|The name of the preparation
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|Atram 25 mg
Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.
The preparation contains the substance:carvedilol
The drug is available on prescription
What is Atram?
A drug that blocks alpha- and beta-adrenergic receptors.
What does Atram contain and how does it work?
The active substance is Carvedilol
. It is a substance belonging to the group of drugs acting on both alpha- and beta-adrenergic receptors (another name for this group of drugs is alpha- and beta-blockers). Carvedilol works by blocking alpha (alpha-1) and beta (both beta-1 and beta-2) adrenergic receptors. These are receptors stimulated in physiological conditions by adrenaline or noradrenaline released after the activation of the sympathetic nervous system. Pharmacological blocking of receptors prevents them from being stimulated, thereby reducing the effects of adrenaline or noradrenaline on target tissues with alpha or beta receptors. The effects of carvedilol lead to vasodilatation, mainly due to the blocking of alpha1-adrenergic receptors. Blockade of beta receptors leads to a decrease in the activity of the renin-angotensin-aldosterone system (increased renin secretion is caused by stimulation of the sympathetic nervous system). There is a significant reduction in plasma renin activity and a reduction in peripheral vascular resistance. In hypertensive patients, the effect of the preparation is a reduction in blood pressure and a slight reduction in heart rate. In patients with stable angina, carvedilol has anti-ischemic activity and reduces the frequency of pain episodes. In patients with left ventricular dysfunction or congestive heart failure
, it positively affects haemodynamic parameters, ejection fraction and left ventricular dimensions. Carvedilol does not adversely affect the lipid profile or electrolyte concentration.
The maximum carvedilol concentration in the blood is reached within about 1 hour after oral ingestion. Food does not affect the bioavailability of carvedilol but increases the time it takes to reach maximum concentration.
When should I use Atram?
The preparation is indicated for the treatment of:
· Essential hypertension
· Chronic, stable angina
· Supporting moderate or severe stable, chronic heart failure.
When not to use this preparation?
Unfortunately, even if there are indications to use the preparation, it can not always be used. You can not use the preparation if you are allergic (you are hypersensitive) to any of the ingredients. You can not use the preparation if you are present:
· Unstable / decompensated heart failure, NYHA class IV, requiring intravenous inotropic medication
· Symptomatic liver dysfunction
· Bronchospasm or bronchial asthma
· Cardiogenic shock
· 2nd or 3rd degree atrioventricular block (in patients without a pacemaker)
· Severe bradycardia (heart rate less than 50 beats per minute)
· Sick sinus syndrome (including sinoatrial block)
· Severe hypotension (systolic blood pressure lower than 85 mm Hg).
The preparation must not be used during pregnancy unless in the opinion of the doctor it is absolutely necessary. The preparation is contraindicated during breast-feeding.
When should you take special care with Atram?
Certain diseases and other circumstances may constitute a contraindication to use or indication to change the dosage of the preparation. In some situations it may be necessary to carry out specific check-ups.
There are insufficient data on the safety and efficacy of the preparation in children and adolescents up to 18 years of age.
Caution should be exercised in patients with chronic heart failure who are treated with digitalis glycosides, diuretics and / or angiotensin-converting enzyme inhibitors, as both carvedilol and digitalis (eg Digoxin
) prolong atrioventricular conduction time.
Patients with chronic stable heart failure should start using the preparation in a hospital under close medical supervision. The use of the preparation is possible only after obtaining a stable clinical condition by means of standard treatment. Patients with severe heart failure, electrolyte depletion, decreased intravascular volume, elderly or hypotension should remain under medical supervision for at least 2 hours after the first dose and after the dose increase, due to the risk of hypotension. Your doctor will advise you on how to manage the symptoms of possible hypotension. Until the symptoms of hypotension disappear, the dose should not be increased.
The doctor will start treatment from the individual dose adjustment stage. In patients with heart failure, worsening symptoms of heart failure or fluid retention may occur during the adjustment period. If necessary, the doctor will increase the dose of diuretics or reduce the dose of the preparation. Until the symptoms of heart failure have subsided, the dose should not be increased.
During the period of application, patients with chronic heart failure and low blood pressure, ischemic heart disease and extensive vascular changes and / or in patients with impaired renal function may experience transient worsening of renal dysfunction. Careful monitoring of renal function is required in these groups of patients, especially when increasing the carvedilol dose. If you have kidney problems, your doctor will advise you to reduce your dose or stop using it.
