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|NAME||STRENGTH||PACK SIZE||DOSAGE FORM|
|Orabis 2.5||2.5 mg||3X10||Tablet|
|Orabis 5||5 mg||3X10||Tablet|
Bisoprolol is a beta1-selective (cardioselective) adrenoceptor blocking agent without significant membrane stabilizing activity or intrinsic sympathomimetic activity in its therapeutic dosage range.
Orabis 2.5 Tablet : Each film coated tablet contains Bisoprolol Fumarate USP 2.5 mg . Orabis 5 Tablet : Each film coated tablet contains Bisoprolol Fumarate USP 5 mg.
Indications And Uses
Bisoprolol is indicated in the treatment of hypertension, angina and heart failure. It may be used alone or in combination with other antihypertensive agents.
Dosage And Administration
The usual starting dose is 5 mg once daily. In some patients, 2.5 mg may be an appropriate starting dose. If the antihypertensive effect of 5 mg is inadequate, the dose may be increased to 10 mg and then, if necessary, to 20 mg once daily. For heart failure: Initially 1.25 mg once daily (in the morning) for 1 week then, if well tolerated, increased to 2.5 mg once daily for 1 week, then 3.75 mg once daily for 1 week, then 5 mg once daily for 4 weeks, then 7.5 mg once daily for 4 weeks, then 10 mg once daily; max. 10 mg daily.
Diarrhoea, dizziness, drowsiness, fatigue, headache, light headedness, nausea, sleeplessness, unusual tiredness, weakness, Severe allergic reactions (rash, hives, itching, difficulty breathing, tightness in the chest, swelling of the mouth, face, lips, or tongue), chest pain, difficulty breathing, light headedness or dizziness when rising from a lying or sitting position, very slow heart beat.
Impaired Renal or Hepatic Function.
Use In Pregnancy Lactation
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Bisoprolol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: Small amounts of bisoprolol fumarate (< 2% of the dose) have been detected in the milk of lactating rats. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk caution should be exercised when bisoprolol fumarate is administered to nursing women.
May interact with following drugs: Calcium antagonists of the verapamil type and to a lesser extent of the diltiazem type and Centrally acting antihypertensive drugs such as clonidine and others e.g. methyldopa, moxonodine, rilmenidine, which may increase the risk of “rebound hypertension”.
The most common signs expected with overdosage of a ß-blocker are bradycardia, hypotension, bronchospasm, acute cardiac insufficiency and hypoglycaemia. To date a few cases of overdose (maximum: 2000 mg) with bisoprolol have been reported. Bradycardia and/or hypotension were noted. All patients recovered. There is a wide interindividual variation in sensitivity to one single high dose of bisoprolol.
Orabis should be stored between 15°C to 30° C.
Bisoprolol is contraindicated in patients with cardiogenic shock, overt cardiac failure, second or third degree AV block and marked sinus bradycardia.
Orabis 2.5 Tablet: Each box contains 30 tablets in blister pack. Orabis 5 Tablet: Each box contains 30 tablets in blister pack.