Expiration date: 05/2025

The composition and form of issue: 

The intravenous solution. 1 ml contains active substance: 

metoprolol tartrate injection 1 mg

excipients: sodium chloride for injection 9 mg water for injection to 1 ml 

in ampoules of 5 ml in a cardboard pack of 5 ampoules.

Tablets. 1 tablet contains active substance: 

metoprolol tartrate 100 mg

excipients: lactose monohydrate magnesium stearate carboximetilkrahmal sodium silica colloidal anhydrous povidone 

in plastic bottles to 30 PCs. in cardboard pack 1 bottle.

Description pharmaceutical form:

Solution for intravenous injection: clear, colorless liquid.

Tablets: biconvex, round, white, scored and engraved A/mE on one side.

Indications:

Solution for intravenous injection:

• supraventricular tachycardia
  
• prevention and treatment of myocardial ischemia, tachycardia and pain in myocardial infarct or suspected him.
  

Tablets:

• hypertension: blood pressure reduction and reduced risk of cardiovascular and coronary death (including sudden death)
  
• angina
  
• of arrhythmias, including supraventricular tachycardia
  
• after myocardial infarction (in combination therapy)
  
• functional cardiac abnormalities, accompanied by palpitations
  
• prevention of migraine attacks
  
• ray (complex therapy).
  

Contraindications:

For both dosage forms

• known hypersensitivity to metoprolol and its components or to other &beta-blockers
  
• AV blockade II and III level, heart failure decompensation, clinically significant sinus bradycardia, sick sinus syndrome node, cardiogenic shock, severe peripheral circulatory disorders, hypotension
  
• patients with acute myocardial infarction with heart rate less than 45 beats per minute, a PQ interval of more than 0,24 or sad less than 100 mm Hg.St
  
• patients receiving &beta-blockers, is contraindicated in intravenous blockers "slow" calcium channels such as verapamil.
  
• severe peripheral vascular disease (with the threat of gangrene)
  
• the age of 18 years (efficacy and safety not established).
  

For solution for in/in the introduction of advanced

In the treatment of supraventricular tachycardia in patients with sad less than 110 mm Hg.St.

For tablets advanced

Patients who receive prolonged Il intermittent inotropic therapy means acting on &beta-adrenergic receptors.

Caution: AV blockade of I degree, Prinzmetal's angina, COPD (emphysema, chronic obstructive bronchitis, bronchial asthma), diabetes, severe renal insufficiency.

Application of pregnancy and breast-feeding:

Pregnancy

Like most drugs Betaloc should not be administered during pregnancy and breastfeeding, except in those cases where the expected benefit to the mother outweighs the potential risk to the fetus. Like other antihypertensive agents, &beta-blockers can cause side effects, e.g., bradycardia in fetus, infants or children, breastfeeding, therefore should be especially careful in the appointment of &beta-blockers in the last trimester of pregnancy and immediately before delivery.

Lactation

Number of metoprolol released in the breast milk, and beta-adrenoblokirtee the action of the child who is breast-feeding (while taking metoprolol mother in therapeutic doses), are insignificant.

Side effects:

For both dosage forms

Betaloc well tolerated by patients, and side effects are mostly mild and reversible.

As a result of clinical studies or when using the drug Betaloc  (metoprolol tartrate) in clinical practice has been described as unwanted side effects. In many cases, a causal relationship with the treatment of drug Betaloc not been established. To assess the frequency of cases has applied the following criteria: very common (>10%), often (1-9,9%), uncommon (0,1–0,9%), rare (0,01–0,09%) and very rare (<0,01%).

From the CCC: often — bradycardia, postural disorders (very rarely accompanied by fainting), cold extremities, palpitations infrequently — temporary increased symptoms of heart failure, cardiogenic shock in patients with acute myocardial infarction, AV blockade of I degree rarely other disorders of heart conduction, arrhythmia, very rarely — gangrene in patients with previous severely impaired peripheral blood circulation.

CNS: very often fatigue often dizziness, headache infrequently, paresthesia, convulsions, depression, weakened attention, drowsiness or insomnia, nightmares rarely — increased nervous irritability, anxiety, impotence/sexual dysfunction very rare: amnesia/memory impairment, depression, hallucinations.

From the digestive tract: often — nausea, pain in the abdomen, diarrhea, constipation infrequently — vomiting rare — dry mouth.

With the skin: rarely — rash (urticaria), increased sweating, rarely hair loss is very rarely photosensitivity, exacerbation of psoriasis.

Hepatic: rarely — infringements of function of a liver.

