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Irbesartan / Hydrochlorothiazide

    Irbesartan / Hydrochlorothiazide

    DAE Class; Rx

    Common Brand Names; Avalide

    • ARB/HCTZ Combos

    Thiazide diuretic and angiotensin II blocker; used for additive efficacy in HTN; once-daily product; irbesartan decreases potassium loss due to HCTZ.

    Indicated for the treatment of hypertension in patients who do not respond to monotherapy and/or as initial therapy in patients likely to need multiple drugs to achieve blood pressure goals.
    Individualize the dosage by titration of the separate components. If the optimal dose corresponds to the ratio contained in the combination formulation, this product can be used for convenient dosing.

    Hypersensitivity to irbesartan, hydrochlorothiazide, or sulfonamides

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


    Do not coadminister with aliskiren in patients with diabetes mellitus

    Adverse reactions with combination products and individual agents



    • Hyperkalemia (19%)


    Chest pain (2%)

    Tachycardia (1%)

    Abnormal urination (2%)

    Musculoskeletal pain (6%)

    Flu-like syndrome (3%)

    Edema (3%)

    Tachycardia (1%)

    Chest pain (2%)

    Creatinine increased (1%)

    Increased BUN (2%)


    • Dizziness (10%)
    • URI (9%)
    • Orthostatic hypotension (5%)
    • Fatigue (4%)
    • Diarrhea (3%)
    • Dyspepsia (2%)

    Frequency Not Defined


    • 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

    Postmarketing Reports




    Jaundice (with irbesartan)

    Heart failure

    Sexual dysfunction


    Impaired renal function, including renal failure (with irbesartan)

    Increased CPK levels (with ARBs)



    • Non-melanoma skin cancer
    • Acute angle-closure glaucoma, acute myopia, choroidal effusion
    • Hypoglycemia in diabetic patients

    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


    If CrCl <30 mL/min, use loop diuretic instead of hydrochlorothiazide

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

    Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease since minor alterations of fluid and electrolyte balance may precipitate hepatic coma

    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

    Instruct patients to protect skin from sun and undergo regular skin cancer screening

    Caution in aortic mitral stenosis, hypercholesterolemia, hypercalcemia, parathyroid disease, or anuria


    Therapy can cause fetal harm when administered to a pregnant woman


    There are no available data on the presence of irbesartan in human milk, effects on milk production, or breastfed infant; irbesartan or some metabolite of irbesartan is secreted in the milk of lactating rats

    Thiazides appear in human milk; because of potential for adverse effects on nursing infant, the drug is not recommended in breastfeeding women


    300 mg/day PO irbesartan and 25 mg/day PO hydrochlorothiazide.


    300 mg/day PO irbesartan and 25 mg/day PO hydrochlorothiazide.


    Safety and efficacy have not been established.


    Safety and efficacy have not been established.

    Irbesartan / Hydrochlorothiazide


    • 150mg/12.5mg
    • 300mg/12.5mg