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candesartan cilexetil and hydrochlorothiazide

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Overview

What is candesartan cilexetil and hydrochlorothiazide?

Candesartan cilexetil and hydrochlorothiazide tablets, USP combine an angiotensin II receptor (type AT) antagonist and a diuretic, hydrochlorothiazide.

 

Candesartan cilexetil, a nonpeptide, is chemically described as (±)-1-Hydroxyethyl 2-ethoxy-1-[-(-1-tetrazol-5-ylphenyl)benzyl]-7-benzimidazolecarboxylate, cyclohexyl carbonate (ester).

Its empirical formula is CHNO, and its structural formula is

Candesartan cilexetil, USP  is a white to almost white powder with a molecular weight of 610.66. It is sparingly soluble in methanol, practically insoluble in water, and soluble in methylene chloride. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral.

Hydrochlorothiazide is 6-chloro-3,4-dihydro-2-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is CHClNOS and its structural formula is

Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids.

Candesartan cilexetil and hydrochlorothiazide is available for oral administration in three tablet strengths.

 

Candesartan cilexetil and hydrochlorothiazide tablets USP, 16 mg/12.5 mg contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.

Candesartan cilexetil and hydrochlorothiazide tablets USP, 32 mg/12.5 mg contains 32 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.

Candesartan cilexetil and hydrochlorothiazide tablets USP, 32 mg/25 mg contains 32 mg of candesartan cilexetil and 25 mg of hydrochlorothiazide.

In addition, each tablet contains the following inactive ingredients: carboxy methyl cellulose calcium, corn starch, glyceryl caprylate, hydroxypropylcellulose, lactose monohydrate and magnesium stearate.

USP dissolution test pending



What does candesartan cilexetil and hydrochlorothiazide look like?



What are the available doses of candesartan cilexetil and hydrochlorothiazide?

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What should I talk to my health care provider before I take candesartan cilexetil and hydrochlorothiazide?

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How should I use candesartan cilexetil and hydrochlorothiazide?

Candesartan cilexetil and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Candesartan cilexetil and hydrochlorothiazide.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

This fixed dose combination is not indicated for initial therapy (see ).

The usual recommended starting dose of candesartan cilexetil is 16 mg once daily when it is used as monotherapy in patients who are not volume depleted. Candesartan cilexetil can be administered once or twice daily with total daily doses ranging from 8 mg to 32 mg. Patients requiring further reduction in blood pressure should be titrated to 32 mg. Doses larger than 32 mg do not appear to have a greater blood pressure lowering effect.

Hydrochlorothiazide is effective in doses of 12.5 to 50 mg once daily.

Use in Renal Impairment: Dosing recommendations for candesartan cilexetil and hydrochlorothiazide in patients with creatinine clearance < 30 mg/min cannot be provided (see ).

Use in moderate to severe Hepatic Impairment: Candesartan cilexetil and hydrochlorothiazide is not recommended for initiation because the appropriate starting dose, 8 mg, cannot be given (see ).


What interacts with candesartan cilexetil and hydrochlorothiazide?

Candesartan cilexetil and hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to candesartan, to hydrochlorothiazide or to other sulfonamide-derived drugs.


Do not coadminister aliskiren with candesartan cilexetil and hydrochlorothiazide tablets in patients with diabetes (see ).


Candesartan cilexetil and hydrochlorothiazide tablets are contraindicated in patients with anuria.



What are the warnings of candesartan cilexetil and hydrochlorothiazide?

Fetal Toxicity

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Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue candesartan cilexetil and hydrochlorothiazide 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 candesartan cilexetil and hydrochlorothiazide, 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 in utero exposure to candesartan cilexetil and hydrochlorothiazide for hypotension, oliguria, and hyperkalemia. (see .)

There was no evidence of teratogenicity or other adverse effects on embryo-fetal development when pregnant mice, rats or rabbits were treated orally with candesartan cilexetil alone or in combination with hydrochlorothiazide. For mice, the maximum dose of candesartan cilexetil was 1000 mg/kg/day (about 150 times the maximum recommended daily human dose [MRHD]). For rats, the maximum dose of candesartan cilexetil was 100 mg/kg/day (about 31 times the MRHD). For rabbits, the maximum dose of candesartan cilexetil was 1 mg/kg/day (a maternally toxic dose that is about half the MRHD). In each of these studies, hydrochlorothiazide was tested at the same dose level (10 mg/kg/day, about 4, 8, and 15 times the MRHD in mouse, rats, and rabbit, respectively). There was no evidence of harm to the rat or mouse fetus or embryo in studies in which hydrochlorothiazide was administered alone to the pregnant rat or mouse at doses of up to 1000 and 3000 mg/kg/day, respectively.

Thiazides cross the placental barrier and appear in cord blood. There is a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.

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Hypotension

Candesartan cilexetil and hydrochlorothiazide can cause symptomatic hypotension. Symptomatic hypotension is most likely to occur in patients who have been volume and/or salt depleted as a result of prolonged diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting. Patients with symptomatic hypotension may require temporarily reducing the dose of candesartan cilexetil and hydrochlorothiazide or volume repletion. Volume and/or salt depletion should be corrected before initiating therapy with candesartan cilexetil and hydrochlorothiazide.

In patients with heart failure, candesartan cilexetil and hydrochlorothiazide may cause excessive hypotension, which may lead to oliguria, azotemia, and (rarely) with acute renal failure and death (see ). In such patients, candesartan cilexetil and hydrochlorothiazide therapy should be started under close medical supervision; they should be followed closely for the first 2 weeks of treatment and whenever the dose of candesartan or diuretic is increased.

Impaired Renal Function

Monitor renal function periodically in patients treated with candesartan cilexetil and hydrochlorothiazide. Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g.patients with renal artery stenosis, chronic kidney disease, severe heart failure, or volume depletion) may be at particular risk of developing oliguria, progressive azotemia, or acute renal failure on candesartan cilexetil and hydrochlorothiazide. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on candesartan cilexetil and hydrochlorothiazide.

Potassium Abnormalities

Drugs that inhibit the renin-angiotensin system can cause hyperkalemia. Hydrochlorothiazide can cause hypokalemia and hyponatremia. Hypomagnesemia can result in hypokalemia which appears difficult to treat despite potassium repletion. Monitor serum electrolytes periodically.

In clinical trials of various doses of candesartan cilexetil and hydrochlorothiazide, the incidence of hypertensive patients who developed hypokalemia (serum potassium < 3.5 mEq/L) was 2.5% versus 2.1% for placebo; the incidence of hyperkalemia (serum potassium > 5.7 mEq/L) was 0.4% versus 1% for placebo. No patient receiving candesartan cilexetil and hydrochlorothiazide 16 mg/12.5 mg or 32 mg/12.5 mg was discontinued due to increases or decreases in serum potassium.

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

Hypersensitivity Reaction

Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history.


What are the precautions of candesartan cilexetil and hydrochlorothiazide?

Metabolic Disturbances

Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides.

Hydrochlorothiazide may raise the serum uric acid level due to reduced clearance of uric acid and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients.

Thiazides decrease urinary calcium excretion and may cause elevation of serum calcium. Avoid using candesartan cilexetil and hydrochlorothiazide in patients with hypercalcemia.

Systemic Lupus Erythematosus

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

Information for Patients

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Female patients of childbearing age should be told about the consequences of exposure to candesartan cilexetil and hydrochlorothiazide 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.

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Tell patients receiving candesartan cilexetil and hydrochlorothiazide that lightheadedness can occur, especially during the first days of therapy, and that it should be reported to the prescribing physician. Tell patients that if syncope occurs, discontinue candesartan cilexetil and hydrochlorothiazide until the physician has been consulted.

Tell all patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope.

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Tell patients receiving candesartan cilexetil and hydrochlorothiazide not to use potassium supplements, salt substitutes containing potassium or other drugs that may increase serum potassium levels without consulting the prescribing physician.

Drug Interactions

Because candesartan is not significantly metabolized by the cytochrome P450 system and at therapeutic concentrations has no effects on P450 enzymes, interactions with drugs that inhibit or are metabolized by those enzymes would not be expected.

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

The antihypertensive effect of angiotensin II receptor antagonists, including candesartan may be attenuated by NSAIDs including selective COX-2 inhibitors.

Lithium

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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 candesartan cilexetil and hydrochlorothiazide and other agents that affect the RAS.

Coadministration of candesartan cilexetil and hydrochlorothiazide with potassium sparing diuretics, potassium supplements, potassium-containing salt substitutes or other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients.

Do not coadminister aliskiren with candesartan cilexetil and hydrochlorothiazide in patients with diabetes. Avoid use of aliskiren with candesartan cilexetil and hydrochlorothiazide in patients with renal impairment (GFR < 60 ml/min) (see ).

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Alcohol, barbiturates, or narcotics

Antidiabetic drugs (oral agents and insulin)

Diazoxide

Ion Exchange resins

Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine)

Digitalis -

Noradrenaline

Steroids or Adrenocorticotropic Hormone

Cytotoxic products

Cyclosporine

Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenicity studies have been conducted with the combination of candesartan cilexetil and hydrochlorothiazide. There was no evidence of carcinogenicity when candesartan cilexetil was orally administered to mice and rats for up to 104 weeks at doses up to 100 and 1000 mg/kg/day, respectively. Rats received the drug by gavage whereas mice received the drug by dietary administration. These (maximally-tolerated) doses of candesartan cilexetil provided systemic exposures to candesartan (AUCs) that were, in mice, approximately 7 times and, in rats, more than 70 times the exposure in man at the maximum recommended daily human dose (32 mg). Two-year feeding studies in mice and rats conducted under the auspices of the National Toxicology Program (NTP) uncovered no evidence of a carcinogenic potential of hydrochlorothiazide in female mice (at doses of up to approximately 600 mg/kg/day) or in male and female rats (at doses of up to approximately 100 mg/kg/day). The NTP, however, found equivocal evidence for hepatocarcinogenicity in male mice.

Candesartan cilexetil or candesartan (the active metabolite), in combination with hydrochlorothiazide, tested positive in the Chinese hamster lung (CHL) chromosomal aberration assay and mouse lymphoma mutagenicity assay. The candesartan cilexetil/hydrochlorothiazide combination tested negative for mutagenicity in bacteria (Ames test), for unscheduled DNA synthesis in rat liver, for chromosomal aberrations in rat bone marrow and for micronuclei in mouse bone marrow.

Both candesartan and its O-deethyl metabolite tested positive for genotoxicity in the CHL chromosomal aberration assay. Neither compound tested positive in the Ames microbial mutagenesis assay or in the mouse lymphoma cell assay. Candesartan (but not its O-deethyl metabolite) was also evaluated in the mouse micronucleus test and in the Chinese hamster ovary (CHO) gene mutation assay, in both cases with negative results. Candesartan cilexetil was evaluated in the Ames test, the mouse lymphoma cell assay, the rat hepatocyte unscheduled DNA synthesis assay and the mouse micronucleus test, in each case with negative results. Candesartan cilexetil was not evaluated in the CHL chromosomal aberration or CHO gene mutation assays.

