irbesartan

ir-be-SAR-tan

Therapeutic Classification: antihypertensives

Pharmacologic Classification: angiotensin II receptor antagonists

REMS

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/Excretion: Some hepatic metabolism; 20% excreted in urine, 80% in feces.

Half-Life: 11–15 hr.

(antihypertensive effect with chronic dosing)

ROUTE	ONSET	PEAK	DURATION
PO	within 2 hr	2 wks	24 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)
OB: Pregnancy (may cause fetal harm);
Lactation: Lactation.

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);
Black patients (may not be as effective);
Impaired renal function due to primary renal disease or heart failure (may worsen renal function);
Rep: Women of reproductive potential ;
Pedi: Safety and effectiveness not established in children.

CV: chest pain, edema, hypotension, tachycardia

Derm: rash

F and E: hyperkalemia

GI: abdominal pain, diarrhea, dyspepsia, nausea, vomiting

GU: impaired renal function

MS: pain

Neuro: anxiety, dizziness, fatigue, headache

Misc: ANGIOEDEMA

Drug-drug:

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/min; avoid concurrent use with ACE inhibitors
May ↑ the levels/effects of amiodarone,fluoxetine,glimepiride, glipizide,lithium, phenytoin, warfarin.

PO (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.

(Generic available)

Tablets: 75 mg; 150 mg; 300 mg
In combination with: hydrochlorothiazide (Avalide; see Appendix [not included in this PDA edition]).

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.

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

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. SeeFood Sources for Specific Nutrients.
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.
Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception and notify health care professional if pregnancy is planned or suspected, and to avoid breastfeeding during therapy. Irbesartan should be discontinued as soon as possible when pregnancy is detected. Closely observe infants with histories of in utero exposure to irbesartan for hypotension, oliguria, and hyperkalemia; may require support of blood pressure and renal perfusion. Exchange transfusion or dialysis may be required to reverse hypotension and/or substitute for disordered renal function.
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.

Decrease in BP without appearance of excessive side effects.
Delayed progression of diabetic nephropathy in patients with type 2 diabetes.

Avapro

NDC Code

0024- Sanofi-Aventis U.S. LLC
- 0024-5851- Avapro
  - 0024-5851-30- 30 TABLET, FILM COATED in 1 BOTTLE (0024-5851-30)

0024- Sanofi-Aventis U.S. LLC
- 0024-5852- Avapro
  - 0024-5852-30- 30 TABLET, FILM COATED in 1 BOTTLE (0024-5852-30)

12666- Zhejiang Apeloa Jiayuan Pharmaceutical Co., Ltd.
- 12666-0011-
  - 12666-0011-1- 50 kg in 1 DRUM (12666-0011-1)

12666- Zhejiang Apeloa Jiayuan Pharmaceutical Co., Ltd.
- 12666-0011-
  - 12666-0011-2- 25 kg in 1 DRUM (12666-0011-2)

12666- Zhejiang Apeloa Jiayuan Pharmaceutical Co., Ltd.
- 12666-0011-
  - 12666-0011-3- 20 kg in 1 DRUM (12666-0011-3)

12666- Zhejiang Apeloa Jiayuan Pharmaceutical Co., Ltd.
- 12666-0011-
  12666-0011-4- 10 kg in 1 DRUM (12666-0011-4)

15894- Teva API India Private Ltd
- 15894-0008-
  15894-0008-0- 1 kg in 1 CARTON (15894-0008-0)

29300- Unichem Pharmaceuticals (USA), Inc.
- 29300-212- Irbesartan
  29300-212-05- 500 TABLET in 1 BOTTLE, PLASTIC (29300-212-05)

29300- Unichem Pharmaceuticals (USA), Inc.
- 29300-212- Irbesartan
  - 29300-212-13- 30 TABLET in 1 BOTTLE, PLASTIC (29300-212-13)

29300- Unichem Pharmaceuticals (USA), Inc.
- 29300-212- Irbesartan
  - 29300-212-19- 90 TABLET in 1 BOTTLE, PLASTIC (29300-212-19)

29300- Unichem Pharmaceuticals (USA), Inc.
- 29300-213- Irbesartan
  - 29300-213-05- 500 TABLET in 1 BOTTLE, PLASTIC (29300-213-05)

