irbesartan/hydrochlorothiazide (Rx)

Brand and Other Names:Avalide
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

irbesartan/hydrochlorothiazide

(tablet)

  • 150mg/12.5mg
  • 300mg/12.5mg

Hypertension

150 mg/12.5 mg PO qDay initially; if needed, after 1-2 weeks may titrate up to 300 mg/25 mg PO qDay

Safety and efficacy not established

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Interactions

Interaction Checker

and irbesartan/hydrochlorothiazide

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            Adverse Effects

            Adverse reactions with combination products and individual agents

            >10%

            Irbesartan

            • Hyperkalemia (19%)

            1-10%

            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%)

            Irbesartan

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

            Frequency Not Defined

            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

            Postmarketing Reports

            Urticaria

            Angioedema

            Hepatitis

            Jaundice (with irbesartan)

            Heart failure

            Sexual dysfunction

            Thrombocytopenia

            Impaired renal function, including renal failure (with irbesartan)

            Increased CPK levels (with ARBs)

            Tinnitus

            Hydrochlorothiazide

            • Non-melanoma skin cancer
            • Acute angle-closure glaucoma, acute myopia, choroidal effusion
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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 irbesartan, hydrochlorothiazide, or sulfonamides

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

            Anuria

            Do not coadminister with aliskiren in patients with diabetes mellitus

            Cautions

            Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction resulting in acute angle-closure glaucoma and elevated intraocular pressure with or without a noticeable acute myopic shift and/or choroidal effusions; cases of acute angle-closure glaucoma reported; symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation; untreated acute angle-closure glaucoma may result in permanent vision loss

            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

            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

            Hypotension may occur in patients who are salt or volume-depleted (correct the volume depletion especially in patients receiving high dose diuretics)

            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

            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 may decrease urinary calcium excretion

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

            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

            Therapy can cause fetal harm when administered to a pregnant woman; use of drugs that act on the 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 first trimester have not distinguished drugs affecting reninangiotensin system from other antihypertensive agents; when pregnancy is detected, discontinue therapy as soon as possible

            Hypertension in pregnancy increases maternal risk for preeclampsia, gestational diabetes, premature delivery, and delivery complications (eg, need for cesarean section and postpartum hemorrhage); hypertension increases fetal risk for intrauterine growth restriction and intrauterine death; pregnant women with hypertension should be carefully monitored and managed accordingly

            Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death; perform serial ultrasound examinations to assess intra-amniotic environment; fetal testing may be appropriate,

            Based on week of pregnancy; patients and physicians should be aware, however, that oligohydramnios may not appear until after fetus has sustained irreversible injury; closely observe infants with histories of in utero exposure to drug for hypotension, oliguria, and hyperkalemia and other symptoms of renal impairment; in neonates with a history of in utero exposure to drug, if oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion; exchange transfusion or dialysis may be required as means of reversing hypotension and/or substituting for disordered renal function

            Thiazides cross the placenta, and use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults

            Lactation

            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

            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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            Formulary

            FormularyPatient Discounts

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            Tier Description
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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.