Indicated for:

Hypertension:

• Indicated for the treatment of hypertension in adults and children 1 to < 17 years of age. It may be used alone or in combination with other antihypertensive agents.

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.

Heart Failure:

• Indicated for the treatment of heart failure (NYHA class II-IV) in adults with left ventricular systolic dysfunction (ejection fraction ≤40%) to reduce cardiovascular death and to reduce heart failure hospitalizations. ATACAND also has an added effect on these outcomes when used with an ACE inhibitor.

The usual recommended starting dose of ATACAND is 16 mg once daily when it is used as monotherapy in patients who are not volume depleted. ATACAND 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.

Doses above 0.4 mg/kg (1 to < 6 year olds) or 32 mg (6 to < 17 year olds) have not been studied in pediatric patients.

All pediatric patients with a glomerular filtration rate less than 30 ml/min/1.73m² should not receive ATACAND since ATACAND has not been studied in this population.

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.

Initiate with 8 mg ATACAND in patients with moderate hepatic insufficiency. Dosing recommendations cannot be provided for patients with severe hepatic insufficiency.

Avoid use of aliskiren with ATACAND in patients with renal impairment (GFR <60 ml/min).

If blood pressure is not controlled by ATACAND alone, a diuretic may be added. ATACAND may be administered with other antihypertensive agents.

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.

Drugs that inhibit the renin-angiotensin system can cause hyperkalemia.

Do not co-administer aliskiren with ATACAND in patients with diabetes.

ATACAND is contraindicated in patients who are hypersensitive to candesartan.

Co-administration of ATACAND with potassium sparing diuretics, potassium supplements, potassium-containing salt substitutes or other drugs that raise serum potassium levels may result in hyperkalemia.

Increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists, including ATACAND. Monitor serum lithium levels.

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including candesartan, may result in deterioration of renal function, including possible acute renal failure.

The antihypertensive effect of angiotensin II receptor antagonists, including candesartan may be attenuated by NSAIDs including selective COX-2 inhibitors.

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. Triple combination of ATACAND with an ACE-inhibitor and a mineralocorticoid receptor antagonist is generally not recommended. Closely monitor blood pressure, renal function and electrolytes in patients on ATACAND and other agents that affect the RAS.

When pregnancy is detected, discontinue ATACAND as soon as possible. Drugs that directly on the renin-angiotensin system can cause injury and death to the developing fetus.

It is not known whether candesartan is excreted in human milk, but candesartan has been shown to be present in rat milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue ATACAND, taking into account the importance of the drug to the mother.

GoToSource 

• Use in patients under the age of 1. GoToSource 

• Treatment for heart failure in patients under the age of 18. GoToSource 

• Migraine prophylaxis. GoToSource

• Reduction of proteinuria. GoToSource 

• Diabetic nephropathy. GoToSource

• Arterial hypertension, atrial fibrillation, hypertrophy obstructive or nonobstructive cardiomyopathy, renal diseases, stroke and dementia. GoToSource

• Suppress growth of gastric cancer. GoToSource

• Bronchial asthma. GoToSource

• Chronic glomerulonephritis. GoToSource

Birth defects and fetal deaths. GoToSource

Increased risk of cancer. GoToSource

Erythema multiforme (skin reaction). GoToSource

Pustular psoriasis (skin disorder). GoToSource

Hepatotoxicity (liver damage). GoToSource

Kidney failure. GoToSource

Hyperkalemia (high potassium level in blood), hypotension (low blood pressure) and angioedema (swelling in deep layers of skin). GoToSource

Lawsuits filed for fetal deaths and increased risk of cancer.