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Related to Avapro: irbesartan


Aprovel (UK), Avapro

Pharmacologic class: Angiotensin II receptor antagonist

Therapeutic class: Antihypertensive

Pregnancy risk category D

FDA Box Warning

• When used during second or third trimester of pregnancy, drug may cause fetal injury and even death. Discontinue as soon as pregnancy is detected.


Blocks aldosterone-secreting and potent vasoconstrictive effects of angiotensin II at tissue receptor sites, which reduces vasoconstriction and lowers blood pressure


Tablets: 75 mg, 150 mg, 300 mg

Indications and dosages


Adults: 150 mg/day P.O.; may increase to 300 mg/day

Nephropathy in patients with type 2 diabetes and hypertension

Adults: 300 mg P.O. once daily

Dosage adjustment

• Volume-depleted or hemodialysis patients receiving diuretics


• Hypersensitivity to drug or its components


Use cautiously in:

• heart failure, volume or sodium depletion, renal disease, hepatic impairment

• black patients

• females of childbearing age

• pregnant or breastfeeding patients

• children ages 18 and younger (safety not established).


• Administer with or without food.

• Know that drug may be given with other antihypertensive drugs.

Adverse reactions

CNS: dizziness, fatigue, headache, syncope

CV: orthostatic hypotension, chest pain, peripheral edema

EENT: conjunctivitis, vision disturbance, ear pain, sinus disorders

GI: nausea, diarrhea, constipation, abdominal pain, dry mouth

GU: albuminuria, renal failure

Metabolic: gout, hyperkalemia

Musculoskeletal: joint pain, back pain, muscle weakness

Respiratory: upper respiratory tract infection, cough, bronchitis

Other: dental pain


Drug-drug. Diuretics, other antihypertensives: increased risk of hypotension

Lithium: increased lithium blood level

Nonsteroidal anti-inflammatory drugs: decreased antihypertensive effects

Potassium-sparing diuretics, potassium supplements: increased risk of hyperkalemia

Drug-diagnostic tests. Albumin: increased level

Drug-food. Salt substitutes containing potassium: increased risk of hyperkalemia

Patient monitoring

• Monitor vital signs, especially blood pressure.

• Watch for signs and symptoms of orthostatic hypotension.

• Watch blood pressure closely when volume depletion may cause hypotension (as in diaphoresis, nausea, vomiting, diarrhea, and postoperative period).

• Assess fluid intake and output. Keep patient well hydrated, especially if he's receiving diuretics concurrently.

• Monitor blood urea nitrogen and creatinine levels.

Patient teaching

• Tell patient he may take with or without food.

• Instruct patient to change position slowly and to stay well hydrated, to minimize blood pressure decrease when rising.

• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.

• Tell female patient that drug has been linked to fetal injury and deaths. Caution her not to get pregnant during therapy. Advise her to use barrier contraception.

• Instruct female patient to report pregnancy.

• Instruct patient to report fever, chills, dizziness, severe vomiting, diarrhea, and dehydration.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and foods mentioned above.

McGraw-Hill Nurse's Drug Handbook, 7th Ed. Copyright © 2013 by The McGraw-Hill Companies, Inc. All rights reserved


(ir-be-sar-tan) ,


(trade name)


Therapeutic: antihypertensives
Pharmacologic: angiotensin ii receptor antagonists
Pregnancy Category: D


Alone or with other agents in the management of hypertension.Treatment of diabetic nephropathy in patients with type 2 diabetes and hypertension.


Blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II at various receptor sites, including vascular smooth muscle and the adrenal glands.

Therapeutic effects

Lowering of BP in patients with hypertension.
Decreased progression of diabetic nephropathy.


Absorption: 60–80% absorbed following oral administration.
Distribution: Crosses the placenta.
Protein Binding: 90%.
Metabolism and Excretion: Some hepatic metabolism; 20% excreted in urine, 80% in feces.
Half-life: 11–15 hr.