Patients with left ventricular dysfunction after myocardial infarction should start using the preparation in a hospital under strict medical supervision. The use of the preparation is possible only after obtaining a stable clinical condition (the dosage of the angiotensin converting enzyme inhibitor must be determined in advance).
Before starting treatment with patients with chronic obstructive pulmonary disease (COPD) who do not take oral or inhalation medicines, the doctor will consider the benefit / risk ratio and will in each case individually decide whether to start carvedilol treatment.
People with an increased risk of bronchoconstriction should exercise extreme caution as they may experience an increase in airway resistance and respiratory distress. Treatment should be carried out under close medical supervision. If necessary, your doctor will advise you to reduce your dose accordingly.
Patients with diabetes should be especially careful because the preparation may mask the symptoms of hypoglycaemia (decrease in blood Glucose
), such as palpitations, increased heart rate (tachycardia) or sweating. The blood glucose should be monitored, especially during the initial period of application and every time the dose is increased.
Special care should be exercised when using peripheral vascular disease (including Raynaud's syndrome, peripheral arterial occlusive disease) because symptoms may be worsening.
The preparation may also mask symptoms of hyperthyroidism, including increased heart rate (tachycardia).
If you are planning any surgery requiring anesthesia, please inform your doctor that you are using carvedilol. Between carvedilol and drugs used during anesthesia, there may be interactions that lead to serious side effects.
The preparation may reduce the frequency of heart rhythm (bradycardia). If the heart rate at rest is 55 beats per minute or less, please consult your doctor, as it may be necessary to reduce the dose.
The preparation may increase sensitivity to allergens and intensify hypersensitivity reactions (including Anaphylactic reactions
, including anaphylactic shock). Special care should be taken when using the preparation during the treatment of desensitisation and in people prone to hypersensitivity reactions.
Before starting to use the product in people with psoriasis, the doctor will consider the benefit / risk ratio and will in each case individually decide whether to start treatment with carvedilol.
In the case of parallel use of the preparation and Calcium
antagonists, such as Verapamil
or diltiazem or other anti-arrhythmic drugs, careful control of blood pressure and ECG is necessary. Intravenous intake of these drugs is contraindicated.
In patients with unstable or secondary hypertension, caution should be exercised.
In patients with pheochromocytoma, therapy to block alpha-adrenergic receptors is necessary before starting treatment with the beta-blocker and during treatment. The preparation (carvedilol), in addition to blocking beta receptors, also has an alpha blocking activity, however, due to the lack of clinical experience regarding the use of the preparation in this group of patients, care should be taken.
Caution should be exercised in patients with vasospastic angina (Prinzmetal); has no clinical experience regarding the use of the preparation in this group of patients.
Patients wearing contact lenses should know that the preparation may reduce tears.
Do not stop using the product suddenly, especially in people with ischemic heart disease. If cessation of treatment is required, the dose should be gradually reduced as prescribed by your doctor (usually within 2 weeks). Abrupt cessation of treatment in people with ischemic heart disease may lead to an increase in the symptoms of the disease.
Use with caution in patients with depression, myasthenia gravis (a disease characterized by muscle fatigue) or metabolic acidosis.
Additional information about the other ingredients of the preparation:
· The product contains lactose; people with galactose intolerance, lactase deficiency or malabsorption of glucose-galactose, should not use this preparation
· The product contains sucrose; people with inherited disorders associated with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not use this preparation.
Does this preparation affect the ability to drive vehicles?
The preparation, depending on individual response to treatment, may cause dizziness, fainting, fatigue and other symptoms that may impair the ability to drive vehicles and operate equipment / machines. This effect may occur especially at the beginning of treatment, during dose escalation, when the preparation is changed into another medicine and if alcohol is consumed during the treatment period.
Dosage of Atram
The preparation is in the form of tablets for oral use. The tablets should be taken with a sufficient amount of liquid during a meal. Do not exceed the recommended doses because it will not increase the effectiveness of the drug and may harm your health and life. If you have any doubts regarding the use of the preparation, consult a physician.
Arterial hypertension: initially 12.5 mg once daily for the first 2 days, followed by 25 mg once daily. If necessary, your doctor may gradually increase your dose at intervals of at least 2 weeks to a maximum dose of 50 mg a day, taken once daily or in 2 divided doses. The preparation can be used as monotherapy or combination therapy. In the elderly, initially 12.5 mg once daily (increasing the dose and the maximum dose as above).
