Candesartan-Hydrochlorothiazid (candesartan cilexetil/hydrochlorothiazide)

Available as candesartan cilexetil; dosage is expressed in terms of the salt.

Dosage of hydrochlorothiazide should be individualized according to the patient's requirements and response. The lowest dosage necessary to produce the desired clinical effect should be used. If hydrochlorothiazide is added to the regimen of a patient stabilized on a potent hypotensive agent, dosage of the hypotensive agent should initially be reduced to avoid the possibility of severe hypotension.

Candesartan cilexetil is administered orally as tablets, and can be taken without regard to meals. It is also commercially available in fixed-combination tablets containing candesartan cilexetil and hydrochlorothiazide; see the full prescribing information for administration of this combination product.

Candesartan cilexetil tablets should be stored at 20-25degreesC (excursions permitted between 15-30degreesC).

For pediatric patients who cannot swallow tablets, candesartan may be administered orally as an extemporaneously prepared suspension. Candesartan cilexetil oral suspension can be extemporaneously prepared in concentrations within the range of 0.1-2 mg/mL; a concentration of 1 mg/mL generally is suitable for administering most dosages. Any strength of candesartan cilexetil tablets can be used to prepare the suspension. To prepare a suspension that will yield 160 mL of a 1-mg/mL suspension, equal volumes (80 mL each) of Ora-Plus(R) and Ora-Sweet SF(R) or, alternatively, 160 mL of Ora-Blend SF(R) should be used. A small amount of the vehicle should be added to five 32-mg candesartan cilexetil tablets and subsequently ground into a smooth paste using a mortar and pestle. The paste should then be added to a container of suitable size. The mortar and pestle should be rinsed clean using the vehicle and the resulting vehicle mixture should then be added to the container; this step should be repeated as necessary. The final amount of suspension should be prepared by adding the remaining vehicle to the container and mixing the suspension thoroughly. The suspension should be dispensed into suitably sized amber polyethylene terephthalate (PET) bottles. Each bottle of candesartan suspension should be labeled with an expiration date of 100 days and marked with the following instructions: store at room temperature (below 30degreesC), use within 30 days after first opening, do not use after the expiration date on the bottle, do not freeze, and shake well before each use.

Hydrochlorothiazide is administered orally.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Known hypersensitivity to candesartan or any ingredient in the formulation.

*Concomitant use of candesartan and aliskiren in patients with diabetes mellitus.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects occurring in 1% or more of patients receiving candesartan cilexetil for the management of hypertension and more frequently than placebo include back pain, dizziness, upper respiratory tract infection, pharyngitis, and rhinitis.

Adverse effects occurring in 1% or more of patients receiving candesartan cilexetil for the management of heart failure and more frequently than placebo include hyperkalemia, hypotension, and abnormal renal function.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

The antihypertensive effects and pharmacokinetics of candesartan have been established in pediatric patients 1 to <17 years of age.

The pharmacokinetics of candesartan in pediatric patients 1 to <17 years of age are not modified by age, sex, or body weight.

Safety and efficacy of candesartan in pediatric patients with a glomerular filtration rate <30 mL/minute per 1.73 m2 have not been established.

Candesartan must not be administered to pediatric patients <1 year of age for hypertension; drugs that act directly on the RAS can have effects on the development of immature kidneys.

Candesartan can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the RAS during the second or third trimester of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Oligohydramnios in pregnant women who use drugs affecting the RAS in the second or third trimester of pregnancy can result in reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations (including skull hypoplasia), hypotension, and death.

Discontinue candesartan as soon as possible when pregnancy is detected. In the rare case that there is no appropriate alternative therapy, apprise the mother of the potential risk to the fetus. If candesartan is taken during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment; if oligohydramnios is observed, consider alternative treatment. Oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe neonates who have been exposed to candesartan in utero for signs of hypotension, oliguria, hyperkalemia, and other signs of renal impairment. If oliguria or hypotension occurs, support blood pressure and renal perfusion. Exchange transfusions or dialysis may be required.

Candesartan is distributed into milk in rats; it is not known whether the drug is distributed into human breast milk. Because of the potential for serious adverse reactions to candesartan in breast-feeding infants, advise women not to breast-feed during treatment with candesartan.

The manufacturer states that no initial dosage modification of candesartan cilexetil is necessary in geriatric patients.

In pharmacokinetic studies of geriatric patients (>=65 years of age), the maximum serum plasma concentration and AUC of candesartan were approximately 50% and 80% higher, respectively. In clinical studies evaluating candesartan for hypertension, the antihypertensive effect was similar in patients older and younger than 65 years of age.