olmesartan (Rx)

Brand and Other Names:Benicar
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Dosing & Uses

AdultPediatricGeriatric

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

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Interactions

Interaction Checker

and olmesartan

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            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

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            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; initiate treatment in such patients under close medical supervision and consider starting at a lower dose

            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

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            Pregnancy & Lactation

            Pregnancy

            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 the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents

            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

            Fetal adverse reactions

            • Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters 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
            • In patients taking drug during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment
            • Fetal testing may be appropriate, based on the week of gestation
            • Patients and physicians should be aware, that oligohydramnios may not appear until after the fetus has sustained irreversible injury
            • Closely observe infants with histories of in utero exposure to drug for hypotension, oliguria, and hyperkalemia
            • In neonates with a history of in utero exposure to drug, if oliguria or hypotension occurs, utilize measures to maintain adequate blood pressure and renal perfusion
            • Exchange transfusions or dialysis may be required as a means of reversing hypotension and supporting renal function

            Animal data

            • In animal reproduction studies, treatment during organogenesis resulted in increased embryofetal toxicity in rats at doses lower than maternally toxic doses
            • Discontinue therapy as soon as possible when pregnancy detected; consider alternative antihypertensive therapy during pregnancy

            Lactation

            There is no information regarding presence of drug in human milk, effects on breastfed infant, or on milk production; drug is secreted at low concentration in milk of lactating rats; because of potential for adverse effects on nursing infant, a decision should be made whether to discontinue nursing or discontinue drug, considering importance of drug to mother

            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.

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            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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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.