Sopalol 2.5/Sopalol 5

Sopalol 2.5/Sopalol 5

bisoprolol

Manufacturer:

Intas Pharmaceuticals

Distributor:

Berlin Pharm
Concise Prescribing Info
Contents
Bisoprolol fumarate
Indications/Uses
As monotherapy or in combination w/ other agents for HTN. Sopalol 5 CHD (stable angina pectoris). Prevent or delay the overt of heart failure in patients w/ asymptomatic systolic left ventricular dysfunction & a history of MI.
Dosage/Direction for Use
HTN Initially 5 mg once daily. 2.5 mg once daily may be considered in some patients (Sopalol 2.5 only). Max: 20 mg once daily. Dosage titration: May be increased to 10-20 mg once daily. Patients w/ hepatic impairment Initially 2.5 mg daily. Patients w/ renal dysfunction (CrCl <40 mL/min) Initially 2.5 mg daily. Sopalol 5 Angina pectoris Initial: 5 mg once daily. Elderly 2.5 mg once daily. Max: 20 mg once daily. Dosage titration: May be increased to 10-20 mg once daily. Patients w/ renal dysfunction (CrCl <40 mL/min) Initial daily dose: 2.5 mg. Severe renal impairment (CrCl <20 mL/min) Should not exceed 10 mg once daily which may be divided into halves. Patients w/ hepatic function impairment Initially 2.5 mg daily. CHF Start w/ the lowest dose & gradually up titration according to the following: 1.25 mg once daily in the morning for 1 wk, if well tolerated increase to 2.5 mg once daily for a further wk, if well tolerated increase to 3.75 mg once daily for a further wk, if well tolerated increase to 5 mg once daily for the 4 following wk, if well tolerated increase to max recommended dose: 10 mg once daily for the maintenance therapy.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Cardiogenic shock. Acute heart failure. 2nd or 3rd degree AV block. Severe sick sinus syndrome. SA block. Symptomatic bradycardia & hypotension. Severe bronchial asthma or severe COPD. Late stages of peripheral arterial occlusive disease or Raynaud's syndrome. Untreated phaeochromocytoma. Metabolic acidosis.
Special Precautions
Prior to initiating treatment, ensure that patient does not have preexisting condition eg, sick sinus syndrome. Do not w/draw abruptly. Patients w/ CAD should have a gradual & careful titration to avoid acute tachycardia, HTN &/or ischemia. May mask signs of hyperthyroidism eg, tachycardia. Adequate α-blockade is required prior to therapy in patients w/ untreated pheochromocytoma. May induce or exacerbate psoriasis. Concomitant use w/ digoxin, verapamil or diltiazem; β-blockers. Hepatic or renal dysfunction. Monitor for CHF especially in patients w/ restrictive cardiomyopathy, congenital heart disease, haemodynamically significant organic valvular disease or type I DM, severely impaired hepatic/renal function. Discontinue treatment at least 48 hr before anesth. Bronchial asthma or chronic obstructive lung diseases or emphysema. DM. Do not use in patients w/ narrow peripheral arterial disease or occlusive or Raynaud's disease. Pregnancy & lactation. Childn.
Adverse Reactions
Chest pain; diarrhea, nausea, vomiting; arthralgia, weakness, upper resp infection; rhinitis; sinusitis; dyspnea. Bradycardia in patients w/ CHF. Worsening of preexisting heart failure.
Drug Interactions
Conivaptan, floctafenine, methacholine. May increase levels/effects of direct-acting α- or β-agonists, α1-blockers, α2-agonists, amifostine, antihypertensives, antipsychotic agents (eg, phenothiazines), bupivacaine, cardiac glycosides, cholinergic agonists, ergot derivatives, fingolimod, hypotensive agents, insulin, systemic & topical lidocaine, mepivacaine, methacholine, midodrine, rituximab, sulfonylureas. Increased level/effects by acetylcholinesterase inhibitors, α2-agonists, antimalarial (eg, aminoquinolines), amiodarone, anilidopiperidine, opioids, antipsychotic agents (eg, phenothiazines), Ca channel blockers (eg, dihydropyridine, nondihydropyridine), conivaptan, enzyme CYP3A4 inhibitors (moderate-strong), dasatinib, diazoxide, dipyridamole, disopyramide, dronedarone, floctafenine, herbs, ivacaftor, MAOIs, mifepristone, pentoxyfylline, phosphodiesterase 5 inhibitors, propafenone, prostacyclin analogues, quinidine, reserpine. May decrease levels/effects of β2-agonists & theophylline derivatives. Decreased levels/effects w/ barbiturates, strong CYP3A4 inducers, deferasirox, herbs, methylphenidate, NSAIDs, peginterferon α-2b, rifamycin derivatives, tocilizumab, yohimbine. Avoid dong quai, ephedra, ginseng, garlic. Sopalol 5: May increase levels/effects of oral anti-diabetic medicines, mefloquine. Increased level/effects by flecainide, phenytoin, topical β-blockers, anaesth agents, antihypertensive agents & other medicines w/ BP-lowering potential (eg, TCAs, barbiturates, phenothiazines). Decrease levels/effects w/ St. John's wort.
MIMS Class
Beta-Blockers
ATC Classification
C07AB07 - bisoprolol ; Belongs to the class of selective beta-blocking agents. Used in the treatment of cardiovascular diseases.
Presentation/Packing
Form
Sopalol 2.5 tab 2.5 mg
Packing/Price
10 × 10's
Form
Sopalol 5 tab 5 mg
Packing/Price
10 × 10's
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