Probis 2.5mg

Tablet
Bisoprolol Fumarate
ACI Pharmaceuticals

Other Strength:
- Probis 5mg
- Probis Plus 2.5mg+6.25mg
- Probis Plus 5mg+6.25mg

Alternative:
- Betapro 2.5mg
- BETABIS 2.5mg
- Bisopro 2.5mg
- Betacor 2.5mg
- Cardicor 2.5mg
- Bisocor 2.5mg



Probis
Description
Probis®is apreparation of Bisoprololfumaratewhich isβ1-selective (cardioselective) adrenoceptor blocking agent without significant membrane stabilizing activity or intrinsic sympathomimetic activity in its therapeutic dosage range.It blockstheactionofthesympatheticnervoussystemontheheart byblockingthe heart’s β1-adrenergicreceptors.It reduces theheartrate&forceofcontraction oftheheart,thuslowersbloodpressure.

Indications
Probis®isindicated for the management of essentialhypertension, angina pectoris & heart failure. It may be used or alone in combination with other anti hypertensive agents.

Dosage and administration
For EssentialHypertension and Angina pectoris: Theusual starting dose is 5 mg once daily. In some patients, 2.5 mg may be anappropriate 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.

Geriatric Patients:It is not necessary to adjust the dose in the elderly, unless there is also significant renal or hepatic dysfunction.

Pediatric Patients:There is no pediatric experience with this.
Use in pregnancy & lactation
Pregnancy category C. There are no adequate and well-controlled studiesin pregnant women. This 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.Therefore, caution should be exercised when it is administered to nursing mother.

Side effects
The most common side effects includes Diarrhea; dizziness; drowsiness; fatigue; headache; lightheadedness; nausea; sleeplessness; unusual tiredness; weakness.It can also showssevere allergic reactions (rash; hives; itching, difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; difficulty breathing; lightheadedness or dizzinesswhen rising from a lying or sitting position; very slow heartbeatin rare cases.

Precautions
Impairedrenal orhepatic fun cti on:Usecaution inadjusting t h edoseofBisoprololinpatients withrenalorhepatic impairment. Riskofanaphylactic reaction:While taking β-blockers, patients with a history of severe anaphylactic reaction to a variety ofallergens may be more reactive to repeatedchallenge,accidental,diagnosticortherapeutic.Such patientsmaybe unresponsivetotheusualdosesofepinephrineusedtotreatallergicreaction.

Contraindications
Bisoprololis contraindicated in patients with cardiogenic shock, overt cardiac failure, second or third degree AV block, and marked sinus bradycardia.Itis also contra indicated in patients with known hypersensitivity of any of the components.

Drug interaction
Bisoprololshould not be combined with other β-blocking agents. Patients receiving catecholamine-depleting drugsshould be closely monitored, because the added beta-adrenergic blocking action of Bisoprololmay produce excessive reduction of sympathetic activity. In patients receiving concurrent therapy with clonidine, if therapy is to be discontinued, it is suggested that Bisoprololbe discontinued for several days before the withdrawal of clonidine. Bisoprololshould be used with care when myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists or antiarrhythmic agents are used concurrently. Concomitant use with digitalis glycosides can increase the risk of bradycardia.Concurrent use of rifampin increases the metabolic clearance of Bisoprolol, resulting in a shortened elimination half-life of Bisoprolol. However, initial dose modification is generally not necessary.

Overdose
The most common signs expected with overdosage of a β-blocker are bradycardia, hypotension, congestive heart failure, bronchospasm, and hypoglycemia. In general, if overdose occurs, Bisoprolol therapy should be stopped and supportive and symptomatic treatment should be provided.

Pharmaceutical precautions
Store in a cool & dry placeprotectedfrom light. Keep away from the reach of children.

Presentation
Probis®2.5 tablet: Eachcoatedtablet contains BisoprololFumarateUSP 2.5mg.Probis®5 tablet: Each coated tablet contains BisoprololFumarateUSP 5mg.

Package quantities
Probis®2.5 tablet: Carton of 30 tablets in blisterpack.
Probis®5 tablet: Cartonof 30 tablets in blister pack.

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