Bisogamma

Bisogamma®

Termination of therapy and “withdrawal syndrome”

You should not abruptly interrupt treatment with bisoprolol or change the recommended dose without first consulting your doctor, as this may lead to a temporary deterioration in heart function.

Treatment should not be interrupted suddenly, especially in patients with coronary artery disease (increased severity of angina attacks, the development of myocardial infarction and the occurrence of ventricular arrhythmias in patients with coronary artery disease when suddenly stopping beta-blockers were noted). If discontinuation of treatment is necessary, the dose of bisoprolol should be reduced gradually. In case of significant worsening of angina or development of acute coronary syndrome, bisoprolol should be temporarily resumed.

Diseases for which the drug should be used with caution

Bisoprolol should be used with caution in the following cases:

- severe forms of COPD and non-severe forms of bronchial asthma;

- diabetes mellitus with significant fluctuations in blood glucose concentrations: bisoprolol may mask symptoms of hypoglycemia (a marked decrease in blood glucose concentrations), such as tachycardia, palpitations or increased sweating;

- strict diet;

— carrying out desensitizing therapy;

— atrioventricular block of the first degree;

- vasospastic angina (Prinzmetal's angina); cases of coronary spasm have been observed. Despite its high beta1 selectivity, angina attacks cannot be completely excluded when taking bisoprolol in patients with Prinzmetal's angina. You should take the drug with extreme caution;

- mild to moderate peripheral arterial circulation disorders (increased symptoms may occur at the beginning of therapy);

- psoriasis (including history).

Diseases of the cardiovascular system

Beta blockers should not be used in decompensated chronic heart failure until the patient's condition has stabilized. At the initial stages of using bisoprolol, patients need constant monitoring.

Beta blockers may cause bradycardia. If the heart rate at rest decreases to less than 50-55 beats/min, the dose should be reduced or discontinued taking bisoprolol.

Like other beta blockers, bisoprolol may cause a prolongation of the PQ interval on the ECG. Bisoprolol should be used with caution in patients with first degree atrioventricular block.

Non-selective beta-blockers may increase the frequency and duration of anginal attacks in patients with vasospastic angina (Prinzmetal's angina) due to alpha-receptor-mediated coronary artery vasoconstriction.

Cardioselective beta-blockers (including bisoprolol) should be used with caution in vasospastic angina.

To date, there is insufficient data regarding the use of bisoprolol in patients with CHF in combination with type 1 diabetes mellitus, severe renal and/or liver dysfunction, restrictive cardiomyopathy, congenital heart defects or heart valve disease with severe hemodynamic disturbances. Also, sufficient data have not yet been obtained regarding patients with CHF with myocardial infarction within the last three months.

Respiratory system

Despite the fact that selective beta-blockers have a lesser effect on the function of the respiratory system than non-selective beta-blockers, patients with COPD and mild forms of bronchial asthma should be prescribed bisoprolol with extreme caution and only if the possible benefits of its use exceed potential risk. For bronchial asthma or COPD, simultaneous use of bronchodilators is indicated. In patients with bronchial asthma, there may be an increase in airway resistance, which requires a higher dose of beta2-agonists.

In patients with COPD, bisoprolol prescribed in combination therapy for the treatment of heart failure should be started at the lowest possible dose, and patients should be carefully monitored for the appearance of new symptoms (eg, shortness of breath, exercise intolerance, cough).

Major surgery and general anesthesia

If surgical interventions are necessary, the anesthesiologist should be warned that the patient is taking beta-blockers (risk of drug interactions with the development of severe bradyarrhythmias, reduction of reflex tachycardia and arterial hypotension). It is recommended not to stop taking bisoprolol in the perioperative period unless clearly necessary (since beta-adrenergic receptor blockade reduces the risk of arrhythmias and myocardial ischemia during induction of anesthesia and tracheal intubation).

If it is necessary to interrupt treatment with bisoprolol before surgery, the drug should be discontinued at least 48 hours before surgery.

Pheochromocytoma

In patients with pheochromocytoma, bisoprolol can only be prescribed while using alpha-blockers.

Thyrotoxicosis

With hyperthyroidism, beta-blockers (including bisoprolol) can mask tachycardia and reduce the severity of symptoms of thyrotoxicosis. Abrupt withdrawal of the drug can cause exacerbation of symptoms of the disease and the development of thyrotoxic crisis.

Hypersensitivity reactions

Beta blockers, including bisoprolol, may increase sensitivity to allergens and the severity of anaphylactic/hypersensitivity reactions due to decreased adrenergic compensatory regulation by beta blockers. The use of usual therapeutic doses of epinephrine (adrenaline) while taking beta-blockers does not always lead to achieving the desired clinical effect. Caution should be exercised when prescribing bisoprolol to patients with a history of severe hypersensitivity reactions or undergoing desensitization.