When hydrochlorothiazide was tested alone, positive results were obtained in the CHO sister chromatid exchange (clastogenicity) and mouse lymphoma cell (mutagenicity) assays and in the non-disjunction assay. Hydrochorothiazide was not genotoxic in the Ames test for point mutations and the CHO test for chromosomal aberrations, or in assays using mouse germinal cell chromosomes, Chinese hamster bone marrow chromosomes, and the Drosophila sex-linked recessive lethal trait gene.

No fertility studies have been conducted with the combination of candesartan cilexetil and hydrochlorothiazide. Fertility and reproductive performance were not affected in studies with male and female rats given oral doses of up to 300 mg candesartan cilexetil/kg/day (83 times the maximum daily human dose of 32 mg on a body surface area basis). Hydrochlorothiazide had no adverse effects on the fertility of mice and rats of either sex in studies wherein these species were exposed, via their diet, to doses of up to 100 and 4 mg/kg, respectively, prior to conception and throughout gestation. tation.

Nursing Mothers

It is not known whether candesartan is excreted in human milk, but candesartan has been shown to be present in rat milk. Thiazides appear in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Neonates with a history of in utero exposure to candesartan cilexetil and hydrochlorothiazide:

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 in pediatric patients have not been established.


What are the side effects of candesartan cilexetil and hydrochlorothiazide?

Candesartan Cilexetil-Hydrochlorothiazide

Candesartan cilexetil and hydrochlorothiazide has been evaluated for safety in more than 2800 patients treated for hypertension. More than 750 of these patients were studied for at least six months and more than 500 patients were treated for at least one year. Adverse experiences have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. The overall incidence of adverse events reported with candesartan cilexetil and hydrochlorothiazide was comparable to placebo. The overall frequency of adverse experiences was not related to dose, age, gender, or race.

 

In placebo-controlled trials that included 1089 patients treated with various combinations of candesartan cilexetil (doses of 2 to 32 mg) and hydrochlorothiazide (doses of 6.25 to 25 mg) and 592 patients treated with placebo, adverse events, whether or not attributed to treatment, occurring in greater than 2% of patients treated with candesartan cilexetil and hydrochlorothiazide and that were more frequent for candesartan cilexetil and hydrochlorothiazide than placebo were:

 

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Upper respiratory tract infection (3.6% vs 3%);

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Back pain (3.3% vs 2.4%); influenza-like symptoms (2.5% vs 1.9%);

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Dizziness (2.9% vs 1.2%).

Postmarketing Experience

The following have been very rarely reported in postmarketing experience with candesartan cilexetil:

 

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Abnormal hepatic function and hepatitis.

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Neutropenia, leukopenia, and agranulocytosis.

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Angioedema

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Hyperkalemia, hyponatremia.

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Cough

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Pruritus, rash and urticaria.

Rare reports of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers.

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Other adverse experiences that have been reported with hydrochlorothiazide, without regard to causality, are listed below:

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pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, constipation, gastric irritation, anorexia

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aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia

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anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, urticaria, purpura

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muscle spasm

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erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia

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transient blurred vision, xanthopsia

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impotence


What should I look out for while using candesartan cilexetil and hydrochlorothiazide?

Candesartan cilexetil and hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to candesartan, to hydrochlorothiazide or to other sulfonamide-derived drugs.

Do not coadminister aliskiren with candesartan cilexetil and hydrochlorothiazide tablets in patients with diabetes (see ).

Candesartan cilexetil and hydrochlorothiazide tablets are contraindicated in patients with anuria.


What might happen if I take too much candesartan cilexetil and hydrochlorothiazide?


How should I store and handle candesartan cilexetil and hydrochlorothiazide?