29300- Unichem Pharmaceuticals (USA), Inc.
- 29300-213- Irbesartan
  - 29300-213-13- 30 TABLET in 1 BOTTLE, PLASTIC (29300-213-13)

29300- Unichem Pharmaceuticals (USA), Inc.
- 29300-213- Irbesartan
  - 29300-213-19- 90 TABLET in 1 BOTTLE, PLASTIC (29300-213-19)

29300- Unichem Pharmaceuticals (USA), Inc.
- 29300-214- Irbesartan
  - 29300-214-05- 500 TABLET in 1 BOTTLE, PLASTIC (29300-214-05)

29300- Unichem Pharmaceuticals (USA), Inc.
- 29300-214- Irbesartan
  - 29300-214-13- 30 TABLET in 1 BOTTLE, PLASTIC (29300-214-13)

29300- Unichem Pharmaceuticals (USA), Inc.
- 29300-214- Irbesartan
  - 29300-214-19- 90 TABLET in 1 BOTTLE, PLASTIC (29300-214-19)

31722- Camber Pharmaceuticals, Inc.
- 31722-160- Irbesartan
  - 31722-160-05- 500 TABLET in 1 BOTTLE (31722-160-05)

31722- Camber Pharmaceuticals, Inc.
- 31722-161- Irbesartan
  - 31722-161-10- 1000 TABLET in 1 BOTTLE (31722-161-10)

31722- Camber Pharmaceuticals, Inc.
- 31722-162- Irbesartan
  - 31722-162-05- 500 TABLET in 1 BOTTLE (31722-162-05)

31722- Camber Pharmaceuticals, Inc.
- 31722-729- Irbesartan
  - 31722-729-05- 500 TABLET in 1 BOTTLE (31722-729-05)

31722- Camber Pharmaceuticals, Inc.
- 31722-729- Irbesartan
  - 31722-729-30- 30 TABLET in 1 BOTTLE (31722-729-30)

31722- Camber Pharmaceuticals, Inc.
- 31722-729- Irbesartan
  - 31722-729-31- 120 BLISTER PACK in 1 CARTON (31722-729-31) / 10 TABLET in 1 BLISTER PACK

31722- Camber Pharmaceuticals, Inc.
- 31722-729- Irbesartan
  - 31722-729-90- 90 TABLET in 1 BOTTLE (31722-729-90)

31722- Camber Pharmaceuticals, Inc.
- 31722-730- Irbesartan
  - 31722-730-05- 500 TABLET in 1 BOTTLE (31722-730-05)

31722- Camber Pharmaceuticals, Inc.
- 31722-730- Irbesartan
  - 31722-730-30- 30 TABLET in 1 BOTTLE (31722-730-30)

31722- Camber Pharmaceuticals, Inc.
- 31722-730- Irbesartan
  - 31722-730-31- 120 BLISTER PACK in 1 CARTON (31722-730-31) / 10 TABLET in 1 BLISTER PACK

31722- Camber Pharmaceuticals, Inc.
- 31722-730- Irbesartan
  - 31722-730-90- 90 TABLET in 1 BOTTLE (31722-730-90)

31722- Camber Pharmaceuticals, Inc.
- 31722-731- Irbesartan
  - 31722-731-05- 500 TABLET in 1 BOTTLE (31722-731-05)

31722- Camber Pharmaceuticals, Inc.
- 31722-731- Irbesartan
  - 31722-731-30- 30 TABLET in 1 BOTTLE (31722-731-30)

31722- Camber Pharmaceuticals, Inc.
- 31722-731- Irbesartan
  - 31722-731-31- 120 BLISTER PACK in 1 CARTON (31722-731-31) / 10 TABLET in 1 BLISTER PACK

31722- Camber Pharmaceuticals, Inc.
- 31722-731- Irbesartan
  - 31722-731-90- 90 TABLET in 1 BOTTLE (31722-731-90)

33342- Macleods Pharmaceuticals Limited
- 33342-047- Irbesartan
  - 33342-047-07- 30 TABLET in 1 BOTTLE (33342-047-07)

