Tradename
Concor COR 2.5 mg
Generic Name
Bisoprolol fumarate
Category
Cardiovascular System
Form
Tablets
Composition
Bisoprolol fumarate..........2.5 mg
Description
Cardioselective beta-receptor blocker
Properties/Actions
Indications
Treatment of stable chronic, moderate to severe heart failure (myocardial insufficiency) with impaired systolic ventricular function (ejection fraction ≤ 35%, determined by echocardiography) in addition to ACE inhibitors and diuretics, and optionally cardiac glycosides.
Contraindications
Concor COR 2.5 must not be taken:
  • Acute myocardial insufficiency (heart failure) or during deterioration (decomposition) of heart failure requiring intravenous therapy with substances increasing the contractility of the heart.
  • Shock induced by disorders of cardiac function (cardiogenic shock).
  • Severe disturbances of atrioventricular impulse conduction (second or third degree AV block) without a pacemaker.
  • Sick sinus syndrome.
  • Disturbed impulse conduction between sinus node and atrium (sinoatrial block).
  • Markedly slowed heart beat (pulse rate less than 50 beats/min) before the start of treatment.
  • Markedly decreased blood pressure (systolic blood pressure below 100 mmHg).
  • Severe bronchial asthma or severe chronic obstructive lung disease.
  • Late stages of peripheral arterial occlusive disease or vascular spasms in toes and fingers (Raynaud's syndrome).
  • Untreated tumors of the adrenal medulla (phaeochromocytoma).
  • Metabolic acidosis.
  • Known hypersensitivity to bisoprolol.
In the following cases you may take Concor COR 2.5 mg only under certain conditions and with particular caution, after cosulting with your doctor:
  • Bronchospasm (bronchial asthma, obstructive airway diseases).
  • Treatment with inhalation anesthetics.
  • Diabete mellitus with extremely flucutating glucose levels; symptoms of markedly reduced blood glucose (hypoglycemia) can be masked.
  • Strict fasting.
  • Ongoing desensitisation therapy.
  • Mild disturbances of atrioventricular impulse conduction (first degree AV block).
  • Disturbed cardiac blood flow due to vasospasms of the coronary vessels (Prinzmetal's angina).
  • Peripheral arterial occlusive disease (intesification of complaints may occur especially when starting therapy).
  • In patients with a personal or family history of psoriasis, beta-blockers should only be used if the benefit-to-risk ratio has been carefully weighed.
  • In patients with a tumor of the adrenal medulla (phaeochromocytoma) Concor COR 2.5 mg may only be adminsitered after previous alpha-receptor blockade.
Drug Interactions
Simultaneous administration of the following drugs is not recommended:
  • Calcium antagonists: Increased lowering of blood pressure, delayed atriventricular impulse conduction, as well as, reduced contractility of the heart muscle.
  • Clonidine: Stronger reduction of heart rate and delayed impusle conduction in the heart. Discontinuation of clonidine can also bring about an excessive increase in blood pressure.
  • MAOIs: Simultaneous administration of MAOIs (except MAO-B inhibitors) can affect the blood pressure (lowering of blood pressure, but also excessive increase in blood pressure).
The following drugs may only be used at the same time under certain conditions and with particular caution:
  • The depressant effect of bisoprolol and antiarrhythmics on impulse conduction and contractility of the heart can become addictive.
  • Parasympathomimetics (including tacrine) can prolong the atriventricular conduction time. Other beta-blockers, even if contained in eye drops, potentiate the effect of bisoprolol.
  • The concurrent administration of Concor COR 2.5 mg and anesthetics may lead to a pronounced drop in blood pressure. Counter-regulatory mechanisms, e.g. increase in heart rate (reflex tachycardia) can be impaired. Continuation of beta blockade reduces the risk of arrhythmia during initiation of anesthesia and intubation. The anaesthetist should be informed about treatment with Concor COR 2.5 mg.
  • Concurrent therapy with digitalis can lead to marked slowing of the heart beat and of impulse conduction in the heart.
  • Cocurrent administration of mefloquine also furthers slowing of heart beat.
