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

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Irbesartan and Hydrochlorothiazide

Macleods Pharmaceuticals Limited

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use Irbesartan and Hydrochlorothiazide Tablets USP safely and effectively. See full prescribing information for Irbesartan and Hydrochlorothiazide Tablets USP. Irbesartan and Hydrochlorothiazide Tablets USPInitial U.S. Approval: 1997 RECENT MAJOR CHANGES5.95.15.6BOXED WARNING5.15.1INDICATIONS AND USAGEIrbesartan and hydrochlorothiazide tablet  USP is a combination of irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension: 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 2.12.15.8Hypertension 2.22.3DOSAGE FORMS AND STRENGTHS33CONTRAINDICATIONS4444WARNINGS AND PRECAUTIONS Hypotension: Correct volume-depletion prior to administration.(5.2). Impaired renal function (5.8). Thiazide diuretics may cause an exacerbation or activation of systemic lupus erythematosus (5.4). Acute myopia and secondary angle-closure glaucoma. (5.9) Side Effects6.1To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc. at 1-888-943-3210or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchDRUG INTERACTIONS77USE IN SPECIFIC POPULATIONS8.3


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING




Warnings and Precautions (5.1)
See Warnings and Precautions (5.1)

1 INDICATIONS & USAGE











Clinical Studies (14.2)


 Irbesartan and Hydrochlorothiazide

 Irbesartan and Hydrochlorothiazide
Figure 1a: Probability of Achieving SBP <140 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)* Figure 1b: Probability of Achieving SBP <130 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)*
 Irbesartan and Hydrochlorothiazide  Irbesartan and Hydrochlorothiazide
Figure 2a: Probability of Achieving DBP <90 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)* Figure 2b: Probability of Achieving DBP <80 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)*












2 DOSAGE & ADMINISTRATION

2.1 General Considerations


See Adverse Reactions (6)







Renal impairment.

Hepatic impairment.

2.2 Add-On Therapy


Clinical Studies (14.2)

2.3 Replacement Therapy


2.4 Initial Therapy


Clinical Studies (14.2)Warnings and Precautions (5.2)

3 DOSAGE FORMS & 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 tablets 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

Drug Interactions (7)

5.6 Electrolyte and Metabolic Imbalances


Irbesartan and hydrochlorothiazide





Hydrochlorothiazide









5.7 Hepatic Impairment


Hydrochlorothiazide

5.8 Impaired Renal Function


7

5.9 Acute Myopia and Secondary Angle-Closure Glaucoma


 Sulfonamide or sulfonamide derivative drugs, such as hydrochlorothiazide, can cause 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 and hydrochlorothiazide






 

Irbesartan/
HCTZ
(n=898)
(%)  

 Placebo
(n=236)
(%) 

 Irbesartan
(n=400)
(%)

HCTZ
(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

The following adverse events were also reported at a rate of 1% or greater, but were as, or more, common in the placebo group: headache, sinus abnormality, cough, URI, pharyngitis, diarrhea, rhinitis, urinary tract infection, rash, anxiety/nervousness, and muscle cramp.

Adverse events occurred at about the same rates in men and women, older and younger patients, and black and non-black patients.

Adverse events in Studies V and VI were similar to those described above in Studies I through IV.

Irbesartan

Other adverse events that have been reported with irbesartan, without regard to causality, are listed below:

Body as a Whole: fever, chills, orthostatic effects, facial edema, upper extremity edema
Cardiovascular: flushing, hypertension, cardiac murmur, myocardial infarction, angina pectoris, hypotension, syncope, arrhythmic/conduction disorder, cardiorespiratory arrest, heart failure, hypertensive crisis
Dermatologic: pruritus, dermatitis, ecchymosis, erythema face, urticaria
Endocrine/Metabolic/Electrolyte Imbalances: sexual dysfunction, libido change, gout

Gastrointestinal: diarrhea, constipation, gastroenteritis, flatulence, abdominal distention

Musculoskeletal/Connective Tissue: musculoskeletal trauma, extremity swelling, muscle cramp, arthritis, muscle ache, musculoskeletal chest pain, joint stiffness, bursitis, muscle weakness

Nervous System: anxiety/nervousness, sleep disturbance, numbness, somnolence, vertigo, emotional disturbance, depression, paresthesia, tremor, transient ischemic attack, cerebrovascular accident

Renal/Genitourinary: prostate disorder

Respiratory: cough, upper respiratory infection, epistaxis, tracheobronchitis, congestion, pulmonary congestion, dyspnea, wheezing

Special Senses: vision disturbance, hearing abnormality, ear infection, ear pain, conjunctivitis

Hydrochlorothiazide

Other adverse events that have been reported with hydrochlorothiazide, without regard to causality, are listed below:

Body as a Whole: weakness

Digestive: pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation

Hematologic: aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia

Hypersensitivity: purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactions

Metabolic: hyperglycemia, glycosuria, hyperuricemia

Musculoskeletal: muscle spasm

Nervous System/Psychiatric: restlessness

Renal: renal failure, renal dysfunction, interstitial nephritis

Skin: erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis


Special Senses


Initial Therapy



Clinical Studies (14.2).

