Serdol - instructions for use, doses, side effects, contraindications

Excipients: lactose monohydrate, corn starch, polyvidone, sodium starch glycolate, talc, silicon colloidal dioxide, sodium lauryl sulfate, magnesium stearate.

Description:

Round, biconcave, white or almost white or almost white with a yellowish tinge of a tablet with a uniform surface and solid edges, having on one side the risk and labeling "M 50" (50 mg tablets) or "M 100" (100 mg tablets) .

Pharmacotherapeutic group:beta1-blocker selective

ATX: & nbsp

C.07.A.B Selective beta-blockers

C.07.A.B.02 Metoprolol

Pharmacodynamics:

Metoprolol - cardioselective beta₁-adrenergic blocker. Has antihypertensive, antianginal, antiarrhythmic effect. It does not render membrane-stimulating action and does not possess internal sympathomimetic activity.

Reducing the stimulating effect of catecholamines on the heart, leads to a decrease in heart rate, the force of myocardial contractions, cardiac output.

Reduces high blood pressure at rest, with physical stress and stress. In the first days of treatment, it increases the OPSS, in the future, with prolonged use, it normalizes or even decreases.

Reducing the need for myocardium in oxygen (decreasing heart rate and reducing myocardial contractility), reduces the number and severity of angina attacks and increases tolerance to physical exertion.

With supraventricular tachycardia, atrial fibrillation, sinus tachycardia in functional heart diseases and hyperthyroidism, the heart rate decreases, or even lead to the restoration of sinus rhythm. Antiarrhythmic effect is due to the suppression of the automatism of the heart (including in the pathological focus) and the slowing of AV conduction.

Prevents the development of migraine.

To a lesser extent than non-selective beta-blockers, it affects the release of insulin and carbohydrate metabolism, masks the symptoms of hypoglycemia in diabetic patients, raises blood triglycerides, reduces free fatty acids and high-density lipoproteins.

Pharmacokinetics:

After oral administration metoprolol almost completely absorbed. The maximum concentration in the blood plasma is achieved after 1.5-2 hours. Bioavailability increases with food intake and increases during course treatment. Relationship with plasma proteins 10%. Metoprolol It is intensively metabolized in the liver with the formation of inactive metabolites. The half-life of plasma is about 3.5 hours. It is excreted mostly by the kidneys, about 3% is unchanged, the rest - in the form of metabolites. At the same time, a decrease in renal function causes a decrease in the elimination of metabolites and hardly affects the excretion of the active drug.

Bioavailability increases with cirrhosis of the liver.

Penetrates through the placental, blood-brain barrier.

Indications:

- Arterial hypertension;

- prevention of angina pectoris attacks;

- myocardial infarction (secondary prophylaxis);

- disturbance of the heart rhythm: supraventricular arrhythmias (tachycardia, atrial flutter, atrial fibrillation, ventricular arrhythmias (ventricular extrasystoles, ventricular tachycardia).

Contraindications:

Hypersensitivity to metoprolol or other components of the drug, chronic obstructive pulmonary disease, heart failure in decompensation, cardiogenic shock, atrioventricular block II-III prinzmetal angina, sinus node weakness syndrome, sinoatrial block, pronounced bradycardia, severe forms of Raynaud's syndrome, obliterating peripheral vascular diseases, untreated pheochromocytoma, arterial hypotension, Type I diabetes mellitus, depression, pregnancy, lactation.

Pregnancy and lactation:

The drug is prescribed only on strict indications in connection with the possible development of a newborn bradycardia, arterial hypotension, hypoglycemia, respiratory paralysis. Treatment with the drug must be discontinued 48-72 hours before delivery.It requires careful medical supervision of newborns in the first 3-5 days of life. No teratogenic effect was observed with the drug.

The drug penetrates into breast milk, so breastfeeding is incompatible with taking the drug.

Dosing and Administration:

Serdol is administered orally during or after a meal.

Usually the daily dose is 200 mg, once in the morning (4 tablets of 50 mg or 2 tablets of 100 mg) or in two divided doses of 100 mg of 2 tablets of 50 mg or 1 tablet of 100 mg each morning and evening.