Chronic, stable angina: initially 12.5 mg twice daily for the first 2 days, then 25 mg twice daily.If necessary, your doctor may gradually increase your dose at intervals of at least 2 weeks to a maximum dose of 100 mg a day, taken in 2 divided doses. In the elderly, initially 12.5 mg 2 times a day for 2 days; the doctor will continue treatment using a dose of 25 mg 2 times a day; this is the maximum daily dose in this group of patients.
Stable, chronic heart failure: the product is used in combination with other medicines commonly used to treat chronic heart failure; the preparation may also be used in people who can not be treated with ACE inhibitors or in patients not treated with digitalis, hydralazine or nitrates. The doctor will start treatment from the individual dose adjustment stage. Typically, the doctor will gradually increase the dose according to the following scheme: initially 3.125 mg 2 times a day for 2 weeks; in case of good tolerance, the doctor may double the dose every 2 weeks to the highest dose tolerated by the patient. The maximum dose is 25 mg twice daily in patients with severe congestive heart failure and in patients with mild to moderate congestive heart failure and weighing less than 85 kg. In patients with mild and moderate congestive heart failure and weighing more than 85 kg, the maximum dose is 50 mg twice daily. Elderly people may be more sensitive to carvedilol; caution and careful observation of the patients is recommended.
During the adjustment period, transient worsening of heart failure and fluid retention may occur. Sometimes it is necessary to increase the dose of diuretics. Until the symptoms of heart failure have subsided, the dose should not be increased. Your doctor will advise you to take appropriate measures to control your symptoms. When starting treatment and after each dose increase, the patient should be closely monitored by a cardiologist for at least two hours. Your doctor will recommend observing your heart rate, your blood pressure, and monitoring your kidney function and any signs of worsening heart failure. Do not stop the treatment suddenly. If cessation of treatment is required, the dose should be gradually reduced (usually within a period of 7-10 days) as prescribed by your doctor. Sudden discontinuation of carvedilol therapy may lead to worsening of heart failure.
If the use of the preparation is discontinued for 2 weeks or more, re-treatment should be initiated at a dose of 3, 125 mg 2 times a day and increased gradually, as described above.
Do not use the preparation in patients with severe hepatic impairment. A dose adjustment may be necessary in patients with moderate hepatic impairment.
The safety and efficacy of the preparation in children and adolescents up to 18 years have not been established.
Can Atram be used during pregnancy and breastfeeding?
During pregnancy, do not use any medicine without consulting your doctor!
It is very important that before using any medicine during pregnancy or breastfeeding, consult a physician and explain beyond any doubt the potential risks and benefits associated with the use of the drug. If you are pregnant or plan to become pregnant, please inform the doctor prescribing the prescription for this medicine.
The preparation must not be used during pregnancy unless the physician, after considering the expected benefits and possible risks, will not consider the use of the preparation to be strictly necessary. If the doctor considers the use of the preparation to be strictly necessary, he will recommend appropriate precautions and necessary tests. Treatment will usually be discontinued 2-3 days before delivery, as prescribed by your doctor.
The use of the preparation is contraindicated during breast-feeding.
Can I use other preparations in parallel?
Tell your doctor about all medicines you have recently taken, including those that are over the counter.
Carvedilol may affect the bioavailability of drugs transported by the P-glycoprotein.
If carvedilol is used in parallel with drugs that increase or inhibit the activity of 2D6 or 2C9 cytochrome P450 isoenzymes, the carvedilol concentration may change. The following are some examples of such interactions.
