METOSTAD . 50 mg.30 tablets

indications
  Hypertension Coronary Artery Disease Cardiac arrhythmia, including in particular the House tachycardia prevention of morbidity and mortality from cardiovascular events and reinfarction after acute myocardial infarction, palpitations due to functional cardiac disorders Prophylaxis of migraine in the combined treatment symptomatic chronic heart failure

METOSTAD . 50 mg.30 tablets
 

PHARMACEUTICAL FORM

prolonged-release tablet.
Metostad 50 mg prolonged-release tablets are white, oval, biconvex, film-coated, approx. 11 mm x 6 mm, scored on both sides.
 

CLINICAL DATA

 
Indications
 Hypertension
Coronary Artery Disease
 Cardiac arrhythmia, including in particular the House tachycardia
 Prevention of morbidity and mortality from cardiovascular events and reinfarction after acute myocardial infarction
 Palpitations due to functional cardiac disorders
 Prophylaxis of migraine
 The combination treatment of symptomatic chronic heart failure in combination with other treatments for heart failure
 

DOSAGE AND ADMINISTRATION

 
Tablets METOSTAD prolonged release for once daily dosing. Preferably be taken in the morning at breakfast. Prolonged-release tablets should be swallowed whole or split into halves. It should not be chewed or crushed. They should be taken with water / at least half a glass /.
The dose may be determined in accordance with the instructions given below:
 
Hypertension
 
The recommended dose in patients with mild to moderate hypertension is 47.5 mg daily metoprololov succinate. If necessary, the dose may be increased to 95-190 mg daily metoprololov succinate or combined with other antihypertensive agents.
 
Ischaemic heart disease
 
95-190 mg once daily metoprololov succinate. If necessary, treatment can include other drugs for the treatment of atherosclerosis.
 
Heart arrhythmia
 
95-190 mg once daily metoprololov succinate.
 
Prevention after myocardial infarction
 
Metiprololov succinate 190 mg once daily.
 
Palpitations due to functional cardiac disorders
 
Metoprololov succinate 95 mg once daily. If necessary, the dose may be increased to 190 mg once daily metoprololov succinate.
 
Prophylaxis of migraine
 
95-190 mg once daily metoprololov succinate.
 
Stable symptomatic heart failure
 
Metoprololov succinate dose should be individually adjusted in patients with stable symptomatic heart failure who are concomitantly administered another treatment of heart failure. The recommended starting dose for patients with chronic heart failure, NYHA functional class III-IV was 11.88 mg metoprololov succinate once daily during the first week. During the second week the dose may be increased to 23.75 mg metoprololov succinate once daily.
The recommended starting dose for patients with stable heart failure NYHA functional class II was 23.75 mg metoprololov succinate once daily during the first two weeks.
Recommended dose is then set to double. The dose should be increased every second week to 190 mg daily metoprololov succinate is reached or until the maximum tolerated dose. With prolonged treatment, the planned dose should be fixed at 190 mg daily metoprololov succinate is reached or until the maximum tolerated dose. It is recommended that the physician is familiar with treating the symptoms of stable symptomatic heart failure. After each dose increase, the patient should be carefully monitored. If blood pressure is lowered, you may need to be reduced concomitant medication. Not necessarily lowering blood pressure to prevent the continued use of metoprolol, but in this case the dosage should be reduced while the patient is stabilized.
 
Impaired renal function
 
There is no need for dose adjustment.
 
Impaired liver function
 
In patients with acute liver failure, as patients with portokavalen shunt, the dose should be decreased.
 

Elderly

 
There is little information on the use of this drug in patients aged over 80 years. should take the necessary special precautions when increasing the dose.
 
Children and adolescents
 
Experience in the treatment of children and adolescents with Metostad prolonged release tablets is limited.
 

CONTRAINDICATIONS:

 
 Hypersensitivity to metoprololov succinate, beta-blockers or one or more of the ingredients of this product.
 Atrioventricular block II and III degree.
Uncompensated heart failure and continuous or intermittent inotropic therapy acting through beta-agonist receptors.
 Proven and clinically significant sinus bradycardia
 Syndrome sick sinus
 Cardiogenic shock
 Severe peripheral arterial disease
 Hypotension
 Metabolic acidosis
 Severe asthma or chronic obstructive pulmonary disease
 Untreated pheochromocytoma
 Concurrent administration of MAO inhibitors
 
METOSTAD should not be used in patients with suspected acute myocardial infarction if the heart rate is less than 45 beats / minute, PQ interval greater than 0.24 seconds, or systolic blood pressure less than 100 mmHg
 
In addition, METOSTAD is contraindicated in patients with heart failure and prolonged hypotension.
Simultaneous administration of calcium channel blockers of the verapamil or diltiazem type or other antiarrhythmic drugs is contraindicated.
 

