CONCOR 10MG 50 TABS - MADE IN GERMANY - FREE SHIPPING
(CONCOR 10MG)
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Description CONCOR 10MG 50 TABS - MADE IN GERMANY - FREE SHIPPING
Indications
Ag;
ischemic heart disease (angina pectoris); chronic heart failure with left
ventricular systolic dysfunction in combination with APF inhibitors, diuretics,
and, if necessary, cardiac glycosides.
Application
Concor
should be taken without chewing in the morning on an empty stomach or during
breakfast, with a small amount of liquid.
AG;
Ischemic heart disease (angina pectoris). Treatment should be started gradually
with low doses, followed by dose increases. The recommended dose is 5 mg (1
tablet of Concor 5 mg) per day. For mild hypertension (diastolic pressure up to
105 mm Hg), a dose of 2.5 mg is suitable.
If
necessary, the daily dose can be increased to 10 mg (1 tablet of 10 mg Concor).
Further dose increases are only justified in exceptional cases.
The maximum
recommended dose is 20 mg / day.
Dose
adjustment is carried out by the doctor individually, depending on the pulse
rate and therapeutic benefit.
Chronic
heart failure with left ventricular systolic dysfunction in combination with
ACE inhibitors, diuretics, and, if necessary, cardiac glycosides. Standard
therapy for chronic heart failure: ACE inhibitors (or angiotensin receptor
blockers in case of intolerance to ACE inhibitors), β-adrenoreceptor
blockers, diuretics and, if necessary, cardiac glycosides.
Concor is
prescribed for the treatment of patients with chronic heart failure without
signs of exacerbation.
Therapy
should be performed by a physician experienced in the management of chronic
heart failure.
Treatment
of patients with stable chronic heart failure with Concor begins according to
the titration scheme presented below and can be adjusted depending on the
individual reactions of the body:- 1.25 mg *
bisoprolol fumarate 1 time per day for 1 week, if well tolerated, increase
to
- 2.5 mg *
bisoprolol fumarate 1 time per day for the next 1 week, if well tolerated,
increase to
- 3.75 mg *
bisoprolol fumarate 1 time per day for the next 1 week, if well tolerated,
increase to
- 5 mg bisoprolol
fumarate once a day for the next 4 weeks, if well tolerated, increase to
- 7.5 mg
bisoprolol fumarate once a day for the next 4 weeks, if well tolerated,
increase to
- 10 mg bisoprolol
fumarate 1 time per day as maintenance therapy.
* At the beginning of therapy for chronic
heart failure, it is recommended to use Concor Cor film-coated tablets, 2.5 mg
each.
The
maximum recommended dose of bisoprolol fumarate is 10 mg once a day.
During
the titration phase, it is necessary to monitor the following vital signs
(blood pressure, heart rate) and symptoms of progression of heart failure.
Symptoms can develop from the first day of treatment.
Treatment
modification. If the maximum recommended dose is poorly tolerated, a gradual
dose reduction is possible. If, during or after the titration phase, there is a
gradual worsening of heart failure, arterial hypotension or bradycardia
develops, a dose adjustment of the preparation is recommended, which may
require a temporary reduction in the dose of bisoprolol or, possibly,
suspension of treatment. After stabilization of the condition, the possibility
of re-initiating treatment with bisoprolol should always be considered.
You
should not stop treatment with the preparation suddenly, especially in patients
with coronary artery disease, as this can lead to a worsening of the patient's
condition. If necessary, treatment is recommended to be completed slowly,
gradually reducing the dose (for example, reducing the dose by half weekly).
Treatment
for stable chronic heart failure is usually long-term.
The
course of treatment with Concor is long and depends on the nature and severity
of the disease.
Patients
with hepatic and renal impairment
AG;
Ischemic heart disease. For patients with mild to moderate hepatic or renal
impairment, dose selection usually should not be done. In patients with severe
renal impairment (creatinine clearance 20 ml / min) and with severe hepatic
impairment, the dose should not exceed a daily dose of 10 mg Concor. There are
limited data on the use of bisoprolol in dialysis patients. There is no need to
change the dosage regimen.
Chronic
heart failure. There are no data on the pharmacokinetics of bisoprolol in
patients with chronic heart failure simultaneously with impaired liver and / or
kidney function, therefore, the dose should be increased with caution.
Elderly
patients do not need dose adjustment.