Time/action profile (antihypertensive effect with chronic dosing)

POwithin 2 hr2 wks24 hr


Contraindicated in: Hypersensitivity; Bilateral renal artery stenosis; Concurrent use with aliskiren in patients with diabetes or moderate-to-severe renal impairment (CCr <60 mL/min) Obstetric: Can cause injury or death of fetus – if pregnancy occurs, discontinue immediately. Lactation: Discontinue drug or use formula.
Use Cautiously in: Volume- or salt-depleted patients or patients receiving high doses of diuretics (correct deficits before initiating therapy or initiate at lower doses); genetic implication Black patients (may not be as effective); Impaired renal function due to primary renal disease or heart failure (may worsen renal function); Women of childbearing potential–if pregnancy occurs, discontinue immediately; Pediatric: Safety not established.

Adverse Reactions/Side Effects

Central nervous system

  • anxiety
  • dizziness
  • fatigue
  • headache


  • chest pain
  • edema
  • hypotension
  • tachycardia


  • rash


  • abdominal pain
  • diarrhea
  • dyspepsia
  • nausea
  • vomiting


  • impaired renal function

Fluid and Electrolyte

  • hyperkalemia (most frequent)


  • pain


  • angioedema (life-threatening)


Drug-Drug interaction

NSAIDs and selective COX-2 inhibitors may blunt the antihypertensive effect and ↑ the risk of renal dysfunction.Additive hypotension with other antihypertensives.Excessive hypotension may occur with concurrent use of diuretics.Concurrent use of potassium-sparing diuretics, potassium-containing salt substitutes, or potassium supplements may ↑ risk of hyperkalemia.↑ risk of hyperkalemia, renal dysfunction, hypotension, and syncope with concurrent use of ACE inhibitors or aliskiren ; avoid concurrent use with aliskiren in patients with diabetes or CCr <60 mL/minMay ↑ the levels/effects of amiodarone,fluoxetine,glimeperide, glipizide,phenytoin,rosiglitazone,warfarin.


Oral (Adults) Hypertension—150 mg once daily; may be ↑ to 300 mg once daily. Initiate therapy at 75 mg once daily in patients who are receiving diuretics or are volume depleted.Nephropathy in patients with type 2 diabetes—300 mg once daily.

Availability (generic available)

Tablets: 75 mg, 150 mg, 300 mg
In combination with: hydrochlorothiazide (Avalide; see combination drugs).

Nursing implications

Nursing assessment

  • Assess BP (lying, sitting, standing) and pulse frequently during initial dose adjustment and periodically during therapy. Notify.health care professional of significant changes.
  • Monitor frequency of prescription refills to determine compliance.
  • Assess patients for signs of angioedema (dyspnea, facial swelling). May rarely cause angioedema.
  • Lab Test Considerations: Monitor renal function. May cause ↑ BUN and serum creatinine.
    • May cause hyperkalemia.
    • May cause slight ↓ hemoglobin.

Potential Nursing Diagnoses

Risk for injury (Adverse Reactions)
Noncompliance (Patient/Family Teaching)


  • Correct volume depletion, if possible, before initiation of therapy.
  • Oral: Administer once daily without regard to food.

Patient/Family Teaching

  • Emphasize the importance of continuing to take as directed, even if feeling well. Take missed doses as soon as remembered if not almost time for next dose; do not double doses. Instruct patient to take medication at the same time each day. Warn patient not to discontinue therapy unless directed by health care professional.
  • Caution patient to avoid salt substitutes containing potassium or foods containing high levels of potassium or sodium unless directed by health care professional. See.
  • Caution patient to avoid sudden changes in position to decrease orthostatic hypotension. Use of alcohol, standing for long periods, exercising, and hot weather may increase orthostatic hypotension.
  • May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to avoid concurrent use of Rx, OTC, and herbal products, especially NSAIDs and cough, cold, or allergy medications, without consulting health care professional.
  • Instruct patient to notify health care professional of medication regimen before treatment or surgery.
  • Instruct patient to notify health care professional if swelling of face, eyes, lips, or tongue or if difficulty swallowing or breathing occur.
  • Advise women of childbearing age to use contraception and notify health care professional if pregnancy is planned or suspected, or if breastfeeding. Irbesartan should be discontinued as soon as possible when pregnancy is detected.
  • Emphasize the importance of follow-up exams to evaluate effectiveness of medication.
  • Hypertension: Encourage patient to comply with additional interventions for hypertension (weight reduction, low-sodium diet, discontinuation of smoking, moderation of alcohol consumption, regular exercise, stress management). Medication controls but does not cure hypertension.
    • Instruct patient and family on proper technique for monitoring BP. Advise them to check BP at least weekly and to report significant changes.