From the side of respiratory system: often — shortness of breath during physical effort rarely, bronchospasm in patients with bronchial asthma; rare — rhinitis.

From the sensory organs: rare — visual disturbances, dry and/or irritated eyes, conjunctivitis very rarely tinnitus, breach of taste sensations.

From the metabolic: rare — increase in body weight.

From the skeletal-muscular system: very rarely — artralgia.

From the side of blood system: rarely — thrombocytopenia.

For tablets advanced

The liver: very rarely — hepatitis.

Method of application and dose:

The intravenous solution

Supraventricular tachycardia

Begin the introduction with 5 mg (5 ml) of the drug Betaloc at a speed of 1-2 mg/min Can be repeated with the introduction of 5-minute intervals until a therapeutic effect. Usually the total dose is 10-15 mg (10-15 ml). The recommended maximum dose at/in the introduction is 20 mg (20 ml).

Prevention and treatment of myocardial ischemia, tachycardia and pain in myocardial infarct or suspected him

I/5 mg (5 ml) of the drug. You can repeat the introduction in 2-minute intervals, maximum dose 15 mg (15 ml). 15 min after the last injection metoprolol is prescribed for oral administration at a dose of 50 mg (Betaloc) every 6 h for 48 h.

Pills

Inside, along with food and on an empty stomach.

Hypertension

100-200 mg of drug Betaloc single dose in the morning or in 2 divided doses morning and evening. If necessary, the dose can be increased or add another antihypertensive agent.

Long-term antihypertensive therapy is 100-200 mg of drug Betaloc a day reduces overall mortality, including sudden death, as well as the incidence of cerebral strokes and coronary circulation in patients with arterial hypertension.

Angina

100-200 mg/day in 2 doses morning and evening. If necessary, therapy can be added to other antianginal drug.

Rhythm disorders of the heart

100-200 mg/day in 2 doses morning and evening. If necessary, therapy may be added another antiarrhythmic drug.

Maintenance treatment after myocardial infarction

The maintenance dose is 200 mg/day in 2 doses morning and evening. The appointment of Betaloc at a dose of 200 mg/day allows to reduce mortality in patients after myocardial infarction and reduce the risk of recurrent myocardial infarction (including patients with diabetes).

Functional cardiac abnormalities, accompanied by palpitations

100 mg of drug Betaloc 1 time a day, it is recommended to take the pill in the morning. If necessary, the dose may be increased.

Prevention of migraine attacks

100-200 mg/day in 2 doses morning and evening.

Hyperthyroidism

150-200 mg/day in 3-4 reception.

Total for both dosage forms

Violation of kidney function

There is no need to adjust the dose in patients with impaired renal function.

The liver

Usually due to low degree of Association with plasma proteins dose adjustment of metoprolol is required. However, in severe liver dysfunction (in patients with severe liver cirrhosis or portocaval anastomosis) may require dose reduction.

Old age

No need to adjust the dose in elderly patients.

Children.

The experience of the drug Betaloc in children is limited.

Overdose:

For solution for intravenous

Toxicity

Metoprolol at a dose of 7.5 g in an adult caused intoxication with fatal outcome. 5-year-old child who took 100 mg metoprolol, after gastric lavage were observed for signs of intoxication. Receiving 450 mg metoprolol teenager 12 years has led to moderate intoxication. Reception 1.4 g and 2.5 g of metoprolol adults caused moderate and severe intoxication, respectively. Receiving 7.5 g adults has led to extremely severe intoxication.

Symptoms: in overdose metoprolol most serious are the symptoms of SSS, but sometimes, especially in children and adolescents, may prevail symptoms of the Central nervous system and suppression of lung function. Bradycardia, AV blockade of I–III extent, asystole, marked reduction in blood pressure, weak peripheral perfusion, cardiac failure, cardiogenic shock. Inhibition of the function of the lungs, apnea, and fatigue, impairment of consciousness, loss of consciousness, tremor, convulsions, sweating, paresthesia, bronchospasm, nausea, vomiting, possible esophagial spasm, hypoglycaemia (especially in children) or hyperglycemia, hyperkalemia effects on the kidneys transient myasthenic syndrome. Concomitant ingestion of alcohol, antihypertensive drugs, quinidine or barbiturates may worsen the patient's condition.

The first signs of overdose may be observed 20 minutes to 2 hours after administration of the drug.

Treatment: use activated charcoal, if necessary gastric lavage.

