The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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). Monitor patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. Continue typing to refine. Candesartan Cilexetil has not been studied in children with glomerular filtration rate less than 30 ml/min/1.73m2 (see section 4.4). Derington CG, King JB, Delate T, Botts SR, Kroehl M, Kao DP, Trinkley KE. Doses above 32 mg have not been studied in paediatric patients. The objective of this review was to explore the efficacy of angiotensin II receptor blockers (ARBs) for the treatment of hyperuricemia in individuals diagnosed with gout or hyperuricemia defined as 7 mg/dl at baseline. Fourteen patients needed to be treated for the duration of the study to prevent one patient from dying of a cardiovascular event or being hospitalised for treatment of heart failure. The most commonly reported adverse reactions were hyperkalaemia, hypotension and renal impairment. Most of the antihypertensive effect is attained within 4 weeks. Candesartan (Oral Route) Proper Use - Mayo Clinic In rats, it has been demonstrated that candesartan crosses the blood-brain barrier poorly, if at all. Candesartan cilexetil and hydrochlorothiazide tablets contain 16 mg or 32 mg of candesartan cilexetil and 12.5 mg or 25 mg of hydrochlorothiazide providing for the following available combinations: 16 mg/12.5 mg, 32 mg/12.5 mg or 32 mg/25 mg. Unless your patient is on a high ACEi/ARB dose, start ENTRESTO at 24/26 mg twice daily and double the dose every 2 to 4 weeks, as tolerated by the patient. No dose adjustment is required in patients with mild (CrCL60-90mL/min) or moderate (CrCL30-60mL/min) renal impairment. Steroids or Adrenocorticotropic Hormone Hypokalemia may develop during concomitant use of steroids or adrenocorticotropic hormone (ACTH). We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. Safety and effectiveness of candesartan cilexetil and hydrochlorothiazide tablets in patients with severe renal impairment (CrCL30mL/min) have not been established. For children unable to swallow tablets, an extemporaneous suspension may be used instead. The safety of candesartan cilexetil was monitored in 255 hypertensive children and adolescents,aged 6 to <18 years old, during a 4 week clinical efficacy study and a 1 year open label study(see section 5.1). This placebo controlled, double-blind study programme in chronic heart failure (CHF) patients with NYHA functional class II to IV consisted of three separate studies: CHARM-Alternative (n=2,028) in patients with LVEF 40% not treated with an ACE inhibitor because of intolerance (mainly due to cough, 72%), CHARM-Added (n=2,548) in patients with LVEF 40% and treated with an ACE inhibitor, and CHARM-Preserved (n=3,023) in patients with LVEF > 40%. In hypertensive patients with renal insufficiency, serum concentrations of candesartan were elevated. In children aged 1 to <6 years, 10 children weighing 10 to <25 kg received a single dose of 0.2 mg/kg, oral suspension. Less than 50 kg: Adult: No adjustment recommended Each tablet contains 2 mg candesartan cilexetil. Ion Exchange resins Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85% and 43%, respectively. Careers. Unable to load your collection due to an error, Unable to load your delegates due to an error. The combination should be administered with caution, especially in the elderly. In spite of the effect of candesartan cilexetil on aldosterone secretion, very little effect on serum potassium was observed. Candesartan: medicine to treat high blood pressure (hypertension - NHS The adverse experience profile of Candesartan cilexetil in adult heart failure patients was consistent with the pharmacology of the drug and the health status of the patients. Candesartan is highly bound to plasma protein (more than 99%). Candesartan cilexetil is a nonpeptide selective blocker of the angiotensin II receptor sub-type 1. 2007;27(11):735-53. doi: 10.2165/00044011-200727110-00001. 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. The results of this study suggest that identical daily doses of candesartan cilexetil administered once or twice daily have comparable efficacy and tolerability and that no additional clinical benefit is derived from twice-daily administration. Caution should be observed when initiating therapy and correction of hypovolemia should be attempted. Managing Hypertension Using Combination Therapy | AAFP 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. Hydrochlorothiazide is a thiazide diuretic. Patients with symptomatic hypotension may require temporarily reducing the dose of candesartan cilexetil and hydrochlorothiazide tablets or volume repletion. 2009 May;63(5):766-75. doi: 10.1111/j.1742-1241.2009.02028.x. The overall frequency of adverse experiences was not related to dose, age, gender, or race. The usual recommended initial dose of Candesartan Cilexetil is 4 mg once daily. The table below presents adverse reactions from clinical trials and post-marketing experience. For rabbits, the maximum dose of candesartan cilexetil was 1 mg/kg/day (a maternally toxic dose that is about half the MRHD1). This randomized, double-masked, placebo-controlled, forced-titration, parallel-arm study was designed to compare the blood pressure (BP)-lowering effect of candesartan cilexetil, a potent antagonist of the angiotensin II receptor subtype AT1, administered once daily with that of the same agent administered twice daily at the same total daily dose of 16 mg. After a 4- to 5-week placebo run-in period, 277 patients with a sitting diastolic BP of 95 to 109 mm Hg were randomly allocated to receive placebo (n = 92) or candesartan cilexetil 8 mg once daily for 4 weeks, followed by forced titration to either 16 mg once daily (n = 91) or 8 mg twice daily (n = 94) for 4 weeks. Cytotoxic products Thiazides may reduce the renal excretion of cytotoxic medicinal products (e.g. Candesartan in heart failure - PMC - National Center for Biotechnology There is a Black Box Warning for this drug as shown here. The pharmacokinetics of candesartan cilexetil have not been investigated in patients <18 years of age. Brand name: Amias. FETAL TOXICITY: If pregnancy is detected, discontinue this drug as soon as possible. Patients requiring further reduction in blood pressure should be titrated to 32 . Candesartan inhibits the pressor effects of angiotensin II infusion in a dose-dependent manner. