HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ATACAND safely and effectively. See full prescribing information for ATACAND.
ATACAND® (candesartan cilexetil) TABLETS
INITIAL U.S. APPROVAL: 1998
WARNING: USE IN PREGNANCY: See Full Prescribing Information for complete boxed warning.
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 should be discontinued as soon as possible. See WARNINGS AND PRECAUTIONS, Fetal/Neonatal Morbidity and Mortality (5.1).
RECENT MAJOR CHANGES
Dosage and Administration: pediatric hypertension 1 to < 17 years of age (2.2). 10/2009
INDICATIONS AND USAGE
ATACAND is an angiotensin II receptor blocker (ARB) indicated for:
· Treatment of hypertension in adults and children 1 to < 17 years of age (1.1).
· Treatment of heart failure (NYHA class II-IV); ATACAND reduces cardiovascular death and heart failure hospitalization (1.2).
DOSAGE AND ADMINISTRATION
Starting Dose
Dose Range
Target Maintenance Dose
Adult Hypertension (2.1)
16 mg tablet once daily
8 - 32 mg tablet total daily dose
–
Pediatric Hypertension (1 to < 6 years) (2.2)
0.20 mg/kg oral suspension once daily
0.05 - 0.4 mg/kg oral suspension once daily or consider divided dose
-
Pediatric Hypertension (6 to < 17 years) (2.2)
< 50 kg 4 – 8 mg tablet once daily
> 50 kg 8 – 16 mg tablet once daily
< 50 kg 4 – 16 mg tablet once daily or consider divided dose
> 50 kg 4 – 32 mg tablet once daily or consider divided dose
–
Adult Heart Failure (2.3)
4 mg tablet once daily
32 mg tablet once daily
DOSAGE FORMS AND STRENGTHS
Tablets 4 mg, 8 mg, 16 mg, 32 mg (3).
CONTRAINDICATIONS
Known hypersensitivity to product components (4).
WARNINGS AND PRECAUTIONS
·Avoid fetal (in utero) and neonatal exposure (5.1).
·Children < 1 year of age must not receive ATACAND for hypertension (5.2).
·Observe for signs and symptoms of hypotension (5.3).
·Use with caution in patients with impaired hepatic (5.4) or renal (5.5) function.
·Hyperkalemia may occur in heart failure patients treated with ATACAND (5.6).
ADVERSE REACTIONS
·Most common adverse reactions which caused adult patients to discontinue therapy for:
·Hypertension were headache (0.6%) and dizziness (0.3%) (6.1).
·Heart Failure were hypotension (4.1%) (5.3), abnormal renal function (6.3%) (5.5), and hyperkalemia (2.4%) (5.6).
·Most common adverse reactions (incidence ≥ 2% and greater than placebo) are back pain, dizziness, upper respiratory tract infection, pharyngitis and rhinitis (6.1).
To report SUSPECTED ADVERSE REACTIONS contact AstraZeneca LP at 1–800–236–9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
·Lithium: Reversible increases in serum lithium concentrations and toxicity (7).
USE IN SPECIFIC POPULATIONS
·Nursing Mothers: Either nursing or drug should be discontinued (8.3).
·Pediatrics: Children < 1 year of age must not receive ATACAND for hypertension (5.2). Inhibitors of the renin-angiotensin system can cause renal abnormalities in neonatal animals (12.3).
·Geriatrics: No overall difference in efficacy or safety vs. younger adult patients, but greater sensitivity of some older individuals cannot be ruled out (8.5).
See 17 for PATIENT COUNSELING INFORMATION
Revised: 10/2009
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Back to Highlights and TabsFULL PRESCRIBING INFORMATION: CONTENTS*
*Sections or subsections omitted from the full prescribing information are not listed
WARNING: USE IN PREGNANCY:
Recent Major Changes
1 INDICATIONS AND USAGE
1.1 Hypertension
1.2 Heart Failure
2 DOSAGE AND ADMINISTRATION
2.1 Adult Hypertension
2.2 Pediatric Hypertension 1 to < 17 Years of age
2.3 Adult Heart Failure
3 DOSAGE FORMS and STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Fetal/Neonatal Morbidity and Mortality
5.2 Morbidity in Infants
5.3 Hypotension
5.4 Impaired Hepatic Function
5.5 Renal Function Deterioration
5.6 Hyperkalemia
6 ADVERSE REACTIONS
6.1 Clinical Studies Experience
6.2 Postmarketing Experience
6.3 Laboratory Test Findings
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Hypertension
14.2 Heart Failure
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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FULL PRESCRIBING INFORMATION
WARNING: 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 should be discontinued as soon as possible [see WARNINGS AND PRECAUTIONS, Fetal/Neonatal Morbidity and Mortality (5.1)].
