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Irbesartan

Aurobindo Pharma Limited

Irbesartan Tablets, USP


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

WARNING: FETAL TOXICITY

  • When pregnancy is detected, discontinue irbesartan as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS: Fetal Toxicity.

IRBESARTAN DESCRIPTION


1

poH

25286
Irbesartan


CLINICAL PHARMACOLOGY


Mechanism of Action 

12

1 12

1

Pharmacokinetics








Metabolism and Elimination
 
14

14

In vitro

Distribution 
 
1

Special Populations








max



max



WARNINGS: Hypotension in Volume- or Salt-Depleted Patients DOSAGE AND ADMINISTRATION







PRECAUTIONS: Drug Interactions

Pharmacodynamics
 




Clinical Studies







IrbesartanIrbesartan
















Irbesartan


Table 1: IDNT: Components of Primary Composite Endpoint
Irbesartan
N=579
(%)		 Comparison With Placebo Comparison With Amlodipine
Placebo
N=569
(%)		 Hazard
Ratio		 95% CI Amlodipine
N=567
(%)		 Hazard
Ratio		 95% CI
 Primary Composite
 Endpoint
 32.6
 39
 0.8
 0.66-0.97
(p=0.0234)
 41.1
 0.77
 0.63-0.93
 Breakdown of first occurring event contributing to primary endpoint
     2x creatinine
14.2
 19.5
 ---
 ---
 22.8
 ---
 ---
     ESRD
7.4
 8.3
 ---
 ---
 8.8
 ---
 ---
     Death
11.1
 11.2
 ---
 ---
 9.5
 ---
 ---
 Incidence of total events over entire period of follow-up
     2x creatinine
16.9
 23.7
 0.67
 0.52-0.87
 25.4
 0.63
 0.49-0.81
     ESRD
14.2
 17.8
 0.77
 0.57-1.03
 18.3
 0.77
 0.57-1.03
     Death
15
 16.3
 0.92
 0.69-1.23
 14.6
 1.04
 0.77-1.4



Table 2: IDNT: Primary Efficacy Outcome Within Subgroups
Baseline
Factors		 Irbesartan
N=579
(%)		 Comparison With Placebo
Placebo
N=569
(%)		 Hazard
Ratio		 95% Cl
 Gender
     Male
 27.5
 36.7
 0.68
 0.53-0.88
     Female
 42.3
 44.6
 0.98
 0.72-1.34
 Race
     White
 29.5
 37.3
 0.75
 0.6-0.95
     Non-White
 42.6
 43.5
 0.95
 0.67-1.34
 Age (years)
     < 65
 31.8
 39.9
 0.77
 0.62-0.97
     ≥ 65
 35.1
 36.8
 0.88
 0.61-1.29

IRBESARTAN INDICATIONS AND USAGE


Hypertension



Nephropathy in Type 2 Diabetic Patients 
 
 CLINICAL PHARMACOLOGY: Clinical Studies

IRBESARTAN CONTRAINDICATIONS




PRECAUTIONS,  Drug Interactions

WARNINGS

Fetal Toxicity



 



in utero PRECAUTIONS: Pediatric Use



Hypotension in Volume- or Salt-Depleted Patients


DOSAGE AND ADMINISTRATION

PRECAUTIONS

Impaired Renal Function




Information for Patients




Drug Interactions




In vitro in vitro





Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)





Dual Blockade of the Renin-Angiotensin System (RAS)



 

Carcinogenesis, Mutagenesis, Impairment of Fertility


0-24 hour

in vitroin vitroin vivo

0-24 hour

Pregnancy


Pregnancy Category D

WARNINGS: Fetal Toxicity

Nursing Mothers


Pediatric Use


Neonates with a history of in utero exposure to irbesartan





Geriatric Use


CLINICAL PHARMACOLOGY: Pharmacokinetics Special Populations Clinical Studies

IRBESARTAN ADVERSE REACTIONS


Hypertension















Body as a Whole:

