Candesartan Cilexetil

Candesartan Cilexetil Manufacturers

• American Health Packaging.
  

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  Candesartan Cilexetil | American Health Packaging.

  

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  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.

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• American Health Packaging
  

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  Candesartan Cilexetil | American Health Packaging

  

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  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 tablets is 16 mg once daily when it is used as monotherapy in patients who are not volume depleted. Candesartan cilexetil tablets 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 tablets.

  Use in Hepatic Impairment: Initiate with 8 mg candesartan cilexetil tablets in patients with moderate hepatic insufficiency. Dosing recommendations cannot be provided for patients with severe hepatic insufficiency [see CLINICAL PHARMACOLOGY (12.3)].

  Candesartan cilexetil tablets may be administered with or without food.

  If blood pressure is not controlled by candesartan cilexetil tablets alone, a diuretic may be added. Candesartan cilexetil tablets may be administered with other antihypertensive agents.

  2.2 Pediatric Hypertension 1 to < 17 Years of age

  Candesartan cilexetil tablets 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 tablets 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 tablets.

  Children < 1 year of age must not receive candesartan cilexetil tablets for hypertension.

  All pediatric patients with a glomerular filtration rate less than 30 mL/min/1.73m2 should not receive candesartan cilexetil tablets since candesartan cilexetil tablets have 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 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 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature]. 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.

  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.

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• Sandoz Inc
  

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  Candesartan Cilexetil | Sandoz Inc

  

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  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 tablets is 16 mg once daily when it is used as monotherapy in patients who are not volume depleted. Candesartan cilexetil tablets 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 tablets.

  Use in Hepatic Impairment: Initiate with 8 mg candesartan cilexetil tablets in patients with moderate hepatic insufficiency. Dosing recommendations cannot be provided for patients with severe hepatic insufficiency [see CLINICAL PHARMACOLOGY (12.3)].

  Candesartan cilexetil tablets may be administered with or without food.

  If blood pressure is not controlled by candesartan cilexetil tablets alone, a diuretic may be added. Candesartan cilexetil tablets may be administered with other antihypertensive agents.

  2.2 Pediatric Hypertension 1 to < 17 Years of age

  Candesartan cilexetil tablets 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 tablets 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 [seeCLINICAL 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 tablets.

  Children < 1 year of age must not receive candesartan cilexetil tablets for hypertension.

  All pediatric patients with a glomerular filtration rate less than 30 ml/min/1.73m2 should not receive candesartan cilexetil tablets since candesartan cilexetil tablets have 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 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 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature]. 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.

  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.

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• Par Pharmaceutical Inc.
  

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  Candesartan Cilexetil | Zydus Pharmaceuticals (usa) Inc.

  

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  Under no circumstances should ribavirin capsules be opened, crushed, or broken. Ribavirin capsules should be taken with food [see Clinical Pharmacology (12.3)]. Ribavirin capsules should not be used in patients with creatinine clearance less than 50 mL/min.

  2.2 Ribavirin capsules /INTRON A Combination Therapy

  Adults

  Duration of Treatment – Interferon Alpha-nave Patients

  The recommended dose of INTRON A is 3 million IU three times weekly subcutaneously. The recommended dose of ribavirin capsules depends on the patient's body weight (refer to Table 3). The recommended duration of treatment for patients previously untreated with interferon is 24 to 48 weeks. The duration of treatment should be individualized to the patient depending on baseline disease characteristics, response to therapy, and tolerability of the regimen [see Indications and Usage (1.1), and Clinical Studies (14)]. After 24 weeks of treatment, virologic response should be assessed. Treatment discontinuation should be considered in any patient who has not achieved an HCV-RNA below the limit of detection of the assay by 24 weeks. There are no safety and efficacy data on treatment for longer than 48 weeks in the previously untreated patient population.

  Duration of Treatment – Re-treatment with INTRON A/ribavirin capsules in Relapse Patients

  In patients who relapse following nonpegylated interferon monotherapy, the recommended duration of treatment is 24 weeks.