Store at 20˚ to 25˚C (68˚ to 77˚F)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '4' on either side of breakline and are supplied as follows:NDC 70771-1325-3 in bottle of 30 tabletsNDC 70771-1325-9 in bottle of 90 tabletsNDC 70771-1325-1 in bottle of 100 tabletsNDC 70771-1325-0 in bottle of 1000 tabletsNDC 70771-1325-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '5' on either side of breakline and are supplied as follows:NDC 70771-1326-3 in bottle of 30 tabletsNDC 70771-1326-9 in bottle of 90 tabletsNDC 70771-1326-1 in bottle of 100 tabletsNDC 70771-1326-0 in bottle of 1000 tabletsNDC 70771-1326-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '41' & '6' on either side of breakline and are supplied as follows:NDC 70771-1327-3 in bottle of 30 tabletsNDC 70771-1327-9 in bottle of 90 tabletsNDC 70771-1327-1 in bottle of 100 tabletsNDC 70771-1327-0 in bottle of 1000 tabletsNDC 70771-1327-4 in carton of 100 tablets (10 x 10 unit-dose)Storage:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This product's package insert may have been updated. For current package insert, please visit www.zydususa.comCandesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '4' on either side of breakline and are supplied as follows:NDC 70771-1325-3 in bottle of 30 tabletsNDC 70771-1325-9 in bottle of 90 tabletsNDC 70771-1325-1 in bottle of 100 tabletsNDC 70771-1325-0 in bottle of 1000 tabletsNDC 70771-1325-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '5' on either side of breakline and are supplied as follows:NDC 70771-1326-3 in bottle of 30 tabletsNDC 70771-1326-9 in bottle of 90 tabletsNDC 70771-1326-1 in bottle of 100 tabletsNDC 70771-1326-0 in bottle of 1000 tabletsNDC 70771-1326-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '41' & '6' on either side of breakline and are supplied as follows:NDC 70771-1327-3 in bottle of 30 tabletsNDC 70771-1327-9 in bottle of 90 tabletsNDC 70771-1327-1 in bottle of 100 tabletsNDC 70771-1327-0 in bottle of 1000 tabletsNDC 70771-1327-4 in carton of 100 tablets (10 x 10 unit-dose)Storage:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This product's package insert may have been updated. For current package insert, please visit www.zydususa.comCandesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '4' on either side of breakline and are supplied as follows:NDC 70771-1325-3 in bottle of 30 tabletsNDC 70771-1325-9 in bottle of 90 tabletsNDC 70771-1325-1 in bottle of 100 tabletsNDC 70771-1325-0 in bottle of 1000 tabletsNDC 70771-1325-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '5' on either side of breakline and are supplied as follows:NDC 70771-1326-3 in bottle of 30 tabletsNDC 70771-1326-9 in bottle of 90 tabletsNDC 70771-1326-1 in bottle of 100 tabletsNDC 70771-1326-0 in bottle of 1000 tabletsNDC 70771-1326-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '41' & '6' on either side of breakline and are supplied as follows:NDC 70771-1327-3 in bottle of 30 tabletsNDC 70771-1327-9 in bottle of 90 tabletsNDC 70771-1327-1 in bottle of 100 tabletsNDC 70771-1327-0 in bottle of 1000 tabletsNDC 70771-1327-4 in carton of 100 tablets (10 x 10 unit-dose)Storage:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This product's package insert may have been updated. For current package insert, please visit www.zydususa.comCandesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '4' on either side of breakline and are supplied as follows:NDC 70771-1325-3 in bottle of 30 tabletsNDC 70771-1325-9 in bottle of 90 tabletsNDC 70771-1325-1 in bottle of 100 tabletsNDC 70771-1325-0 in bottle of 1000 tabletsNDC 70771-1325-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '5' on either side of breakline and are supplied as follows:NDC 70771-1326-3 in bottle of 30 tabletsNDC 70771-1326-9 in bottle of 90 tabletsNDC 70771-1326-1 in bottle of 100 tabletsNDC 70771-1326-0 in bottle of 1000 tabletsNDC 70771-1326-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '41' & '6' on either side of breakline and are supplied as follows:NDC 70771-1327-3 in bottle of 30 tabletsNDC 70771-1327-9 in bottle of 90 tabletsNDC 70771-1327-1 in bottle of 100 tabletsNDC 70771-1327-0 in bottle of 1000 tabletsNDC 70771-1327-4 in carton of 100 tablets (10 x 10 unit-dose)Storage:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This product's package insert may have been updated. For current package insert, please visit www.zydususa.comCandesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '4' on either side of breakline and are supplied as follows:NDC 70771-1325-3 in bottle of 30 tabletsNDC 70771-1325-9 in bottle of 90 tabletsNDC 70771-1325-1 in bottle of 100 tabletsNDC 70771-1325-0 in bottle of 1000 tabletsNDC 70771-1325-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '5' on either side of breakline and are supplied as follows:NDC 70771-1326-3 in bottle of 30 tabletsNDC 70771-1326-9 in bottle of 90 tabletsNDC 70771-1326-1 in bottle of 100 tabletsNDC 70771-1326-0 in bottle of 1000 tabletsNDC 70771-1326-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '41' & '6' on either side of breakline and are supplied as follows:NDC 70771-1327-3 in bottle of 30 tabletsNDC 70771-1327-9 in bottle of 90 tabletsNDC 70771-1327-1 in bottle of 100 tabletsNDC 70771-1327-0 in bottle of 1000 tabletsNDC 70771-1327-4 in carton of 100 tablets (10 x 10 unit-dose)Storage:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This product's package insert may have been updated. For current package insert, please visit www.zydususa.comCandesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '4' on either side of breakline and are supplied as follows:NDC 70771-1325-3 in bottle of 30 tabletsNDC 70771-1325-9 in bottle of 90 tabletsNDC 70771-1325-1 in bottle of 100 tabletsNDC 70771-1325-0 in bottle of 1000 tabletsNDC 70771-1325-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '5' on either side of breakline and are supplied as follows:NDC 70771-1326-3 in bottle of 30 tabletsNDC 70771-1326-9 in bottle of 90 tabletsNDC 70771-1326-1 in bottle of 100 tabletsNDC 70771-1326-0 in bottle of 1000 tabletsNDC 70771-1326-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '41' & '6' on either side of breakline and are supplied as follows:NDC 70771-1327-3 in bottle of 30 tabletsNDC 70771-1327-9 in bottle of 90 tabletsNDC 70771-1327-1 in bottle of 100 tabletsNDC 70771-1327-0 in