Rising Pharmaceuticals Inc.
Emcure Pharmaceuticals Ltd.
Bethanechol Chloride Tablets USP
FULL PRESCRIBING INFORMATION: CONTENTS*
FULL PRESCRIBING INFORMATION
BETHANECHOL CHLORIDE DESCRIPTION
71722
CLINICAL PHARMACOLOGY
INDICATIONS & USAGE
Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.
BETHANECHOL CHLORIDE CONTRAINDICATIONS
PRECAUTIONS
General
In urinary retention, if the sphincter fails to relax as bethanechol contracts the bladder, urine may be forced up the ureter into the kidney pelvis. If there is bacteriuria, this may cause reflux infection.
Information for Patients
Bethanechol chloride tablets should preferably be taken one hour before or two hours after meals to avoid nausea or vomiting. Dizziness, lightheadedness or fainting may occur, especially when getting up from a lying or sitting position.
Drug Interactions
Carcinogenesis & Mutagenesis & Impairment Of Fertility
Pregnancy
Nursing Mothers
Pediatric Use
BETHANECHOL CHLORIDE ADVERSE REACTIONS
Body as a Whole:Digestive:Renal:Nervous System:Cardiovascular:Skin:Special Senses:
Causal Relationship Unknown:Body as a Whole:Nervous System:OVERDOSAGE
Atropine Sulfate is a specific antidote.DOSAGE & ADMINISTRATION
OVERDOSAGE
HOW SUPPLIED
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
BETHANECHOL CHLORIDE
BETHANECHOL CHLORIDE TABLET
Product Information
|
|
Product Type
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Human prescription drug label |
Item Code (Source)
|
NDC:64980-160 |
|
Route of Administration
|
ORAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
BETHANECHOL CHLORIDE BETHANECHOL |
|
5 mg
|
Product Characteristics
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|
Color
|
Size
|
Imprint Code
|
Shape
|
|
WHITE |
6 mm |
EP118 |
ROUND |
Packaging
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|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:64980-160-01 |
100 in 1 BOTTLE |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
ANDA |
ANDA091256 |
2010-08-24 |
|
|
BETHANECHOL CHLORIDE
BETHANECHOL CHLORIDE TABLET
Product Information
|
|
Product Type
|
Human prescription drug label |
Item Code (Source)
|
NDC:64980-161 |
|
Route of Administration
|
ORAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
BETHANECHOL CHLORIDE BETHANECHOL |
|
10 mg
|
Product Characteristics
|
|
Color
|
Size
|
Imprint Code
|
Shape
|
|
WHITE |
8 mm |
EP119 |
ROUND |
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:64980-161-01 |
100 in 1 BOTTLE |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
ANDA |
ANDA091256 |
2010-04-06 |
|
|
BETHANECHOL CHLORIDE
BETHANECHOL CHLORIDE TABLET
Product Information
|
|
Product Type
|
Human prescription drug label |
Item Code (Source)
|
NDC:64980-162 |
|
Route of Administration
|
ORAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
BETHANECHOL CHLORIDE BETHANECHOL |
|
25 mg
|
Product Characteristics
|
|
Color
|
Size
|
Imprint Code
|
Shape
|
|
WHITE |
9 mm |
EP120 |
ROUND |
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:64980-162-01 |
100 in 1 BOTTLE |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
ANDA |
ANDA091256 |
2010-04-06 |
|
|
BETHANECHOL CHLORIDE
BETHANECHOL CHLORIDE TABLET
Product Information
|
|
Product Type
|
Human prescription drug label |
Item Code (Source)
|
NDC:64980-163 |
|
Route of Administration
|
ORAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
BETHANECHOL CHLORIDE BETHANECHOL |
|
50 mg
|
Product Characteristics
|
|
Color
|
Size
|
Imprint Code
|
Shape
|
|
WHITE |
11 mm |
EP121 |
ROUND |
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:64980-163-01 |
100 in 1 BOTTLE |
|
|
Marketing Information
|
|
Marketing Category
|
Application Number or Monograph Citation
|
Marketing Start Date
|
Marketing End Date
|
|
ANDA |
ANDA091256 |
2010-04-06 |
|
|
