Dosing & Uses
Dosage Forms & Strengths
tablet
- 4mg
- 8mg
- 16mg
- 32mg
Hypertension
16 mg PO qDay, titrate to 8-32 mg PO qDay OR divided q12hr
CHF (NYHA Class II-IV & Ejection Fraction <40%)
Initial 4 mg PO qDay; double dose q2Weeks up to 32 mg PO qDay
Renal Impairment
No dose adjustment necessary for patients with mild renal impairment
Initiate therapy at lower dose if moderate renal impairment
Hepatic Insufficiency
Mild Impairment: No dosage adjustment
Moderate Impairment: Consider initiating at lower dose
Severe Impairment: Contraindicated
Dosage Forms & Strengths
tablet
- 4mg
- 8mg
- 16mg
- 32mg
Hypertension
1-6 Years
- Usual starting dose: 0.2 mg/kg PO qDay or divided q12hr
- Dosing Range: 0.05-0.4 mg/kg/day PO
- Refer to manufacturer's recommendations for suspension preparation
6-17 Years (<50 kg)
- Usual starting dose: 4-8 mg/day PO
- Dosing Range: Titrate within 2 weeks to dose range 2-16 mg/day PO; not to exceed 32 mg/day
6-17 Years (>50 kg)
- Usual starting dose: 8-16 mg/day PO
- Dosing Range: Titrate within 2 weeks to dose range 4-32 mg/day PO; not to exceed 32 mg/day
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Adverse Effects
Frequency Not Defined
Peripheral edema
Dizziness
Hypertriglyceridemia
Hyperuricemia
Fatigue
Abdominal pain
Diarrhea
Nausea
Arthralgia
Back pain
Chest pain
Angina
Tachycardia
MI
Palpitation
Albuminuria
Bronchitis
Coughing
Pharyngitis
Dyspepsia
Gastroenteritis
Rhinitis
URI
Rash
Angioedema
Postmarketing Reports
Digestive: Abnormal hepatic function and hepatitis
Hematologic: Neutropenia, leukopenia, and agranulocytosis
Immunologic: Angioedema
Metabolic and nutritional disorders: Hyperkalemia, hyponatremia
Respiratory system disorders: Cough
Skin and appendages disorders: Pruritus, rash and urticaria
Rare reports of rhabdomyolysis have been reported with ARBs
Warnings
Black Box Warnings
Discontinue as soon as possible when pregnancy is detected; affects renin-angiotensin system causing oligohydramnios, which may result in fetal injury and/or death
Contraindications
Hypersensitivity
Severe hepatic impairment
Do not coadminister with aliskiren in patients with diabetes
Cautions
History of angioedema
Hypovolemia
Risk of hypotension, especially in hypovolemic/hyponatremic patients, concomitant diuretics, dialysis, or during major surgery
Renal deterioration may occur
Discontinue immediately with pregnancy (see Black Box Warnings)
Caution in patients with CHF; may need to adjust dose
Hyperkalemia may occur with renal failure or drugs that increase potassium levels; monitor serum potassium levels periodically
Dual blockade of the renin angiotensin system with ARBs, ACE inhibitors, or aliskiren associated with increased risk for renal function changes (including acute renal failure) compared to monotherapy
Risk of anaphylactoid reactions and/or angioedema
Caution in hepatic impairment, hypercholesterolemia, hypercalcemia, parathyroid disease, pre-existing renal insufficiency, systemic lupus erythematosus, anuria
Caution in patients with aortic/mitral stenosis
Caution in patients with unstented unilateral/bilateral artery stenosis
Infants <1year must not receive candesartan; may have effects on the development of immature kidneys
In-utero exposure in neonates: If oliguria or hypotension occur, exchange transfusions or dialysis may be required to reverse hypotension and/or substitute for disordered renal function
Pregnancy & Lactation
Pregnancy
Therapy can cause fetal harm when administered to a pregnant woman; use of drugs that act on renin-angiotensin system during second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death
Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents;
when pregnancy is detected, discontinue drug as soon as possible
Disease-associated maternal/embryo/fetal risk
- Hypertension in pregnancy increases maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage)
- Hypertension increases fetal risk for intrauterine growth restriction and intrauterine death; pregnant women with hypertension should be carefully monitored and managed accordingly
- Pregnant women with chronic heart failure are at increased risk for preterm birth; stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester
- Heart failure may worsen with pregnancy and may lead to maternal death; closely monitor pregnant patients for destabilization of their heart failure
- Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension and death
- In the unusual case that there is no appropriate alternative to therapy with drugs affecting renin-angiotensin system for a particular patient, apprise the mother of the potential risk to fetus
- Perform serial ultrasound examinations to assess intra-amniotic environment; fetal testing may be appropriate, based on the week of pregnancy; patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury; if oligohydramnios is observed, consider alternative drug treatment
- Closely observe infants with histories of in utero exposure to drug for hypotension, oliguria, hyperkalemia or other symptoms of renal impairment; in neonates with a history of in utero exposure, if oliguria or hypotension occurs, support blood pressure and renal perfusion; exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function
Lactation
Not known whether drug is excreted in human milk, but shown to be present in rat milk; because of potential for serious adverse reactions in breastfed infants, advise a nursing woman that breastfeeding is not recommended during therapy
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Angiotensin II receptor blocker (ARB); prevents angiotensin II from binding to its receptor, which in turn blocks the vasoconstriction and aldosterone secreting effects of angiotensin II.
Pharmacokinetics
Half-Life: 5-9 hr
Peak Plasma Time: 3-4 hr
Metabolism: Liver (minimal)
Excretion: Urine (26%)
Dialyzable: No (HD)
Bioavailability: 15%
Onset of action: 2-3 hr
Peak effect: 6-8hr
Duration: >24hr
Vd: 0.13 L/kg
Protein binding: >99%
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Formulary
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