bottle of 1000 tabletsNDC 70771-1327-4 in carton of 100 tablets (10 x 10 unit-dose)Storage:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This product's package insert may have been updated. For current package insert, please visit www.zydususa.comCandesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '4' on either side of breakline and are supplied as follows:NDC 70771-1325-3 in bottle of 30 tabletsNDC 70771-1325-9 in bottle of 90 tabletsNDC 70771-1325-1 in bottle of 100 tabletsNDC 70771-1325-0 in bottle of 1000 tabletsNDC 70771-1325-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '5' on either side of breakline and are supplied as follows:NDC 70771-1326-3 in bottle of 30 tabletsNDC 70771-1326-9 in bottle of 90 tabletsNDC 70771-1326-1 in bottle of 100 tabletsNDC 70771-1326-0 in bottle of 1000 tabletsNDC 70771-1326-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '41' & '6' on either side of breakline and are supplied as follows:NDC 70771-1327-3 in bottle of 30 tabletsNDC 70771-1327-9 in bottle of 90 tabletsNDC 70771-1327-1 in bottle of 100 tabletsNDC 70771-1327-0 in bottle of 1000 tabletsNDC 70771-1327-4 in carton of 100 tablets (10 x 10 unit-dose)Storage:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This product's package insert may have been updated. For current package insert, please visit www.zydususa.comCandesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '4' on either side of breakline and are supplied as follows:NDC 70771-1325-3 in bottle of 30 tabletsNDC 70771-1325-9 in bottle of 90 tabletsNDC 70771-1325-1 in bottle of 100 tabletsNDC 70771-1325-0 in bottle of 1000 tabletsNDC 70771-1325-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '5' on either side of breakline and are supplied as follows:NDC 70771-1326-3 in bottle of 30 tabletsNDC 70771-1326-9 in bottle of 90 tabletsNDC 70771-1326-1 in bottle of 100 tabletsNDC 70771-1326-0 in bottle of 1000 tabletsNDC 70771-1326-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '41' & '6' on either side of breakline and are supplied as follows:NDC 70771-1327-3 in bottle of 30 tabletsNDC 70771-1327-9 in bottle of 90 tabletsNDC 70771-1327-1 in bottle of 100 tabletsNDC 70771-1327-0 in bottle of 1000 tabletsNDC 70771-1327-4 in carton of 100 tablets (10 x 10 unit-dose)Storage:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This product's package insert may have been updated. For current package insert, please visit www.zydususa.comCandesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '4' on either side of breakline and are supplied as follows:NDC 70771-1325-3 in bottle of 30 tabletsNDC 70771-1325-9 in bottle of 90 tabletsNDC 70771-1325-1 in bottle of 100 tabletsNDC 70771-1325-0 in bottle of 1000 tabletsNDC 70771-1325-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '5' on either side of breakline and are supplied as follows:NDC 70771-1326-3 in bottle of 30 tabletsNDC 70771-1326-9 in bottle of 90 tabletsNDC 70771-1326-1 in bottle of 100 tabletsNDC 70771-1326-0 in bottle of 1000 tabletsNDC 70771-1326-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '41' & '6' on either side of breakline and are supplied as follows:NDC 70771-1327-3 in bottle of 30 tabletsNDC 70771-1327-9 in bottle of 90 tabletsNDC 70771-1327-1 in bottle of 100 tabletsNDC 70771-1327-0 in bottle of 1000 tabletsNDC 70771-1327-4 in carton of 100 tablets (10 x 10 unit-dose)Storage:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This product's package insert may have been updated. For current package insert, please visit www.zydususa.comCandesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '4' on either side of breakline and are supplied as follows:NDC 70771-1325-3 in bottle of 30 tabletsNDC 70771-1325-9 in bottle of 90 tabletsNDC 70771-1325-1 in bottle of 100 tabletsNDC 70771-1325-0 in bottle of 1000 tabletsNDC 70771-1325-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '5' on either side of breakline and are supplied as follows:NDC 70771-1326-3 in bottle of 30 tabletsNDC 70771-1326-9 in bottle of 90 tabletsNDC 70771-1326-1 in bottle of 100 tabletsNDC 70771-1326-0 in bottle of 1000 tabletsNDC 70771-1326-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '41' & '6' on either side of breakline and are supplied as follows:NDC 70771-1327-3 in bottle of 30 tabletsNDC 70771-1327-9 in bottle of 90 tabletsNDC 70771-1327-1 in bottle of 100 tabletsNDC 70771-1327-0 in bottle of 1000 tabletsNDC 70771-1327-4 in carton of 100 tablets (10 x 10 unit-dose)Storage:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This product's package insert may have been updated. For current package insert, please visit www.zydususa.comCandesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '4' on either side of breakline and are supplied as follows:NDC 70771-1325-3 in bottle of 30 tabletsNDC 70771-1325-9 in bottle of 90 tabletsNDC 70771-1325-1 in bottle of 100 tabletsNDC 70771-1325-0 in bottle of 1000 tabletsNDC 70771-1325-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '5' on either side of breakline and are supplied as follows:NDC 70771-1326-3 in bottle of 30 tabletsNDC 70771-1326-9 in bottle of 90 tabletsNDC 70771-1326-1 in bottle of 100 tabletsNDC 70771-1326-0 in bottle of 1000 tabletsNDC 70771-1326-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '41' & '6' on either side of breakline and are supplied as follows:NDC 70771-1327-3 in bottle of 30 tabletsNDC 70771-1327-9 in bottle of 90 tabletsNDC 70771-1327-1 in bottle of 100 tabletsNDC 70771-1327-0 in bottle of 1000 tabletsNDC 70771-1327-4 in carton of 100 tablets (10 x 10 unit-dose)Storage:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This product's package insert may have been updated. For current package insert, please visit www.zydususa.comCandesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '4' on either side of breakline and are supplied as follows:NDC 70771-1325-3 in bottle of 30 tabletsNDC 70771-1325-9 in bottle of 90 tabletsNDC 70771-1325-1 in bottle of 100 tabletsNDC 70771-1325-0 in bottle of 1000 tabletsNDC 70771-1325-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '5' on either side of breakline and are supplied as follows:NDC 70771-1326-3 in bottle of 30 tabletsNDC 70771-1326-9 in bottle of 90 tabletsNDC 70771-1326-1 in bottle of 100 tabletsNDC 70771-1326-0 in bottle of 1000 tabletsNDC 70771-1326-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '41' & '6' on