Advertisement
Advertisement
NIKP-Bisoprolol

NIKP-Bisoprolol

bisoprolol

Manufacturer:

Nichi-Iko

Distributor:

DKSH

Marketer:

Nichi-Iko
Concise Prescribing Info
Contents
Bisoprolol fumarate
Indications/Uses
2.5 mg: Stable chronic heart failure. 5 mg: HTN. Chronic stable angina pectoris. Stable chronic heart failure w/ reduced systolic left ventricular function in addition to ACE inhibitors, diuretics, & cardiac glycosides.
Dosage/Direction for Use
Stable chronic heart failure Adult Initially 1.25 mg once daily for 1 wk, gradually increased to 2.5 mg once daily for further wk, then 3.75 mg once daily for further wk, then 5 mg once daily for the following 4 wk, then 7.5 mg once daily for the following 4 wk. Maintenance & max recommended dose: 10 mg once daily. 5 mg: HTN & chronic angina pectoris Adult Individualized dose. Initially 5 mg once daily. Usual dose: 10 mg once daily. Max recommended dose: 20 mg daily. Severe renal (CrCl <20 mL/min) & hepatic impairment Max: 10 mg once daily. May divide dosage into halves.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Acute heart failure or during episodes of heart failure decompensation requiring IV inotropic therapy; cardiogenic shock; 2nd or 3rd degree AV block; sick sinus syndrome; SA block; symptomatic bradycardia & hypotension; severe bronchial asthma; severe forms of peripheral arterial occlusive disease or Raynaud's syndrome; untreated phaeochromocytoma; metabolic acidosis.
Special Precautions
Not to administer in patients w/ phaeochromocytoma until after α-receptor blockade. Gradually w/draw therapy before surgery (completed about 48 hr before anaesth). Avoid use in patients w/ obstructive airway diseases. Worsening of heart condition especially in patients w/ ischaemic heart disease upon abrupt cessation of therapy. Coronary vasospasm. Increased airway resistance in patients w/ asthma. May mask symptoms of hypoglycaemia (eg, tachycardia, palpitations, sweating); thyrotoxicosis. May increase sensitivity towards allergens & of anaphylactic reactions. Patients w/ insulin dependent type 1 DM; restrictive cardiomyopathy; congenital heart disease; haemodynamically significant organic valvular disease; MI w/in 3 mth; bronchospasm (bronchial asthma, obstructive airways diseases); DM w/ large fluctuating blood glucose values; strict fasting; ongoing desensitisation therapy; 1st degree AV block; Prinzmetal's angina; peripheral arterial occlusive disease (aggravation of symptoms might occur especially when starting therapy); psoriasis or history of psoriasis. Patients undergoing general anaesth. Regularly monitor initiation & cessation of treatment in patients w/ chronic heart failure. Not recommended to use in combination w/ Ca antagonists (of verapamil or diltiazem type), class-I antiarrhythmics, & centrally acting antihypertensives. May impair ability to drive & use machines. Severe renal & hepatic function impairment. Pregnancy. Not recommended to breastfeed during treatment. Not recommended in paed. 5 mg: Patients w/ HTN or angina pectoris & accompanying heart failure.
Adverse Reactions
Dizziness, headache; feeling of coldness or numbness in the extremities, hypotension especially in patients w/ heart failure; nausea, vomiting, diarrhoea, constipation; fatigue. Patient w/ chronic heart failure: Bradycardia. Worsening of pre-existing heart failure; asthenia.
Drug Interactions
Increased risk of hypotension w/ antihypertensives & drugs w/ BP-lowering potential eg, TCAs, barbiturates, phenothiazines. Profound hypotension & AV block w/ Ca antagonists of verapamil & diltiazem type. Increased risk of hypotension & further deterioration of ventricular pump w/ Ca antagonists of dihydropyridine type eg, nifedipine, amlodipine, felodipine. Decreased central sympathetic tonus leading to reduced heart rate, cardiac output, & vasodilation w/ centrally acting antihypertensives eg, clonidine, methyldopa, moxonidine, rilmenidine. Potentiated effect on AV conduction time & increased -ve inotropic effect w/ class-I antiarrhythmics (eg, disopyramide, quinidine, lidocaine, phenytoin; flecainide, propafenone); class-III antiarrhythmics (eg, amiodarone). Increased AV conduction time & risk of bradycardia w/ parasympathomimetics. Increased hypoglycemic effects & may mask symptoms of hypoglycaemia w/ insulin & oral antidiabetics. Increased BP & exacerbated intermittent claudication w/ sympathomimetics that activate both β- & α-adrenoceptors eg, noradrenaline, adrenaline. Added systemic effects w/ topical β-blockers (eg, eye drops for glaucoma treatment). Attenuation of reflex tachycardia & increased risk of hypotension w/ anaesthetics. Reduced heart rate & increased AV conduction time w/ digitalis glycosides. Reduced hypotensive effect w/ NSAIDs. Reduced effect w/ sympathomimetics eg, β-sympathomimetics (eg, isoprenaline, dobutamine). Enhanced hypotensive effect & risk for hypertensive crisis w/ MAOIs except MAO-B inhibitors. Increased risk of bradycardia w/ mefloquine.
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
NIKP-Bisoprolol tab 2.5 mg
Packing/Price
10 × 10's
Form
NIKP-Bisoprolol tab 5 mg
Packing/Price
10 × 10's
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement