as follows:NDC 0378-0083-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 50 mg/15 mg are supplied as white, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with on one side and is partially bisected on both sides. They are available as follows:NDC 0378-0084-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 50 mg/25 mg are supplied as peach, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with on one side and is partially bisected on both sides. They are available as follows:NDC 0378-0086-01bottles of 100 tabletsDispense in a tight, light-resisitant container as defined in the USP using a child-resistant closure.Keep container tightly closed.Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from moisture.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED MARCH 2006CPHZ:R7Captopril and Hydrochlorothiazide Tablets, USP 25 mg/15 mg are supplied as white, round, quadrisected, biconvex tablets containing 25 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with on one side and is quadrisected on the reverse side. They are available as follows:NDC 0378-0081-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 25 mg/25 mg are supplied as peach, round, quadrisected, biconvex, tablets containing 25 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with on one side and is quadrisected on the reverse side. They are available as follows:NDC 0378-0083-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 50 mg/15 mg are supplied as white, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with on one side and is partially bisected on both sides. They are available as follows:NDC 0378-0084-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 50 mg/25 mg are supplied as peach, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with on one side and is partially bisected on both sides. They are available as follows:NDC 0378-0086-01bottles of 100 tabletsDispense in a tight, light-resisitant container as defined in the USP using a child-resistant closure.Keep container tightly closed.Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from moisture.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED MARCH 2006CPHZ:R7Captopril and Hydrochlorothiazide Tablets, USP 25 mg/15 mg are supplied as white, round, quadrisected, biconvex tablets containing 25 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with on one side and is quadrisected on the reverse side. They are available as follows:NDC 0378-0081-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 25 mg/25 mg are supplied as peach, round, quadrisected, biconvex, tablets containing 25 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with on one side and is quadrisected on the reverse side. They are available as follows:NDC 0378-0083-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 50 mg/15 mg are supplied as white, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with on one side and is partially bisected on both sides. They are available as follows:NDC 0378-0084-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 50 mg/25 mg are supplied as peach, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with on one side and is partially bisected on both sides. They are available as follows:NDC 0378-0086-01bottles of 100 tabletsDispense in a tight, light-resisitant container as defined in the USP using a child-resistant closure.Keep container tightly closed.Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from moisture.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED MARCH 2006CPHZ:R7Captopril and Hydrochlorothiazide Tablets, USP 25 mg/15 mg are supplied as white, round, quadrisected, biconvex tablets containing 25 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with on one side and is quadrisected on the reverse side. They are available as follows:NDC 0378-0081-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 25 mg/25 mg are supplied as peach, round, quadrisected, biconvex, tablets containing 25 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with on one side and is quadrisected on the reverse side. They are available as follows:NDC 0378-0083-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 50 mg/15 mg are supplied as white, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 15 mg of hydrochlorothiazide. The tablet is debossed with on one side and is partially bisected on both sides. They are available as follows:NDC 0378-0084-01bottles of 100 tabletsCaptopril and Hydrochlorothiazide Tablets, USP 50 mg/25 mg are supplied as peach, partially bisected, biconvex, capsule shaped tablets containing 50 mg of captopril and 25 mg of hydrochlorothiazide. The tablet is debossed with on one side and is partially bisected on both sides. They are available as follows:NDC 0378-0086-01bottles of 100 tabletsDispense in a tight, light-resisitant container as defined in the USP using a child-resistant closure.Keep container tightly closed.Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from moisture.Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED MARCH 2006CPHZ:R7

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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.

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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

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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).

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