Important Safety Information

WARNING: FETAL TOXICITY When pregnancy is detected, discontinue ATACAND and ATACAND HCT as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS Adobe PDF: Fetal Toxicity.

  • ATACAND is contraindicated in patients who are hypersensitive to any component of this product
  • 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
  • Do not co-administer aliskiren with ATACAND or ATACAND HCT in patients with diabetes
  • Advise patients as to the risks of using ATACAND or ATACAND HCT during pregnancy. When pregnancy is detected, ATACAND and ATACAND HCT should be discontinued as soon as possible. Neonates with a history of in utero exposure to ATACAND or ATACAND HCT should be closely observed for hypotension, oliguria, and hyperkalemia. If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion
  • Children <1 year of age must not receive ATACAND for hypertension
  • Patients with symptomatic hypotension may require temporarily reducing the dose of ATACAND and ATACAND HCT and volume repletion. Volume and/or salt depletion should be corrected before initiating therapy with ATACAND or ATACAND HCT
  • Hypotension may occur during major surgery and anesthesia in patients treated with angiotensin II receptor antagonists including ATACAND and ATACAND HCT
  • ATACAND and ATACAND HCT should be used with caution in patients with severe renal impairment. Monitor renal function periodically in patients treated with ATACAND and ATACAND HCT. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on ATACAND and ATACAND HCT. ATACAND and ATACAND HCT should be used with caution in patients with moderate hepatic impairment
  • Drugs that inhibit the renin-angiotensin system can cause hyperkalemia. Monitor serum electrolytes periodically
  • In heart failure patients receiving ATACAND, hypotension, increases in serum creatinine, and hyperkalemia have occurred. Caution should be observed 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
  • During concomitant use of ATACAND or ATACAND HCT with NSAIDs in patients who are elderly, volume depleted, or with compromised renal function, periodic monitoring of renal function is recommended
  • Thiazide diuretics have been reported to cause acute myopia and secondary angle-closure glaucoma
  • Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma
  • The most common adverse reactions reported with ATACAND (incidence ≥2% and greater than placebo) were back pain, dizziness, upper respiratory tract infection, pharyngitis, and rhinitis
  • The most common adverse reactions reported with ATACAND HCT (incidence ≥2% and greater than placebo) were upper respiratory tract infection, back pain, flu-like symptoms, and dizziness

Indications for ATACAND and ATACAND HCT

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.

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

Please see full Prescribing Information for ATACAND Adobe PDF and ATACAND HCT Adobe PDF, including Boxed WARNING regarding fetal toxicity and use in pregnancy.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.1-800-FDA-1088.

United States FlagThis product information is intended for US health care professionals only.

Atacand and Atacand HCT are registered trademarks of the AstraZeneca group of companies. ©2016 AstraZeneca. All rights reserved. 2005404-3250804 Last Updated 6/16

TakedaManufactured under the license from Takeda Pharmaceutical Company, Ltd. by: AstraZeneca AB, S-151, 85 Södertälje, Sweden