Irbesartan and Hydrochlorothiazide description, usages, side effects, indications, overdosage, supplying and lots more!

Menu
Search

Irbesartan and Hydrochlorothiazide

Aurobindo Pharma Limited

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use irbesartan and hydrochlorothiazide safely and effectively. See full prescribing information for irbesartan and hydrochlorothiazide tablets, USP. Irbesartan and Hydrochlorothiazide Tablets, USPInitial U.S. Approval: 1997RECENT MAJOR CHANGES(5.9)(5.1)(5.6)BOXED WARNINGWARNING: FETAL TOXICITY  See full prescribing information for complete boxed warning.   When pregnancy is detected, discontinue irbesartan and hydrochlorothiazide as soon as possible. (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1) INDICATIONS AND USAGE In patients not adequately controlled with monotherapy. (1) As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. (1) DOSAGE AND ADMINISTRATIONGeneral Considerations Maximum effects within 2 to 4 weeks after dose change. (2.1) Renal Impairment: Not recommended for patients with severe renal impairment (creatinine clearance


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

WARNING: FETAL TOXICITY

1 INDICATIONS AND USAGE












[see Clinical Studies (14.2)]
Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide





2 DOSAGE AND ADMINISTRATION

2.1 General Considerations


[see Adverse Reactions (6)]







Renal impairment.


Hepatic impairment.

2.2 Add-On Therapy


In patients not controlled on monotherapy with irbesartan or hydrochlorothiazide, the recommended doses of irbesartan and hydrochlorothiazide tablets, in order of increasing mean effect, are (irbesartan-hydrochlorothiazide) 150 mg/12.5 mg, 300 mg/12.5 mg, and 300 mg/25 mg. The largest incremental effect will likely be in the transition from monotherapy to 150 mg/12.5 mg [see Clinical Studies (14.2)].

2.3 Replacement Therapy


Irbesartan and hydrochlorothiazide tablets may be substituted for the titrated components.

2.4 Initial Therapy


[see Clinical Studies (14.2)][see Warnings and Precautions (5.2) ].

3 DOSAGE FORMS AND STRENGTHS




4 CONTRAINDICATIONS

  • Irbesartan and hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to any component of this product.
  • Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
  • Do not co-administer aliskiren with irbesartan and hydrochlorothiazide tablets in patients with diabetes [see Drug Interactions (7)].

5 WARNINGS AND PRECAUTIONS

5.1 Fetal Toxicity

Pregnancy Category D

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue irbesartan and hydrochlorothiazide as soon as possible [see Use in Specific Populations (8.1)].

Thiazides cross the placenta, and use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.

5.2 Hypotension in Volume- or Salt-Depleted Patients




5.3 Hypersensitivity Reaction


Hydrochlorothiazide
 

5.4 Systemic Lupus Erythematosus


Hydrochlorothiazide
 

5.5 Lithium Interaction


Hydrochlorothiazide
 
[see Drug Interactions (7)].

5.6 Electrolyte and Metabolic Imbalances


Irbesartan-Hydrochlorothiazide

In double-blind clinical trials of various doses of irbesartan and hydrochlorothiazide, the incidence of hypertensive patients who developed hypokalemia (serum potassium <3.5 mEq/L) was 7.5% versus 6% for placebo; the incidence of hyperkalemia (serum potassium >5.7 mEq/L) was <1% versus 1.7% for placebo. No patient discontinued due to increases or decreases in serum potassium. On average, the combination of irbesartan and hydrochlorothiazide had no effect on serum potassium. Higher doses of irbesartan ameliorated the hypokalemic response to hydrochlorothiazide.

 

Based on experience with the use of other drugs that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium. Concurrent therapy with hydrochlorothiazide may reduce the frequency of this effect.
 

Hydrochlorothiazide

Hydrochlorothiazide can cause hypokalemia and hyponatremia. Hypomagnesemia can result in hypokalemia which appears difficult to treat despite potassium repletion. Drugs that inhibit the renin-angiotensin system can cause hyperkalemia. Monitor serum electrolytes periodically.

Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.

Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides.




5.7 Hepatic Impairment


Hydrochlorothiazide
 

5.8 Impaired Renal Function


[see Drug Interactions (7)]

5.9 Acute Myopia and Secondary Angle-Closure Glaucoma

Sulfonamide or sulfonamide derivative drugs, such as hydrochlorothiazide, can cause an idiosyncratic reaction, resulting in transient myopia and acute angle-closure glaucoma. Cases of acute angle-closure glaucoma have been reported with hydrochlorothiazide. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue drug intake as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience




Irbesartan-Hydrochlorothiazide
 



  Irbesartan/Hydrochlorothiazide
 (n=898)
(%)
Placebo (n=236)
(%)
Irbesartan (n=400)
(%)
Hydrochlorothiazide
(n=380)
(%)
 Body as a Whole
     Chest Pain
2
1
2
2
     Fatigue
6
3
4
3
     Influenza
3
1
2
2
 Cardiovascular
     Edema
3
3
2
2
     Tachycardia
1
0
1
1
 Gastrointestinal
     Abdominal Pain
2
1
2
2
     Dyspepsia/heartburn
2
1
0
2
     Nausea/vomiting
3
0
2
2
 Immunology
     Allergy
1
0
1
1
 Musculoskeletal
     Musculoskeletal Pain
6
5
6
10
 Nervous System
     Dizziness
8
4
6
5
     Dizziness Orthostatic
1
0
1
1
 Renal/Genitourinary
     Abnormality Urination
2
1
1
2






Irbesartan 
 


Body as a Whole:


Cardiovascular:


Dermatologic:


Endocrine/Metabolic/Electrolyte Imbalances:


Gastrointestinal:


Musculoskeletal/Connective Tissue:


Nervous System:


Renal/Genitourinary:


Respiratory:


Special Senses:


Hydrochlorothiazide 
 


Body as a Whole:


Digestive:


Hematologic:


Hypersensitivity:


Metabolic:


Musculoskeletal:


Nervous System/Psychiatric:


Renal:


Skin:


Special Senses:


Initial Therapy

hydrochlorothiazide

[see Clinical Studies (14.2)].

6.2 Postmarketing Experience










6.3 Laboratory Abnormalities




Creatinine, Blood Urea Nitrogen:


Liver Function Tests:


Serum Electrolytes: [see Warnings and Precautions (5.2, 5.6)].

7 DRUG INTERACTIONS


Irbesartan

[see Clinical Pharmacology (12.3)]

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




Dual Blockade of the Renin-Angiotensin System (RAS)





Hydrochlorothiazide




Alcohol, Barbiturates, or Narcotics:


Antidiabetic Drugs (oral agents and insulin):


Other Antihypertensive Drugs:


Cholestyramine and Colestipol Resins:


Corticosteroids, ACTH:


Pressor Amines (e.g., Norepinephrine):


Skeletal Muscle Relaxants, Nondepolarizing (e.g., Tubocurarine):


Lithium:
[see Warnings and Precautions (5.5)]

Non-steroidal Anti-inflammatory Drugs:


Carbamazepine

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy


Pregnancy Category D



in utero[see Use in Specific Populations (8.4)]

[see Nonclinical Toxicology (13.2)]





8.3 Nursing Mothers




8.4 Pediatric Use


Neonates with a history of in utero exposure to irbesartan and hydrochlorothiazide: 



8.5 Geriatric Use


[see Clinical Pharmacology (12.3) and Clinical Studies (14)].

10 OVERDOSAGE


Irbesartan



Physicians’ Desk Reference



2

Hydrochlorothiazide
 
50

11 DESCRIPTION


1

poH25286
Irbesartan and Hydrochlorothiazide


H78342
Irbesartan and Hydrochlorothiazide


12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action


Irbesartan

12

11 2

1



Hydrochlorothiazide
 


12.2 Pharmacodynamics


Irbesartan







Hydrochlorothiazide
 

12.3 Pharmacokinetics


Irbesartan







Hydrochlorothiazide
 


Metabolism and Elimination
 
Irbesartan
 
14

14

In vitro


Hydrochlorothiazide
 


Distribution
 
Irbesartan
 
1



Hydrochlorothiazide
 


Pediatric
 


Gender
 


Geriatric
 
max

Race
 
max

Renal Insufficiency
 
[see Warnings and Precautions (5.2)].

