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 candesartan cilexetil is 16 mg once daily when it is used as monotherapy in patients who are not volume depleted. Candesartan cilexetil 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 candesartan cilexetil.
Use in Hepatic Impairment: Initiate with 8 mg candesartan cilexetil in patients with moderate hepatic insufficiency. Dosing recommendations cannot be provided for patients with severe hepatic insufficiency [see CLINICAL PHARMACOLOGY (12.3)].
Candesartan cilexetil may be administered with or without food.
If blood pressure is not controlled by candesartan cilexetil alone, a diuretic may be added. Candesartan cilexetil may be administered with other antihypertensive agents.
2.2 Pediatric Hypertension 1 to < 17 Years of age
Candesartan cilexetil 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 candesartan cilexetil 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 candesartan cilexetil.
Children < 1 year of age must not receive candesartan cilexetil for hypertension.
All pediatric patients with a glomerular filtration rate less than 30 ml/min/1.73m2 should not receive candesartan cilexetil since candesartan cilexetil has not been studied in this population [see SPECIAL POPULATIONS (8)].
For children who cannot swallow tablets, an oral suspension may be substituted as described below:
Preparation of Oral Suspension:
Candesartan cilexetil 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 candesartan cilexetil 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 candesartan cilexetil 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®.
2.3 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.