33342- Macleods Pharmaceuticals Limited
- 33342-047- Irbesartan
  - 33342-047-10- 90 TABLET in 1 BOTTLE (33342-047-10)

33342- Macleods Pharmaceuticals Limited
- 33342-047- Irbesartan
  - 33342-047-12- 10 BLISTER PACK in 1 CARTON (33342-047-12) / 10 TABLET in 1 BLISTER PACK

33342- Macleods Pharmaceuticals Limited
- 33342-047- Irbesartan
  - 33342-047-15- 500 TABLET in 1 BOTTLE (33342-047-15)

33342- Macleods Pharmaceuticals Limited
- 33342-047- Irbesartan
  - 33342-047-68- 13600 TABLET in 1 POUCH (33342-047-68)

33342- Macleods Pharmaceuticals Limited
- 33342-048- Irbesartan
  - 33342-048-07- 30 TABLET in 1 BOTTLE (33342-048-07)

33342- Macleods Pharmaceuticals Limited
- 33342-048- Irbesartan
  - 33342-048-10- 90 TABLET in 1 BOTTLE (33342-048-10)

33342- Macleods Pharmaceuticals Limited
- 33342-048- Irbesartan
  - 33342-048-12- 10 BLISTER PACK in 1 CARTON (33342-048-12) / 10 TABLET in 1 BLISTER PACK

33342- Macleods Pharmaceuticals Limited
- 33342-048- Irbesartan
  - 33342-048-15- 500 TABLET in 1 BOTTLE (33342-048-15)

33342- Macleods Pharmaceuticals Limited
- 33342-048- Irbesartan
  - 33342-048-65- 6800 TABLET in 1 POUCH (33342-048-65)

33342- Macleods Pharmaceuticals Limited
- 33342-049- Irbesartan
  - 33342-049-07- 30 TABLET in 1 BOTTLE (33342-049-07)

33342- Macleods Pharmaceuticals Limited
- 33342-049- Irbesartan
  - 33342-049-10- 90 TABLET in 1 BOTTLE (33342-049-10)

33342- Macleods Pharmaceuticals Limited
- 33342-049- Irbesartan
  - 33342-049-15- 500 TABLET in 1 BOTTLE (33342-049-15)

33342- Macleods Pharmaceuticals Limited
- 33342-049- Irbesartan
  - 33342-049-39- 9 BLISTER PACK in 1 CARTON (33342-049-39) / 10 TABLET in 1 BLISTER PACK

33342- Macleods Pharmaceuticals Limited
- 33342-049- Irbesartan
  - 33342-049-76- 3400 TABLET in 1 POUCH (33342-049-76)

42291- AvKARE
- 42291-940- IRBESARTAN
  - 42291-940-90- 90 TABLET in 1 BOTTLE (42291-940-90)

42291- AvKARE
- 42291-941- IRBESARTAN
  - 42291-941-90- 90 TABLET in 1 BOTTLE (42291-941-90)

42291- AvKARE
- 42291-942- IRBESARTAN
  - 42291-942-90- 90 TABLET in 1 BOTTLE (42291-942-90)

42419- CTX Lifesciences Pvt. Ltd.
- 42419-011-
  - 42419-011-01- 25 kg in 1 DRUM (42419-011-01)

42419- CTX Lifesciences Pvt. Ltd.
- 42419-011-
  42419-011-02- 25 kg in 1 DRUM (42419-011-02)

42658- Hisun Pharmaceuticals USA Inc.
- 42658-121- IRBESARTAN
  42658-121-01- 30 TABLET, FILM COATED in 1 BOTTLE (42658-121-01)

42658- Hisun Pharmaceuticals USA Inc.
- 42658-121- IRBESARTAN
  - 42658-121-04- 90 TABLET, FILM COATED in 1 BOTTLE (42658-121-04)

42658- Hisun Pharmaceuticals USA Inc.
- 42658-122- IRBESARTAN
  - 42658-122-01- 30 TABLET, FILM COATED in 1 BOTTLE (42658-122-01)

42658- Hisun Pharmaceuticals USA Inc.
- 42658-122- IRBESARTAN
  - 42658-122-04- 90 TABLET, FILM COATED in 1 BOTTLE (42658-122-04)