Evaluation/Desired Outcomes

  • Decrease in BP without appearance of excessive side effects.
  • Delayed progression of diabetic nephropathy in patients with type 2 diabetes.
Drug Guide, © 2015 Farlex and Partners


A trademark for the drug irbesartan.
The American Heritage® Medical Dictionary Copyright © 2007, 2004 by Houghton Mifflin Company. Published by Houghton Mifflin Company. All rights reserved.


Irbesartan Cardiovascular disease A once-daily angiotensin II receptor antagonist used for treating HTN. See Hypertension.
McGraw-Hill Concise Dictionary of Modern Medicine. © 2002 by The McGraw-Hill Companies, Inc.
References in periodicals archive ?
The company added that its Irbesartan Tablets USP 75mg, 150mg and 300mg, is the generic equivalent to Sanofi's Avapro.
Such a move holds the promise of giving consumers access to chronic-condition drugs such as Avapro, Diovan and Atacand for hypertension; Lescol and Tricor for hyperlipidemia; Maxalt and Zomig for migraine; and Singulair and Xopenex for asthma.
TYPES AND FUNCTIONS OF BLOOD PRESSURE DRUGS TYPE GENERIC NAME FUNCTION (BRAND NAME) Diuretics Furosemide Help rid the body of (Lasix) excess sodium and water Chlorthalidone (Hygroton) Beta blockers Acebutolol Reduce the heart rate, (Sectral) the heart's workload and its output of blood Atenolol (Tenormin) Betaxolol (Kerlone) Angiotensin-converting Ramipril Help reduce the enzyme (ACE) inhibitors (Altace) production of angiotensin, which causes blood vessels to narrow Benazepril hydrochloride (Lotensin) Angiotensin II receptor Irbesarten Help prevent the blockers (ARBs) (Avapro) receptors in blood vessels from binding with angiotensin Eprosartan mesylate (Teveten) Valsartan (Diovan)
While Moody's is upbeat about the ongoing launch of Bristol's Yervoy therapy and the pending regulatory filing for its Eliquis medication, it voiced concerns over a potential sharp decline in revenues when Plavix and Avapro go off-patent in the United States.
There are seven single-ingredient ARBs approved by the FDA for treating hypertension: candesartan (Atacand), irbesartan (Avapro), olmesartan (Benicar), losartan (Cozaar), valsartan (Diovan), telmisartan (Micardis), and eprosartan (Teveten).
Disclosures: ACTIVE-I was funded by Bristol-Myers Squibb and Sanofi-Aventis, which in partnership distribute irbesartan (Avapro).
Drugs that were frequently prescribed by doctors seeking Bristol-MyersA[sup.3] generosity include Abilify, Plavix and Avapro.
However we cannot definitively exclude this possibility." Other lots of Avalide 300/25 mg, as well as other dosage strengths of both Avalide and Avapro, or irbesartan, are not affected, and no interruption in supply is anticipated, the company said.
The May 2004 MIMS CD has given the following side effects for the following three antihypertensives/cardiac agents: a) Felodur: fatigue, depression, cardiovascular effects, impotence/sexual dysfunction; b) Karvea: fatigue, sleep disturbances, arrythmias, depression, anxiety/ nervousness, sexual dysfunction/libido change; c) Avapro: sleep disturbances, depression, cardiovascular symptoms, anxiety/nervousness, depression, sexual dysfunction and stress related disorders.
Also, supported by sales of new products Lonasen (agent for the treatment of schizophrenia) and Avapro (agent for the treatment of hypertension), sales grew by JPY 4.5 billion over the same period last year to JPY 62.9 billion.
Commonly prescribed antihypertensive medications include diuretics (HydroDiuril); angiotensin-converting enzyme (ACE) inhibitors (Vasotec); angiotensin receptor blockers (Avapro); beta blockers (Lopressor); calcium channel blockers (Verapamil); and a new class of drugs called renin inhibitors (Aliskiren).
Also at risk is anyone on a medication that causes the body to hold onto potassium, including potassium-sparing diuretics like Dyazide and Spirozide, ACE inhibitors like Lotensin and Vasotec, angiotensin-receptor blockers such as Tevetan and Avapro and daily doses of nonsteroidal anti-inflammatory drugs like aspirin and ibuprofen.