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irbesartan (Rx)Brand and Other Names:Avapro

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 75mg
  • 150mg
  • 300mg
more...

Hypertension

150 mg/day PO initially; may be increased to 300 mg/day PO

Hypovolemia: 75 mg/day PO initially

Nephropathy in Type 2 Diabetes

75-300 mg/day PO

Dosage Modifications

Mild-to-severe renal impairment: Dosage adjustment not necessary unless patient is hypovolemic

Dosing Considerations

Also given in combination with hydrochlorothiazide (Avalide)

Generally, adjust dosage monthly; adjust more aggressively in high-risk patients

Focal Segmental Glomerulosclerosis (Orphan)

Irbesartan and propagermanium: Orphan designation for treatment of focal segmental glomerulosclerosis

Sponsor

  • Dimerix Bioscience Ltd; Level 2, 25 Flinders Lane; Melbourne

Dosage Forms & Strengths

tablet

  • 75mg
  • 150mg
  • 300mg
more...

Hypertension

<6 years: Safety and efficacy not established

6-12 years: 75 mg/day PO initially; not to exceed 150 mg/day

>12 years: 150 mg/day PO initially; may be increased to 300 mg/day PO

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Interactions

Interaction Checker

irbesartan and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Hyperkalemia (19%)

            1-10%

            Dizziness (10%)

            Upper respiratory tract infection (URTI) (9%)

            Orthostatic hypotension (5%)

            Fatigue (4%)

            Diarrhea (3%)

            Dyspepsia (2%)

            Postmarketing Reports

            Urticaria; angioedema (involving swelling of the face, lips, pharynx, or tongue); elevated liver function testresults; jaundice; hepatitis; hyperkalemia, and thrombocytopenia

            Impaired renal function, including cases of renal failure, has been reported

            Increased creatine phosphokinase (CPK) levels and rhabdomyolysis have been reported in patients receiving angiotensin-receptor blockers (ARBs)

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            Warnings

            Black Box Warnings

            Discontinue as soon as possible when pregnancy is detected; drug affects renin-angiotensin system, causing oligohydramnios, which may result in fetal injury or death

            Contraindications

            Hypersensitivity

            Do not coadminister with aliskiren in patients with diabetes

            Cautions

            Angioedema, volume-depletion, severe congestive heart failure (CHF), hepatic or renal impairment, hypertrophic cardiomyopathy, aortic or mitral valve stenosis, surgery or anesthesia

            Discontinue immediately if patient is pregnant; risk of congenital malformations (see Contraindications and Black Box Warnings)

            Use with caution in renal artery stenosis; avoid in bilateral renal artery stenosis

            Risk of hypotension or hyperkalemia

            Dual blockade of the renin-angiotensin system with ARBs, angiotensin-converting enzyme (ACE) inhibitors, or aliskiren is associated with increased risk of hypotension, hyperkalemia, and altered renal function (including acute renal failure) in comparison with monotherapy

            Risk of heart failure-related morbidity; concomitant treatment with ACE inhibitors and beta-adrenergic agents is not recommended

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            Pregnancy & Lactation

            Pregnancy category: 1st trimester, C; 2nd and 3rd trimesters, D

            Lactation: Potential harm to nursing infant; 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.

            more...
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            Pharmacology

            Mechanism of Action

            Angiotensin II receptor blocker; inhibits vasoconstrictor and aldosterone-secreting effects of angiotensin II

            Absorption

            Bioavailability: 60-80%

            Onset: 1-2 hr (peak effect)

            Duration: 24 hr

            Peak plasma time: 1.5-2 hr

            Distribution

            Protein bound: 90%

            Vd: 53-93 L

            Metabolism

            Metabolized by hepatic CYP2C9 and minimally by CYP3A4

            Metabolites: Irbesartan glucuronide conjugate (inactive)

            Elimination

            Half-life: 11-15 hr

            Renal clearance: 3-3.5 mL/min

            Total body clearance: 157-176 mL/min

            Excretion: Feces (80%), urine (20%)

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            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.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            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.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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