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Welcome to the Session of
Betabis
(Bisoprolol hemifumarate USP)
Highly selective beta blocker
Presented by
Mohammed Moshiur Rahaman
Product Information
 Brand Name : BETABIS 2.5 & 5
(“Beta” from “Beta blocker” and “Bis” from “Bisoprolol”)
 Composition : Bisoprolol hemifumarate USP
2.5 mg & 5 mg
Therapeutic group : Antihypertensive (β1-blocker)
 Pack Size : 3 X 10’ tablets for both strength
 Unit Price (proposed) : 06.00 tk (2.5 mg tablet)
10.00 tk (5 mg tablet)
Total Market of BISOPROLOL
20 core with 105% positive growth
Brands Yearly value sale Growth
BISLOL OPI 95,972,044 87.64
BISLOL 2.50 53,707,538 74.91
BISLOL 5 39,384,996 92.66
BISLOL 10 2,879,510 999.00
CONCOR MCK 41,289,193 99.18
CONCOR 2.50 20,844,909 50.55
CONCOR 5 20,308,556 195.03
CONCOR 10 135,728 999.00
ANCOR ATP 28,196,448 119.39
ANCOR 2.50 15,724,136 100.21
ANCOR 5 MG 12,472,311 149.53
BISOCOR SQA 21,590,349 119.58
BISOCOR 2.50 11,446,372 103.01
BISOCOR 5 9,944,507 138.47
BISOCOR 10 199,470 724.43
TENOBIS D-I 8,985,688 94.59
TENOBIS 2.50 4,806,887 95.46
Questions
1. What is happening when β1 receptor is
activated?
2. What is happening when β2 receptor is
activated?
Answers
1. Activation of the β1 receptor leads to
increases in contraction force and heart
rate (In Heart).
2. Activation of the β2 receptor leads to
smooth muscle relaxation (In Lung).
Non-selective VS Selective
Non selective Selective
Causes bronchoconstriction
So not safe for asthma patients
Does not cause bronchoconstriction
So safe for asthma patients
Decreases insulin secretion &
impairs insulin sensitivity.
Thus Increases blood sugar
level, even may causes new
onset of diabetes
Not safe for Diabetes patients
Does not decrease insulin secretion &
impair insulin sensitivity
Does not increase blood sugar level
,does not cause new onset of diabetes
Safe for Diabetes patients
Has unfavorable effect on
Blood lipid profile
Has no effect on blood lipid profile
Generatio
n
Selectivity Generic
1st Non selective beta blocker (blocks both
β1 & β2)
Propanolol
2nd Selective beta blocker (blocks only β1 )
cardioselective
Atenolol ( Tenoloc),
Metoprolol,
Bisoprolol
3rd Beta blocker + Vasodilatory activity
1. Non selective beta blocker (blocks
both β1 & β2) and α blocker activity
(Vasodilation)
2. Selective beta blocker (blocks only
β1) and α blocker activity
(Vasodilation)
1. Carvedilol
(Carvipress)
2. Nevibolol
Indications
Indicated in the management of
 Hypertension
 Angina.
It may be used alone or in combination with other
antihypertensive agents
Mechanism of Action
Bisoprolol is the most potent β1-selective β-blocker. It has
the highest level of β1-selectivity and by blocking the
heart’s β1 adrenergic receptors it reduces heart rate &
force of contraction of the heart, thus lowers blood
pressure.
Dosage And Administration
The dose of Betabis must be individualized to the needs of the
patient. The usual starting dose is Betabis 5 mg once daily. In
some patients, Betabis 2.5 mg may be an appropriate starting
dose. If the antihypertensive effect of Betabis 5 mg is
inadequate, the dose may be increased to Betabis 10 mg and
then, if necessary, to 20 mg once daily.
Patients with renal or Hepatic Impairment : In patients with
hepatic impairment (hepatitis or cirrhossis) or renal dysfunction
(creatinine clearance <40 mL/min), the initial daily dose should be
2.5 mg and caution should be used in dose-titration Since limited
data suggest that Bisopolol hemifumarate is not dialyzable, drug
replacement is not necessary in patients undergoing dialysis.
Geriatric Patients: It is not necessary to adjust the dose in the
elderly, unless there is also significant renal or hepatic
dysfunction.