42658- Hisun Pharmaceuticals USA Inc.
- 42658-122- IRBESARTAN
  - 42658-122-07- 500 TABLET, FILM COATED in 1 BOTTLE (42658-122-07)

42658- Hisun Pharmaceuticals USA Inc.
- 42658-123- IRBESARTAN
  - 42658-123-01- 30 TABLET, FILM COATED in 1 BOTTLE (42658-123-01)

42658- Hisun Pharmaceuticals USA Inc.
- 42658-123- IRBESARTAN
  - 42658-123-04- 90 TABLET, FILM COATED in 1 BOTTLE (42658-123-04)

42658- Hisun Pharmaceuticals USA Inc.
- 42658-123- IRBESARTAN
  - 42658-123-07- 500 TABLET, FILM COATED in 1 BOTTLE (42658-123-07)

43547- Solco Healthcare U.S., LLC
- 43547-374- Irbesartan
  - 43547-374-03- 30 TABLET in 1 BOTTLE (43547-374-03)

43547- Solco Healthcare U.S., LLC
- 43547-374- Irbesartan
  - 43547-374-09- 90 TABLET in 1 BOTTLE (43547-374-09)

43547- Solco Healthcare U.S., LLC
- 43547-374- Irbesartan
  - 43547-374-50- 500 TABLET in 1 BOTTLE (43547-374-50)

43547- Solco Healthcare U.S., LLC
- 43547-375- Irbesartan
  - 43547-375-03- 30 TABLET in 1 BOTTLE (43547-375-03)

43547- Solco Healthcare U.S., LLC
- 43547-375- Irbesartan
  - 43547-375-09- 90 TABLET in 1 BOTTLE (43547-375-09)

43547- Solco Healthcare U.S., LLC
- 43547-375- Irbesartan
  - 43547-375-50- 500 TABLET in 1 BOTTLE (43547-375-50)

43547- Solco Healthcare U.S., LLC
- 43547-376- Irbesartan
  - 43547-376-03- 30 TABLET in 1 BOTTLE (43547-376-03)

43547- Solco Healthcare U.S., LLC
- 43547-376- Irbesartan
  - 43547-376-09- 90 TABLET in 1 BOTTLE (43547-376-09)

43547- Solco Healthcare U.S., LLC
- 43547-376- Irbesartan
  - 43547-376-50- 500 TABLET in 1 BOTTLE (43547-376-50)

46708- Alembic Pharmaceuticals Limited
- 46708-439- IRBESARTAN
  - 46708-439-30- 30 TABLET in 1 BOTTLE (46708-439-30)

46708- Alembic Pharmaceuticals Limited
- 46708-439- IRBESARTAN
  - 46708-439-31- 100 TABLET in 1 BOTTLE (46708-439-31)

46708- Alembic Pharmaceuticals Limited
- 46708-439- IRBESARTAN
  - 46708-439-71- 500 TABLET in 1 BOTTLE (46708-439-71)

46708- Alembic Pharmaceuticals Limited
- 46708-439- IRBESARTAN
  - 46708-439-90- 90 TABLET in 1 BOTTLE (46708-439-90)

46708- Alembic Pharmaceuticals Limited
- 46708-439- IRBESARTAN
  - 46708-439-91- 1000 TABLET in 1 BOTTLE (46708-439-91)

46708- Alembic Pharmaceuticals Limited
- 46708-440- IRBESARTAN
  - 46708-440-30- 30 TABLET in 1 BOTTLE (46708-440-30)

46708- Alembic Pharmaceuticals Limited
- 46708-440- IRBESARTAN
  - 46708-440-31- 100 TABLET in 1 BOTTLE (46708-440-31)

46708- Alembic Pharmaceuticals Limited
- 46708-440- IRBESARTAN
  - 46708-440-71- 500 TABLET in 1 BOTTLE (46708-440-71)

46708- Alembic Pharmaceuticals Limited
- 46708-440- IRBESARTAN
  - 46708-440-90- 90 TABLET in 1 BOTTLE (46708-440-90)

46708- Alembic Pharmaceuticals Limited
- 46708-440- IRBESARTAN
  - 46708-440-91- 1000 TABLET in 1 BOTTLE (46708-440-91)

