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olmesartan/amlodipine/hydrochlorothiazide (Rx)Brand and Other Names:Tribenzor

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosing Form & Strengths

olmesartan/amlodipine/hydrochlorothiazide

tablet

  • 20mg/5mg/12.5mg
  • 40mg/5mg/12.5mg
  • 40mg/5mg/25mg
  • 40mg/10mg/12.5mg
  • 40mg/10mg/25mg

Hypertension

Indicated treatment of hypertension in patients who have been previously titrated on the individual components, olmesartan, amlodipine, and hydrochlorothiazide

May be used as add-on/switch therapy to provide additional blood pressure lowering for patient not adequately controlled on agents from 2 of the antihypertensive classes (ie, ARBs, CCBs, diuretics)

Not for initial therapy

Administer once daily

Add-on/switch/replacement therapy: 5-10 mg amlodipine, 20-40 mg olmesartan, 12.5-25 mg hydrochlorothiazide daily; dosage may be increased at 2-week intervals; titrate by increasing 1 component at a time; not to exceed 40 mg olmesartan/10 mg amlodipine/25 mg hydrochlorothiazide qDay

Renal Impairment

CrCl >30 mL/min: No dosage adjustment required

CrCl 30 mL/min or less: Avoid use; loop diuretics are preferred to thiazides with severe renal impairment; thiazides may precipitate azotemia

CrCl 20 mL/min or less: Olmesartan AUC approximately tripled

Hepatic Impairment

Mild-to-moderate impairment: Use caution; not studied

Severe hepatic impairment: Do not use; requires starting amlodipine at 2.5 mg, which is not available with Tribenzor

Safety and efficacy not established

No overall differences in efficacy or safety observed in elderly; however, greater sensitivity of some older individuals cannot be ruled out

>75 years: Do not use; severe hepatic impairment requires starting amlodipine at 2.5 mg, which is not available with combination product Tribenzor

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Interactions

Interaction Checker

olmesartan/amlodipine/hydrochlorothiazide and

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    Contraindicated

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            Adverse Effects

            1-10%

            Dizziness (5.8-8.9%)

            Peripheral edema (7.7%)

            Fatigue (4%)

            Headache (6.4%)

            Nausea (3%)

            Muscle spasms (3.1%)

            Nausea (3%)

            Diarrhea (2.6%)

            Joint swelling (2.1%)

            Syncope (1%)

            Urinary tract infection (2%)

            Nasopharyngitis (4%)

            Upper respiratory tract infection (3%)

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            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 to any drug component or sulfonamide-derived drug

            Anuria

            Condomitant use with aliskiren in patients with diabetes mellitus

            Pregnancy (2nd and 3rd trimesters): significant risk of fetal/neonatal morbidity and mortality

            Cautions

            Angioedema, severe CHF, surgery/anesthesia, volume depletion (consider lower dose)

            Discontinue STAT if pregnant: potential risk of congenital malformations (see Black Box Warnings)

            Risk of hypotension, especially in patients with volume/salt depletion; correct volume-depletion prior to administration

            Increased angina or myocardial infarction with calcium channel blockers may occur upon dosage initiation or increase

            Risk of hyperkalemia

            Dual blockade of the renin angiotensin system with ARBs, ACE inhibitors, or aliskiren associated with increased risk for hypotension, hyperkalemia, and renal function changes (including acute renal failure) compared to monotherapy; closely monitor blood pressure

            Intestinal problems (ie, sprue-like enteropathy) reported with olmesartan; symptoms may include severe, chronic diarrhea with substantial weight loss

            Avoid with severe renal impairment (<30 mL/min)

            Withhold/discontinue if progressive renal impairment occurs

            Thiazides: use with caution with mild/moderate liver impairment or progressive liver disease; avoid in patients with severe liver impairment

            Monitor for fluid/electrolyte imbalance

            Use caution in heart failure, severe aortic stenosis (amlodipine), hepatic impairment, renal artery stenosis, or hypertrophic cardiomyopathy

            Thiazide diuretics may exacerbate or activate SLE

            Acute transient myopia and acute angle-closure glaucoma has been reported, particularly with history of sulfonamide or penicillin allergy (hydrochlorothiazide is a sulfonamide)

            Caution in  aortic mitral stenosis, hepatic impairment, hypercholesterolemia, hypercalcemia, parathyroid disease, pre-existing renal insufficiency, systemic lupus erythematosus, bilateral renal artery stenosis or anuria

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            Pregnancy & Lactation

            Pregnancy Category: C (1st trimester); D (2nd/3rd trimesters)

            Lactation: Unknown whether olmesartan or amlodipine distributed in breast milk; hydrochlorothiazide secreted at low concentration in breastmilk; potential for adverse effects on nursing infant

            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.

            more...
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            Pharmacology

            Mechanism of Action

            Olmesartan: Blocks binding of angiotensin II to type 1 angiotensin II receptors; blocks vasoconstrictive and aldosterone-secretion properties of angiotensin II; elicits natriuresis and kaliuresis

            Amlodipine: Dihydropyridine calcium channel blocker; inhibits extracellular Ca ions across the membranes of myocardial cells and vascular smooth muscle cells, without changing serum calcium concentrations; this results in inhibition of cardiac and vascular smooth muscle contraction, thereby dilating the main coronary and systemic arteries

            Hydrochlorothiazide: Thiazide diuretic; Inhibits Na reabsorption in distal renal tubules resulting in increased Na and water excretion; lowers blood pressure and decreases edema

            Pharmacokinetics

            Olmesartan

            • Half-Life: 13 hr
            • Bioavailability: 26% (olmesartan medoxomil); rapidly and completely bioactivated by ester hydrolysis from olmesartan medoxomil to olmesartan
            • Vd: 17 L
            • Peak Plasma Time: 1-2 hr
            • Metabolism: Olmesartan medoxomil is hydrolyzed in GI tract to active olmesartan
            • Onset: >90% effective at 24 hr
            • Protein Bound: 99%
            • Clearance: 1.3 L/hr (plasma); 0.6 L/hr (renal)
            • Excretion: Feces (50-65%); urine (35-50%)

            Amlodipine

            • Half-Life: 30-50 hr
            • Bioavailability: 64-90%
            • Vd: 21L/kg
            • Duration of antihypertensive effects: 24 hr
            • Absorption: Well absorbed
            • Peak plasma time: 6-12 hr
            • Protein Bound: 93-98%
            • Metabolism: Liver (>90% converted to inactive metabolites via hepatic metabolism)
            • Excretion: Urine (10% parent compound and 60% metabolites within 24 hr)

            Hydrochlorothiazide

            • Half-Life: 6-15 hr
            • Bioavailability: 70%
            • Onset: 2 hr (diuresis); 4-6 hr (peak effect)
            • Duration: 6-12 hr (diuresis); 1 wk (HTN)
            • Vd: 3.6-7.8 L/kg
            • Peak Plasma:1.5-2.5 hr
            • Protein Bound: 68%
            • Metabolism: Minimally metabolized
            • Clearance: 335 mL/min
            • Excretion: Urine 50-70%
            • Dialyzable: No
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            Formulary

            FormularyPatient Discounts

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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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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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