Candez Plus Special Precautions

Candesartan: Fetal/Neonatal Morbidity and Mortality: The use of drugs that act directly on the renin-angiotensin system during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function; oligohydramnios in this setting has been associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patent ductus arteriosus have also been observed, although it is not clear whether these occurrences were due to exposure to the drug.
These adverse effects do not appear to have resulted from intrauterine drug exposure that has been limited to the first trimester. Mothers whose embryos and fetuses are exposed to an angiotensin II receptor antagonist only during the first trimester should be so informed. Discontinue candesartan as soon as possible when pregnancy is detected.
If oligohydramnios is observed, candesartan should be discontinued unless it is considered life saving for the mother. Contraction stress testing (CST), a nonstress test (NST), or biophysical profiling (BPP) may be appropriate, depending upon the week of pregnancy. However, physicians and patients should be aware that oligohydramnios may not appear until after the fetus has sustained irreversible injury.
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 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.
Renal Artery Stenosis: Candesartan may increase blood urea and serum creatinine in patients with bilateral renal artery stenosis or stenosis of the artery of a solitary kidney.
Renal Disease: Periodically monitor serum potassium and creatinine levels in hypertensive patients with severe renal impairment during candesartan therapy.
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 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.
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 lead to increases in serum potassium in hypertensive patients.
Periodically monitor serum potassium in patients with heart failure during treatment with candesartan, particularly when coadministered with ACE inhibitors and potassium-sparing diuretics (e.g., spironolactone).
Primary Hyperaldosteronism: Patients with primary hyperaldosteronism will not generally respond to antihypertensive drugs 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.
Hydrochlorothiazide: Fluid/Electrolyte Imbalance: Patients should be observed for clinical signs of fluid or electrolyte imbalance (e.g., volume depletion, hyponatremia, hypochloremic alkalosis, hypomagnesemia, or hypokalemia) which may occur during intercurrent diarrhea or vomiting. Serum electrolytes should be monitored regularly.
Signs and symptoms of fluid and electrolyte imbalance include dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, confusion, seizures, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances including nausea and vomiting.
Renal Disease: Use with caution in patients with renal disease resulting in severe renal impairment because HCTZ decreases glomerular filtration rate and may precipitate azotemia.
Hepatic Disease: Use with caution in patients with hepatic disease or progressive liver disease since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Hypersensitivity Reaction: Hypersensitivity reactions to HCTZ may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history.
Systemic Lupus Erythematosus: Exacerbation or activation of systemic lupus erythematosus has been associated with the use of thiazide diuretics.
Metabolic and Endocrine Effects: Thiazide therapy may impair glucose tolerance. Dosage adjustment of antidiabetic agents, including insulin, may be required.
Thiazides may decrease urinary calcium excretion and may cause intermittent and slight elevation of serum calcium. Marked hypercalcemia may be evidence of hidden hyperparathyroidism. Discontinue thiazides before taking parathyroid function test.
Thiazide diuretic therapy may increase cholesterol and triglyceride levels.
Hyperuricemia may occur or acute gout may be precipitated in certain patients taking thiazide therapy.
Candesartan-HCTZ: Hypotension in Volume- and Salt-depleted Patients: Excessive blood pressure reduction was rarely observed in patients with uncomplicated hypertension taking candesartan-HCTZ combination. Symptomatic hypotension may be observed after starting antihypertensive therapy in patients with intravascular volume- and salt-depletion (e.g., patients on dialysis or treated vigorously with diuretics). These conditions should be corrected before taking candesartan-HCTZ or treatment should be under the strict supervision of a physician.
Use in Children: Safety and effectiveness in children have not been established.
Use in Elderly: There were no notable differences in efficacy or the incidence of adverse events between older and younger patients.