Psoriasis

When deciding on the use of bisoprolol in patients with psoriasis, the expected benefits of the drug should be carefully weighed against the possible risk of exacerbation of psoriasis.

Contact lenses

Patients who use contact lenses should take into account that the use of beta-blockers may reduce the production of tear fluid.

Bisogamma, 30 pcs., 5 mg, film-coated tablets

Monitoring of patients taking bisoprolol should include measurement of heart rate and blood pressure (at the beginning of treatment - daily, then - once every 3-4 months), an ECG, determination of blood glucose levels in patients with diabetes mellitus (once every 4-5 months). months). In elderly patients, it is recommended to monitor renal function (once every 4–5 months).

The patient should be taught how to calculate heart rate and instructed about the need for medical consultation if heart rate is <50 beats/min.

Before starting treatment, it is recommended to conduct a study of external respiratory function in patients with a burdened bronchopulmonary history.

In approximately 20% of patients with angina, beta blockers are ineffective. The main causes are severe coronary atherosclerosis with a low ischemic threshold (heart rate <100 beats/min) and increased left ventricular end-diastolic volume, impairing subendocardial blood flow.

Beta blockers are less effective in smokers.

Patients using contact lenses should take into account that during treatment the production of tear fluid may decrease.

When used in patients with pheochromocytoma, there is a risk of developing paradoxical arterial hypertension (if effective alpha-blockade is not previously achieved).

In case of thyrotoxicosis, bisoprolol can mask certain clinical signs of thyrotoxicosis (for example, tachycardia). Abrupt withdrawal in patients with thyrotoxicosis is contraindicated because it can increase symptoms.

In diabetes mellitus, it can mask tachycardia caused by hypoglycemia. Unlike non-selective beta-blockers, it practically does not enhance insulin-induced hypoglycemia and does not delay the restoration of blood glucose concentrations to normal levels.

When taking clonidine concomitantly, it can be discontinued only a few days after bisoprolol is discontinued.

It is possible that the severity of the hypersensitivity reaction may increase and there will be no effect from usual doses of epinephrine against the background of a burdened allergic history.

If planned surgical treatment is necessary, the drug should be discontinued 48 hours before the start of general anesthesia. If the patient took the drug before surgery, he should select a drug for general anesthesia with minimal negative inotropic effect.

Reciprocal activation of the vagus nerve can be eliminated by intravenous atropine (1–2 mg).

Drugs that reduce catecholamine reserves (including reserpine) can enhance the effect of beta-blockers, so patients taking such combinations of drugs should be under constant medical supervision to detect a pronounced decrease in blood pressure or bradycardia.

Patients with bronchospastic diseases can be prescribed cardioselective adrenergic blockers in case of intolerance and/or ineffectiveness of other antihypertensive drugs. An overdose is dangerous due to the development of bronchospasm.

If increasing bradycardia (<50 beats/min), a pronounced decrease in blood pressure (sBP <100 mm Hg), or AV blockade is detected in elderly patients, it is necessary to reduce the dose or stop treatment.

It is recommended to discontinue therapy if depression develops.

Treatment should not be abruptly interrupted due to the risk of developing severe arrhythmias and myocardial infarction. Cancellation is carried out gradually, reducing the dose over 2 weeks or more (by 25% in 3-4 days). It should be discontinued before testing the content of catecholamines, normetanephrine and vanillylmandelic acid in the blood and urine, and titers of antinuclear antibodies.

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Instructions for use GABAGAMMA

Skin rash combined with eosinophilia and systemic symptoms (DRESS syndrome)

Severe, life-threatening systemic hypersensitivity reactions, such as DRESS syndrome (skin rash combined with eosinophilia, fever and systemic symptoms), have been reported with the use of anticonvulsants, including gabapentin.

Early manifestations of hypersensitivity reactions, such as fever or lymphadenopathy, may develop when the rash is not yet apparent. If the above symptoms appear, the patient should be immediately examined by a doctor. If other causes of DRESS syndrome cannot be identified, gabapentin should be discontinued.

Anaphylaxis

The use of gabapentin may lead to the development of anaphylaxis. Signs and symptoms of reported cases have included difficulty breathing, swelling of the lips, throat and tongue, and hypotension, requiring emergency treatment. Patients should stop taking gabapentin and seek immediate medical attention if they experience signs or symptoms of anaphylaxis.

