Atacand

Generic Name: candesartan cilexetil
Dosage Form: tablet

FULL PRESCRIBING INFORMATION

Indications and Usage for Atacand

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.

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.

Atacand Dosage and Administration

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.

 Follow the steps below for preparation of the suspension. The number of tablets and volume of vehicle specified below will yield 160 mL of a 1 mg/mL suspension.

 · Prepare the vehicle by adding equal volumes of *Ora-Plus® (80 mL) and *Ora-Sweet SF® (80 mL) or, alternatively, use *,†Ora-Blend SF® (160 mL).

 · Add a small amount of vehicle to the required number of Atacand tablets (five 32 mg tablets) and grind into a smooth paste using a mortar and pestle.

 · Add the paste to a preparation vessel of suitable size.

 · Rinse the mortar and pestle clean using the vehicle and add this to the vessel. Repeat, if necessary.

 · Prepare the final volume by adding the remaining vehicle.

 · Mix thoroughly.

 · Dispense into suitably sized amber PET bottles.

 · Label with an expiry date of 100 days and include the following instructions:

 Store at room temperature (below 30°C/86°F). Use within 30 days after first opening. Do not use after the expiry date stated on the bottle.

 Do not freeze.

 Shake well before each use.

 *Ora-Plus®, Ora-Sweet SF®, and Ora-Blend SF® are registered trademarks of Paddock Laboratories, Inc.

 †Supplied as a 50/50% pre-mix of Ora-Plus® and Ora-Sweet SF®.

Adult Heart Failure

The recommended initial dose for treating heart failure 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.

DOSAGE FORMS and STRENGTHS

4 mg are white to off-white, circular/biconvex-shaped, non-film-coated scored tablets, coded ACF on one side and 004 on the other.

8 mg are light pink, circular/biconvex-shaped, non-film-coated scored tablets, coded ACG on one side and 008 on the other.

16 mg are pink, circular/biconvex-shaped, non-film-coated scored tablets, coded ACH on one side and 016 on the other.

32 mg are pink, circular/biconvex-shaped, non-film-coated scored tablets, coded ACL on one side and 032 on the other.

Patient Counseling Information

Pregnancy – Female patients of childbearing age should be told about the consequences of second- and third-trimester exposure to drugs that act on the renin-angiotensin system, and they should also be told that these consequences do not appear to have resulted from intrauterine drug exposure that has been limited to the first trimester. These patients should be asked to report pregnancies to their physicians as soon as possible.

Post-menarche adolescents should be questioned on a regular basis as to changes in menstrual pattern and the possibility of pregnancy.

Manufactured under the license

from Takeda Pharmaceutical Company, Ltd.

by: AstraZeneca AB, S-151 85 Södertälje, Sweden

for: AstraZeneca LP, Wilmington, DE 19850

Made in Sweden

Rev. 10/09

Atacand is a trademark of the AstraZeneca group of companies.

©AstraZeneca 2009

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Atacand is an angiotensin II receptor blocker (ARB). It works by relaxing blood vessels. This helps to lower blood pressure.This information is a summary only. It does not contain all information about Atacand . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.