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy. Females of childbearing age should be informed of the consequences of exposure to this drug during pregnancy; ask these patients to report pregnancies as soon as possible. Following oral administration, candesartan cilexetil is converted to the active substance candesartan. The effects of candesartan cilexetil 8-16 mg (mean dose 12 mg), once daily, on cardiovascular morbidity and mortality were evaluated in a randomised clinical trial with 4,937 elderly patients (aged 70-89 years; 21% aged 80 or above) with mild to moderate hypertension followed for a mean of 3.7 years (Study on COgnition and Prognosis in the Elderly). Therapy should be adjusted according to blood pressure response. In preclinical safety studies candesartan had effects on the kidneys and on red cell parameters at high doses in mice, rats, dogs and monkeys. The relative bioavailability of the tablet formulation compared with the same oral solution is approximately 34% with very little variability. As for other inhibitors of the renin-angiotensin-aldosterone system, small decreases in haemoglobin have been seen. Whilst the nature and severity of the adverse events are similar to those in adults (see the table above), the frequency of all adverse events are higher in the children and adolescent, particularly in: Headache, dizziness and upper respiratory tract infection, are very common (ie, 1/10) in children and common ( 1/100 to < 1/10) in adults. The combination of candesartan cilexetil and hydrochlorothiazide 32 mg/25 mg resulted in placebo-adjusted decreases in sitting systolic and diastolic blood pressures of 16-19/9-11 mm Hg. Use: Treatment of New York Heart Association (NYHA) class II through IV heart failure. . Compounds which have been investigated in clinical pharmacokinetic studies include hydrochlorothiazide, warfarin, digoxin, oral contraceptives (i.e. These studies have shown no significant beneficial effect on renal and/or cardiovascular outcomes and mortality, while an increased risk of hyperkalaemia, acute kidney injury and/or hypotension as compared to monotherapy was observed. Antihypertensive effect is present within 2 weeks; maximum blood pressure reduction at a given dose is generally observed within 4 weeks of starting that dose. The absolute bioavailability of candesartan is approximately 40% after an oral solution of candesartan cilexetil. Skin and Appendages Disorders: Pruritus, rash and urticaria. 2002;41(1):7-17. doi: 10.2165/00003088-200241010-00002. sharing sensitive information, make sure youre on a federal Thiazide diuretics are eliminated by the kidney, with a terminal half-life of 5-15 hours. Neonates with a history of in utero exposure to candesartan cilexetil and hydrochlorothiazide tablets: If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. The site is secure. During dose titration of Candesartan Cilexetil, monitoring of serum creatinine and potassium is recommended. Plasma concentrations of angiotensin I and angiotensin II, and plasma renin activity (PRA), increased in a dose-dependent manner after single and repeated administration of candesartan cilexetil to healthy subjects and hypertensive patients. GFR 30 mL/min/1.73 m2 or greater: Data not available, GFR less than 30 mL/min/1.73 m2: Not recommended, Mild liver dysfunction (Child-Pugh A): No adjustment recommended, Moderate liver dysfunction (Child-Pugh B): Initial dose: 8 mg orally once a day, Severe liver dysfunction (Child-Pugh C): Data not available. In general, there were no clinically important influences of Candesartan cilexetil on routine laboratory variables. Monitor serum lithium levels during concomitant use. Thiazides decrease urinary calcium excretion and may cause elevation of serum calcium. Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. Patients should be asked to report pregnancies to their physicians as soon as possible. PLoS One. The inactive ingredients of the tablets are carboxymethylcellulose calcium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, corn starch, polyethylene glycol 8000, and ferric oxide (yellow). Candesartan - wikidoc Candesartan increases renal blood flow and either has no effect on or increases glomerular filtration rate while renal vascular resistance and filtration fraction are reduced. Aortic and mitral valve stenosis (obstructive hypertrophic cardiomyopathy). It is practically insoluble in water and sparingly soluble in methanol. Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. For patients weighing < 50 kg: In patients whose blood pressure is not adequately controlled, the dose can be increased to a maximum of 8 mg once daily. Because no information is available regarding the use of Candesartan cilexetil during breastfeeding, Candesartan cilexetil is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant. Currently available data are described in section 5.1 but no recommendation on a posology can be made. If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. Atacand (candesartan) dosing, indications, interactions, adverse Candesartan does not inhibit ACE, which converts angiotensin I to angiotensin II and degrades bradykinin. However, in patients with renal impairment, periodic monitoring of serum potassium and creatinine levels is recommended. 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. Candesartan Cilexetil and Hydrochlorothiazide. Thiazides cross the placental barrier and appear in cord blood. These changes were considered to be caused by the pharmacological action of candesartan. Biochemical Data Summary. Int J Clin Pract. Drug information provided by: Merative, Micromedex This medicine comes with a patient information insert. Tell patients receiving candesartan cilexetil and hydrochlorothiazide tablets not to use potassium supplements, salt substitutes containing potassium, or other drugs that may increase serum potassium levels without consulting the prescribing physician. Skin: erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia, Special Senses: transient blurred vision, xanthopsia. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. They are supplied in bottles of 90 tablets (NDC 62559-662-90). In managing overdose, consider the possibilities of multiple-drug overdoses, drug-drug interactions, and altered pharmacokinetics in your patient. When candesartan cilexetil is used together with hydrochlorothiazide, the reduction in blood pressure is additive. The antihypertensive effect was similar in men and women and in patients older and younger than 65. usually once or twice daily. Volume and/or salt depletion should be corrected before initiating therapy with candesartan cilexetil and hydrochlorothiazide tablets. Candesartan and its inactive metabolite do not accumulate in serum upon repeated once-daily dosing. What are the possible side effects of Atacand? In controlled clinical studies adverse reactions were mild and transient. 1998 Oct 15;82(8):961-5. doi: 10.1016/s0002-9149(98)00627-4. Available interaction studies indicate no effect on CYP2C9 and CYP3A4. Doses ranged from 2 to 32 mg candesartan cilexetil and from 6.25 to 25 mg hydrochlorothiazide administered once daily in various combinations. Up-titration to the target dose of 32 mg once daily (maximum dose) or the highest tolerated dose is done by doubling the dose at intervals of at least 2 weeks (see section 4.4). Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Children aged below 1 year (see section 5.3). There is no indication of serious or exaggerated first dose hypotension or rebound effect after cessation of treatment. Before The starting dose is 4 mg in patients with renal impairment, including patients on haemodialysis. The risk of adverse reactions, especially hypotension, hyperkalaemia and decreased renal function (including acute renal failure), may increase when Candesartan is used in combination with an ACE-inhibitor. Hydrochlorothiazide is effective in doses of 12.5 to 50 mg once daily. The once-daily administration of up to 16 mg of candesartan cilexetil to healthy subjects did not influence plasma aldosterone concentrations, but a decrease in the plasma concentration of aldosterone was observed when 32 mg of candesartan cilexetil was administered to hypertensive patients. Please enable it to take advantage of the complete set of features! 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. Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see Sections 4.3, 4.4 and 5.1). 1999 Aug 1;84(3):289-93. doi: 10.1016/s0002-9149(99)00278-7. Atacand is a prescription medicine used to treat the symptoms of high blood pressure (Hypertensio). Ferric oxide (reddish brown) is also added to the 16 mg/12.5 mg and 32 mg/25 mg tablets as colorant. Most of the antihypertensive effect is present within 2 weeks; maximum blood pressure reduction at a given dose is generally observed within 4 to 6 weeks of starting that dose. According to a meta-analysis, the average additional effect of a dose increase from 16 mg to 32 mg once daily was small. Would you like email updates of new search results? Reporting suspected adverse reactions after authorisation of the medicinal product is important. Rare reports of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers. For non-formulary ARBs, an auto-substitution is considered mandatory for indications of hypertension. Drugs that inhibit the renin-angiotensin system can cause hyperkalemia. Closely observe infants with histories of in utero exposure to candesartan cilexetil and hydrochlorothiazide tablets for hypotension, oliguria, and hyperkalemia (see PRECAUTIONS, Pediatric Use). If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. This site needs JavaScript to work properly. Atacand Dosage Generic name: CANDESARTAN CILEXETIL 4mg Dosage form: tablet Drug class: Angiotensin receptor blockers Medically reviewed by Drugs.com. Pediatric: Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. The antihypertensive effects of candesartan were evaluated in hypertensive children aged 1 to<6 years and 6 to <17 years in two randomised, double-blind multicentre, 4 week dose ranging studies. Blood pressure lowering efficacy of angiotensin receptor blockers for primary hypertension. Candesartan cilexetil: comparison of once-daily versus twice-daily administration for systemic hypertension. Candesartan Cilexetil Study Investigators