46708- Alembic Pharmaceuticals Limited
- 46708-441- IRBESARTAN
  - 46708-441-30- 30 TABLET in 1 BOTTLE (46708-441-30)

46708- Alembic Pharmaceuticals Limited
- 46708-441- IRBESARTAN
  - 46708-441-31- 100 TABLET in 1 BOTTLE (46708-441-31)

46708- Alembic Pharmaceuticals Limited
- 46708-441- IRBESARTAN
  - 46708-441-71- 500 TABLET in 1 BOTTLE (46708-441-71)

46708- Alembic Pharmaceuticals Limited
- 46708-441- IRBESARTAN
  - 46708-441-90- 90 TABLET in 1 BOTTLE (46708-441-90)

46708- Alembic Pharmaceuticals Limited
- 46708-441- IRBESARTAN
  - 46708-441-91- 1000 TABLET in 1 BOTTLE (46708-441-91)

50090- A-S Medication Solutions
- 50090-1284- Irbesartan
  - 50090-1284-0- 30 TABLET in 1 BOTTLE (50090-1284-0)

50090- A-S Medication Solutions
- 50090-1284- Irbesartan
  - 50090-1284-1- 90 TABLET in 1 BOTTLE, PLASTIC (50090-1284-1)

50090- A-S Medication Solutions
- 50090-2017- Irbesartan
  - 50090-2017-0- 30 TABLET in 1 BOTTLE (50090-2017-0)

50090- A-S Medication Solutions
- 50090-2017- Irbesartan
  - 50090-2017-1- 90 TABLET in 1 BOTTLE, PLASTIC (50090-2017-1)

50090- A-S Medication Solutions
- 50090-2978- Irbesartan
  - 50090-2978-0- 30 TABLET in 1 BOTTLE (50090-2978-0)

50090- A-S Medication Solutions
- 50090-6938- Irbesartan
  - 50090-6938-0- 90 TABLET in 1 BOTTLE (50090-6938-0)

50090- A-S Medication Solutions
- 50090-7622- Irbesartan
  - 50090-7622-0- 90 TABLET in 1 BOTTLE (50090-7622-0)

50228- ScieGen Pharmaceuticals, Inc.
- 50228-160- Irbesartan
  - 50228-160-05- 500 TABLET in 1 BOTTLE (50228-160-05)

50228- ScieGen Pharmaceuticals, Inc.
- 50228-160- Irbesartan
  - 50228-160-30- 30 TABLET in 1 BOTTLE (50228-160-30)

50228- ScieGen Pharmaceuticals, Inc.
- 50228-161- Irbesartan
  - 50228-161-10- 1000 TABLET in 1 BOTTLE (50228-161-10)

50228- ScieGen Pharmaceuticals, Inc.
- 50228-161- Irbesartan
  - 50228-161-30- 30 TABLET in 1 BOTTLE (50228-161-30)

50228- ScieGen Pharmaceuticals, Inc.
- 50228-162- Irbesartan
  - 50228-162-05- 500 TABLET in 1 BOTTLE (50228-162-05)

50228- ScieGen Pharmaceuticals, Inc.
- 50228-162- Irbesartan
  - 50228-162-30- 30 TABLET in 1 BOTTLE (50228-162-30)

50268- AvPAK
- 50268-441- Irbesartan
  - 50268-441-15- 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-441-15) / 1 TABLET in 1 BLISTER PACK (50268-441-11)

50268- AvPAK
- 50268-442- Irbesartan
  - 50268-442-15- 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-442-15) / 1 TABLET in 1 BLISTER PACK (50268-442-11)

53360- Sanofi Winthrop Industrie
- 53360-1303-
  - 53360-1303-0- 92307 TABLET, FILM COATED in 1 DRUM (53360-1303-0)

53360- Sanofi Winthrop Industrie
- 53360-1305-
  53360-1305-0- 23076 TABLET, FILM COATED in 1 DRUM (53360-1305-0)

53360- Sanofi Winthrop Industrie
- 53360-1307-
  53360-1307-0- 46153 TABLET, FILM COATED in 1 DRUM (53360-1307-0)

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

Code ⬆