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 thearpy 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
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 Category: D
Discontinue as soon as pregnancy detected; during the second and third trimesters of pregnancy, drugs that act directly on the renin-angiotensin have been associated with fetal injury that includes hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death
Lactation: Not known if excreted in breast milk; not recommended
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%
Images
Patient Handout
Formulary
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