Caution should be exercised if the preparation is used in parallel with:
· Digitalis glycosides (digoxin) - the level of digoxin in the blood should be monitored at the beginning of treatment and during the increase or decrease of the carvedilol dose; both digoxin and carvedilol reduce the atrioventricular conduction velocity
· Rifampicin - a possible decrease in carvedilol concentration in blood and a decrease in its activity
· Cyclosporin - the blood concentration of ciclosporin should be monitored; it may be necessary to adjust the dosage of cyclosporin
- there is a risk of increased blockade of beta-adrenergic receptors, due to the increase in the concentration of one of the optical isomers of carvedilol
· Cimetidine - possible increase of carvedilol concentration in blood and intensification of its action
and oral antidiabetic agents - hypoglycemic effect may be exacerbated; beta-blockers, including carvedilol, may mask the symptoms of hypoglycaemia; blood glucose should be checked regularly
· Monoamine oxidase inhibitors (MAO inhibitors) and antihypertensive drugs, such as, for example, clonidine, methyldopa, reserpine, guanethidine, guanfacine, due to the risk of decreased heart rate and significant hypotension; it is recommended to control the parameters of basic vital signs of the patient
· Class I antiarrhythmics (eg quinidine, disopyramide, Lidocaine
, phenytoin, flecainide, propafenone) or amiodarone - risk of worsening atrio-ventricular conduction and weakening of myocardial contraction force; it is recommended that you remain under close medical supervision and be especially cautious; intravenous use of these drugs is contraindicated
· Calcium antagonists from the group of verapamil and diltiazem - the risk of exacerbation of atrioventricular conduction disorders; Take special care, monitor ECG and blood pressure; intravenous use of these drugs is contraindicated
· Calcium dihydropyridine antagonists (eg Nifedipine
, lacidipine, nicardipine, nimodipine, nitrendipine) - risk of severe hypotension and further worsening of symptoms in patients with heart failure; treatment should be carried out under strict medical supervision
· Clonidine - possible aggravation of antihypertensive effect and reduction of cardiac rhythm frequency; the use of clonidine should not be discontinued during the use of carvedilol; if it is planned to discontinue combination therapy, the use of carvedilol should first be discontinued a few days before gradual reduction of clonidine
· Antihypertensive agents (eg angiotensin converting enzyme inhibitors, diuretics), vasodilators (eg Nitroglycerin
and other nitrates) and other drugs that may lower blood pressure (eg tricyclic antidepressants, barbiturates, phenothiazine derivatives, anesthetics, opioid analgesics, sedatives and hypnotics, baclofen, amifostine) - risk of increased antihypertensive effect and hypotension
· Preparations used for anesthesia - may lead to increased weakness of myocardial contraction force and significant hypotension (please inform your anesthesiologist about the use of carvedilol)
· Non-steroidal anti-inflammatory drugs, estrogens, corticosteroid
s - the antihypertensive effect of carvedilol may be reduced
· Beta2 mimetic with bronchodilating effect - careful observation of the patient is recommended because the effect of bronchodilators may be reduced
· Ergotamine derivatives - possible worsening of peripheral circulation disorders, intensification of vasoconstrictor effect
· Drugs blocking neuromuscular conduction - possible intensification of their action.
What side effects can occur?
Like all medicines, also Atram 6.25 mg, -12.5 mg, -25 mg, may cause side effects, although they will not occur in all patients using this product. Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects.
The risk of most adverse reactions is similar in all indications. Very often possible: dizziness, headaches, hypotension, heart failure, fatigue / weariness.Frequent or uncommon: reduced heart rate (bradycardia), fluid retention, increased intravascular volume, edema, worsening of heart failure, atrioventricular conduction disturbances (including atrio-ventricular block), angina pectoris, peripheral circulatory disorders (severity of claudication) punctuation and symptoms of Raynaud's syndrome, such as freezing and limb numbness, peripheral vascular disease), orthostatic arterial hypotension, anemia, depression, mood depression, sleep disturbances, fainting, paresthesia (dysphagia, feeling moley and numbness), decreased tear this is particularly important for people wearing contact lenses), blurred vision, eye irritation, shortness of breath, pulmonary edema, asthma in susceptible persons, upper respiratory tract infections, bronchitis / lungs, weight gain, nausea, vomiting, diarrhea, constipation, abdominal pain, dry mouth, increased / decreased blood glucose (often in diabetic patients), increased cholesterol, pain in the extremities, kidney failure, kidney problems, urinary disorders, urinary tract infections, impotence, cutaneous hypersensitivity reactions (rash, urticaria, pruritus, changes similar to lichen planus), alopecia. Rarely or very rarely: thrombocytopenia, reduced white blood cell count (leukopenia), nasal congestion, increased liver enzymes (AST, ALT), urinary incontinence in women, severe skin reactions such as erythema multiforme, toxic epidermal necrolysis and syndrome Stevens and Johnson.
Other preparations on the Polish market containing carvedilol
Atram 6.25 mg (tablets)
Atram 12.5 mg (tablets)
Avedol (coated tablets)
Carvedilol Genoptim (coated tablets)
Carvedilol Orion (coated tablets)
Carvedilolum 123ratio 6.25 (Carvedilol TEVA) (tablets)
Carvedilolum 123ratio 12.5 (Carvedilol TEVA) (tablets)
Carvedilolum 123ratio 25 (Carvedilol TEVA) (tablets)
Hypotene (coated tablets)
Symtrend (coated tablets)