Hepatic Insufficiency



Drug-Drug Interactions
 


In vitro
in vitro

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility


Irbesartan-Hydrochlorothiazide



in vitroin vitro–in vivo–



Irbesartan
 
0-24 hours

in vitroin vitro–in vivo–

0-24 hours

Hydrochlorothiazide
 


in vitroSalmonella typhimuriumin vivoDrosophila in vitroAspergillus nidulans

13.2 Animal Toxicology and/or Pharmacology


Reproductive Toxicology Studies
 

14 CLINICAL STUDIES

14.1 Irbesartan Monotherapy





Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide




14.2 Irbesartan-Hydrochlorothiazide














Initial Therapy
 












16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied


Irbesartan and Hydrochlorothiazide Tablets USP, 150 mg/12.5 mg






Irbesartan and Hydrochlorothiazide Tablets USP, 300 mg/12.5 mg




16.2 Storage


Store at

17 PATIENT COUNSELING INFORMATION

17.1 Pregnancy

Female patients of childbearing age should be told about the consequences of exposure to irbesartan and hydrochlorothiazide during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physician as soon as possible.

17.2 Symptomatic Hypotension







Aurobindo Pharma USA, Inc.




Aurobindo Pharma Limited




PACKAGE LABEL PRINCIPAL DISPLAY PANEL - 150 mg/12.5 mg (30 Tablet Bottle)


NDC 65862-629-30
Irbesartan and Hydrochlorothiazide Tablets, USP
150 mg/12.5 mg
Rx only       30 Tablets
AUROBINDO
Irbesartan and Hydrochlorothiazide

PACKAGE LABEL PRINCIPAL DISPLAY PANEL - 300 mg/12.5 mg (30 Tablet Bottle)


NDC 65862-630-30
Irbesartan and Hydrochlorothiazide Tablets, USP
300 mg/12.5 mg
Rx only       30 Tablets
AUROBINDO
Irbesartan and Hydrochlorothiazide

Irbesartan and Hydrochlorothiazide

Irbesartan and Hydrochlorothiazide TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:65862-629
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IRBESARTAN IRBESARTAN 150 mg
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 12.5 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
HYPROMELLOSE 2910 (15 MPA.S)
ferric oxide red
lactose monohydrate
POLYETHYLENE GLYCOL 3000
POVIDONE K30
SODIUM STEARYL FUMARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
talc
titanium dioxide
FERRIC OXIDE YELLOW

Product Characteristics

Color Size Imprint Code Shape
ORANGE (Peach) 14 mm H;35 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65862-629-30 30 in 1 BOTTLE
2 NDC:65862-629-90 90 in 1 BOTTLE
3 NDC:65862-629-05 500 in 1 BOTTLE
4 NDC:65862-629-99 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203630 2013-02-22


Irbesartan and Hydrochlorothiazide

Irbesartan and Hydrochlorothiazide TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:65862-630
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IRBESARTAN IRBESARTAN 300 mg
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 12.5 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
HYPROMELLOSE 2910 (15 MPA.S)
ferric oxide red
lactose monohydrate
POLYETHYLENE GLYCOL 3000
POVIDONE K30
SODIUM STEARYL FUMARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
talc
titanium dioxide
FERRIC OXIDE YELLOW

Product Characteristics

Color Size Imprint Code Shape
ORANGE (Peach) 18 mm H;36 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65862-630-30 30 in 1 BOTTLE
2 NDC:65862-630-90 90 in 1 BOTTLE
3 NDC:65862-630-05 500 in 1 BOTTLE
4 NDC:65862-630-99 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203630 2013-02-22


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.