Dosing & Uses
Dosage Forms & Strengths
tablet
- 5mg
- 20mg
- 40mg
Hypertension
20 mg/day PO initially; may be increased to 40 mg/day PO after 2 weeks; a diuretic may be added
Dosing Modifications
Renal impairment
- CrCl ≥40 mL/min: No adjustment needed
- CrCl 20 mL/min to <40 mL/min: No initial adjustment necessary
- CrCl<20 mL/min: Consider lower initial dose and dose not to exceed 20 mg/day
Hepatic impairment
- Mild impairment: Dose adjustment not necessary
- Moderate to severe: Initial dose adjustment not necessary; drug exposure may increase 60% in moderate impairment
Dosing Considerations
Volume-depleted patients: Consider lower initial dosage
Also given in combination with hydrochlorothiazide (Benicar HCT)
Dosage Forms & Strengths
tablet
- 5mg
- 20mg
- 40mg
Hypertension
<6 years
- Safety and efficacy not established (see Cautions)
6-16 years
- <20 kg: Safety and efficacy not established
- 20-35 kg: 10 mg/day PO initially; after 2 weeks, may be increased if response is inadequate; dosage range: 10-20 mg/day
- >35 kg: 20 mg/day PO initially; after 2 weeks, may be increased if response is inadequate; dosage range: 20-40 mg/day; not to exceed 40 mg/day
A lower starting dosage may be used
Hypertension
5-10 mg/day PO initially; may be increased to 40 mg/day PO after 2 weeks (with monitoring of blood pressure); a diuretic may be added
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
1-10%
Dizziness
Headache
Fatigue
Diarrhea
Hyperglycemia
Hypertriglyceridemia
Back pain
Bronchitis
Inflicted injury
Flulike symptoms
Pharyngitis
Rhinitis
Sinusitis
Upper respiratory tract infection (URTI)
Frequency Not Defined (selected)
Anaphylactic reaction
Angioedema
Facial edema
Rhabdomyolysis
Hyperkalemia
Tachycardia
Hypercholesterolemia
Gastroenteritis
Hyperlipidemia
Warnings
Black Box Warnings
Discontinue as soon as possible when pregnancy is detected; drug affects renin-angiotensin system, causing oligohydramnios, which may result in fetal injury or death
Contraindications
Hypersensitivity
Do not coadminister with aliskiren in patients with diabetes mellitus or with renal impairment (ie, GFR <60 mL/min/1.73 m²)
Cautions
Use caution in congestive heart failure (CHF), surgery or anesthesia, volume depletion (consider lower dosage)
Angioedema reported; may occur at any time during treatment, especially after first dose; risk increases in patients with idiopathic or hereditary angioedema or experiencing angioedema following ACE-inhibitor therapy; prolonged monitoring of air pathways may be necessary as reactions are associated with airway obstruction; not for administration to patients with prior history of angioedema following therapy with ARBs; discontinue therapy immediately if angioedema occurs; intramuscular administration of epinephrine may be necessary to manage angioedema
Coadministration with mTOR inhibitors (eg, temsirolimus) may increase risk for angioedema
Risk of hypotension, especially in patients with volume or salt depletion secondary to salt restriction or prolonged diuretic treatment
Risk of hyperkalemia; monitor serum electrolytes periodically; use with caution, if at all and monitor potassium closely in patients with risk factors, including diabetes mellitus, renal dysfunction, potassium supplements and/or potassium containing salts
Use with caution in patients with unstented unilateral/bilateral renal artery stenosis; avoid therapy when unstented bilateral renal artery stenosis is present due to elevated risk of deterioration in renal function unless possible benefits outweigh risks
Renal impairment reported; may occur in patients with low renal blood flow (eg, heart failure, renal artery stenosis), whose glomerular filtration rate is dependent on efferent arteriolar vasoconstriction by angiotensin II, which may result in acute renal failure, oliguria, and progressive azotemia; discontinue therapy only in patients with progressive and/or significant deterioration in renal function
Use caution in patients with pre-existing renal insufficiency
Avoid use in patients with ascites resulting from cirrhosis or refractory ascites; monitor blood pressure and renal function closely if use cannot be avoided
Intestinal problems (ie, sprue-like enteropathy) reported; symptoms may include severe, chronic diarrhea with substantial weight loss; discontinue treatment and consider other antihypertensive therapy
Dual blockade of the renin-angiotensin system with angiotensin-receptor blockers (ARBs), angiotensin-converting enzyme (ACE) inhibitors, or aliskiren is associated with increased risk of hypotension, hyperkalemia, and altered renal function (including acute renal failure) in comparison with monotherapy; closely monitor blood pressure
Children <1 year of age must not receive olmesartan for hypertension; drugs that act directly on the renin-angiotensin-aldosterone system can have adverse effects on the development of immature kidneys
Pregnancy & Lactation
Pregnancy category: 1st trimester, C; 2nd and 3rd trimesters, D
Lactation: No human data; use with caution
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
Blocks binding of angiotensin II to type 1 angiotensin II receptors; blocks vasoconstrictor and aldosterone-secreting effects of angiotensin II
Absorption
Bioavailability: 26%
Onset: <2 weeks
Peak response: 4-6 weeks
Duration: 24 hr
Peak plasma time: 1-2 hr
Distribution
Protein bound: 99%
Vd: 17 L; does not cross blood-brain barrier
Metabolism
Rapidly and completely deesterified to active olmesartan in intestinal wall; no further metabolism occurs
Metabolites: RNH-6270 (deesterified olmesartan; active)
Elimination
Half-life: 13 hr
Renal clearance: 0.5-0.8 L/hr
Total body clearance: 1.3 L/hr
Excretion: Bile (50-65%), urine (35-50%)
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Formulary
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