Alotendin

Alotendin – the combined hypotensive drug containing the selection beta adrenoblocker and a blocker of slow calcium channels.

Form of release and structure

Dosage form – tablets: oblong, slightly convex from two parties, almost white or white color, with risky on one party and an engraving (Е 571, E 572, E 573 or E 574) on another, inodorous (on 7 pieces in the blister, in a pack of cardboard 4 or 8 blisters; on 10 pieces in the blister, in a pack of cardboard 3 or 9 blisters).

Active agents of drug: амлодипин and бисопролол (in the form of a fumarat), their contents, respectively, in tablets with an engraving:

• Е 571 – 5 mg and 5 mg;
• Е 572 – 5 mg and 10 mg;
• Е 573 – 10 mg and 5 mg;
• Е 574 – 10 mg and 10 mg.

Excipients: cellulose microcrystallic, sodium carboxymethylstarch (type A), magnesium stearate, silicon dioxide colloid anhydrous.

Indications to use

• Arterial hypertension (as monodrug or in a combination with other anti-hypertensive means);
• Chronic stable stenocardia (as monodrug or in a combination with other anti-anginal means);
• Replacement therapy of patients at whom the arterial pressure and/or chronic stable stenocardia can adequately be controlled by use of an amlodipin with bisoprololy in the same doses.

Contraindications

Absolute:

• Bradycardia (heart rate less than 60 уд. / minute) before an initiation of treatment;
• Sick sinus syndrome;
• Cardiogenic shock;
• The expressed aorta stenosis;
• Atrioventricular block of II or III degrees (without pacemaker);
• Arterial hypotension (systolic arterial pressure <100 mm hg);
• Unstable stenocardia;
• The acute heart failure or episodes of heart failure demanding intravenous administration of inotropic drugs;
• Sinuatrial blockade;
• Metabolic acidosis;
• Late stages of occlusal diseases of peripheral arteries;
• Severe form of a syndrome of Reynaud;
• Serious chronic obstructive illness of lungs or heavy bronchial asthma;
• Not treated pheochromocytoma;
• Psoriasis, including in the anamnesis;
• Lactation;
• Age up to 18 years (because of insufficiency of data on safety and efficiency of use of Alotendin);
• Hypersensitivity to any component of drug or derivatives of dihydropyridine.

With care:

• The arterial hypertension and stenocardia connected with heart failure;
• Diabetes mellitus with big fluctuations of level of glucose in blood;
• Hyperthyroidism;
• Starvation or rigid diet;
• Printsmetal's stenocardia;
• Atrioventricular block of the I degree;
• Occlusal diseases of peripheral arteries;
• Pheochromocytoma (Alotendin it is possible to apply only after blockade of alpha adrenoceptors);
• Bronchial asthma and other chronic obstructive diseases of lungs (it is necessary to carry out simultaneous bronkhodilatiruyushchy therapy);
• Liver failure;
• At the same time carried out desensibilizing therapy;
• Carrying out surgical intervention under the general anesthesia (drug it is necessary to cancel not later than in 48 hours prior to anesthesia).

Route of administration and dosage

Alotendin it is necessary to accept inside on 1 tablet of 1 times a day, in the morning, swallowing entirely and washing down with enough liquid. Meal does not influence its efficiency.

The doctor defines a specific dose individually.

Side effects

Classification of side effects: often (≥1/100 - <1/10), infrequently (≥1/1 000 - <1/100), it is rare (≥1/10 000 - <1/1 000), is very rare (<1/10 000), frequency is unknown (on the basis of the available data assessment cannot be carried out).

Possible undesirable reactions:

• From cardiovascular system: often – bradycardia, tachycardia; infrequently – arterial hypotension, deterioration in the available heart failure, AV conductivity disturbance;
• From a nervous system: often – fatigue, drowsiness, вертиго, a headache; infrequently – frustration of a dream, a visual disturbance, paresthesia, a hypesthesia, a syncope, a food faddism, changes of mood, a peripheral neuropathy, a tremor, a depression; seldom – dreadful dreams, a hearing disorder, hallucinations;
• From system of bodies of a hemopoiesis: infrequently – thrombocytopenia, a leukopenia, a purpura;
• From the alimentary system: often – abdominal pains, diarrhea or a lock, nausea, vomiting; infrequently – dyspepsia, a hyperplasia of gums, dryness in a mouth, pancreatitis; seldom – increase in activity hepatic enzymes, hepatitis; frequency is unknown – gastritis, jaundice, a cholestasia, hepatitis (these side effects are more often shown in an initiation of treatment, are usually expressed slightly and disappear within 1-2 weeks);
• From system of a respiratory organs: infrequently – rhinitis, short wind, cough, a bronchospasm or bronchial asthma at patients with an obstructive disease of lungs in the anamnesis;
• From a musculoskeletal system: infrequently – arthralgias, spasms in muscles, a mialgiya, muscular weakness, a dorsodynia;
• From endocrine system: often – inflows; infrequently – a hyperglycemia, a gynecomastia, disturbance of a potentiality;
• From an urinary system: infrequently – frustration of an urination, a pollakiuria, a nocturia;
• From an organ of sight: seldom – decrease in secretion of the lacrimal liquid; very seldom – conjunctivitis;
• Dermatological reactions: infrequently – the increased perspiration, decolouration of skin, an alopecia; very seldom – psoriazopodobny changes on skin, development or deterioration in a course of psoriasis;
• Allergic reactions: seldom – skin reactions, rash, an itch, a Quincke's disease, allergic rhinitis, hypersensitivity reactions (inflows, an itch, rash), a mnogoformny exudative erythema; frequency is unknown – a small tortoiseshell;
• From an organism in general: often – feeling of a cold snap and numbness of extremities, hypostases (including peripheral); infrequently – change of body weight (increase or decrease), an adynamy, exhaustion, a vasculitis; seldom – increase in level of triglycerides.