IMPORTANT! Atropine (0.25–0.5 mg in/in adults, 10-20 micrograms/kg for children) should be appointed to gastric lavage (because of the risk of stimulation of the vagus nerve). If necessary — maintain airway (intubation), and adequate ventilation. To fill the BCC and infusion of glucose. Monitoring of ECG. Atropine 1-2 mg in/in, if necessary, repeat the introduction (especially in the case of vagal symptoms). In the case of suppression (depression) of the myocardium is shown infusion introduction dobutamine or dopamine. You can also use glucagon 50-150 µg/kg/every 1 min. In some cases, it may be effectively adding to the therapy of adrenaline. Arrhythmia and increased ventricular complex (QRS) administered infusion solutions of sodium (chloride or bicarbonate). Is possible to install an artificial pacemaker. In case of cardiac arrest due to an overdose may need resuscitation for several hours. For the relief of bronchospasm may be used terbutaline (injectable or via inhalation). Is symptomatic treatment.

For tablets

Symptoms: the effects of an overdose of the drug Betaloc may be expressed lower AD, sinusova aetiology, AV blockade, heart failure, cardiogenic shock, cardiac arrest, bronchospasm, impairment of consciousness/coma, nausea, vomiting and cyanosis.

Concomitant use of alcohol, use of antihypertensive drugs, quinidine or barbiturates may worsen the patient's condition.

The first signs of overdose may appear within 20 min–2 h after administration of the drug.

Treatment: use activated charcoal, if necessary gastric lavage. In the case of expressed lower AD, aetiology or the threat of heart failure should be administered &beta1-agonists (e.g. dobutamine) in/in intervals of 2-5 minutes or by infusion to achieve a therapeutic effect. In case of unavailability of selective &beta1-agonist can be administered in/in dopamine or atropine sulfate for the blockade of the vagus nerve.

If the therapeutic effect is not achieved, you can use other sympathomimetic agents such as dobutamine or norepinephrine.

You can enter glucagon in a dose of 1-10 mg may Occasionally be necessary to use a pacemaker. For the relief of bronchospasm should be entered in/in &beta2-agonists.

Be aware that doses of antidotes that are required to eliminate the symptoms that occur when overdose of &beta-blockers, much higher than therapeutic, since &beta-adrenergic receptors are in the bound state with &beta-blocker.

Special instructions:

For both dosage forms

Patients receiving &beta-blockers should not be administered in/in blockers "slow" calcium channels such as verapamil.

When using a &beta1-blockers risk their effect on carbohydrate metabolism or masking hypoglycaemia is much less than when using non-selective &beta-blockers.

In patients with chronic heart failure decompensation is necessary to achieve the compensation stage, both before and during drug treatment.

Patients suffering from prinzmetals angina, is not recommended non-selective &beta-blockers.

Very rarely in patients with impaired atrioventricular conduction can occur deterioration (possible outcome — AV blockade). If during treatment developed bradycardia, the dose of Betaloc should be reduced. Metoprolol may worsen the symptoms of impaired peripheral blood circulation, mainly due to decline in AD. Caution should be exercised when prescribing the drug to patients suffering from severe renal failure, with metabolic acidosis, a joint appointment with cardiac glycosides.

Patients suffering from pheochromocytoma, in parallel with the drug Betaloc should be appointed &alpha-blocker.

In the case of surgical intervention should inform the anesthetist that the patient is taking &beta-blocker.

In patients receiving &beta-adrenoblokatora, anaphylactic shock occurs in a more severe form.

Additionally, for solution for intravenous

Patients suffering from bronchial asthma or obstructive lung disease, needs to be assigned and related bronchodilatory therapy. If necessary, increase the dose &beta2-agonists.

Should not be administered a second dose in the second or third in heart rate less than 40 beats per minute, a PQ interval of 0.26 with more and garden less 90 mm Hg.St.

Additionally for tablets

Patients suffering from obstructive pulmonary disease, it is not recommended to assign &beta-blockers. In case of poor tolerability of other antihypertensive drugs or their ineffectiveness, you can assign metoprolol because it is a selective drug. You must assign the minimum effective dose, if necessary, you can assign &beta2-agonists.

In patients with liver cirrhosis the bioavailability of metoprolol is increased.

Avoid abrupt discontinuation of the drug. If necessary, discontinuation of the drug, the abolition should be gradual. In most patients the drug can be cancelled up to 14 days. Dose of the drug reduced gradually in stages until the ultimate dose of 25 mg 1 time per day. Patients with coronary artery disease should be under close medical supervision during drug withdrawal.

Effects on ability to drive and work with technical devices. In applying the drug there are episodes of dizziness or General weakness, therefore it is necessary to refrain from driving vehicles and activities potentially hazardous activities, require high concentration and psychomotor speed reactions.

Review:

Before using the drug you must read the instructions for use.