Bisangil

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Dosage and Administration

Adverse reactions

The frequency of adverse reactions listed below was determined accordingly to the following (classification of the World Health Organization): very often - at least 10%; often - not less than 1%, but less than 10%; infrequently - not less than 0.1%), but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely - less than 0.01%>, including individual messages.

On the part of the heart and blood vessels: very often - a decrease in heart rate (bradycardia, especially in patients with chronic heart failure); feeling of heartbeat, often - pronounced decrease in blood pressure (especially in patients with chronic heart failure), manifestation of angiospasm (increased disturbance of peripheral circulation, feeling cold in limbs (paresthesia); rarely - impaired AV conduction (up to the development of complete transverse blockade and cardiac arrest) , arrhythmias, orthostatic hypotension, aggravation of chronic heart failure with the development of peripheral edema (swelling of the ankles, feet; shortness of breath), chest pain.

From the nervous system: often - dizziness, headache, asthenia, fatigue, sleep disturbances, depression, anxiety; rarely - confusion or short-term memory loss, nightmares, hallucinations, myasthenia gravis, tremor, muscle cramps. Usually these phenomena are mild in nature and usually disappear within 1-2 weeks after the start of treatment.

On the part of the senses: rarely - impaired vision, reduced tearing (should be considered when wearing contact lenses), tinnitus, hearing loss, earache; very rarely - dryness and soreness of the eyes, conjunctivitis, taste disturbances.

On the part of the respiratory system: infrequently - bronchospasm in patients with bronchial asthma or obstructive respiratory diseases; rarely - allergic rhinitis; nasal congestion.

On the side of the digestive system: often - nausea, vomiting, diarrhea, constipation, dryness of the oral mucosa, abdominal pain; rarely - hepatitis, increased activity of liver enzymes (ALT, AST), increased concentration of bilirubin, changes in taste.

On the part of the musculoskeletal system: infrequently - arthralgia, back pain.

From the genitourinary system: very rarely - a violation of potency, the weakening of the libido.

Laboratory indicators: rarely - an increase in the concentration of triglycerides in the blood; in some cases - thrombocytopenia, agranulocytosis, leukopenia.

Allergic reactions: rarely - pruritus, rash, urticaria.

On the part of the skin: rarely - increased sweating, skin flushing, rash, psoriasis-like skin reactions; very rarely - alopecia, beta-blockers can aggravate the course of psoriasis.

Other: withdrawal syndrome (increased rate of angina attacks, increased blood pressure).

Hydrochlorothiazide

Water-electrolyte imbalance: hypokalemia, hypomagnesemia, hypercalcemia and hypochloremic alkalosis: dryness of the oral mucosa, thirst, irregular heart rhythm, changes in mood or psyche, cramps and muscle pain, nausea, vomiting, unusual tiredness or weakness.Hypochloremic alkalosis can cause hepatic encephalopathy or hepatic coma. Hyponatremia: confusion, convulsions, lethargy, slow thinking, fatigue, irritability, muscle cramps.

Metabolic disorders: hyperglycemia, glycosuria, hyperuricemia with the development of a gout attack.

Treatment with thiazides may impair glucose tolerance, and latent diabetes mellitus can manifest. At use of high doses concentration of lipids in blood serum can increase.

On the part of the digestive system: cholecystitis or pancreatitis, cholestatic jaundice, diarrhea, sialadenitis, constipation, anorexia.

From the side of the heart and vessels: arrhythmias, orthostatic hypotension, vasculitis.

From the nervous system: dizziness, temporarily blurred vision, headache, paresthesia.

From the side of blood-forming organs: very rarely - leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia.

Allergic reactions: urticaria, purpura, necrotizing vasculitis, Stevens-Johnson syndrome, respiratory distress syndrome (including pneumonitis and non-cardiogenic pulmonary edema), photosensitivity, anaphylactic reactions up to shock.

Other: reduced potency, impaired renal function, interstitial nephritis.

Contraindications

- hypersensitivity to bisoprolol and other components of the drug;

- hypersensitivity to hydrochlorothiazide and other sulfonamide derivatives;

- severe forms of bronchial asthma and chronic obstructive pulmonary disease;

- acute heart failure or chronic heart failure in the stage of decompensation, requiring inotropic therapy;

- cardiogenic shock;

- sick sinus syndrome (including sinoatrial blockade);

- AV blockade of II and III degree without artificial pacemaker;

- severe bradycardia (heart rate less than 50 beats / min.);

- pheochromocytoma (without the simultaneous use of alpha-blockers);

- difficult to control diabetes;

- late stages of impaired peripheral circulation (including Raynaud's syndrome);

- severe hypotension (systolic blood pressure less than 100 mm Hg);

- refractory hypokalemia, hyponatremia, hypercalcemia;

- metabolic acidosis;

- acute renal failure;

- chronic renal failure (creatinine clearance (CC) less than 30 ml / min.), Anuria;

- severe liver dysfunction (including coma and precoma);

- simultaneous use with flaktafenin, sultoprid;

- simultaneous administration of monoamine oxidase inhibitors (MAO) with the exception of MAO inhibitors of type B);

- age up to 18 years (efficacy and safety have not been established);

- lactose intolerance, lactase deficiency or glucose-galactose malabsorption;

- pregnancy;

- lactation period.

