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Torsemide

Aurobindo Pharma Limited

Torsemide Tablets


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

TORSEMIDE DESCRIPTION


m
Torsemide
162043

CLINICAL PHARMACOLOGY


Mechanism of Action

++‾



Pharmacokinetics and Metabolism

maxmaxmax















Clinical Effects























TORSEMIDE INDICATIONS AND USAGE




TORSEMIDE CONTRAINDICATIONS




WARNINGS


Hepatic Disease With Cirrhosis and Ascites



Ototoxicity



Volume and Electrolyte Depletion







PRECAUTIONS

Laboratory Values




WARNINGS































Drug Interactions


















Carcinogenesis, Mutagenesis, Impairment of Fertility




in vivoin vitro

Pregnancy




22

Labor and Delivery


Nursing Mothers


Pediatric Use




Geriatric Use


TORSEMIDE ADVERSE REACTIONS


To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.








Table 1. Reactions Possibly or Probably Drug-Related United States Placebo-Controlled Studies Incidence (Percentages of Patients)
Torsemide
(N=564)		 Placebo
(N=274)
   Headache
7.3
 9.1
   Excessive Urination
6.7
 2.2
   Dizziness
3.2
 4
   Rhinitis
2.8
 2.2
   Asthenia
2
 1.5
   Diarrhea
2
 1.1
   ECG Abnormality
2
 0.4
   Cough Increase
2
 1.5
   Constipation
1.8
 0.7
   Nausea
1.8
 0.4
   Arthralgia
1.8
 0.7
   Dyspepsia
1.6
 0.7
   Sore Throat
1.6
 0.7
   Myalgia
1.6
 1.5
   Chest Pain
1.2
 0.4
   Insomnia
1.2
 1.8
   Edema
1.1
 1.1
   Nervousness
1.1
 0.4









Hypokalemia
 
 WARNINGS.

Postmarketing Experience
 


i.e.,

OVERDOSAGE






TORSEMIDE DOSAGE AND ADMINISTRATION


General



Congestive Heart Failure



Chronic Renal Failure



Hepatic Cirrhosis





Hypertension
 

HOW SUPPLIED


Torsemide Tablets 5 mg





Torsemide Tablets 10 mg





Torsemide Tablets 20 mg





Torsemide Tablets 100 mg





Store at


Aurobindo Pharma USA, Inc.




Aurobindo Pharma Limited




To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (100 Tablet Bottle)


NDC 65862-125-01
Torsemide Tablets
5 mg
Rx only           100 Tablets
AUROBINDO
Torsemide

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (100 Tablet Bottle)


NDC 65862-126-01
Torsemide Tablets
10 mg
Rx only           100 Tablets
AUROBINDO
Torsemide

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (100 Tablet Bottle)


NDC 65862-127-01
Torsemide Tablets
20 mg
Rx only           100 Tablets
AUROBINDO
Torsemide

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg (100 Tablet Bottle)


NDC 65862-128-01
Torsemide Tablets
100 mg
Rx only           100 Tablets
AUROBINDO
Torsemide

Torsemide

Torsemide TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:65862-125
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Torsemide TORSEMIDE 5 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
cellulose, microcrystalline
CROSPOVIDONE
POVIDONE K30
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
WHITE (White to Off-white) 9 mm C;4;1 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65862-125-01 100 in 1 BOTTLE
2 NDC:65862-125-99 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078249 2007-10-17


Torsemide

Torsemide TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:65862-126
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Torsemide TORSEMIDE 10 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
cellulose, microcrystalline
CROSPOVIDONE
POVIDONE K30
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
WHITE (White to Off-white) 11 mm C;4;2 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65862-126-01 100 in 1 BOTTLE
2 NDC:65862-126-99 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078249 2007-10-17


Torsemide

Torsemide TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:65862-127
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Torsemide TORSEMIDE 20 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
cellulose, microcrystalline
CROSPOVIDONE
POVIDONE K30
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
WHITE (White to Off-white) 14 mm C;4;3 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65862-127-01 100 in 1 BOTTLE
2 NDC:65862-127-99 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078249 2007-10-17


Torsemide

Torsemide TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:65862-128
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Torsemide TORSEMIDE 100 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
cellulose, microcrystalline
CROSPOVIDONE
POVIDONE K30
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
WHITE (White to Off-white) 15 mm C;4;4 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65862-128-01 100 in 1 BOTTLE
2 NDC:65862-128-99 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078249 2007-10-17


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