ATACAND HCT: The Complete Profile

ATACAND HCT^® (candesartan cilexetil-hydrochlorothiazide) is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy.

• ATACAND HCT is contraindicated in patients who are hypersensitive to any component of this product. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide derived drugs

USE IN PREGNANCY: When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, ATACAND HCT should be discontinued as soon as possible. See full PI WARNINGS, Fetal/Neonatal Morbidity and Mortality.

• Symptomatic hypotension may occur in volume- and/or salt-depleted patients. Prior to administering ATACAND HCT, correct these conditions or start treatment under close medical supervision

• Due to the thiazide component, patients should be observed for clinical signs of fluid or electrolyte imbalance and for metabolic alterations

• Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus, and hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma

• ATACAND HCT generally should not be given with lithium

• ATACAND HCT is not recommended in patients with severe renal impairment and should be used with caution in patients with hepatic impairment

• While overall incidence of adverse events was similar to placebo in controlled clinical trials, some adverse events that occurred in at least 2% of patients treated with ATACAND HCT were higher than placebo, including upper respiratory infection (URI) (3.6% vs 3.0%), back pain (3.3% vs 2.4%), dizziness (2.9% vs 1.2%), and flu-like symptoms (2.5% vs 1.9%)

• Start candesartan cilexetil 16 mg, titrate to 32 mg, move to ATACAND HCT 32-12.5. ATACAND HCT 16-12.5 is also available for patients uncontrolled on 25 mg of HCT

Please see full Prescribing Information, including boxed WARNING regarding use in pregnancy.