  Table 3Recommended Dosing Body Weight 
  Ribavirin Capsules  
  ≤ 75 kg 
  2 x 200 mg capsules AM
  3 x 200 mg capsules PM
  daily orally
  > 75 kg 
  3 x 200 mg capsules AM
  3 x 200 mg capsules PM
  daily orally
  

  Pediatrics

  The recommended dose of ribavirin is 15 mg/kg per day orally (divided dose AM and PM). INTRON A for Injection by body weight of 25 kg to 61 kg is 3 million IU/m2 three times weekly subcutaneously. The recommended duration of treatment is 48 weeks for pediatric patients with genotype 1. After 24 weeks of treatment, virologic response should be assessed. Treatment discontinuation should be considered in any patient who has not achieved an HCV-RNA below the limit of detection of the assay by this time. The recommended duration of treatment for pediatric patients with genotype 2/3 is 24 weeks.

  2.3 Laboratory Tests

  The following laboratory tests are recommended for all patients treated with ribavirin capsules, prior to beginning treatment and then periodically thereafter.

  Standard hematologic tests - including hemoglobin (pretreatment, Week 2 and Week 4 of therapy, and as clinically appropriate [see Warnings and Precautions (5.2, 5.7) ], complete and differential white blood cell counts, and platelet count. Blood chemistries - liver function tests and TSH. Pregnancy - including monthly monitoring for women of childbearing potential. ECG [see  Warnings and Precautions (5.2) ].   2.4 Dose Modifications

  If severe adverse reactions or laboratory abnormalities develop during combination ribavirin capsules/INTRON A therapy, modify, or discontinue the dose until the adverse reaction abates or decreases in severity [see Warnings and Precautions (5)]. If intolerance persists after dose adjustment, combination therapy should be discontinued.

   

  Ribavirin capsules should not be used in patients with creatinine clearance <   50 mL/min. Patients with impaired renal function and those over the age of 50 should be carefully monitored with respect to development of anemia [see Warnings and Precautions (5.2), Use In Specific Populations (8.5), and Clinical Pharmacology (12.3)]. 

  Ribavirin capsules should be administered with caution to patients with pre-existing cardiac disease. Patients should be assessed before commencement of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be stopped [see Warnings and Precautions (5.2)]. 

  For patients with a history of stable cardiovascular disease, a permanent dose reduction is required if the hemoglobin decreases by greater than or equal to 2 g/dL during any 4-week period. In addition, for these cardiac history patients, if the hemoglobin remains less than 12 g/dL after 4 weeks on a reduced dose, the patient should discontinue combination therapy.

  It is recommended that a patient whose hemoglobin level falls below 10 g/dL have his/her ribavirin capsules dose modified or discontinued per Table 4 [see Warnings and Precautions (5.2)]. 

  Table 4Guidelines for Dose Modification and Discontinuation of Ribavirin Capsules in combination with INTRON A Based on Laboratory Parameters in Adults and Pediatrics

  Note 1: Adult patients: 1st dose reduction of ribavirin is by 200 mg/day (except in patients receiving the 1,400 mg, dose reduction should be by 400 mg/day). If needed, 2nd dose reduction of ribavirin is by an additional 200 mg/day. Patients whose dose of ribavirin is reduced to 600 mg daily receive one 200 mg capsule in the morning and two 200 mg capsules in the evening.
  

  Pediatric patients: 1st dose reduction of ribavirin is to 12 mg/kg/day, 2nd dose reduction of ribavirin is to 8 mg/kg/day.
  

  Note 2: For patients on Ribavirin Capsules/INTRON A combination therapy: reduce INTRON A dose by 50%.
  

  *Pediatric patients who have pre-existing cardiac conditions and experience a hemoglobin decrease greater than or equal to 2 g/dL during any 4 week period during treatment should have weekly evaluations and hematology testing.
  

  †These guidelines are for patients with stable cardiac disease.
  