either side of breakline and are supplied as follows:NDC 70771-1327-3 in bottle of 30 tabletsNDC 70771-1327-9 in bottle of 90 tabletsNDC 70771-1327-1 in bottle of 100 tabletsNDC 70771-1327-0 in bottle of 1000 tabletsNDC 70771-1327-4 in carton of 100 tablets (10 x 10 unit-dose)Storage:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This product's package insert may have been updated. For current package insert, please visit www.zydususa.comCandesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '4' on either side of breakline and are supplied as follows:NDC 70771-1325-3 in bottle of 30 tabletsNDC 70771-1325-9 in bottle of 90 tabletsNDC 70771-1325-1 in bottle of 100 tabletsNDC 70771-1325-0 in bottle of 1000 tabletsNDC 70771-1325-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '5' on either side of breakline and are supplied as follows:NDC 70771-1326-3 in bottle of 30 tabletsNDC 70771-1326-9 in bottle of 90 tabletsNDC 70771-1326-1 in bottle of 100 tabletsNDC 70771-1326-0 in bottle of 1000 tabletsNDC 70771-1326-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '41' & '6' on either side of breakline and are supplied as follows:NDC 70771-1327-3 in bottle of 30 tabletsNDC 70771-1327-9 in bottle of 90 tabletsNDC 70771-1327-1 in bottle of 100 tabletsNDC 70771-1327-0 in bottle of 1000 tabletsNDC 70771-1327-4 in carton of 100 tablets (10 x 10 unit-dose)Storage:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This product's package insert may have been updated. For current package insert, please visit www.zydususa.comCandesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '4' on either side of breakline and are supplied as follows:NDC 70771-1325-3 in bottle of 30 tabletsNDC 70771-1325-9 in bottle of 90 tabletsNDC 70771-1325-1 in bottle of 100 tabletsNDC 70771-1325-0 in bottle of 1000 tabletsNDC 70771-1325-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '5' on either side of breakline and are supplied as follows:NDC 70771-1326-3 in bottle of 30 tabletsNDC 70771-1326-9 in bottle of 90 tabletsNDC 70771-1326-1 in bottle of 100 tabletsNDC 70771-1326-0 in bottle of 1000 tabletsNDC 70771-1326-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '41' & '6' on either side of breakline and are supplied as follows:NDC 70771-1327-3 in bottle of 30 tabletsNDC 70771-1327-9 in bottle of 90 tabletsNDC 70771-1327-1 in bottle of 100 tabletsNDC 70771-1327-0 in bottle of 1000 tabletsNDC 70771-1327-4 in carton of 100 tablets (10 x 10 unit-dose)Storage:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This product's package insert may have been updated. For current package insert, please visit www.zydususa.comCandesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '4' on either side of breakline and are supplied as follows:NDC 70771-1325-3 in bottle of 30 tabletsNDC 70771-1325-9 in bottle of 90 tabletsNDC 70771-1325-1 in bottle of 100 tabletsNDC 70771-1325-0 in bottle of 1000 tabletsNDC 70771-1325-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '5' on either side of breakline and are supplied as follows:NDC 70771-1326-3 in bottle of 30 tabletsNDC 70771-1326-9 in bottle of 90 tabletsNDC 70771-1326-1 in bottle of 100 tabletsNDC 70771-1326-0 in bottle of 1000 tabletsNDC 70771-1326-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '41' & '6' on either side of breakline and are supplied as follows:NDC 70771-1327-3 in bottle of 30 tabletsNDC 70771-1327-9 in bottle of 90 tabletsNDC 70771-1327-1 in bottle of 100 tabletsNDC 70771-1327-0 in bottle of 1000 tabletsNDC 70771-1327-4 in carton of 100 tablets (10 x 10 unit-dose)Storage:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This product's package insert may have been updated. For current package insert, please visit www.zydususa.comCandesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '4' on either side of breakline and are supplied as follows:NDC 70771-1325-3 in bottle of 30 tabletsNDC 70771-1325-9 in bottle of 90 tabletsNDC 70771-1325-1 in bottle of 100 tabletsNDC 70771-1325-0 in bottle of 1000 tabletsNDC 70771-1325-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '5' on either side of breakline and are supplied as follows:NDC 70771-1326-3 in bottle of 30 tabletsNDC 70771-1326-9 in bottle of 90 tabletsNDC 70771-1326-1 in bottle of 100 tabletsNDC 70771-1326-0 in bottle of 1000 tabletsNDC 70771-1326-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '41' & '6' on either side of breakline and are supplied as follows:NDC 70771-1327-3 in bottle of 30 tabletsNDC 70771-1327-9 in bottle of 90 tabletsNDC 70771-1327-1 in bottle of 100 tabletsNDC 70771-1327-0 in bottle of 1000 tabletsNDC 70771-1327-4 in carton of 100 tablets (10 x 10 unit-dose)Storage:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This product's package insert may have been updated. For current package insert, please visit www.zydususa.comCandesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '4' on either side of breakline and are supplied as follows:NDC 70771-1325-3 in bottle of 30 tabletsNDC 70771-1325-9 in bottle of 90 tabletsNDC 70771-1325-1 in bottle of 100 tabletsNDC 70771-1325-0 in bottle of 1000 tabletsNDC 70771-1325-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '5' on either side of breakline and are supplied as follows:NDC 70771-1326-3 in bottle of 30 tabletsNDC 70771-1326-9 in bottle of 90 tabletsNDC 70771-1326-1 in bottle of 100 tabletsNDC 70771-1326-0 in bottle of 1000 tabletsNDC 70771-1326-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '41' & '6' on either side of breakline and are supplied as follows:NDC 70771-1327-3 in bottle of 30 tabletsNDC 70771-1327-9 in bottle of 90 tabletsNDC 70771-1327-1 in bottle of 100 tabletsNDC 70771-1327-0 in bottle of 1000 tabletsNDC 70771-1327-4 in carton of 100 tablets (10 x 10 unit-dose)Storage:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This product's package insert may have been updated. For current package insert, please visit www.zydususa.comCandesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '4' on either side of breakline and are supplied as follows:NDC 70771-1325-3 in bottle of 30 tabletsNDC 70771-1325-9 in bottle of 90 tabletsNDC 70771-1325-1 in bottle of 100 tabletsNDC 70771-1325-0 in bottle of 1000 tabletsNDC 70771-1325-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '5' on either side of breakline and are supplied