irbesartan/hydrochlorothiazide (Rx)Brand and Other Names:Avalide

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

irbesartan/hydrochlorothiazide

(tablet)

  • 150mg/12.5mg
  • 300mg/12.5mg
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Hypertension

150 mg/12.5 mg PO qDay intially; 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

irbesartan/hydrochlorothiazide and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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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

            • AnorexiaEpigastric 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

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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

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

            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

            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: discontinue drug or do not nurse

            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
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
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            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            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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