OR AS DIRECTED BY THE PHYSICIAN.
Side effects
Fatigue, dizziness, headache, sleep disturbance,
bronchospasm, peripheral vasoconstriction, gastro-
intestinal disturbances, bradycardia and worsening
of heart failure.
USE IN PREGNANCY &
LACTATION
There are no adequate and well controlled studies
of safety evidence in pregnant women. Therefore,
Bisoprolol should be used during pregnancy only if
the potential benefit justifies the potential risk to the
fetus.
It is not known whether this drug is excreted in
human milk and therefore caution should be
exercised when Bisoprolol is administered to
nursing women.
Use In Children
Safety and effectiveness have not been
established in children.
Target Doctors
 Cardiology
 Neurologist
 Medicine specialist
 Hospital practitioners
 General practitioners
Highlighting Points
Betabis…
◙ Possesses the highest β1-selectivity
◙ Effectively controls high blood pressure and angina
◙ Shows no impact on lipid parameters
◙ Does not effect blood glucose level
◙ Safe for asthma patients
Ohm's law (For calculation of Airway resistance)
R = resistance
Pmouth = Maximum airway pressure in cm H2O pressure
Palveoli = Static airway pressure in cm H2O pressure
V = Volume rate L/sec
Positioning of Beta blockers
Tenoloc (Atenolol) Betabis (Bisoprolol) Betaone (Metoprolol)
Cardioselective beta blocker Cardioselective beta blocker possesses Highest β1
selectivity
Cardioselective beta blocker
Effective in hypertension and angina
pectoris
Controls high BP and angina pectoris better than
Tenoloc and Betaone
Effective in hypertension & angina
Shows no impact on Lipid parameters
Does not effect on blood glucose level
(Better for Diabetic hypertensive patients)
Controls arrhythmia effectively
Comparatively Safe for asthma patients Ensure post infarct protection & lowers the
risk of reinfarction
Effective beta blocker for heart failure
patients
Cost effective
Unit price
Atenolo 50 – 0.77tk
Atenolo 100 – 1.34tk
Unit price
Betabis 2.5 – 6.00tk
Betabis 5 – 10.00tk
Unit price
Betaone 50 – 2.00tk

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Betabis (Bisoprolol).ppt

  • 1. Welcome to the Session of Betabis (Bisoprolol hemifumarate USP) Highly selective beta blocker Presented by Mohammed Moshiur Rahaman
  • 2. Product Information  Brand Name : BETABIS 2.5 & 5 (“Beta” from “Beta blocker” and “Bis” from “Bisoprolol”)  Composition : Bisoprolol hemifumarate USP 2.5 mg & 5 mg Therapeutic group : Antihypertensive (β1-blocker)  Pack Size : 3 X 10’ tablets for both strength  Unit Price (proposed) : 06.00 tk (2.5 mg tablet) 10.00 tk (5 mg tablet)
  • 3. Total Market of BISOPROLOL 20 core with 105% positive growth
  • 4. Brands Yearly value sale Growth BISLOL OPI 95,972,044 87.64 BISLOL 2.50 53,707,538 74.91 BISLOL 5 39,384,996 92.66 BISLOL 10 2,879,510 999.00 CONCOR MCK 41,289,193 99.18 CONCOR 2.50 20,844,909 50.55 CONCOR 5 20,308,556 195.03 CONCOR 10 135,728 999.00 ANCOR ATP 28,196,448 119.39 ANCOR 2.50 15,724,136 100.21 ANCOR 5 MG 12,472,311 149.53 BISOCOR SQA 21,590,349 119.58 BISOCOR 2.50 11,446,372 103.01 BISOCOR 5 9,944,507 138.47 BISOCOR 10 199,470 724.43 TENOBIS D-I 8,985,688 94.59 TENOBIS 2.50 4,806,887 95.46
  • 5. Questions 1. What is happening when β1 receptor is activated? 2. What is happening when β2 receptor is activated?
  • 6. Answers 1. Activation of the β1 receptor leads to increases in contraction force and heart rate (In Heart). 2. Activation of the β2 receptor leads to smooth muscle relaxation (In Lung).