Suicidal thoughts and behavior

Depression and mood changes have been observed in patients treated with antiepileptic drugs. A meta-analysis of randomized placebo-controlled clinical trials of antiepileptic drugs found a nonsignificant increase in the risk of suicidal ideation and behavior. The mechanism for this increase is unknown, and available information does not exclude the possibility of an increased risk of suicide when taking antiepileptic drugs.

Patients should be closely monitored for signs of depression, suicidal thoughts or behavior. If signs of depression and/or suicidal thoughts or behavior occur, patients should be advised to seek immediate medical attention from a physician.

Acute pancreatitis

If acute pancreatitis develops during the use of gabapentin, discontinuation of gabapentin is indicated.

Epilepsy

Although there is no evidence of seizure resumption with gabapentin use, abrupt discontinuation of anticonvulsants in patients with epilepsy may precipitate the development of status epilepticus.

As with other antiepileptic drugs, some patients may experience an increase in the frequency of seizures or new types of seizures while using gabapentin.

As with other antiepileptic drugs, attempts to discontinue concomitant antiepileptic drugs to switch to gabapentin monotherapy in patients receiving multiple antiepileptic drugs are rarely successful.

Gabapentin is not considered effective for the treatment of primary generalized seizures, such as absence seizures, and may increase the intensity of such seizures in some patients. For this reason, gabapentin should be used with caution in patients with mixed seizures, including absence seizures.

Concomitant use with opioids

Patients who require concomitant treatment with opioids should be closely monitored for signs of CNS depression, such as somnolence, sedation, and respiratory depression. Patients using gabapentin and morphine concomitantly may experience increased gabapentin concentrations. The dose of gabapentin or opioids should be reduced appropriately.

Respiratory depression

The use of gabapentin is associated with the development of severe respiratory depression. Patients with impaired respiratory function, respiratory or neurological diseases, renal failure, concomitant use of CNS depressants, or elderly patients may be at higher risk of developing this severe adverse reaction. It may be necessary to adjust the dose of the drug in this category of patients.

Elderly patients ( over 65 years old)

There have been no systematic studies of the use of gabapentin in patients aged 65 years or older. In one double-blind study of patients with neuropathic pain, patients over 65 years of age were more likely than younger patients to develop drowsiness, peripheral edema, and weakness. Apart from these data, clinical studies in this age group have found no evidence of a different adverse event profile from that in a younger patient population.

Use in pediatrics

The effects of long-term (more than 36 weeks) use of gabapentin on learning, intelligence, and development in children and adolescents have not been adequately studied. In this regard, when deciding on the need for long-term therapy, possible risks should be taken into account.

Abuse and addiction

Cases of abuse and dependence have been reported in post-marketing studies. Patients with a history of substance abuse should be carefully assessed and monitored for signs of potential gabapentin abuse, such as dose escalation, development of tolerance.

Laboratory tests

Semi-quantitative urine protein dipstick tests may result in false positives. Therefore, if necessary, it is recommended to carry out additional analyzes using other methods (biuret method, turbidimetric method, dye tests).

Patients with rare hereditary diseases, such as lactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption, should not take the drug.

Impact on the ability to drive vehicles and operate machinery

Gabapentin may affect your ability to drive and use mechanical equipment. Gabapentin affects the central nervous system and may cause drowsiness, dizziness, or other symptoms. Thus, gabapentin, even when used as directed, may reduce reaction time and impair the ability to drive vehicles or work in hazardous work. This is especially true at the beginning of treatment and after increasing the dose of the drug, as well as while taking alcohol.

Bisogamma®

Monitoring of patients taking the drug Bisogamma® includes measuring heart rate and blood pressure (at the beginning of treatment - daily, then once every 3-4 months), conducting an ECG, determining blood glucose levels with concomitant diabetes mellitus (once every 4-5 months). months). In elderly patients, it is recommended to monitor renal function (once every 4-5 months). The patient should be taught how to calculate heart rate and instructed about the need for medical consultation if the heart rate is less than 50 beats/min.

Before starting treatment, it is recommended to conduct a study of external respiratory function in patients with a burdened bronchopulmonary history.

In approximately 20% of patients with angina, beta blockers are ineffective. The main causes are severe coronary atherosclerosis with a low ischemic threshold (heart rate less than 100 beats/min) and increased end-diastolic volume of the left ventricle, which impairs subendocardial blood flow.

When using the drug in patients with pheochromocytoma, there is a risk of developing paradoxical arterial hypertension (if effective blockade of α-adrenergic receptors is not previously achieved).

In case of thyrotoxicosis, bisoprolol can mask certain clinical symptoms of thyrotoxicosis (for example, tachycardia). Abrupt withdrawal of Bisogamma® in patients with thyrotoxicosis is contraindicated, as it can increase symptoms.

