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Olmesartan/Hydrochlorothiazide

    DEA Class; Rx

    Common Brand Names; Benicar HCT

    • ARB/HCTZ Combos

    Oral antihypertensive combination product containing an angiotensin II receptor antagonist and thiazide diuretic
    Used for the management of hypertension in adults
    Additive blood pressure reduction

    Indicated for the treatment of hypertension in patients who do not respond to monotherapy.

    Hypersensitivity to olmesartan, hydrochlorothiazide or sulfonamides

    Acute transient myopia and acute angle-closure glaucoma in patients with history of sulfonamide or penicillin allergy (hydrochlorothiazide is a sulfonamide)

    Pregnancy (2nd/3rd trimesters)

    Anuria

    Coadministration with aliskiren in patients with diabetes mellitus

    Adverse reactions with combination products and individual agents

    Olmesartan

    • Dizziness (3%)
    • Headache (1%)
    • Fatigue
    • Diarrhea (1%)
    • Hyperglycemia (1%)
    • Hypertriglyceridemia (1%)
    • Back pain (1%)
    • Bronchitis (1%)
    • Flu-like symptoms (1%)
    • Pharyngitis (1%)
    • Rhinitis (1%)
    • Sinusitis (1%)
    • URI (1%)
    • Chest pain
    • Peripheral edema
    • Rash
    • Hyperuricemia
    • Dizziness
    • Hyperlipidemia
    • Diarrhea
    • Hyperuricemia
    • Hematuria
    • Hyperglycemia
    • Upper respiratory infections
    • Increased transaminases
    • Gastroenteritis
    • Dyspepsia
    • Arthralgia
    • Arthritis
    • Myalgia
    • Back pain
    • Increased CPK

    Hydrochlorothiazide

    • Anorexia
    • Epigastric distress
    • Hypotension
    • Orthostatic hypotension
    • Photosensitivity
    • Anaphylaxis
    • Anemia
    • Confusion
    • Erythema multiforme
    • Stevens-Johnson syndrome
    • Exfoliative dermatitis including toxic epidermal necrolysis
    • Dizziness
    • Hypokalemia and/or hypomagnesemia
    • Hyperuricemia
    • Headache
    • Non-melanoma skin cancer

    Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history

    Hyperkalemia, particularly when coadministered with potassium-sparing diuretics, potassium supplements, or salt substitutes; concurrent therapy with hydrochlorothiazide may reduce the frequency of this effect

    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; closely monitor blood pressure

    Hydrochlorothiazide can cause hypokalemia and hyponatremia; hypomagnesemia can result in hypokalemia which appears difficult to treat despite potassium repletion

    Drugs that inhibit the renin-angiotensin system can cause hyperkalemia; monitor serum electrolytes periodically

    Electrolyte disturbances may occur

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

    Hyperuricemia may occur or gout may be precipitated in certain patients receiving thiazide therapy

    Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides

    Thiazides decrease urinary calcium excretion and may cause elevations of serum calcium; monitor calcium levels.

    Thiazide diuretics reported to cause exacerbation or activation of systemic lupus erythematosus

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

    Lactation: discontinue drug or do not nurse

    Adults

    40 mg/day PO olmesartan and 25 mg/day PO hydrochlorothiazide.

    Elderly

    40 mg/day PO olmesartan and 25 mg/day PO hydrochlorothiazide.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Olmesartan/hydrochlorothiazide

    tablet

    • 20mg/12.5mg
    • 40mg/12.5mg
    • 40mg/25mg