  • 8. Non selective Selective Causes bronchoconstriction So not safe for asthma patients Does not cause bronchoconstriction So safe for asthma patients Decreases insulin secretion & impairs insulin sensitivity. Thus Increases blood sugar level, even may causes new onset of diabetes Not safe for Diabetes patients Does not decrease insulin secretion & impair insulin sensitivity Does not increase blood sugar level ,does not cause new onset of diabetes Safe for Diabetes patients Has unfavorable effect on Blood lipid profile Has no effect on blood lipid profile
  • 9. Generatio n Selectivity Generic 1st Non selective beta blocker (blocks both β1 & β2) Propanolol 2nd Selective beta blocker (blocks only β1 ) cardioselective Atenolol ( Tenoloc), Metoprolol, Bisoprolol 3rd Beta blocker + Vasodilatory activity 1. Non selective beta blocker (blocks both β1 & β2) and α blocker activity (Vasodilation) 2. Selective beta blocker (blocks only β1) and α blocker activity (Vasodilation) 1. Carvedilol (Carvipress) 2. Nevibolol
  • 10. Indications Indicated in the management of  Hypertension  Angina. It may be used alone or in combination with other antihypertensive agents
  • 11. Mechanism of Action Bisoprolol is the most potent β1-selective β-blocker. It has the highest level of β1-selectivity and by blocking the heart’s β1 adrenergic receptors it reduces heart rate & force of contraction of the heart, thus lowers blood pressure.
  • 13. The dose of Betabis must be individualized to the needs of the patient. The usual starting dose is Betabis 5 mg once daily. In some patients, Betabis 2.5 mg may be an appropriate starting dose. If the antihypertensive effect of Betabis 5 mg is inadequate, the dose may be increased to Betabis 10 mg and then, if necessary, to 20 mg once daily. Patients with renal or Hepatic Impairment : In patients with hepatic impairment (hepatitis or cirrhossis) or renal dysfunction (creatinine clearance <40 mL/min), the initial daily dose should be 2.5 mg and caution should be used in dose-titration Since limited data suggest that Bisopolol hemifumarate is not dialyzable, drug replacement is not necessary in patients undergoing dialysis.
  • 14. Geriatric Patients: It is not necessary to adjust the dose in the elderly, unless there is also significant renal or hepatic dysfunction. OR AS DIRECTED BY THE PHYSICIAN.
  • 15. Side effects Fatigue, dizziness, headache, sleep disturbance, bronchospasm, peripheral vasoconstriction, gastro- intestinal disturbances, bradycardia and worsening of heart failure.
  • 16. USE IN PREGNANCY & LACTATION There are no adequate and well controlled studies of safety evidence in pregnant women. Therefore, Bisoprolol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk and therefore caution should be exercised when Bisoprolol is administered to nursing women.
  • 17. Use In Children Safety and effectiveness have not been established in children.
  • 18. Target Doctors  Cardiology  Neurologist  Medicine specialist  Hospital practitioners  General practitioners
  • 19. Highlighting Points Betabis… ◙ Possesses the highest β1-selectivity ◙ Effectively controls high blood pressure and angina ◙ Shows no impact on lipid parameters ◙ Does not effect blood glucose level ◙ Safe for asthma patients
  • 20.
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  • 24. Ohm's law (For calculation of Airway resistance) R = resistance Pmouth = Maximum airway pressure in cm H2O pressure Palveoli = Static airway pressure in cm H2O pressure V = Volume rate L/sec
  • 25. Positioning of Beta blockers Tenoloc (Atenolol) Betabis (Bisoprolol) Betaone (Metoprolol) Cardioselective beta blocker Cardioselective beta blocker possesses Highest β1 selectivity Cardioselective beta blocker Effective in hypertension and angina pectoris Controls high BP and angina pectoris better than Tenoloc and Betaone Effective in hypertension & angina Shows no impact on Lipid parameters Does not effect on blood glucose level (Better for Diabetic hypertensive patients) Controls arrhythmia effectively Comparatively Safe for asthma patients Ensure post infarct protection & lowers the risk of reinfarction Effective beta blocker for heart failure patients Cost effective Unit price Atenolo 50 – 0.77tk Atenolo 100 – 1.34tk Unit price Betabis 2.5 – 6.00tk Betabis 5 – 10.00tk Unit price Betaone 50 – 2.00tk