6.2 Post-Marketing Experience









6.3 Laboratory Abnormalities




Creatinine, Blood Urea Nitrogen

Liver Function Tests

Serum ElectrolytesWarnings and Precautions (5.2, 5.6).

7 DRUG INTERACTIONS


Irbesartan

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 (eg, Norepinephrine)

Skeletal Muscle Relaxants, Nondepolarizing (eg, Tubocurarine)

LithiumWarnings and Precautions (5.5)

Non-steroidal Anti-inflammatory Drugs

Carbamazepine

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy


Pregnancy Category D


Use in Specific Populations (8.4)

Nonclinical Toxicology (13.2)




8.3 Nursing Mothers



8.4 Pediatric Use


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


8.5 Geriatric Use


Clinical Pharmacology (12.3) and Clinical Studies (14)

10 OVERDOSAGE


Irbesartan



Physicians’ Desk Reference (PDR)



2

Hydrochlorothiazide

50

11 DESCRIPTION


1

25286

Irbesartan and Hydrochlorothiazide


78342
Irbesartan and Hydrochlorothiazide




12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action


Irbesartan
12

112

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
Warnings and Precautions (5.2)

Hepatic Insufficiency


Drug-Drug Interactions


In vitroin vitro

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis & Mutagenesis & Impairment Of Fertility


Irbesartan -  hydrochlorothiazide







Irbesartan

0-24



0-24

Hydrochlorothiazide


in vitroSalmonella typhimuriumin vivoDrosophilain vitroAspergillus nidulans

13.2 Animal Pharmacology & OR Toxicology


Reproductive Toxicology Studies

14 CLINICAL STUDIES

14.1 Irbesartan Monotherapy






 Irbesartan and Hydrochlorothiazide  Irbesartan and Hydrochlorothiazide






14.2 Irbesartan and Hydrochlorothiazide














Initial Therapy












16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied





Tablet Strength
(irbesartan and
hydrochlorothiazide)   
 Film-Coated
Tablet
Color/Shape 
 Tablet
Markings
 Package Size
NDC Code
150 mg/12.5 mg 
  
peach, oval-shaped 
ML; 34 debossed on one side and plain on the reverse
Bottles of 30
Bottles of 90
Bottles of 500
Blister pack of 30s (3 x 10s unit-dose blister)
Blister pack of 90s (9 x 10s unit-dose blister)

 
33342-057-07
33342-057-10
33342-057-15
33342-057-06
33342-057-39
 
300 mg/12.5 mg  
peach, oval-shaped 
ML; 33 debossed on one side and plain on the reverse
Bottles of 30
Bottles of 90
Bottles of 500
Blister pack of 30s (3 x 10s unit-dose blister)
Blister pack of 90s (9 x 10s unit-dose blister) 

 
33342-058-07
33342-058-10
33342-058-15
33342-058-06
33342-058-39
 

16.2 Storage

17 PATIENT COUNSELING INFORMATION

17.1 Pregnancy



17.2 Symptomatic Hypotension


















PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


REPRESENTATIVE PACKAGING
How Supplied








Irbesartan and Hydrochlorothiazide









Irbesartan and Hydrochlorothiazide









Irbesartan and Hydrochlorothiazide

Irbesartan and Hydrochlorothiazide TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:33342-057
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
carboxymethylcellulose calcium
SILICON DIOXIDE
POVIDONE K29/32
SODIUM STARCH GLYCOLATE TYPE A POTATO
talc
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (15 MPA.S)
titanium dioxide
POLYETHYLENE GLYCOL 3000
lactose monohydrate
FERRIC OXIDE YELLOW
ferric oxide red

Product Characteristics

Color Size Imprint Code Shape
ORANGE (peach) 14 mm ML;34 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:33342-057-07 30 in 1 BOTTLE
2 NDC:33342-057-10 90 in 1 BOTTLE
3 NDC:33342-057-15 500 in 1 BOTTLE
4 10 in 1 BLISTER PACK
5 10 in 1 BLISTER PACK
6 NDC:33342-057-39 9 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202414 2012-09-27


Irbesartan and Hydrochlorothiazide

Irbesartan and Hydrochlorothiazide TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:33342-058
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
carboxymethylcellulose calcium
SILICON DIOXIDE
POVIDONE K29/32
SODIUM STARCH GLYCOLATE TYPE A POTATO
talc
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (15 MPA.S)
titanium dioxide
POLYETHYLENE GLYCOL 3000
lactose monohydrate
FERRIC OXIDE YELLOW
ferric oxide red

Product Characteristics

Color Size Imprint Code Shape
ORANGE (peach) 17 mm ML;33 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:33342-058-07 30 in 1 BOTTLE
2 NDC:33342-058-10 90 in 1 BOTTLE
3 NDC:33342-058-15 500 in 1 BOTTLE
4 10 in 1 BLISTER PACK
5 10 in 1 BLISTER PACK
6 NDC:33342-058-39 9 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202414 2012-09-27


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