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Candesartan
Overview
What is Candesartan?
Candesartan cilexetil, USP a prodrug, is hydrolyzed to candesartan during absorption from the gastrointestinal tract. Candesartan is a selective AT subtype angiotensin II receptor antagonist.
Candesartan cilexetil, USP a nonpeptide, is chemically described as (±)-1-Hydroxyethyl 2-ethoxy-1-[-(-1tetrazol-5-ylphenyl)benzyl]-7-benzimidazolecarboxylate, cyclohexyl carbonate (ester).
Its molecular formula is CHNO, and its structural formula is:
Candesartan cilexetil, USP is a white to off-white powder with a molecular weight of 610.67. It is practically insoluble in water and sparingly soluble in methanol. Candesartan cilexetil USP 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.
Candesartan cilexetil, USP is available for oral use as tablets containing either 4 mg, 8 mg, 16 mg, or 32 mg of candesartan cilexetil and the following inactive ingredients: hydroxypropyl cellulose, lactose monohydrate, corn starch, glycerin, carboxymethylcellulose calcium, and magnesium stearate. Ferric oxide is added to the 8-mg, 16-mg, and 32-mg tablets as a colorant.
What does Candesartan look like?
What are the available doses of Candesartan?
Tablets 4 mg, 8 mg, 16 mg, 32 mg ().
What should I talk to my health care provider before I take Candesartan?
·
Either nursing or drug should be discontinued ().
· Pediatrics
:
How should I use Candesartan?
Candesartan cilexetil tablets are indicated for the treatment of hypertension in adults and in children 1 to <17 years of age, 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.
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.
Candesartan cilexetil tablets may be used alone or in combination with other antihypertensive agents.
Dosage must be individualized. Blood pressure response is dose related over the range of 2 to 32 mg. The usual recommended starting dose of candesartan cilexetil tablets are 16 mg once daily when it is used as monotherapy in patients who are not volume depleted. Candesartan cilexetil tablets can be administered once or twice daily with total daily doses ranging from 8 mg to 32 mg. Larger doses do not appear to have a greater effect, and there is relatively little experience with such doses. Most of the antihypertensive effect is present within 2 weeks, and maximal blood pressure reduction is generally obtained within 4 to 6 weeks of treatment with candesartan cilexetil tablets.
Use in Hepatic Impairment: Initiate with 8 mg candesartan cilexetil tablets in patients with moderate hepatic insufficiency. Dosing recommendations cannot be provided for patients with severe hepatic insufficiency
Candesartan cilexetil tablets may be administered with or without food.
If blood pressure is not controlled by candesartan cilexetil tablets alone, a diuretic may be added. Candesartan cilexetil tablets may be administered with other antihypertensive agents.
What interacts with Candesartan?
Sorry No Records found
What are the warnings of Candesartan?
Sorry No Records found
What are the precautions of Candesartan?
Sorry No Records found
What are the side effects of Candesartan?
Sorry No records found
What should I look out for while using Candesartan?
Candesartan cilexetil tablets are contraindicated in patients who are hypersensitive to candesartan.
Do not co-administer aliskiren with candesartan cilexetil tablets in patients with diabetes
WARNING: FETAL TOXICITY
What might happen if I take too much Candesartan?
No lethality was observed in acute toxicity studies in mice, rats, and dogs given single oral doses of up to 2000 mg/kg of candesartan cilexetil. In mice given single oral doses of the primary metabolite, candesartan, the minimum lethal dose was greater than 1000 mg/kg but less than 2000 mg/kg. The most likely manifestation of overdosage with candesartan cilexetil would be hypotension, dizziness, and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Candesartan cannot be removed by hemodialysis. Treatment: To obtain up-to-date information about the treatment of overdose, consult your Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the (PDR). In managing overdose, consider the possibilities of multiple-drug overdoses, drug-drug interactions, and altered pharmacokinetics in your patient
How should I store and handle Candesartan?
Candesartan cilexetil tablets, USP 4 mg, are white to off-white, circular, biconvex, uncoated tablets, debossed with "ML 52" on one side and breakline on other side. They are supplied as follows: NDC 33342-114-07 unit of use bottles of 30 NDC 33342-114-10 unit of use bottles of 90 NDC 33342-114-51 unit of use bottles of 300 NDC 33342-114-12 unit dose blister packages of 100. Candesartan cilexetil tablets, USP 8 mg, are light pink, circular/biconvex-shaped, uncoated tablets debossed with "ML 53" on one side and breakline on the other. They are supplied as follows: NDC 33342-115-07 unit of use bottles of 30 NDC 33342-115-10 unit of use bottles of 90 NDC-33342-115-51 unit of use bottles of 300 NDC 33342-115-12 unit dose blister packages of 100. Candesartan cilexetil tablets, USP 16 mg, are pink, circular/biconvex-shaped, uncoated tablets, debossed with "ML 54" on one side and breakline on other side.They are supplied as follows: NDC 33342-116-07 unit of use bottles of 30 NDC 33342-116-10 unit of use bottles of 90 NDC 33342-116-51 unit of use bottles of 300 NDC 33342-116-12 unit dose blister packages of 100. Candesartan cilexetil tablets, USP 32 mg, are pink, circular/biconvex-shaped, uncoated tablets, debossed with "ML 55" on one side and breakline on other side. They are supplied as follows: NDC 33342-117-07 unit of use bottles of 30 NDC 33342-117-10 unit of use bottles of 90 NDC 33342-117-51 unit of use bottles of 300 NDC 33342-117-12 unit dose blister packages of 100. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep container tightly closed.
Clinical Information
Chemical Structure
No Image foundClinical 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 ATreceptor 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.
Non-Clinical Toxicology
Candesartan cilexetil tablets are contraindicated in patients who are hypersensitive to candesartan.Do not co-administer aliskiren with candesartan cilexetil tablets in patients with diabetes
WARNING: FETAL TOXICITY
When amiloride HCl is administered concomitantly with an angiotensin-converting enzyme inhibitor, an angiotensin II receptor antagonist, cyclosporine or tacrolimus, the risk of hyperkalemia may be increased. Therefore, if concomitant use of these agents is indicated because of demonstrated hypokalemia, they should be used with caution and with frequent monitoring of serum potassium. (See ).
Lithium generally should not be given with diuretics because they reduce its renal clearance and add a high risk of lithium toxicity. Read circulars for lithium preparations before use of such concomitant therapy.
In some patients, the administration of a non-steroidal anti-inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. Therefore, when amiloride HCl and non-steroidal anti-inflammatory agents are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained. Since indomethacin and potassium-sparing diuretics, including amiloride HCl, may each be associated with increased serum potassium levels, the potential effects on potassium kinetics and renal function should be considered when these agents are administered concurrently.
Pregnancy Category D
[see Use in Specific Populations ()].
2
2
6.1 Clinical Trials Experience
Adult Hypertension
Pediatric Hypertension
Heart Failure
6.2 Postmarketing Experience
Digestive:
Hematologic:
Immunologic:
Metabolic and Nutritional Disorders:
Respiratory system disorders:
Skin and Appendages Disorders:
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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