Usual Adult Dose for Hypertension

Candesartan 16 to 32 mg-Hydrochlorothiazide 12.5 to 50 mg orally daily in 1 to 2 divided doses

Comments:

• The recommended starting dose of candesartan is 16 mg orally once a day when used as monotherapy in patients who are not volume depleted; doses larger than 32 mg do not appear to have a greater blood pressure lowering effect.
• A patient whose blood pressure remains uncontrolled on candesartan 32 mg can expect an incremental effect from candesartan 32 mg-hydrochlorothiazide 12.5 mg
• A patient whose blood pressure remains uncontrolled on hydrochlorothiazide 25 mg can expect an incremental effect from candesartan 16 mg-hydrochlorothiazide 12.5 mg; a patient whose blood pressure is controlled on hydrochlorothiazide 25 mg but is experiencing decreases in serum potassium can expect the same or incremental blood pressure effects from candesartan 16 mg-hydrochlorothiazide 12.5 mg and serum potassium may improve.
• Maximal antihypertensive effect can be expected within 4 weeks of treatment initiation.

Renal Dose Adjustments

Mild to moderate renal dysfunction (CrCl 30 to 90 mL/min): No adjustment recommended
Severe renal dysfunction (CrCl 30 mL/min or less): Safety and effectiveness have not been established

Liver Dose Adjustments

Mild liver dysfunction (Child-Pugh A): No adjustment recommended
Moderate to severe liver dysfunction (Child-Pugh B and C): Not recommended for initiation due to commercially unavailable dose

Precautions

US BOXED WARNING:

• FETAL TOXICITY: If pregnancy is detected, discontinue this drug as soon as possible. Drugs that act directly on the renin angiotensin system (RAS) can cause injury and death to the developing fetus.

Dialysis

Data not available

Other Comments

Administration advice: Administer with or without food.

General: Overall response to this drug was similar in black and non-black patients.

Monitoring:

• Monitor serum electrolytes and renal function periodically.
• Monitor congestive heart failure patients closely for the first 2 weeks of treatment with this drug and following a dose increase of candesartan or a diuretic.
• Monitor patients with impaired hepatic function since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

• Females of childbearing age should be informed of the consequences of exposure to this drug during pregnancy; ask these patients to report pregnancies as soon as possible.
• Encourage patients to report any lightheadedness that may occur during treatment initiation and to stop taking this drug until consulting a physician if syncope occurs.
• Dehydration may lead to excess blood pressure reduction; inform patients to contact their healthcare provider if they experience excessive perspiration, vomiting, or diarrhea.