Contraindications
Acute
heart failure or heart failure in a state of decompensation requiring inotropic
therapy; cardiogenic shock; av-blockade of the ii – iii degree (except for that
in patients with an artificial pacemaker); sick sinus syndrome; sinoatrial
blockade; symptomatic bradycardia; symptomatic arterial hypotension; severe
form of ba; late stages of peripheral circulatory disorders or Raynaud's
disease; untreated pheochromocytoma; metabolic acidosis; hypersensitivity to
bisoprolol or other components of the preparation.
Side effects
In terms
of frequency of occurrence, adverse effects are classified into the following
categories: very often (≥1 / 10), often (≥1 / 100 and 1/10), infrequently (≥1 /
1000 and 1/100), rarely (≥1 / 10,000 and 1/1000), very rarely (1/10 000), unknown
(frequency not determined).
From the
side of the heart: very often - bradycardia (in patients with chronic heart
failure); often - signs of worsening heart failure (in patients with chronic
heart failure); infrequently - a violation of AV conduction, bradycardia (in
patients with hypertension or ischemic heart disease), signs of worsening heart
failure (in patients with hypertension or ischemic heart disease).
From the
nervous system: often - dizziness *, headache *; rarely syncope.
From the
side of the organ of vision: rarely - a decrease in lacrimation (should be
considered when wearing contact lenses); very rarely - conjunctivitis.
From the
side of the organ of hearing: rarely - hearing impairment.
On the
part of the respiratory system: infrequently - bronchospasm in patients with BA
or a history of chronic obstructive airway diseases; rarely, allergic rhinitis.
From the
digestive tract: often - nausea, vomiting, diarrhea, constipation.
On the
part of the skin and connective tissue: rarely - hypersensitivity reactions,
including itching, redness, rash; very rarely - alopecia. When treated with β-adrenergic
receptor blockers, the condition of patients with psoriasis may worsen in the
form of a psoriatic rash.
From the
musculoskeletal system: infrequently - muscle weakness, cramps.
From the
liver: rarely - hepatitis.
From the
side of the vessels: often - a feeling of cold or numbness in the limbs,
arterial hypotension (in patients with chronic heart failure); infrequently -
orthostatic hypotension (in patients with chronic heart failure), arterial
hypotension (in patients with hypertension or coronary artery disease).
From the
reproductive system: rarely - violation of potency.
Mental
disorders: infrequently - depression, sleep disturbances; rarely - nightmares,
hallucinations.
Laboratory
indicators: rarely - an increase in the level of triglycerides in the blood, an
increase in the activity of hepatic enzymes in the blood plasma (AST, ALAT).
General
disorders: often - asthenia (in patients with chronic heart failure), fatigue
*; infrequently - asthenia (in patients with hypertension and ischemic heart
disease).
* Applies
only to patients with hypertension or coronary artery disease. These symptoms
usually occur at the beginning of therapy, are mild and disappear within the
first 1-2 weeks.
In case
of side effects or adverse reactions, you must immediately inform your doctor.
Special
instructions
Treatment
of stable chronic heart failure with bisoprolol should begin with the titration
phase.
Patients
with coronary artery disease should not be stopped suddenly unnecessarily, as
this can lead to a transient worsening of the condition. Initiation and
termination of treatment with bisoprolol requires regular monitoring.
Currently,
there is not enough therapeutic experience in the treatment of heart failure in
patients with the following diseases and pathological conditions: type 1
diabetes mellitus (insulin-dependent), severe renal dysfunction, severe liver
dysfunction, restrictive cardiomyopathy, congenital heart defects,
hemodynamically significant acquired valvular heart defects, myocardial
infarction within the last 3 months.
The preparation
should be used with caution in patients with conditions such as:
·
bronchospasm (with asthma, obstructive respiratory diseases);
·
diabetes mellitus with significant fluctuations in blood glucose levels,
while the symptoms of hypoglycemia (tachycardia, palpitations, increased
sweating) may be hidden;
·
strict diet;
·
desensitization. Like other blockers of β-adrenergic receptors, bisoprolol can
increase sensitivity to allergens and increase the severity of anaphylactic
reactions. In such cases, epinephrine treatment does not always give a positive
therapeutic effect;
·
AV block I degree;
·
Prinzmetal's angina;
·
obliterating diseases of peripheral arteries (at the beginning of
therapy, complaints may increase);
·
general anesthesia.
