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 BISOPROLOL20 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

TENOBIS 5 4,178,801 93.60

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 bronchoconstrictionSo safe for asthma patients

Decreases insulin secretion &impairs insulin sensitivity.

Thus Increases blood sugar level, even may causes new onset of diabetesNot 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

Generation

Selectivity Generic

1st Non selective beta blocker (blocks both 1 & 2)

Propanolol

2nd Selective beta blocker (blocks only 1 ) cardioselective

Atenolol ( Tenoloc), Metoprolol, Bisoprolol

3rd Beta blocker + Vasodilatory activity

1. Non selective beta blocker (blocks both 1 & 2) and blocker activity (Vasodilation)

2. Selective beta blocker (blocks only

1) and 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 priceAtenolo 50 – 0.77tkAtenolo 100 – 1.34tk

Unit priceBetabis 2.5 – 6.00tkBetabis 5 – 10.00tk

Unit priceBetaone 50 – 2.00tk