Caution should be used for heart failure, AV block I degree, Prinzmetal angina pectoris, peripheral circulatory disorders, coronary heart disease, liver failure, renal failure (CC more than 30 ml / min); hyperthyroidism, pheochromocytoma (with treatment with alpha-blockers), water and electrolyte disturbances (hyponatremia, hypokalemia, hypercalcemia); depression (including history), myasthenia, gout, psoriasis, as well as in elderly patients, hyperuricemia, diabetes mellitus with significant fluctuations in glucose concentration in the blood, a strict diet, hypovolemia, asthma, bronchospasm (in history), conducting desensitization therapy.

Drug interactions

Combinations, the use of which is contraindicated

In case of shock or arterial hypotension caused by taking floctafenin, beta-blockers cause a decrease in compensatory cardiovascular reactions.

Bisoprolol should not be used concurrently with sultoprid, since there is a high risk of ventricular arrhythmias, including like "pirouette".

MAO type A inhibitors should not be taken concurrently with bisoprolol, since there is a danger of developing a hypertensive crisis.

Not recommended combinations

Class I antiarrhythmic drugs (for example, quinidine, disopyramide, lidocaine, phenytoin; flecainide, propafenone), while being used with bisoprolol, can reduce AV conductivity and cardiac contractility. Slow calcium channel blockers (BCCA) of verapamil type and, to a lesser extent, diltiazem, when used simultaneously with bisoprolol, can lead to a decrease in myocardial contractility and impairment of AV conduction. In particular, in / in the introduction of verapamil patients taking beta-blockers, can lead to severe arterial hypotension and AV blockade. Centrally acting antihypertensive drugs (such as clonidine, methyldopa, moxonidine, rilmenidine) can lead to a decrease in heart rate and a decrease in cardiac output, as well as to vasodilation due to a decrease in central sympathetic tone. Abrupt cancellation of antihypertensive drugs of central action, especially before the abolition of beta-blockers may increase the risk of ricochet hypertension.

Combinations that require caution

Class III antiarrhythmic drugs (eg, amiodarone) may exacerbate the violation of AV conduction.

The action of beta-blockers for local use (for example, eye drops for the treatment of glaucoma) may enhance the systemic effects of bisoprolol (lower blood pressure, decrease in heart rate).

Parasympathomimetics with simultaneous use with bisoprolol may increase the violation of AV conduction and increase the risk of developing bradycardia. The simultaneous use of the drug Bisangil with beta-adrenomimetics (for example, isoprenaline, dobutamine) can lead to a decrease in the effect of both drugs. The combination of bisoprolol with adrenomimetic agents that affect beta and alpha adrenoreceptors (for example, norepinephrine, epinephrine) may increase

vasoconstrictor effects of these agents, which occur with the participation of alpha-adrenergic receptors, leading to an increase in blood pressure. Such interactions are more likely when using non-selective beta-blockers.

Mefloquine with simultaneous use with bisoprolol may increase the risk of developing bradycardia.

Allergens used for immunotherapy or allergen extracts for skin tests increase the risk of severe systemic allergic reactions or anaphylaxis in patients receiving bisoprolol.

Iodine radiopaque diagnostic agents for IV administration increase the risk of anaphylactic reactions.

Phenytoin with the on / in the introduction, means for inhalation anesthesia (derivatives of hydrocarbons) increase the severity of cardiodepressive action and the likelihood of lowering blood pressure.

The effectiveness of insulin and hypoglycemic agents for oral administration may vary with treatment with bisoprolol (masks the symptoms of developing hypoglycemia: tachycardia, increased blood pressure).

Clearance of lidocaine and xanthines (except for theophylline) may decrease due to a possible increase in their plasma concentration, especially in patients with initially elevated clearance of theophylline under the influence of smoking. The antihypertensive effect is weakened by non-steroidal anti-inflammatory drugs (NSAIDs) (sodium ion retention and prostaglandin synthesis blockade by the kidneys), corticosteroids and estrogens (sodium ion retention).

Cardiac glycosides, methyldopa, reserpine and guanfacine, slow calcium channel blockers (verapamil, diltiazem), amiodarone and other antiarrhythmic drugs increase the risk of developing or worsening bradycardia, AV blockade, cardiac arrest and heart failure.

Antiarrhythmic drugs that can cause pirouette tachycardia (class IA, for example, quinidine, hydrohidin, disopyramide, and class III, for example, amiodarone, dofetilide, ibutilide) and sotalol: hypokalemia can provoke the occurrence of pirouette tachycardia.