as follows:NDC 70771-1326-3 in bottle of 30 tabletsNDC 70771-1326-9 in bottle of 90 tabletsNDC 70771-1326-1 in bottle of 100 tabletsNDC 70771-1326-0 in bottle of 1000 tabletsNDC 70771-1326-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '41' & '6' on either side of breakline and are supplied as follows:NDC 70771-1327-3 in bottle of 30 tabletsNDC 70771-1327-9 in bottle of 90 tabletsNDC 70771-1327-1 in bottle of 100 tabletsNDC 70771-1327-0 in bottle of 1000 tabletsNDC 70771-1327-4 in carton of 100 tablets (10 x 10 unit-dose)Storage:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This product's package insert may have been updated. For current package insert, please visit www.zydususa.comCandesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '4' on either side of breakline and are supplied as follows:NDC 70771-1325-3 in bottle of 30 tabletsNDC 70771-1325-9 in bottle of 90 tabletsNDC 70771-1325-1 in bottle of 100 tabletsNDC 70771-1325-0 in bottle of 1000 tabletsNDC 70771-1325-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '5' on either side of breakline and are supplied as follows:NDC 70771-1326-3 in bottle of 30 tabletsNDC 70771-1326-9 in bottle of 90 tabletsNDC 70771-1326-1 in bottle of 100 tabletsNDC 70771-1326-0 in bottle of 1000 tabletsNDC 70771-1326-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '41' & '6' on either side of breakline and are supplied as follows:NDC 70771-1327-3 in bottle of 30 tabletsNDC 70771-1327-9 in bottle of 90 tabletsNDC 70771-1327-1 in bottle of 100 tabletsNDC 70771-1327-0 in bottle of 1000 tabletsNDC 70771-1327-4 in carton of 100 tablets (10 x 10 unit-dose)Storage:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This product's package insert may have been updated. For current package insert, please visit www.zydususa.comCandesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '4' on either side of breakline and are supplied as follows:NDC 70771-1325-3 in bottle of 30 tabletsNDC 70771-1325-9 in bottle of 90 tabletsNDC 70771-1325-1 in bottle of 100 tabletsNDC 70771-1325-0 in bottle of 1000 tabletsNDC 70771-1325-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '5' on either side of breakline and are supplied as follows:NDC 70771-1326-3 in bottle of 30 tabletsNDC 70771-1326-9 in bottle of 90 tabletsNDC 70771-1326-1 in bottle of 100 tabletsNDC 70771-1326-0 in bottle of 1000 tabletsNDC 70771-1326-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '41' & '6' on either side of breakline and are supplied as follows:NDC 70771-1327-3 in bottle of 30 tabletsNDC 70771-1327-9 in bottle of 90 tabletsNDC 70771-1327-1 in bottle of 100 tabletsNDC 70771-1327-0 in bottle of 1000 tabletsNDC 70771-1327-4 in carton of 100 tablets (10 x 10 unit-dose)Storage:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This product's package insert may have been updated. For current package insert, please visit www.zydususa.comCandesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '4' on either side of breakline and are supplied as follows:NDC 70771-1325-3 in bottle of 30 tabletsNDC 70771-1325-9 in bottle of 90 tabletsNDC 70771-1325-1 in bottle of 100 tabletsNDC 70771-1325-0 in bottle of 1000 tabletsNDC 70771-1325-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '5' on either side of breakline and are supplied as follows:NDC 70771-1326-3 in bottle of 30 tabletsNDC 70771-1326-9 in bottle of 90 tabletsNDC 70771-1326-1 in bottle of 100 tabletsNDC 70771-1326-0 in bottle of 1000 tabletsNDC 70771-1326-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '41' & '6' on either side of breakline and are supplied as follows:NDC 70771-1327-3 in bottle of 30 tabletsNDC 70771-1327-9 in bottle of 90 tabletsNDC 70771-1327-1 in bottle of 100 tabletsNDC 70771-1327-0 in bottle of 1000 tabletsNDC 70771-1327-4 in carton of 100 tablets (10 x 10 unit-dose)Storage:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This product's package insert may have been updated. For current package insert, please visit www.zydususa.comCandesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '4' on either side of breakline and are supplied as follows:NDC 70771-1325-3 in bottle of 30 tabletsNDC 70771-1325-9 in bottle of 90 tabletsNDC 70771-1325-1 in bottle of 100 tabletsNDC 70771-1325-0 in bottle of 1000 tabletsNDC 70771-1325-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '5' on either side of breakline and are supplied as follows:NDC 70771-1326-3 in bottle of 30 tabletsNDC 70771-1326-9 in bottle of 90 tabletsNDC 70771-1326-1 in bottle of 100 tabletsNDC 70771-1326-0 in bottle of 1000 tabletsNDC 70771-1326-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '41' & '6' on either side of breakline and are supplied as follows:NDC 70771-1327-3 in bottle of 30 tabletsNDC 70771-1327-9 in bottle of 90 tabletsNDC 70771-1327-1 in bottle of 100 tabletsNDC 70771-1327-0 in bottle of 1000 tabletsNDC 70771-1327-4 in carton of 100 tablets (10 x 10 unit-dose)Storage:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This product's package insert may have been updated. For current package insert, please visit www.zydususa.comCandesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '4' on either side of breakline and are supplied as follows:NDC 70771-1325-3 in bottle of 30 tabletsNDC 70771-1325-9 in bottle of 90 tabletsNDC 70771-1325-1 in bottle of 100 tabletsNDC 70771-1325-0 in bottle of 1000 tabletsNDC 70771-1325-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '19' & '5' on either side of breakline and are supplied as follows:NDC 70771-1326-3 in bottle of 30 tabletsNDC 70771-1326-9 in bottle of 90 tabletsNDC 70771-1326-1 in bottle of 100 tabletsNDC 70771-1326-0 in bottle of 1000 tabletsNDC 70771-1326-4 in carton of 100 tablets (10 x 10 unit-dose)Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg are white to off-white, oval, biconvex, uncoated tablets with breakline on both sides and engraved on one side with '41' & '6' on either side of breakline and are supplied as follows:NDC 70771-1327-3 in bottle of 30 tabletsNDC 70771-1327-9 in bottle of 90 tabletsNDC 70771-1327-1 in bottle of 100 tabletsNDC 70771-1327-0 in bottle of 1000 tabletsNDC 70771-1327-4 in carton of 100 tablets (10 x 10 unit-dose)Storage:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This product's package insert may have been updated. For current package insert, please visit www.zydususa.com