1 INDICATIONS AND USAGE
1.1 Hypertension
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.
1.2 Heart Failure
ATACAND is indicated for the treatment of heart failure (NYHA class II-IV) in adults with left ventricular systolic dysfunction (ejection fraction ≤ 40%) to reduce cardiovascular death and to reduce heart failure hospitalizations [see CLINICAL STUDIES (14.2)]. ATACAND also has an added effect on these outcomes when used with an ACE inhibitor.
2 DOSAGE AND ADMINISTRATION
2.1 Adult Hypertension
Dosage must be individualized. Blood pressure response is dose related over the range of 2 to 32 mg. The usual recommended starting dose of ATACAND is 16 mg once daily when it is used as monotherapy in patients who are not volume depleted. ATACAND can be administered once or twice daily with total daily doses ranging from 8 mg to 32 mg. Larger doses do not appear to have a greater effect, and there is relatively little experience with such doses. Most of the antihypertensive effect is present within 2 weeks, and maximal blood pressure reduction is generally obtained within 4 to 6 weeks of treatment with ATACAND.
No initial dosage adjustment is necessary for elderly patients, for patients with mildly impaired renal function, or for patients with mildly impaired hepatic function [see CLINICAL PHARMACOLOGY (12.3)]. In patients with moderate hepatic impairment, consideration should be given to initiation of ATACAND at a lower dose [see CLINICAL PHARMACOLOGY (12.3)]. For patients with possible depletion of intravascular volume (eg, patients treated with diuretics, particularly those with impaired renal function), ATACAND should be initiated under close medical supervision and consideration should be given to administration of a lower dose [see WARNINGS AND PRECAUTIONS (5.3)].
ATACAND may be administered with or without food.
If blood pressure is not controlled by ATACAND alone, a diuretic may be added. ATACAND may be administered with other antihypertensive agents.
2.2 Pediatric Hypertension 1 to < 17 Years of age
ATACAND may be administered once daily or divided into two equal doses. Adjust the dosage according to blood pressure response. For patients with possible depletion of intravascular volume (e.g., patients treated with diuretics, particularly those with impaired renal function), initiate ATACAND under close medical supervision and consider administration of a lower dose [see WARNINGS AND PRECAUTIONS (5.3)].
Children 1 to < 6 years of age:
The dose range is 0.05 to 0.4 mg/kg per day. The recommended starting dose is 0.20 mg/kg (oral suspension).
Children 6 to < 17 years of age:
For those less than 50 kg, the dose range is 2 to 16 mg per day. The recommended starting dose is 4 to 8 mg.
For those greater than 50 kg, the dose range is 4 to 32 mg per day. The recommended starting dose is 8 to 16 mg.
Doses above 0.4 mg/kg (1 to < 6 year olds) or 32 mg (6 to < 17 year olds) have not been studied in pediatric patients [see CLINICAL STUDIES (14.1)].
An antihypertensive effect is usually present within 2 weeks, with full effect generally obtained within 4 weeks of treatment with ATACAND.
Children < 1 year of age must not receive ATACAND for hypertension.
All pediatric patients with a glomerular filtration rate less than 30 ml/min/1.73m2 should not receive ATACAND since ATACAND has not been studied in this population [see WARNINGS AND PRECAUTIONS (5.2)].
For children who cannot swallow tablets, an oral suspension may be substituted [see Preparation of Oral Suspension].
Preparation of Oral Suspension:
ATACAND oral suspension can be prepared in concentrations within the range of 0.1 to 2.0 mg/mL. Typically, a concentration of 1 mg/mL will be suitable for the prescribed dose. Any strength of ATACAND tablets can be used in the preparation of the suspension.