In diabetes mellitus, Bisogamma® can mask tachycardia caused by hypoglycemia. Unlike non-selective beta-blockers, it practically does not enhance insulin-induced hypoglycemia and does not delay the restoration of blood glucose concentrations to normal levels.

It is possible that the severity of the hypersensitivity reaction may increase and there will be no effect from usual doses of epinephrine against the background of a burdened allergic history.

If planned surgical treatment is necessary, Bisogamma® should be discontinued 48 hours before the start of general anesthesia. If the patient took the drug before surgery, he should select a drug for general anesthesia with minimal negative inotropic effects.

Reciprocal activation of the vagus nerve can be eliminated by intravenous atropine (1-2 mg).

Medicines that reduce the reserves of catecholamines (including reserpine) can enhance the effect of beta-blockers, so patients taking such combinations of drugs should be under constant medical supervision for timely monitoring of a pronounced decrease in blood pressure or bradycardia.

If increasing bradycardia (less than 50 beats/min), a pronounced decrease in blood pressure (systolic blood pressure below 100 mm Hg), or AV blockade is detected in elderly patients, it is necessary to reduce the dose or stop treatment.

It is recommended to discontinue therapy if depression develops.

Treatment should not be abruptly interrupted due to the risk of developing severe arrhythmia and myocardial infarction. Cancellation is carried out gradually, reducing the dose over 2 weeks or more (reduce the dose by 25% in 3-4 days).

When used in combination with clonidine, its use can be discontinued only a few days after bisoprolol is discontinued.

In smoking patients, the effectiveness of beta-blockers is lower.

Patients who use contact lenses should take into account that during treatment with Bisogamma there may be a decrease in the production of tear fluid.

The drug should be discontinued before testing the content of catecholamines, normetanephrine and vanillinmandelic acid in the blood and urine, and titers of antinuclear antibodies.

Impact on the ability to drive vehicles and operate machinery

During the treatment period, patients should be careful when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Monitoring of patients receiving treatment with the drug should include monitoring heart rate and blood pressure (at the beginning of treatment - daily, then once every 3-4 months), ECG, blood glucose levels in patients with diabetes (once every 4-5 months) . In elderly patients, it is recommended to monitor renal function (once every 4-5 months).

The patient should be taught how to calculate heart rate and instructed about the need for medical consultation if the heart rate is less than 50/min.

Before starting treatment, it is recommended to conduct a study of external respiratory function in patients with a burdened bronchopulmonary history.

In approximately 20% of patients with angina, beta blockers are ineffective. The main causes are severe coronary atherosclerosis with a low ischemic threshold (heart rate less than 100/min) and increased LV EDV, which impairs subendocardial blood flow. In smokers, the effectiveness of beta-blockers is lower.

Patients using contact lenses should take into account that during treatment the production of tear fluid may decrease.

When used in patients with pheochromocytoma, there is a risk of developing paradoxical arterial hypertension (if effective alpha-blockade is not previously achieved).

In case of thyrotoxicosis, the active substance of the drug can mask certain clinical signs of thyrotoxicosis (for example, tachycardia). Abrupt withdrawal in patients with thyrotoxicosis is contraindicated because it can increase symptoms.

When taking clonidine concomitantly, it can be discontinued only a few days after discontinuation of the drug.

It is possible that the severity of the hypersensitivity reaction may increase and the absence of effect from usual doses of epinephrine against the background of a burdened allergic history.

Reciprocal activation of the n.vagus can be eliminated by intravenous administration of atropine (1-2 mg).

Drugs that reduce catecholamine reserves (for example, reserpine) can enhance the effect of beta-blockers, so patients taking such combinations of drugs should be under constant medical supervision to detect arterial hypotension or bradycardia.

Patients with bronchospastic diseases can be prescribed cardioselective adrenergic blockers in case of intolerance and/or ineffectiveness of other antihypertensive drugs, but the dosage should be strictly monitored. An overdose is dangerous due to the development of bronchospasm.

If elderly patients develop increasing bradycardia (less than 50/min), arterial hypotension (systolic blood pressure below 100 mm Hg), AV block, bronchospasm, ventricular arrhythmias, severe liver and kidney dysfunction, it is necessary to reduce the dose or stop treatment . It is recommended to discontinue therapy if depression caused by taking beta-blockers develops.

Use during pregnancy and lactation is possible if the benefit to the mother outweighs the risk of side effects in the fetus and child.

Should be discontinued before testing the content of catecholamines, normetanephrine and vanillylmandelic acid in the blood and urine; antinuclear antibody titers.

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.