In
patients undergoing general anesthesia, the use of β-adrenergic
receptor blockers reduces the risk of arrhythmia and myocardial ischemia during
induction of anesthesia, intubation and the postoperative period. It was
recommended to continue the use of β-adrenergic receptor blockers during the
perioperative period. It is imperative to warn the anesthesiologist about
taking β-adrenergic
receptor blockers, since the doctor must take into account the potential
interaction with other preparations, which can lead to bradyarrhythmias, reflex
tachycardia and a decrease in the ability of the reflex mechanism to compensate
for blood loss. In the case of discontinuation of bisoprolol before surgery,
the dose should be gradually reduced and the preparation should be discontinued
48 hours before general anesthesia.
Combinations
of bisoprolol with calcium antagonists of the verapamil or diltiazem group,
with class I antiarrhythmic preparations and with centrally acting
antihypertensive preparations are not recommended (see INTERACTIONS).
Despite
the fact that cardioselective β-adrenergic receptor blockers (β1) have
less effect on lung function compared to non-selective β-adrenergic
receptor blockers, their use, like all β-adrenergic receptor blockers, should be
avoided in obstructive airway diseases unless there are compelling reasons for
therapy. If necessary, the preparation Concor should be used with caution. In
patients with obstructive airways disease, treatment with bisoprolol should be
started with the lowest possible dose and the patient's condition should be
monitored for the onset of new symptoms (such as shortness of breath, exercise
intolerance, cough).
In asthma
or other COPD that can cause symptoms, concomitant therapy with bronchodilators
is indicated. In some cases, while taking the preparation, patients with asthma
due to increased airway resistance may require the use of higher doses of β2-sympathomimetics.
Patients
with psoriasis (including a history) are prescribed β-adrenergic
receptor blockers (eg bisoprolol) after careful study of the benefit / risk
ratio.
Patients
with pheochromocytoma are prescribed Concor only after the appointment of
therapy with α-adrenergic receptor blockers. Symptoms of thyrotoxicosis can be masked
while taking the preparation. When using the preparation Concor, a positive
result may be observed during doping control.
Use
during pregnancy and lactation. Pregnancy. Bisoprolol has pharmacological
properties that can have harmful effects on pregnancy and / or fetal / newborn
development. Typically, β-adrenoreceptor blockers reduce placental
blood flow, which can cause intrauterine growth retardation, intrauterine
death, spontaneous abortion, or premature birth. Side effects in the fetus and
newborn (eg hypoglycemia, bradycardia) may develop. If treatment with β-adrenergic
receptor blockers is necessary, it is desirable that it be a selective β1-adrenergic
blocker.
During
pregnancy, the preparation is used only when the expected benefit to the mother
outweighs the potential risk to the fetus. It is necessary to control the
uteroplacental blood flow and fetal growth. In case of harmful effects on the
course of pregnancy or the fetus, alternative treatment should be considered.
After
delivery, the newborn should be closely monitored. Symptoms of hypoglycemia and
bradycardia can be expected within the first 3 days.
Breastfeeding
period. There is no data on the excretion of bisoprolol into breast milk,
therefore it is not recommended to use the preparation Concor during breastfeeding.
Children.
There are no clinical data on the efficacy and safety of the preparation in
children; therefore, the preparation should not be used in patients of this
category.
The
ability to influence the reaction rate when driving or operating other
mechanisms. In the course of studies involving patients with coronary artery
disease, the preparation did not affect the ability to drive vehicles. However,
in individual cases, the preparation may affect the ability to drive vehicles
or operate machinery. Particular attention must be paid at the beginning of
treatment, when changing the dose of the preparation or when interacting with
alcohol.
Interactions
Combinations
not recommended for use
Treatment
of chronic heart failure. Class I antiarrhythmics (for example, quinidine,
disopyramide, lidocaine, phenytoin, flecainide, propafenone): potentiation of
the effect with respect to AV conduction and an increase in the severity of the
negative inotropic effect is possible.
All
indications. Calcium antagonists such as verapamil, to a lesser extent
diltiazem: negative effect on myocardial contractile function and AV
conduction. IV administration of verapamil can lead to severe arterial
hypotension and AV block.
Antihypertensive
preparations with a central mechanism of action (clonidine, methyldopa, moxonidine,
rilmenidine): may worsen the course of heart failure due to a decrease in
central sympathetic tone (decreased heart rate and cardiac output,
vasodilation). Sudden preparation withdrawal, especially if it is preceded by
withdrawal of β-adrenergic receptor blockers, may increase the risk of rebound
hypertension.