  Laboratory Parameters 
  Reduce Ribavirin Capsules Daily Dose
  (see note 1) if:
  Reduce INTRON A Dose
  (see note 2) if:
  Discontinue Therapy if:
  WBC 
  N/A
  1 to < 1.5 x 109/L
  < 1 x 109/L
  Neutrophils 
  N/A
  0.5 to < 0.75 x 109/L
  < 0.5 x 109/L
  Platelets 
  N/A
  25 to < 50 x 109 /L (adults)
  < 25 x 109/L (adults)
  
  N/A
  50 to < 70 x 109/L (pediatrics)
  < 50 x 109/L (pediatrics)
  Creatinine  
  N/A
  N/A
  > 2 mg/dL (pediatrics)
  Hemoglobin in patients without history of cardiac disease 
  8.5 to < 10 g/dL
  N/A
  < 8.5 g/dL
  
  Reduce Ribavirin Capsules Dose by 200 mg/day and INTRON A Dose by Half if: 
  
  Hemoglobin in patients with  history of stable cardiac disease*† 
  ≥ 2 g/dL decrease in hemoglobin during any four week period during treatment 
  < 8.5 g/dL or < 12 g/dL after four weeks of dose reduction 
  

  Refer to labeling for INTRON A for additional information about how to reduce an INTRON A dose.

  2.5 Discontinuation of Dosing

  Adults

  Regardless of genotype, previously treated patients who have detectable HCV-RNA at week 12 or 24 are highly unlikely to achieve SVR and discontinuation of therapy should be considered.

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• Apotex Corp
  

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  Candesartan Cilexetil | Johnson & Johnson Consumer Products Company, Division Of Johnson & Johnson Consumer Companies, Inc.

  

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  Moisten face and pump AVEENO® Clear Complexion Foaming Cleanser into your hand or cloth. Massage lather over your face. Rinse and pat dry.

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• Carilion Materials Management
  

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  Candesartan Cilexetil | Carilion Materials Management

  

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  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 tablets is 16 mg once daily when it is used as monotherapy in patients who are not volume depleted. Candesartan cilexetil tablets 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 tablets.

  Use in Hepatic Impairment: Initiate with 8 mg candesartan cilexetil tablets in patients with moderate hepatic insufficiency. Dosing recommendations cannot be provided for patients with severe hepatic insufficiency [see ]. CLINICAL PHARMACOLOGY ( ) 12.3

  Candesartan cilexetil tablets may be administered with or without food.

  If blood pressure is not controlled by candesartan cilexetil tablets alone, a diuretic may be added. Candesartan cilexetil tablets may be administered with other antihypertensive agents.

  2.2 Pediatric Hypertension 1 to < 17 Years of age

  Candesartan cilexetil tablets 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 tablets 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 tablets.

  Children < 1 year of age must not receive candesartan cilexetil tablets for hypertension.

  All pediatric patients with a glomerular filtration rate less than 30 ml/min/1.73m should not receive candesartan cilexetil tablets since candesartan cilexetil tablets have not been studied in this population [see ]. 2SPECIAL 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 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 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature]. 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.

  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.

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• American Health Packaging
  

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  Candesartan Cilexetil | American Health Packaging

  

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  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.

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• American Health Packaging
  

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  Candesartan Cilexetil | American Health Packaging

  

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  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 tablets is 16 mg once daily when it is used as monotherapy in patients who are not volume depleted. Candesartan cilexetil tablets 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 tablets.

  Use in Hepatic Impairment: Initiate with 8 mg candesartan cilexetil tablets in patients with moderate hepatic insufficiency. Dosing recommendations cannot be provided for patients with severe hepatic insufficiency [see CLINICAL PHARMACOLOGY (12.3)].

  Candesartan cilexetil tablets may be administered with or without food.

  If blood pressure is not controlled by candesartan cilexetil tablets alone, a diuretic may be added. Candesartan cilexetil tablets may be administered with other antihypertensive agents.

  2.2 Pediatric Hypertension 1 to < 17 Years of age

  Candesartan cilexetil tablets 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 tablets 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 tablets.

  Children < 1 year of age must not receive candesartan cilexetil tablets for hypertension.

  All pediatric patients with a glomerular filtration rate less than 30 ml/min/1.73m2 should not receive candesartan cilexetil tablets since candesartan cilexetil tablets have 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 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 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature]. 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.

  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.

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