Separate cases of such heavy reactions as arrhythmia (ciliary arrhythmia and ventricular tachycardia), stenocardia, myocardial infarction are known. They are connected with a basic disease or using Alotendin, authentically it is not established.

Special instructions

Drug should not be cancelled sharply, especially at coronary heart disease since deterioration in a clinical state is possible. It is recommended to reduce a dose gradually.

Alotendin reduces secretion of the lacrimal liquid, it should be considered to patients who carry contact lenses.

In some cases drug can influence the speed of reactions and ability to concentration of attention, especially at the beginning of use, at change of a dose and simultaneous alcohol intake.

Medicinal interaction

Alotendin it is not necessary to apply along with blockers of calcium channels of the I class (for example, verapamil) and the III class (diltiazem) as they negatively influence sokratitelny ability, arterial pressure and atrioventricular carrying out. Intravenous administration of verapamil to the patients receiving beta adrenoblockers (бисопролол) can lead to the expressed arterial hypotension and an atrioventricular block.

Alotendin is not recommended to combine with anti-hypertensive drugs of the central action (for example, metildopy, moksonidiny, a clonidine, rilmenidiny) as such combination can lead to a vazodilatation, an urezheniye of heart rate and minute volume of heart. In case of sharp drug withdrawal the risk of development of the withdrawal which is shown in the form of hypertensia increases.

Alotendin it is necessary to apply with care at the same time with the following drugs: nitrates of long action, beta adrenoblockers, thiazide diuretics, peroral hypoglycemic drugs, non-steroidal anti-inflammatory drugs, antibiotics, trinitrate glyceryl drugs for sublingual use.

In a combination with the following medicines Alotendin it is also necessary to apply carefully:

• Dihydropyridine derivatives (nifedipine), blockers of calcium channels of the II class: can raise arterial hypotension; at patients with heart failure – to increase probability of strengthening of further deterioration in pumping function of ventricles;
• Parasympathomimetic means: can cause increase in time of atrioventricular carrying out and by that to strengthen risk of development of bradycardia;
• Non-steroidal anti-inflammatory drugs: can reduce anti-hypertensive effect of Alotendin;
• Peroral hypoglycemic drugs and insulin: can cause strengthening of hypoglycemic effect, because of blockade of β-adrenoceptors masking of symptoms of a hypoglycemia is possible;
• Antiarrhytmic drugs I of a class (for example, пропафенон, lidocaine, quinidine, Phenytoinum, Disopyramidum, флекаинид): can strengthen effect of drug for the period of atrioventricular carrying out, and also exponentiate a negative inotropic effect;
• Antiarrhytmic drugs III of a class (for example, Amiodaronum): can strengthen effect for the period of atrioventricular carrying out;
• The drugs for topical administration containing beta adrenoblocker (for example, eye drops for treatment of glaucoma): can influence system effects of Alotendin;
• Foxglove glycosides: can urezhat heart rate and increase time of atrioventricular carrying out;
• Anti-hypertensive drugs and other means with hypotensive effect (for example, fenotiazina, tricyclic antidepressants and barbiturates): can increase risk of development of arterial hypotension;
• Beta and sympathomimetic means (for example, Dobutaminum and изопреналин): can reduce effect of both active ingredients of Alotendin.

At patients to whom the general anesthesia is carried out beta adrenoblockers (in this case бисопролол) reduce the frequency of arrhythmia and ischemia of a myocardium during induction of anesthesia, an intubation and in the postoperative period. Now maintenance of beta blockade is recommended to be provided perioperatsionno. The anesthesiologist has to remember beta blockade since there is a potential probability of interaction with other drugs owing to what easing of reflex tachycardia is possible, development of a bradyarrhythmia, oppression of a reflex opportunity to compensate blood loss. If before surgical intervention it is necessary to stop Alotendin's reception, it is necessary to do it gradually, having completely completed administration of drug approximately in 48 hours prior to anesthesia.

Meflokhin can increase risk of bradycardia. Monoamine oxidase inhibitors (except for inhibitors like B) can strengthen hypotensive effect of a bisoprolol and increase risk of development of hypertensive crisis. The possibility of simultaneous use of these medicines in each case is solved individually.

Terms and storage conditions

To store at a temperature up to 25 °C in the place, dry, dark and unavailable to children.

Period of validity – 2 years.