Olmesartan/Amlodipine/Hydrochlorothiazide

DEA Class; Rx

Common Brand Names; Tribenzor

• ARB/CCB/Diuretic Combos

Combination product containing a dihydropyridine calcium-channel blocker (amlodipine), an angiotensin II receptor blocker (ARB, olmesartan) and a thiazide diuretic (hydrochlorothiazide, HCTZ)
Used for the maintenance treatment of HTN in adults after titration of individual drugs

Indicated for the treatment of hypertension.

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

• 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%)
• Acute renal failure, increased blood creatinine, jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis), extrapyramidal disorder (associated with amlodipine)

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

Photosensitivity may occur; instruct patients to protect skin from sun and undergo regular skin cancer screening

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

Therapy can cause fetal harm in pregnant women; 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

There is limited information regarding the presence of drug in human milk, effects on breastfed infant, or on milk production; amlodipine is present in human milk