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Candesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is, therefore, independent of the pathways for angiotensin II synthesis.

There is also an AT receptor found in many tissues, but AT is not known to be associated with cardiovascular homeostasis. Candesartan has much greater affinity (> 10,000 fold) for the AT receptor than for the AT receptor.

Blockade of the renin-angiotensin system with ACE inhibitors, which inhibit the biosynthesis of angiotensin II from angiotensin I, is widely used in the treatment of hypertension. ACE inhibitors also inhibit the degradation of bradykinin, a reaction also catalyzed by ACE. Because candesartan does not inhibit ACE (kininase II), it does not affect the response to bradykinin. Whether this difference has clinical relevance is not yet known. Candesartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and angiotensin II circulating levels do not overcome the effect of candesartan on blood pressure.

Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. The renin-aldosterone link is mediated by angiotensin II, so coadministration of an angiotensin II receptor antagonist tends to reverse the potassium loss associated with these diuretics.

The mechanism of the antihypertensive effect of thiazides is unknown.

Non-Clinical Toxicology
Candesartan cilexetil and hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to candesartan, to hydrochlorothiazide or to other sulfonamide-derived drugs.

Do not coadminister aliskiren with candesartan cilexetil and hydrochlorothiazide tablets in patients with diabetes (see ).

Candesartan cilexetil and hydrochlorothiazide tablets are contraindicated in patients with anuria.

Because candesartan is not significantly metabolized by the cytochrome P450 system and at therapeutic concentrations has no effects on P450 enzymes, interactions with drugs that inhibit or are metabolized by those enzymes would not be expected.





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

The antihypertensive effect of angiotensin II receptor antagonists, including candesartan may be attenuated by NSAIDs including selective COX-2 inhibitors.

Lithium





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 candesartan cilexetil and hydrochlorothiazide and other agents that affect the RAS.

Coadministration of candesartan cilexetil and hydrochlorothiazide with potassium sparing diuretics, potassium supplements, potassium-containing salt substitutes or other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients.

Do not coadminister aliskiren with candesartan cilexetil and hydrochlorothiazide in patients with diabetes. Avoid use of aliskiren with candesartan cilexetil and hydrochlorothiazide in patients with renal impairment (GFR < 60 ml/min) (see ).





Alcohol, barbiturates, or narcotics

Antidiabetic drugs (oral agents and insulin)

Diazoxide

Ion Exchange resins

Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine)

Digitalis -

Noradrenaline

Steroids or Adrenocorticotropic Hormone

Cytotoxic products

Cyclosporine

Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides.

Hydrochlorothiazide may raise the serum uric acid level due to reduced clearance of uric acid and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients.

Thiazides decrease urinary calcium excretion and may cause elevation of serum calcium. Avoid using candesartan cilexetil and hydrochlorothiazide in patients with hypercalcemia.

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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

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).