Combinations
to be used with caution
Treatment
of hypertension or ischemic heart disease (angina pectoris). Class I
antiarrhythmics (for example, quinidine, disopyramide, lidocaine, phenytoin,
flecainide, propafenone): potentiation of the effect with respect to AV
conduction and an increase in the severity of the negative inotropic effect is
possible.
All
indications. Calcium antagonists such as dihydropyridine (eg nifedipine,
felodipine, amlodipine) may increase the risk of arterial hypotension. The
possibility of increasing the negative effect on the inotropic function of the
myocardium in patients with heart failure is not excluded.
Class III
antiarrhythmic preparations (eg amiodarone) can increase the negative effect on
AV conduction.
Local β-adrenergic
receptor blockers (for example, contained in eye drops for the treatment of
glaucoma): an increase in the severity of the systemic effects of bisoprolol is
possible.
Parasympathomimetics:
AV conduction time may increase and the risk of bradycardia may increase.
Insulin
and oral hypoglycemic agents: increased hypoglycemic action. Blockade of β-adrenergic
receptors can mask the symptoms of hypoglycemia.
Anesthetics:
the risk of myocardial function depression and arterial hypotension increases
(see SPECIAL INSTRUCTIONS).
Cardiac
glycosides: decreased heart rate, increased AV conduction time.
NSAIDs
can weaken the hypotensive effect of bisoprolol.
β-Sympathomimetics (for example, orciprenaline, isoprenaline,
dobutamine): use in combination with Concor can lead to a decrease in the
therapeutic effect of both preparations. Higher doses of epinephrine may be
needed to treat allergic reactions.
Sympathomimetics
that activate α- and β-adrenergic receptors (eg epinephrine, norepinephrine): a
vasoconstrictor effect mediated through α-adrenergic receptors is possible, which
leads to an increase in blood pressure and an increase in intermittent
claudication. Such an interaction is more likely with the use of non-selective β-adrenergic
receptor blockers.
When
combined with antihypertensive preparations and preparations that exhibit
hypotensive effects (for example, tricyclic antidepressants, barbiturates,
phenothiazine), the risk of arterial hypotension may increase.
Possible
combinations
Mefloquine
may increase the risk of developing bradycardia.
MAO
inhibitors (with the exception of MAO type B inhibitors) increase the
hypotensive effect of β-adrenergic receptor blockers, but there
is a risk of developing a hypertensive crisis.
Overdose
Symptoms
in case of an overdose (for example, a daily dose of 15 mg instead of 7.5 mg),
cases of the development of grade III av blockade, bradycardia and dizziness
were recorded. frequent signs of an overdose of β-adrenergic receptor blockers are
bradycardia, arterial hypotension, acute heart failure, hypoglycemia and
bronchospasm. currently, several cases of overdose are known in patients with
ag and / or ischemic heart disease (the maximum dose is 2000 mg of bisoprolol).
bradycardia and / or arterial hypotension were noted. all patients recovered.
There is wide variability in individual sensitivity to a single high dose of
bisoprolol; patients with heart failure may be more sensitive to the preparation.
therefore, treatment should be started with a gradual increase in dose (see
application).
Treatment.
In case of an overdose, discontinue treatment with the preparation and conduct
supportive and symptomatic therapy. There is limited evidence that bisoprolol
is difficult to dialysis. If an overdose is suspected in accordance with the
expected pharmacological action and based on the recommendations for other β-adrenergic
receptor blockers, the following general measures should be considered.
With
bradycardia: intravenous administration of atropine. If there is no reaction,
isoprenaline or another preparation with a positive chronotropic effect is
administered with caution. In exceptional cases, transvenous administration of
an artificial pacemaker may be required.
With
arterial hypotension: intravenous administration of fluid and vasoconstrictor preparations.
IV glucagon can be helpful.
For AV
block II and III degrees: careful observation and infusion of isoprenaline or
transvenous administration of a pacemaker.
With
exacerbation of chronic heart failure: the introduction of diuretics, inotropic
preparations, vasodilators.
With
bronchospasm: bronchodilators (for example isoprenaline), β2-adrenergic
agonists and / or aminophylline.
With
hypoglycemia: intravenous glucose.
Storage
conditions
At a
temperature not higher than 30 ° C.
Tags: CONCOR
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