Warnings AND SPECIAL PRECAUTIONS FOR USE

 
In patients with asthma, beta-blockers should be used with caution. If asthmatic used ?2-agonist retseptiren when initiating treatment with Metostad dose received ?2-agonist should be monitored and improved if necessary. Tablets Metostad prolonged release affect ?2-receptors to a lesser extent than conventional tablet form of ?1 selective beta-blockers.
 
Metostad can reduce the effect of treatment of diabetes and mask the symptoms of hypoglycaemia. Risakt breaches of carbohydrate metabolism or masking of hypoglycaemia was lower when using a tablet Metostad prolonged release than the conventional tablet forms of the ?1 selective beta-blockers and significantly lower with the use of non-selective beta-blockers.
 
In rare cases can worsen an existing violation of AV conduction during treatment with Metostad.
Metostad may intensify symptoms of circulatory disorders of the peripheral arteries, due to its antihypertensive effect.
Metostad treatment can mask symptoms of thyrotoxicosis.
 
Treatment with beta-blockers should not be stopped suddenly. Any discontinuation of, if possible, should be done gradually over a minimum of two weeks during which the dose should be halved in each step until the lowest dose that is half a prolonged release tablet containing 23 , 75 mg metoprololov succinate. The last dose should be taken at least four days before completely stopping. If the patient experiences any symptoms recommended dose should be reduced more slowly. Abrupt discontinuation of beta-blockers can worsen chronic heart failure and increase the risk of myocardial infarction.
 

Pregnancy and lactation

 
Pregnancy
 
In the absence of well-controlled studies of metoprolol during pregnancy Metostad can be taken during pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus.
Beta-blockers reduce placental perfusion, which can lead to fetal death and preterm birth. There was a delay of intrauterine growth continuously treated pregnant women with mild to moderate hypertension. Beta-blockers may cause delays in delivery and bradycardia in fetus and newborn. There are reports of hypoglycemia, hypotension, increased bilirubinemia or inhibited response to anoxia in the newborn. Treatment with metoprolol should be discontinued 48-72 hours before the anticipated birth. If this is not possible, the infant should be observed 48-72 hours after delivery for adverse effects from the use of beta-blockers.
 
Breastfeeding
 
Metoprolol concentration in breast milk is approximately three times higher than in maternal plasma. Although the risk of adverse reactions in nursing infants, after administration of therapeutic doses of this drug is small, it should be observed for signs of beta blockade.
 

SIDE EFFECTS

 
Blood and lymphatic system
Very rare: thrombocytopenia, leukopenia
 
Ednokrinnita system disorders
 
Rare - Deterioration of latent diabetes mellitus
 
Metabolism and nutrition
 
Uncommon - Weight Gain
 
Psychiatric Disorders
 
Uncommon - depression, impaired concentration, drowsiness or insomnia, nightmares
Rare - Nervousness, anxiety
Very rare - Amnesia
 
Nervous System
 
Common - Dizziness, headache
Uncommon - Paresthesia
 
Eye Disorders
 
Rare - Visual disturbances, dryness or irritation in the eyes, conjunctivitis
 
Ear and labyrinth disorders
 
Rare - tinnitus, hearing problem
 
Cardiac disorders
Common - bradycardia, orthostatic dysregulation heartbeat
Rare - Temporary worsening symptoms of heart failure, atrial pain
Very rare - Functional heart disorders, arrhythmia, conduction abnormalities
 
Vascular Disorders
 
Very common - Significant decrease in blood pressure and orthostatic
 Common hypotension - coldness
Very rare - necrosis in patients with acquired severe peripheral vascular disorders, intermittent worsening of claudication or Raynaud's syndrome
 
Respiratory, thoracic and metiastinalni violations
 
Common - average adjustment during exercise
Uncommon - Bronchospasm
Rare - Rhinitis
 
Gastrointestinal Disorders
 
Common - Nausea, diarrhea, constipation
Uncommon - Vomiting
Rare - Dry Mouth
Very rare - Dysgeusia
 
Skin and subcutaneous tissue disorders
 
Uncommon - rash, increased sweating
Rare - Hair Loss
Very rare - worsening psoriasis appearance of new psoriasis-like skin changes
 
Disorders of the musculoskeletal system and connective tissue
 
Uncommon - Muscle spasms
Very rare - Muscle weakness
General disorders
Very common - Fatigue
Uncommon - Oedema