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Torsemide

Camber Pharmaceuticals, Inc.
Hetero Labs Limited


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

TORSEMIDE DESCRIPTION




Torsemide
162043

CLINICAL PHARMACOLOGY


Mechanism of Action

++-



Pharmacokinetics and Metabolism

maxmaxmax















Clinical Effects























INDICATIONS & 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 & Delivery


Nursing Mothers


Pediatric Use





Geriatric Use


TORSEMIDE ADVERSE REACTIONS


contact Hetero Labs Limited at 866-495-1995 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 Tablets
(N=564)
Placebo
(N=274)

Headache
7.3
9.1
Excessive Urination 6.7
 2.2
Dizziness
 3.2
 4.0
Rhinitis
 2.8
 2.2

Asthenia		 2.0
 1.5
Diarrhea
 2.0
 1.1
ECG Abnormality
 2.0
 0.4
Cough Increase
 2.0
 1.5
Constipation
 1.8
 0.7

Nausea		 1.8
0.4
Arthralgia
 1.8
 0.7
Dyspespsia
 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: See WARNINGS

Postmarketing Experience



i.e









DOSAGE & ADMINISTRATION


General


Congestive Heart Failure



Chronic Renal Failure



Hepatic Cirrhosis




Hypertension


HOW SUPPLIED

























Torsemide




By: HETEROTM

 

Hetero Labs Limited                                                                                                          

Jeedimetla, Hyderabad – 500 055, India.                                                            




contact Hetero Labs Limited at 866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL



Torsemide


Torsemide


Torsemide


Torsemide

Torsemide

Torsemide TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:31722-529
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
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
WHITE 8 mm 56;H OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 100 in 1 BOTTLE
2 500 in 1 BOTTLE
3 NDC:31722-529-05 12 in 1 CASE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079234 2011-01-01


Torsemide

Torsemide TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:31722-530
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
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
WHITE 11 mm 57;H OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 100 in 1 BOTTLE
2 500 in 1 BOTTLE
3 NDC:31722-530-05 12 in 1 CASE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079234 2011-01-01


Torsemide

Torsemide TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:31722-531
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
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
WHITE 13 mm 59;H OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 100 in 1 BOTTLE
2 500 in 1 BOTTLE
3 NDC:31722-531-05 12 in 1 CASE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079234 2011-01-01


Torsemide

Torsemide TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:31722-532
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
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
WHITE 13 mm 60;H OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 100 in 1 BOTTLE
2 500 in 1 BOTTLE
3 NDC:31722-532-05 12 in 1 CASE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079234 2011-01-01


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