Label Changes for:
Atacand (candesartan cilexetil) Tablets
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- Increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists, including Atacand.
- Atacand is contraindicated in patients who are hypersensitive to candesartan. Do not administer Aliskiren with Atacand in patients with diabetes.
WARNINGS AND PRECAUTIONS
- 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…
- 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.
Impaired Renal Function
- 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
- 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.
- Immunologic: Angioedema
USE IN SPECIFIC POPULATIONS
Patient Information - Who should not take Atacand?
- are diabetic and taking Aliskiren