  • Prostaglandin synthesis inhibitors (e.g. acetylsalicylic acid) can reduce the antihypertensive effect of Concor COR 2.5 mg.
  • Concurrent administration of ergotamine derivatives (e.g. ergotamine containing drugs against migraine) and Concor COR 2.5 mg can lead to an increase in peripheral circulatory disturbances.
  • Cocomintant administration of Concor COR 2.5 mg and sympathomimeticscan reduce the effect of the two substances.
  • The treatment of allergic reactions may require an increased adrenaline dose.
  • The antihypertensive effect of Concor COR 2.5 mg can be potentiated by tricyclic antidepressants, barbiturates, phenothiazines and other antihypertensive drugs.
Side Effects/Adverse Effects
Central Nervous System:
  • Occasionally: Tiredness, exhaustion, dizziness, headache.
  • Rare: Sleep disorders, depression.
  • Very rarely: Nightmares, hallucinations.
Eyes:
  • Very Rarely: Reduced tear flow (to be taken into consideration in patients wearing contact lenses).
  • Single cases: Conjunctivitis.
Ears:
  • Very rarely: Hearing disorders
Cardiovascular System:
  • Occasionally: Sensation of cold and numb extremities.
  • Rare: Slowing heart beat (bradycardia), disturbed atrioventricular impulse conduction (AV block), deterioration of heart failure.
Respiratory System:
  • Rare: Bronchospasm in patients with a history of bronchial asthma or obstructive airway disease.
  • Very rarely: Allergic cold (rhinitis).
Gastrointestinal Tract:
  • Occasionally: Nausea, vomiting, diarrhea, constipation.
Muscles and Skeleton (locomotor system):
  • Rare: Muscles, weakness, muscle cramps.
Skin:
  • Very rarely: Hypersensitivity reactions (itching, temporary flush, rash).
  • Single cases: Beta-receptor blockers can trigger psoriasis, aggravate the condition or lead to psoriasiform rash. Loss of hair.
Genitourinary Organs:
  • Very rarely: Potency disorders.
Metabolism:
  • Very rarely: Increased liver enzyme levels (GOT, GPT), hepatitis, increased triglyceride levels.
These symptoms occur especially at the start of treatment. They are mild and usually disappear within 1 to 2 weeks after the start of treatment.
Pregnancy & Lactation
During pregnancy, Concor COR 2.5 mg should only be used after the doctor has carefully weighed the benefit-to-risk ratio.
In general, beta-blockers reduce placental blood flow and can affect the development of the unborn child. Placental and uterine blood flow as well as the growth of the unborn child must be monitored and, if required, alternative therapeutic measures considered.
The newborn child must be monitored closely after delivery. Symptoms of reduced blood glucose and slowed pulse rate generally occur within the first three days of life.
It is not known whether bisoprolol passes into breast milk, therefore, breastfeeding is not recommended during Concor COR 2.5 mg therapy.
Dosage & Administration
The following dosage instructions apply for Concor COR 2.5 mg unless your doctor has prescribed otherwise. Please follow these directions carefully, otherwise Concor COR 2.5 mg cannot have the proper effect.
In order to commence therapy, you should have stable chronic heart failure without any acute deterioration within the last 6 weeks. You should already be treated with an ACE inhibitor at optimal dosage (or in case of intolerance to ACE inhibitors, a different vasodilator), a diuretic and, if required, a digitalis preparation. This first-line medication should have remained largely unchanged for 2 weeks before starting Concor COR. Treatment with bisoprolol should be initiated with slow, gradual dose increases. The attending physician should have experience in the therapy of chronic heart failure.
Concor COR 2.5 mg is intended for initial treatment; however, in some patients it may be sufficient for maintenance therapy.
The following dose increases are recommended:
  • 1.25 mg bisoprolol (equivalent to 1/2 tablet Concor COR 2.5 mg) once daily for 1 week.
  • If this dose is well tolerated, increase to 2.5 mg bisoprolol once daily for 1 week.
  • If this dose is well tolerated, increase to 3.75 mg bisoprolol (equivalent to 1.5 tablets Concor COR 2.5 mg) once daily for 1 week.
