Candez Special Precautions

Fetal Toxicity: The use of drugs that act on the renin-angiotensin-aldosterone 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 as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimesters 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-aldosterone 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-aldosterone system for a particular patient, the mother should be informed of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue candesartan, unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. However, physicians and patients should be aware that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to candesartan for hypotension, oliguria and hyperkalemia.
Infants with history of in utero exposure to an angiotensin II receptor antagonist should be closely observed for hypotension, oliguria and hyperkalemia. If oliguria occurs, attention should be directed toward support of blood pressure and renal perfusion. Exchange transfusion or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function.
Hypotension: Observe caution when starting candesartan therapy. Carefully monitor blood pressure during initial dose titration or subsequent upward adjustment in candesartan dosage. Hypotension may occur during treatment in heart failure and hypertensive patients with intravascular volume depletion. Hypovolemia should be corrected.
Use in Heart Failure: Triple combination of candesartan with an ACE inhibitor and a mineralocorticoid receptor antagonist in heart failure is not recommended. Closely monitor blood pressure, renal function and electrolytes in patients receiving candesartan and other agents that affect the renin-angiotensin-aldosterone system.
Renal Impairment: As with other agents inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in some individuals treated with candesartan.
Periodically monitor serum potassium and creatinine levels in hypertensive patients with severe renal impairment during candesartan therapy.
Hepatic Impairment: Observe caution when administering candesartan in patients with impaired hepatic function. The elimination of candesartan may be reduced in these patients and lower doses may therefore be required.
Aortic and Mitral Valve Stenosis (Obstructive Hypertrophic Cardiomyopathy): Observe caution when administering candesartan in patients suffering from hemodynamically relevant aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy.
Anesthesia and Surgery: Hypotension due to blockage of the renin-angiotensin-aldosterone system may be observed in patients treated with angiotensin II antagonists during anesthesia and surgery. The use of intravenous fluids and/or vasopressors may be required in severe hypotension.
Renal Artery Stenosis: Drugs affecting the renin-angiotensin-aldosterone system, including angiotensin II receptor antagonists, may increase blood urea nitrogen (BUN) and serum creatinine in patients with unilateral or bilateral renal artery stenosis.
Hemodialysis: Carefully titrate candesartan and monitor blood pressure in patients on hemodialysis.
Hyperkalemia: Concomitant use of candesartan with potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g., heparin) may result in hyperkalemia.
Periodically monitor serum potassium during treatment with candesartan. The combination of candesartan with an ACE inhibitor and a potassium-sparing diuretic (e.g., spironolactone) in patients with heart failure is not recommended.
Primary Hyperaldosteronism: Patients with primary hyperaldosteronism will not generally respond to antihypertensive agents acting through inhibition of the renin-angiotensin-aldosterone system. Therefore, the use of candesartan is not recommended.
General: Treatment with drugs that affect the renin-angiotensin-aldosterone system has been associated with acute hypotension, azotemia, oliguria or, rarely, acute renal failure in patients whose vascular tone and renal function depend predominantly on the activity of this system (e.g., patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis). As with any antihypertensive agent, excessive hypotension in patients with ischemic cardiopathy or ischemic cerebrovascular disease could result in a myocardial infarction or stroke.
Effects on Ability to Drive and Use Machines: No studies have been conducted on the effects of candesartan on the ability to drive and use machines. However, dizziness or fatigue may occasionally occur when taking antihypertensives. Patients should exercise caution when driving vehicles or operating machinery.
Use in Children: The safety and efficacy of candesartan have not been established in children less than 18 years old.
Use in the Elderly: There were no age-related differences in efficacy or safety profile of candesartan, but greater sensitivity of some older individuals cannot be ruled out.