Avapro


Also found in: Dictionary.
Related to Avapro: irbesartan

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.

Action

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

Availability

Tablets: 75 mg, 150 mg, 300 mg

Indications and dosages

Hypertension

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

Contraindications

• Hypersensitivity to drug or its components

Precautions

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).

Administration

• 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

Interactions

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.

irbesartan

(ir-be-sar-tan) ,

Avapro

(trade name)

Classification

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

Indications

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

Action

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.

Pharmacokinetics

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)

ROUTEONSETPEAKDURATION
POwithin 2 hr2 wks24 hr

Contraindications/Precautions

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

Cardiovascular

  • chest pain
  • edema
  • hypotension
  • tachycardia

Dermatologic

  • rash

Gastrointestinal

  • abdominal pain
  • diarrhea
  • dyspepsia
  • nausea
  • vomiting

Genitourinary

  • impaired renal function

Fluid and Electrolyte

  • hyperkalemia (most frequent)

Musculoskeletal

  • pain

Miscellaneous

  • angioedema (life-threatening)

Interactions

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.

Route/Dosage

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)

Implementation

  • 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.

Avapro

(ăv′ə-prō′)
A trademark for the drug irbesartan.

Avapro®

Irbesartan Cardiovascular disease A once-daily angiotensin II receptor antagonist used for treating HTN. See Hypertension.
References in periodicals archive ?
Bristol-Myers Squibb reported worldwide sales of Avalide and Avapro of $307 million for the first half of 2010, which was down 2% from the 2009 period.
Bristol-Myers Squib and Sanofi-Synthelabo report the FDA approval was based on results from an Irbesartan Diabetic Nephropathy Trial which demonstrated that when patients with high blood pressure, type 2 diabetes and evidence of kidney disease were treated with Avapro the risk of progression of their nephropathy or death was 20% lower than that of the placebo group and 23% lower than the group treated with amlodipine, a calcium-channel blocker.
Adams had included Avapro HCT under the medication section on his entry form for the Games three months ago, but it was not picked up.
The medication is currently sold under brand names as Diovan, Micardis, Cozaar, Benicar and Avapro.
Bristol-Myers and Sanofi share profits of the anti-clotting drug Plavix, the world's second-biggest selling drug, and of the hypertension treatment Avapro.
Hatfield worked as a senior executive at Bristol-Myers Squibb in a variety of positions and was directly associated with the success of products like Pravachol, Plavix, Avapro, Abilify, Reyataz and Atripla.
Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Irbesartan Tablets USP, 75 mg, 150 mg and 300 mg, which is the generic version of Sanofi's Avapro.
Sanofi and Bristol-Myers work together to sell the blood thinner Plavix and Avapro, a hypertension drug.
Cozaar and Avapro (irbesartan) are the first ARBs approved for this indication.
Higher leverage arises at a time when Bristol Myers Squibb faces its greatest operational challenge of overcoming its patent cliff that is expected to negatively affect sales during 2012 - 2013 of two top-selling pharmaceuticals, Plavix and Avapro, which represented 36.
It is difficult to see a revenue replacement strategy that could cover the various generic and competitive threats to key franchises such as Lovenox, Plavix, Avapro, Taxotere and Eloxatin over the next few years," London-based analysts Jeff Holford and James Dodwell wrote in a note to investors.
However, Bristol-Myers Squibb and Sanofi-Synthelabo, which comarket the drug under the trade name Avapro, are continuing to discuss the issues raised by the panel with the FDA, according to a Bristol-Myers Squibb spokesperson.