  • If this dose is well tolerated, increase to 5 mg bisoprolol once daily for 4 weeks.
  • If this dose is well tolerated, increase to 7.5 mg bisoprolol once daily for 4 weeks.
  • If this dose is well tolerated, increase to 10 mg bisoprolol once daily as maintenance dose.
At the start of treatment with 1.25 mg bisoprolol, the patients should be monitored for 4 hours (blood pressure, heart rate, impulse conduction disorders, as well as, heart failure symptoms). The recommended maximal dose of 10 mg bisoprolol per day is reached at the earliest after a dose increase over 12 weeks and should not be exceeded.
A result of adverse reactions (e.g. slowing of heart beat with symptoms or drop in blood pressure or symptoms of deteriorating heart failure) may be that not all patients can be treated with the highest recommended dose. If necessary, the beta-blocker can be gradually reduced again, or the treatment can be discontinued and resumed again at a later time. If deterioration of heart failure or intolerance occur during the titration phase, the attending physician is advised to reduce or, in the presence of compelling reasons, immediately discontinue bisoprolol.
Treatment of stable chronic heart failure generally means long-term therapy.

Dosage in Impaired Liver and/or Kidney Function:
Dose titration in heart failure patients with impaired liver or kidney function should be carried out with particular care since no pharmacokinetic investigations are available on this subject.

How and When to Take the Dose:
You should take the tablet whole with some liquid in the morning before, during or after breakfast.

Duration of Treatment:
Treatment of stable chronic myocardial insufficiency is a long-term therapy. The dosage may only be changed by direction of your doctor. Also, treatment with Concor COR should only be interrupted or discontinued prematurely by direction of your doctor. For termination of therapy with Concor COR, the dose should be gradually reduced (e.g. halcing of the dose at weekly intervals). You should not discontinue treatment with Concor COR abruptly as this may lead to temporary deterioration of heart failure.
Overdosage
In case of suspected overdosage, please inform you doctor immediately. Depending on the extent of overdosage, your doctor can then decide which measures to take. The most frequent signs of overdosage include slowed heart beat (bradycardia), marked drop in blood pressure, bronchospasm, acute heart failure, as well as, hypoglycemia.
In case of overdosage, therapy with Concor COR 2.5 mg should be discontinued after consultation of the attending physician.
Warnings
The treatment of myocardial insufficiency with Concor COR 2.5 mg requires regular monitoring. This is absolutely necessary especially at the start of therapy.
In bronchial asthma or other chronic obstructive pulmonary diseases that may be associated with symptoms, concomitant bronchodilator therpay is indicated. An increase in airways resistance may occasionally occur in asthma patients, requiring a higher B2-sympathomimetic dose. Like other beta-blockers, bisoprolol can increase the sensitivity to allergens and the severity of anaphylactic reactions, i.e. acute general allergic reactions. Adrenaline does not always produce the desired therapeutic effect in these cases.
The symptoms of thyroid hyperfunction (thyrotoxicosis) can be masked by bisoprolol. So far no adequate therapeutic experience is available for Concor COR 2.5 mg in heart failure patients with concomitant insulin-dependent type-1 diabetes mellitus, impaired kidney function (serium creatinine ≥ 3.4 mg/dl), impaired liver function, restrictive caridomyopathy, congenital heart diseases or hemodynamically relevant  cardiac valve diseases. No adequate therapeutic experience is available either in patients with mild heart failure (NYHA II) as well as heart failure and myocardial infarction with the last 3 months. Therapy with bisoprolol should not be discontinued abruptly without compelling indication.
In a study on patients with coronary heart disease, bisoprolol did not affect the driving performance of the patients. However, due to individually different reactions to the drug, the ability to drive a vehicle, or operate machinery, or to work without a firm hold may be impaired. This is particularly the case at the start of treatment, when the dosage is increased or the medication changed, as well as, in conjunction with alcohol.
Notes
Storage
Packaging
  • Do not store above 25°C.
  • Pack of 20 tablets.
Manufacturer
Merck
Date Added/Updated
3rd April 2011 5:48pm

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