Composition
Active ingredients in one tablet:
10 mg bisoprolol and 10 mg amlodipine (as 13.9 mg amlodipine besylate) fumarate.
Excipients: microcrystalline cellulose 261.1 mg, sodium carboxymethyl starch (type A) 10 mg, magnesium stearate 3.0 mg, colloidal anhydrous silica 2 mg.
Pharmacotherapeutic group
beta1-adrenoblocker selective;
Indications
Arterial hypertension: substitution therapy with amlodipine and bisoprolol in the same dose.
Contraindications
For amlodipine:
- Unstable angina pectoris (except for Prinzmetal angina);
- Acute myocardial infarction (within the first 28 days);
- clinically significant aortic stenosis.
On bisoprolol:
- Acute heart failure or decompensated chronic heart failure (CHF) requiring inotropic therapy;
- Atrioventricular (AV) block of II and III degree, without pacemaker;
- sinus node weakness syndrome (SSNS);
- sinoatrial block;
- Severe bradycardia (heart rate less than 60 beats/min);
- Severe bronchial asthma or chronic obstructive pulmonary disease (COPD);
- Severe peripheral arterial circulatory disorders or Raynaud's syndrome;
- pheochromocytoma (without concomitant use of alpha-adrenoblockers);
- metabolic acidosis;
On amlodipine/bisoprolol combination:
- Hypersensitivity to amlodipine, other dihydropyridine derivatives, bisoprolol and/or any of the excipients;
- Severe arterial hypotension (systolic BP less than 100 mmHg);
- shock (including cardiogenic shock);
- children under 18 years of age (efficacy and safety have not been determined).
Caution:
CHF (including nonischemic etiology of III-IV functional class according to NYHA classification), liver failure, renal failure, hyperthyroidism, diabetes with significant blood glucose fluctuations, AV block of degree I, Prinzmetal angina pectoris, peripheral artery occlusive disease, psoriasis (including In anamnesis, fasting (strict diet), pheochromocytoma (with simultaneous use of alpha-adrenoblockers), bronchial asthma and COPD, desensitization therapy simultaneously, general anesthesia, elderly age, arterial hypotension, type 1 diabetes, aortic stenosis, mitral stenosis, acute myocardial infarction (after the first 28 days).
Pregnancy and lactation:
On amlodipine:
Fetotoxic and embryotoxic effects of the drug have not been established in experimental studies, but use in pregnancy is possible only when the benefit to the mother exceeds the potential risk to the fetus.
There is no evidence of excretion of amlodipine in the breast milk. However, other dihydropyridine derivatives are known to be excreted with breast milk. Therefore, if amlodipine needs to be administered during lactation, discontinuation of breastfeeding should be considered.
On bisoprolol:
The use of bisoprololol in pregnancy is possible only when the anticipated benefit to the mother outweighs the potential risk to the foetus. Beta-adrenoblockers reduce placental blood flow and may affect foetal development. Blood flow in the placenta and uterus should be monitored and the growth and development of the unborn child should be monitored and alternative therapies should be used if there are any adverse events in relation to pregnancy and/or foetus.
The newborn should be carefully examined after birth. Symptoms of bradycardia and hypoglycaemia may occur during the first three days of life.
There is no evidence that bisoprolol is excreted into breast milk. Therefore, it is not recommended for women while breastfeeding. If administration of bisoprolol during lactation is necessary, breastfeeding should be discontinued.
Dosage and administration
Tablets are for oral administration. Tablets should be taken in the morning, regardless of meals, without chewing.
The recommended daily dose is 1 tablet per day.
Selection and titration of dose is performed individually for each patient by a physician during the prescription of monocomponent preparation containing active ingredients of Concor® AM.
Treatment duration
Treatment with Concor® AM is usually a long-term therapy.
Impaired hepatic function
Excretion of amlodipine may be delayed in patients with hepatic impairment. A specific dosing regimen has not been defined for this group of patients, but the drug should be administered with caution in this case.
In patients with severe hepatic impairment, the maximum daily dose of bisoprolol is 10 mg.
Renal dysfunction
Patients with mild to moderate renal dysfunction do not usually require dosing adjustments. Amlodipine is not excreted by dialysis. Patients undergoing dialysis should be prescribed amlodipine with special caution.
In patients with significant renal impairment (creatinine clearance (CK) less than 20 ml/min) the maximum daily dose of bisoprolol is 10 mg.
Elderly patients
Elderly patients can be prescribed the usual doses of the drug. Caution is required only when increasing the dose.
Children
Due to lack of efficacy and safety data, it is not recommended for children under 18 years of age. Treatment should not be discontinued abruptly as this may lead to temporary worsening of the clinical condition. Especially, treatment should not be discontinued abruptly in patients with CHD. A gradual reduction in dose is recommended.
Dosage et administration
Les comprimés sont destinés à être administrés par voie orale. Les comprimés doivent être pris le matin, indépendamment des repas, sans être mâchés.
La dose quotidienne recommandée est de 1 comprimé par jour.
Le choix et la titration de la dose sont effectués individuellement pour chaque patient par un médecin lors de la prescription de la préparation monocomposante contenant les principes actifs de Concor® AM.
Durée du traitement
Le traitement par Concor® AM est généralement un traitement à long terme.
Altération de la fonction hépatique
L'excrétion de l'amlodipine peut être retardée chez les patients présentant une insuffisance hépatique. Un schéma posologique spécifique n'a pas été défini pour ce groupe de patients, mais le médicament doit être administré avec prudence dans ce cas.
Chez les patients présentant une insuffisance hépatique sévère, la dose quotidienne maximale de bisoprolol est de 10 mg.
Dysfonctionnement rénal
Les patients présentant un dysfonctionnement rénal léger à modéré ne nécessitent généralement pas d'ajustement de la posologie. L'amlodipine n'est pas excrétée par la dialyse. Les patients sous dialyse doivent se voir prescrire l'amlodipine avec une prudence particulière.
Chez les patients présentant une insuffisance rénale significative (clairance de la créatinine (CK) inférieure à 20 ml/min), la dose quotidienne maximale de bisoprolol est de 10 mg.
Patients âgés
Les patients âgés peuvent se voir prescrire les doses habituelles du médicament. La prudence n'est requise que lors de l'augmentation de la dose.
Enfants
En raison du manque de données d'efficacité et de sécurité, ce médicament n'est pas recommandé chez les enfants de moins de 18 ans. Le traitement ne doit pas être interrompu brutalement car cela peut entraîner une aggravation temporaire de l'état clinique. En particulier, le traitement ne doit pas être interrompu brusquement chez les patients atteints de coronaropathie. Une réduction progressive de la dose est recommandée.