Cardiovascular:

Dermatologic:

Endocrine/Metabolic/Electrolyte Imbalances:

Gastrointestinal:

Musculoskeletal/Connective Tissue:

Nervous System:

Renal/Genitourinary:

Respiratory:

Special Senses:

Nephropathy in Type 2 Diabetic Patients
 

Postmarketing Experience
 








Laboratory Test Findings





Creatinine, Blood Urea Nitrogen: PRECAUTIONS: Impaired Renal Function

Hematologic: 3



Hyperkalemia:

OVERDOSAGE




Physicians’ Desk Reference



2

IRBESARTAN DOSAGE AND ADMINISTRATION




Hypertension 
 


CLINICAL PHARMACOLOGY: Clinical Studies



Nephropathy in Type 2 Diabetic Patients 
 
 CLINICAL PHARMACOLOGY: Clinical Studies

Volume- and Salt-Depleted Patients 
 
 WARNINGS: Hypotension in Volume- or Salt-Depleted Patients

HOW SUPPLIED


Irbesartan Tablets USP, 75 mg





Irbesartan Tablets USP, 150 mg






Irbesartan Tablets USP, 300 mg





Storage 

Store at


Aurobindo Pharma USA, Inc.




Aurobindo Pharma Limited




PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 75 mg (90 Tablet Bottle)


NDC 65862-637-90
Irbesartan Tablets, USP
75 mg
Rx only               90 Tablets
AUROBINDO
Irbesartan

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg (90 Tablet Bottle)


NDC 65862-638-90
Irbesartan Tablets, USP
150 mg
Rx only               90 Tablets
AUROBINDO
Irbesartan

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg Blister Carton (10 x 10 Unit-dose)


NDC 65862-638-78
Irbesartan Tablets, USP
150 mg
Rx only               100 Tablets ( 10 x 10 Unit-dose)
AUROBINDO
Irbesartan

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 300 mg (90 Tablet Bottle)


NDC 65862-639-90
Irbesartan Tablets, USP
300 mg
Rx only               90 Tablets
AUROBINDO
Irbesartan

Irbesartan

Irbesartan TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:65862-637
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IRBESARTAN IRBESARTAN 75 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
Hypromellose 2910 (5 Mpa.s)
cellulose, microcrystalline
polysorbate 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
SODIUM STEARYL FUMARATE
talc

Product Characteristics

Color Size Imprint Code Shape
WHITE (White to Off-white) 11 mm T31 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65862-637-30 30 in 1 BOTTLE
2 NDC:65862-637-90 90 in 1 BOTTLE
3 NDC:65862-637-05 500 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203081 2012-09-27


Irbesartan

Irbesartan TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:65862-638
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IRBESARTAN IRBESARTAN 150 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
Hypromellose 2910 (5 Mpa.s)
cellulose, microcrystalline
polysorbate 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
SODIUM STEARYL FUMARATE
talc

Product Characteristics

Color Size Imprint Code Shape
WHITE (White to Off-white) 14 mm T32 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65862-638-30 30 in 1 BOTTLE
2 NDC:65862-638-90 90 in 1 BOTTLE
3 NDC:65862-638-05 500 in 1 BOTTLE
4 NDC:65862-638-10 10 in 1 BLISTER PACK
5 NDC:65862-638-78 10 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203081 2012-09-27


Irbesartan

Irbesartan TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:65862-639
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IRBESARTAN IRBESARTAN 300 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
Hypromellose 2910 (5 Mpa.s)
cellulose, microcrystalline
polysorbate 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
SODIUM STEARYL FUMARATE
talc

Product Characteristics

Color Size Imprint Code Shape
WHITE (White to Off-white) 17 mm T33 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65862-639-30 30 in 1 BOTTLE
2 NDC:65862-639-90 90 in 1 BOTTLE
3 NDC:65862-639-05 500 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203081 2012-09-27


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Be sure to consult your doctor before taking any medication!
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