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| __NOTOC__
| | #REDIRECT [[Candesartan#Warnings]] |
| {{Candesartan}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Warnings and Precautions==
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| ===Fetal Toxicity===
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| ===Pregnancy Category D===
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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 ATACAND as soon as possible [see USE IN SPECIFIC POPULATIONS (8.1)].
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| Oral doses ≥10 mg of candesartan cilexetil/kg/day administered to pregnant rats during late gestation and continued through lactation were associated with reduced survival and an increased incidence of [[hydronephrosis]] in the offspring. The 10-mg/kg/day dose in rats is approximately 2.8 times the maximum recommended daily human dose (MRHD) of 32 mg on a mg/m2 basis (comparison assumes human body weight of 50 kg). Candesartan cilexetil given to pregnant rabbits at an oral dose of 3 mg/kg/day (approximately 1.7 times the MRHD on a mg/m2 basis) caused maternal toxicity (decreased body weight and death) but, in surviving dams, had no adverse effects on fetal survival, fetal weight, or external, visceral, or skeletal development. No maternal toxicity or adverse effects on fetal development were observed when oral doses up to 1000 mg of candesartan cilexetil/kg/day (approximately 138 times the MRHD on a mg/m2 basis) were administered to pregnant mice.
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| ===Morbidity in Infants===
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| Children < 1 year of age must not receive ATACAND for [[hypertension]]. Drugs that act directly on the renin-angiotensin system (RAS) can have effects on the development of immature kidneys.
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| ===hypotension===
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| ATACAND 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 ATACAND, diuretic or both, and volume repletion. Volume and/or salt depletion should be corrected before initiating therapy with ATACAND.
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| In the CHARM program (heart failure patients), [[hypotension]] was reported in 18.8% of patients on ATACAND versus 9.8% of patients on placebo. The incidence of [[hypotension]] leading to drug discontinuation in ATACAND-treated patients was 4.1% compared with 2.0% in placebo-treated patients. In the CHARM-Added program, where candesartan or placebo was given in addition to ACE inhibitors, [[hypotension]] was reported in 22.6% of patients treated with ATACAND versus 13.8% treated with placebo [see DRUG INTERACTIONS (7)].
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| Monitoring of blood pressure is recommended during dose escalation and periodically thereafter.
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| Major Surgery/Anesthesia
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| [[hypotension]] may occur during major surgery and anesthesia in patients treated with angiotensin II receptor antagonists, including ATACAND, due to blockade of the renin-angiotensin system. Very rarely, [[hypotension]] may be severe such that it may warrant the use of intravenous fluids and/or vasopressors.
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| ===Impaired Renal Function===
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| Monitor renal function periodically in patients treated with ATACAND. Changes in renal function including acute [[renal failure]] can be caused by drugs that inhibit the renin-angiotensin system. Patients whose renal function may depend, in part, on the activity of the renin-angiotensin system (e.g., patient 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]] when treated with ATACAND. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on ATACAND.
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| In the CHARM program (heart failure patients), the incidence of abnormal renal function (e.g., creatinine increase) was 12.5% in patients treated with ATACAND versus 6.3% in patients treated with placebo. The incidence of abnormal renal function (e.g., creatinine increase) leading to drug discontinuation in ATACAND-treated patients was 6.3% compared with 2.9% in placebo-treated patients. In the CHARM-Added program, where candesartan or placebo was given in addition to ACE inhibitors, the incidence of abnormal renal function (e.g., creatinine increase) was 15% in patients treated with ATACAND versus 9% in patients treated with placebo [see DRUG INTERACTIONS (7)].
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| ===Hyperkalemia===
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| Drugs that inhibit the renin-angiotensin system can cause hyperkalemia. Monitor serum potassium periodically.
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| In the CHARM program (heart failure patients), the incidence of hyperkalemia was 6.3% in patients treated with ATACAND versus 2.1% in patients treated with placebo. The incidence of hyperkalemia leading to drug discontinuation in ATACAND-treated patients was 2.4% compared with 0.6% in placebo-treated patients. In the CHARM-Added program where candesartan or placebo was given in addition to ACE inhibitors, the incidence of hyperkalemia was 9.5% in patients treated with ATACAND versus 3.5% in patients treated with placebo [see DRUG INTERACTIONS (7)].<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ATACAND (CANDESARTAN CILEXETIL) TABLET [ASTRAZENECA LP] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a73e1339-9643-4eea-2cbe-e879c88fb50e | publisher = | date = | accessdate = 20 February 2014 }}</ref>
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| ==References==
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| {{Reflist}}
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| {{Angiotensin II receptor antagonists}}
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| [[Category:Angiotensin II receptor antagonists]]
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| [[Category:Tetrazoles]]
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| [[Category:Benzimidazoles]]
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| [[Category:Ethers]]
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| [[Category:Carboxylic acids]]
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| [[Category:Biphenyls]]
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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