Other arrhythmic drugs that can cause tachycardia of the type "pirouette" (for example, astemizol, erythromycin for IV injection, halofantrine, pentamidine, sparfloxacin, terfenadine, vincammine): hypopotassemia can provoke the development of tachycardia of the type "pirouette".

Nifedipine may cause a significant decrease in blood pressure.

Diuretics, clonidine, sympatholytics, hydralazine and other antihypertensive drugs can lead to an excessive decrease in blood pressure.

The action of non-depolarizing muscle relaxants and the anticoagulant effect of coumarins during bisoprolol treatment may be prolonged.

Tricyclic and tetracyclic antidepressants, antipsychotics (neuroleptics), ethanol, sedatives and hypnotics increase CNS depression.

Not recommended simultaneous use with MAO inhibitors due to a significant increase in antihypertensive action. A break in treatment between taking MAO inhibitors and bisoprolol should be at least 14 days. Unhydrogenated ergot alkaloids increase the risk of developing peripheral circulatory disorders.

Ergotamine increases the risk of developing impaired peripheral circulation. Sulfasalazine increases the concentration of bisoprolol in the blood plasma. Rifampicin shortens the half-life of bisoprolol. Hydrochlorothiazide

With thiazide diuretics, drugs such as ethanol, barbiturates and narcotics can potentiate the risk of orthostatic hypotension.

Hypoglycemic agents (for oral administration and insulin) - may require dose adjustment of hypoglycemic agents.

Other antihypertensives - additive effect.

Kolestiramin and colestipol - in the presence of anion-exchange resins the absorption of hydrochlorothiazide is broken. Kolestiramin and colestipol bind hydrochlorothiazide in a single dose and reduce its absorption in the gastrointestinal tract by 85% and 43%, respectively.

Corticosteroids, ACTH (adrenocorticotropic hormone) or glycyrrhizic acid (found in licorice root) - a pronounced decrease in the content of electrolytes, in particular, the risk of hypokalemia.

Pressor amines (for example, epinephrine, norepinephrine) - reducing the severity of the response to the reception of pressor amines.

Muscle relaxants of non-depolarizing type of action (for example, tubocurarine) - increased effect of muscle relaxants.

Lithium - diuretics reduce renal clearance of lithium and increase the risk of developing the toxic effect of lithium; simultaneous use is not recommended.

Nonsteroidal anti-inflammatory drugs (NSAIDs) (including COX-2 inhibitors) - can reduce the diuretic, natriuretic, and antihypertensive effects of diuretics.

In some patients with impaired renal function (for example, elderly patients or patients with dehydration, including receiving diuretics), receiving NSAID therapy, including COX-2 inhibitors, treatment with angiotensin II receptor antagonists or ACE inhibitors may cause further deterioration in kidney function, including development of acute renal failure. These effects are reversible. The simultaneous use of these drugs should be carried out with caution in patients with impaired renal function.

Due to the effect on calcium metabolism, their intake may distort the results of the study of the function of the parathyroid glands.

He should stop abruptly therapy, especially in patients with coronary artery disease. The dose should be reduced gradually over a period of two weeks. If necessary, you should simultaneously begin the appropriate antianginal therapy.

Particular attention is required in cases of surgery under general anesthesia in patients taking beta-blockers. Such patients should discontinue the drug Bisangil 48 hours before the surgery, warn the anesthesiologist surgeon that the patient is taking the drug Bisangil. As a means for general anesthesia, a drug with minimal negative inotropic effect should be chosen.

During therapy with beta-blockers, exacerbation of the course of psoriasis is possible. Patients with this disease should be prescribed Bisangil with caution. With indications of anaphylactic reactions in history, regardless of the cause of their occurrence, especially during desensitization therapy, treatment with Bisangil (due to the presence of bisoprolol in it) may increase the risk of allergic reactions and contribute to the development of resistance to treatment with epinephrine (adrenaline) in usual doses. .

Patients using contact lenses should be careful when using the drug Bisangil, since beta-blockers can reduce the production of tear fluid.

In patients with hyperuricemia, the risk of developing an exacerbation of gout is increased. In this case, the dose of the drug Bisangil should be selected individually under the control of the concentration of uric acid in the serum. Before examining the function of the parathyroid glands, treatment with Bisangil must be discontinued, since transient hypercalcemia may occur against the background of its administration.

Athletes should be informed that the drug Bisangil contains bisoprolol, which can give false positive results during doping control.

Influence on ability to drive motor transport and control mechanisms

Bisangil should be used with caution when driving vehicles and machinery in connection with the possibility of dizziness.

Pregnancy and Lactation

Special instructions

Overdosage

• Brand name: Bisangil
• Active ingredient: Bisoprolol, hydrochlorothiazide
• Dosage form: Pills.
• Manufacturer: Ozone
• Country of Origin: Russia