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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: 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
• Advise patients as to the risks of using ATACAND or ATACAND HCT during pregnancy. When pregnancy is detected, ATACAND or 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
• In hypertension, volume and/or salt depletion should be corrected in patients prior to administering ATACAND or ATACAND HCT, or symptomatic hypotension may occur
• 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
• ATACAND and ATACAND HCT should be used with caution in patients with moderate hepatic impairment
• 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
• ATACAND or ATACAND HCT generally should not be given with lithium
• Thiazide diuretics have been reported to cause acute myopia and secondary angle-closure glaucoma, and to exacerbate or activate systemic lupus erythematosus
• Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma
• Due to the thiazide component of ATACAND HCT, patients should be observed for clinical signs of fluid or electrolyte imbalance and for metabolic alterations
• Hyperuricemia may occur or acute gout may be precipitated in certain patients receiving thiazide therapy
• 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
• ATACAND - dosing for patients with hypertension:
  • In adults, the usual recommended starting dose 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
  • In pediatric patients between 1 and <6 years of age, the usual recommended starting dose is 0.20 mg/kg once-daily oral suspension with a dose range of 0.05-0.4 mg/kg per day. In pediatric patients between 6 and <17 years of age, the recommended starting dosing is based on weight (<50 kg: 4-8 mg per day and >50 kg: 8-16 mg per day)
• ATACAND - dosing for adults with heart failure:
  • In adults, the recommended initial dose is 4 mg once daily. The target dose is 32 mg once daily, which is achieved by doubling the dose at approximately 2-week intervals, as tolerated by the patient
• ATACAND HCT - dosing for adults with hypertension:
  • In adults, the usual recommended starting dose is candesartan cilexetil 16 mg, titrate to 32 mg. If uncontrolled, move to ATACAND HCT 32-12.5 and then ATACAND HCT 32-25 if needed. ATACAND HCT 16-12.5 is also available for patients uncontrolled on
    25 mg of HCT

Approved Uses 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 and ATACAND HCT, 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.

This product information is intended for US health care professionals only.

Atacand and Atacand HCT are registered trademarks of the AstraZeneca group of companies.
©2012 AstraZeneca, All rights reserved. 1104603-2299800 Last Updated 12/12

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

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