In the case of hypertension The daily dose is 100-200 mg (2-4 tablets of 50 mg or 1-2 tablets of 100 mg) in 1-2 divided doses. Serdole is used both in monotherapy and in combination with other drugs. The dose is selected depending on the therapeutic effect: it can be reduced (up to 50 mg per day) or, conversely, increased.

To prevent attacks of angina pectoris treatment begins with 50 mg (one tablet of 50 mg or 54 tablets of 100 mg) per day in 1-2 divided doses. AT dependencies the clinical effect of the dose can then increase once a week.

With acute myocardial infarction after arresting an attack of arrhythmia patients are transferred to oral Serdol in a dose of 50 mg 4 times a day,the first dose being taken 15 minutes after the stopping of intravenous metoprolol. The recommended dose for prolonged treatment of myocardial infarction is 100-200 mg per day in 2-3 doses.

Side effects:

From the nervous system: increased fatigue, headache, slowing of the speed of mental and motor reactions. Rarely: paresthesia, convulsions, depression, decreased attention, drowsiness, insomnia, "nightmarish" dreams, confusion, hallucinations.

From the side of the cardiovascular system: bradycardia (dizziness), orthostatic hypotension (sometimes with loss of consciousness). Rarely: congestive heart failure (swelling, edema of the feet and / or lower legs, shortness of breath), heart rhythm disturbances, Raynaud's syndrome, atrioventricular block, cardialgia.

From the digestive system: nausea, vomiting, dry mouth, diarrhea, constipation, in some cases - a violation of liver function.

From the skin: rashes on the skin (exacerbation of psoriasis), photodermatosis, hyperhidrosis, reversible alopecia.

From the respiratory system: bronchospasm (incl.in the absence of previously obstructive pulmonary diseases), vasomotor rhinitis.

From the endocrine system: hyperoxemia in patients with diabetes mellitus.

From the genitourinary system: rarely - decreased libido, impotence.

From the sense organs: rarely - reduced vision, reduced lacrimal gland secretion, conjunctivitis, tinnitus, hearing loss.

Allergic reactions: urticaria, itching.

Other: pain in the back or joints, leukopenia, thrombocytopenia, weight gain, with a sharp cessation of treatment - withdrawal syndrome.

Overdose:

Symptoms: nausea, vomiting, cyanosis, decreased blood pressure, sinus bradycardia, AV blockade, heart failure, cardiogenic shock, bronchospasm, loss of consciousness, coma.

Treatment: In the case of severe arterial hypotension, bradycardia, heart failure - in / with, with an interval of 2-5 min, beta-adrenostimulants to achieve the desired effect. In the absence of beta-adrenostimulyatorov - in / in 0,5-2 mg of atropine sulfate. In the absence of a positive effect - the introduction of dopamine, dobutamine or norepinephrine. Further, the administration of glucagon (1-10 mg) is possible.You may need to install a pacemaker.

When bronchospasm - intravenous beta₂-adrenomimetics.

With ventricular extrasystole - lidocaine (preparations IA class do not apply).

With convulsions - intravenous diazepam.

Interaction:

Unrecommended combinations

Co-administration with amiodarone may result in a heart rhythm disorder.

Combinations that require caution when applying

Joint application with calcium channel blockers (including beprideal, diltiazem, verapamil, nifedipine), cardiac glycosides, reserpine, nitrates, clonidine, antiarrhythmics can increase the severity of bradycardia, lead to inhibition of conduction, arterial hypotension. In these cases, the treatment is carried out under medical supervision with monitoring of the electrocardiogram, especially in elderly patients and at the beginning of treatment.

Means for inhalation anesthesia against the use of metoprolol may inhibit the function of the myocardium and provoke the development of arterial hypotension.

Baclofen increases the antihypertensive effect of metoprolol.It is necessary to monitor blood pressure and, possibly, dose adjustment of metoprolol.

Cimetidine increases the concentration of the drug in the blood plasma. The use of this combination requires medical supervision; if necessary, the dose of metoprolol should be reduced for the duration of treatment with cimetidine and increased after its withdrawal.

Antatsidnye drugs (derivatives of aluminum, magnesium, calcium) reduce the absorption of metoprolol, so the time interval between taking metoprolol and antacid preparations should be at least two hours.

