Bisoprolol Fumarate description, usages, side effects, indications, overdosage, supplying and lots more!

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Bisoprolol Fumarate

Aurobindo Pharma Limited

Bisoprolol Fumarate Tablets, USP


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BISOPROLOL FUMARATE DESCRIPTION


1E183142444
Bisoprolol Fumarate



CLINICAL PHARMACOLOGY


12

Pharmacokinetics and Metabolism











Pharmacodynamics















121





CLINICAL STUDIES



Sitting Systolic/Diastolic Pressure (BP) and Heart Rate (HR) Mean Decrease (D) After 3 to 4 Weeks
Study A   Bisoprolol Fumarate
  Placebo 5 mg 10 mg 20 mg
a Observed total change from baseline minus placebo.
 n=
61
 61
 61
 61
 Total ΔBP (mm Hg)
5.4/3.2
 10.4/8
 11.2/10.9
 12.8/11.9
 Drug Effecta
-
 5/4.8
 5.8/7.7
 7.4/8.7
 Total ΔHR (bpm)
 0.5
 7.2
 8.7
 11.3
 Drug Effecta
-
 6.7
 8.2
 10.8
Study B
Bisoprolol Fumarate
Placebo
2.5 mg
10 mg
 n=
56
 59
 62
 Total ΔBP (mm Hg)
3/3.7
 7.6/8.1
 13.5/11.2
 Drug Effecta
-
 4.6/4.4
 10.5/7.5
 Total ΔHR (bpm)
 1.6
 3.8
 10.7
 Drug Effecta
-
 2.2
 9.1


BISOPROLOL FUMARATE INDICATIONS AND USAGE


BISOPROLOL FUMARATE CONTRAINDICATIONS


WARNINGS


Cardiac Failure



In Patients Without a History of Cardiac Failure



Abrupt Cessation of Therapy



Peripheral Vascular Disease

Bronchospastic Disease


PATIENTS WITH BRONCHOSPASTIC DISEASE SHOULD, IN GENERAL, NOT RECEIVE BETA-BLOCKERS. Because of its relative beta1-selectivity, however, bisoprolol fumarate may be used with caution in patients with bronchospastic disease who do not respond to, or who cannot tolerate other antihypertensive treatment. Since beta1-selectivity is not absolute, the lowest possible dose of bisoprolol fumarate should be used, with therapy starting at 2.5 mg. A beta2 agonist (bronchodilator) should be made available.

Major Surgery 



Diabetes and Hypoglycemia

1

Thyrotoxicosis

PRECAUTIONS


Impaired Renal or Hepatic Function

CLINICAL PHARMACOLOGY DOSAGE AND ADMINISTRATION

Drug Interactions









Risk of Anaphylactic Reaction:

Information for Patients






Carcinogenesis, Mutagenesis, Impairment of Fertility


in vitroin vivo

Pregnancy Category C




Nursing Mothers


Pediatric Use


Geriatric Use




BISOPROLOL FUMARATE ADVERSE REACTIONS









Body System/Adverse Experience All Adverse Experiences (%a)
Bisoprolol Fumarate
Placebo
(n=132)
% 		5 to 20 mg
(n=273)
% 		2.5 to 40 mg
(n=404)
%
a percentage of patients with event
 Skin
 
 
 
     increased sweating
1.5
 0.7
 1
     Musculoskeletal
 
 
 
     arthralgia
2.3
 2.2
 2.7
 Central Nervous System
 
 
 
     dizziness
3.8
 2.9
 3.5
     headache
11.4
 8.8
 10.9
     hypoaesthesia
0.8
 1.1
 1.5
 Autonomic Nervous System
 
 
 
     dry mouth
1.5
 0.7
 1.3
 Heart Rate/Rhythm
 
 
 
     bradycardia
0
 0.4
 0.5
 Psychiatric
 
 
 
     vivid dreams
0
 0
 0
     insomnia
2.3
 1.5
 2.5
     depression
0.8
 0
 0.2
 Gastrointestinal
  
 
 
     diarrhea
1.5
 2.6
 3.5
     nausea
1.5
 1.5
 2.2
     vomiting
0
 1.1
 1.5
 Respiratory
 
 
 
     bronchospasm
0
 0
 0
     cough
4.5
 2.6
 2.5
     dyspnea
0.8
 1.1
 1.5
     pharyngitis
2.3
 2.2
 2.2
     rhinitis
3
 2.9
 4
     sinusitis
1.5
 2.2
 2.2
     URI
3.8
 4.8
 5
 Body as a Whole
 
 
 
     asthenia
0
 0.4
 1.5
     chest pain
0.8
 1.1
 1.5
     fatigue
1.5
 6.6
 8.2
     edema (peripheral)
3.8
 3.7
 3



Central Nervous System
 
unsteadinesssyncopesleep disturbances

Autonomic Nervous System
 

Cardiovascular
 

Psychiatric
 

Gastrointestinal
 

Musculoskeletal
 
arthralgia

Skin
 
psoriasisdermatitisangioedema, exfoliative dermatitis,

Special Senses
 
decreased hearing

Metabolic
 

Respiratory
 

Genitourinary
 
Peyronie‘s disease,

Hematologic
 

General
 




Central Nervous System
 

Allergic
 

Hematologic
 

Gastrointestinal
 

Miscellaneous
 


LABORATORY ABNORMALITIES
 








OVERDOSAGE






Bradycardia



Hypotension



Heart Block (second or third degree)



Congestive Heart Failure



Bronchospasm



Hypoglycemia

BISOPROLOL FUMARATE DOSAGE AND ADMINISTRATION


Bronchospastic Disease WARNINGS

Patients with Renal or Hepatic Impairment



Geriatric Patients

Geriatric Use in PRECAUTIONS

Pediatric Patients

HOW SUPPLIED




Bisoprolol Fumarate Tablets, USP 5 mg




Bisoprolol Fumarate Tablets, USP 10 mg




Store at



Dispense in tight, light-resistant containers as defined in the USP.


Aurobindo Pharma USA, Inc.




Aurobindo Pharma Limited


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (30 Tablet Bottle)


NDC 65862-086-30
Bisoprolol Fumarate Tablets, USP
5 mg
Rx only           30 Tablets
AUROBINDO
Bisoprolol Fumarate

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30 Tablet Bottle)


NDC 65862-087-30
Bisoprolol Fumarate Tablets, USP
10 mg
Rx only           30 Tablets
AUROBINDO
Bisoprolol Fumarate

Bisoprolol Fumarate

Bisoprolol Fumarate TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:65862-086
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BISOPROLOL FUMARATE BISOPROLOL 5 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CROSPOVIDONE
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
polyethylene glycol 400
polysorbate 80
titanium dioxide
ferric oxide red
FERRIC OXIDE YELLOW

Product Characteristics

Color Size Imprint Code Shape
PINK 7 mm C;86 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65862-086-30 30 in 1 BOTTLE
2 NDC:65862-086-01 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077910 2006-12-27


Bisoprolol Fumarate

Bisoprolol Fumarate TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:65862-087
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BISOPROLOL FUMARATE BISOPROLOL 10 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CROSPOVIDONE
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
polyethylene glycol 400
polysorbate 80
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 7 mm C;87 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65862-087-30 30 in 1 BOTTLE
2 NDC:65862-087-01 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077910 2006-12-27


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