For US Health Care Professionals

Safety Profile for Atacand

Learn about the adverse events for Atacand and Atacand HCT in heart failure and hypertension patients.

For Atacand

The adverse-event profile of Atacand in heart failure patients was consistent with the pharmacology of the drug and the health status of the patients1

In the CHARM trials, comparing Atacand in total daily doses up to 32 mg once daily (n=3803) with placebo (n=3796), 21.0% of patients discontinued Atacand for adverse events vs 16.1% of placebo patients. Greater sensitivity of some older individuals (eg, >75 years) with heart failure must be considered.

  • Adverse events in hypertension patients
    In hypertension, the overall incidence of adverse events was similar to that of placebo in controlled clinical trials. The adverse events that occurred in at least 1% of patients treated with Atacand and at a higher incidence with Atacand than with placebo included upper respiratory infection (URI) (6% vs 4%), dizziness (4% vs 3%), back pain (3% vs 2%), pharyngitis (2% vs 1%), and rhinitis (2% vs 1%).

For Atacand HCT

Adverse events in patients taking Atacand HCT for hypertension18

While the overall incidence of adverse events was similar to that of placebo in controlled clinical trials, some adverse events that occurred in at least 2% of patients treated with Atacand HCT were higher than with 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%).

Important Safety Information for Atacand & Atacand HCT

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 and Atacand HCT should be discontinued as soon as possible. See full Prescribing Information warnings and precautions, Fetal/Neonatal Morbidity and Mortality.

  • 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
  • In heart failure patients receiving Atacand, hypotension, increases in serum creatinine, and hyperkalemia have occurred. Caution should be observed for hypotension when initiating therapy. Evaluation of patients with heart failure should always include assessment of renal function and volume status. Monitoring of blood pressure, serum creatinine, and serum potassium is recommended during drug dose escalation and periodically thereafter
  • In hypertension, volume and/or salt depletion should be corrected in adult and children patients prior to administering Atacand or Atacand HCT or symptomatic hypotension may occur
  • In patients with a history of sulfonamide or penicillin allergy, hydrochlorothiazide can cause acute transient myopia and acute angle-closure glaucoma, leading to permanent vision loss if left untreated. Atacand HCT should be discontinued
  • During concomitant use of Atacand and lithium, careful monitoring of serum lithium levels is recommended. Atacand HCT generally should not be given with lithium
  • 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 is not recommended in patients with severe renal impairment and should be used with caution in patients with hepatic impairment
  • Greater sensitivity of some older individuals (eg, >75 years) with heart failure must be considered when taking Atacand
  • The adverse-event profile of Atacand in heart failure patients was consistent with the pharmacology of the drug and the health status of the patients. In the CHARM program, comparing Atacand in total daily doses up to 32 mg once daily (n=3803) with placebo (n=3796), 21.0% of patients discontinued Atacand for adverse events vs 16.1% of placebo patients
  • In hypertension, the AEs that occurred more frequently (>1% and greater than placebo) with Atacand were upper respiratory tract infection (URI) (6% vs 4%), dizziness (4% vs 3%), back pain (3% vs 2%), pharyngitis (2% vs 1%), and rhinitis (2% vs 1%)
  • 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%)
  • The recommended initial dose for treating heart failure for Atacand is 4 mg once daily. The target dose for Atacand is 32 mg once daily, which is achieved by doubling the dose at approximately 2-week intervals, as tolerated by the patient
  • In adults with hypertension, the usual recommended starting dose for Atacand is 16 mg once daily as monotherapy in patients who are not volume depleted. Administration can be once or twice daily with total daily doses ranging from 8 to 32 mg for Atacand. Blood pressure response is dose related over the range of 2-32 mg for Atacand
  • In pediatric patients between 1 and <6 years of age with hypertension, the usual starting dose for Atacand is 0.20 mg/kg once daily with a daily dose range of 0.05-0.4 mg/kg once or twice daily. In pediatric patients between 6 and <17 years of age, the dosing is based on weight. Please see full Prescribing Information for dosage and administration
  • In adults with hypertension, 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

Indications for Atacand & Atacand HCT

Atacand is indicated for the treatment of heart failure (NYHA Class II-IV) in patients 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.

Atacand is 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. This fixed dose combination is not indicated for initial therapy.

Atacand HCT is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy.

If you would like additional information regarding AstraZeneca products, please contact the Information Center at AstraZeneca in the US at 1-800-236-9933, Monday through Friday 8 AM – 7 PM ET, excluding holidays.

Please see full Prescribing Information for Atacand and Atacand HCT, including Boxed Warning regarding use in pregnancy.