Before radiological examination with iodine-containing contrast preparations, treatment with metoprolol should be stopped in advance. In cases where metoprolol is absolutely necessary and can not be canceled, appropriate treatment should be prescribed.

Combinations that need to be considered

Nonsteroidal anti-inflammatory drugs, estrogens, beta-adrenostimulators, theophylline, cocaine weaken the hypotensive effect of the drug.

Simultaneous use with imipramine antidepressant (tricyclic) drugs and with antipsychotic drugs increases the risk of developing arterialhypotension and severe orthostatic hypotension.

Glucocorticoids and tetracosactide reduce the antihypertensive effect of the drug.

Phenobarbital and rifampicin reduce the concentration of metoprolol in the blood plasma, thereby reducing the effect of its use.

Special instructions:

Treatment with Cirdol should be performed starting with small doses with a gradual increase in the dose within 1-2 weeks, the drug should be taken at the same time.

With arterial hypertension, the effect of treatment occurs after 2-5 days, a stable therapeutic effect is observed after 1-2 months.

It is unacceptable to abruptly stop taking the drug, as this can lead to severe heart rhythm disturbances, myocardial infarction, sudden death. Treatment should be stopped gradually, reducing the dose for at least 10 days. Patients with ischemic heart disease should be under close medical supervision during this period /

In the case of development of severe bradycardia (heart rate below 50-55 per minute), the dose of Serdol should be reduced.

With atrioventricular blockade of the I degree, the drug is administered with caution, given the dromotropic effect it provides.

In the case of angina Prinzmetal, beta-blockers may increase the number and duration of seizures.

In patients with peripheral arterial disease (Raynaud's disease or syndrome, arteritis, chronic obliterating arteriopathy of the lower limbs), the administration of beta-blockers may exacerbate the course of these diseases, so the drug should be used with caution and with the simultaneous administration of alpha-blockers.

The use of Cirdola in the treatment of arterial hypertension caused by pheochromocytoma requires constant monitoring of blood pressure (BP).

In bronchial asthma and other chronic obstructive lung diseases, the drug should be used with caution.

In elderly patients, treatment should be started with low doses and carried out under constant medical supervision.

It is recommended to monitor the kidney function.

Patients with diabetes mellitus should be monitored for blood sugar.

When taking Serdola with psoriasis patients may exacerbate the course of the disease.

Patients with a predisposition to severe anaphylactic reactions, regardless of their origin, especially after the administration of iodine contrast preparations or time desensitizing treatment, the use of beta-blockers can lead to increased allergic reactions and to the lack of the effect of adrenaline treatment in usual doses.

In the case of general anesthesia, beta-adrenoblockers lead to a decrease in reflex tachycardia and an increased risk of hypotension. An anesthesiologist should be warned about the patient's admission of beta-blockers. In patients with coronary insufficiency, it is preferable to continue treatment before surgery due to the risk associated with withdrawal of the drug. When carrying out general anesthesia, the agent with the lowest negative inotropic effect should be selected.

In the case of insufficient kidney function, periodic heart rate control is necessary.

It should be borne in mind that in the case of thyrotoxicosis, beta-adrenoblockers can mask hypoglycemia syndromes.

Patients using contact lenses should take into account that, against the background of beta-blocker therapy, tear production can be reduced.

The drug may give a positive reaction during doping control.

Form release / dosage:Tableti, 50 mg and 100 mg.

Packaging:

Primary packaging: 10 tablets in a blister (PVC / aluminum).

Consumer packaging: two, or three, or six blisters of 10 tablets each together with instructions for use in a cardboard box.

Storage conditions:

At a temperature of 15-25 ° C in a dry place, protected from light, out of reach of children.

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N014353 / 01-2002

Date of registration:05.11.2008

Expiration Date:Unlimited

The owner of the registration certificate: K.O. LaborMed Farma S.A. K.O. LaborMed Farma S.A. Romania

Manufacturer: & nbsp

LaborMed Pharma, S.A. Romania

Representation: & nbspРомфарма ОООРомфарма ООО

Information update date: & nbsp25.07.2016

Illustrated instructions

Instructions

Serdol (Serdol)