bisoprolol, bisoprolol Hydrohlorotyazyd | Lodoz tablets are coated. 2.5 mg + 6.25 mg 30 pcs.

Special Price $20.37 Regular Price $29.00
In stock
SKU
BID464607
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Release form

film-coated tablets.
Release form

film-coated tablets.

Packing

30 pcs.

Pharmacological action

Lodosis is a combined antihypertensive drug.

Bisoprolol is a highly selective beta1-blocker without sympathomimetic and membrane-stabilizing activity. The mechanism of action of bisoprolol in hypertension is associated primarily with a decrease in plasma renin level and a decrease in heart rate.

Hydrochlorothiazide is a thiazide diuretic with an antihypertensive effect. Its diuretic effect is due to the inhibition of the transport of sodium ions from the renal tubules into the blood, thereby preventing its reabsorption.

In clinical studies, potentiation of the effects of the active substances of this combination was observed. The effectiveness for the treatment of mild to moderate degrees of arterial hypertension was noted even when used in the lowest doses - 2.5 mg + 6.25 mg.

Side effects, such as hypokalemia (when using hydrochlorothiazide) and bradycardia, asthenia, and headache (when using bisoprolol), are dose-dependent. Therefore, to reduce undesirable effects, the amount of each active ingredient in Lodosa is reduced by 2-4 times.

Contraindications

- Severe forms of bronchial asthma, COPD.

- Chronic heart failure in the decompensation stage, not amenable to drug therapy.

- Cardiogenic shock.

- SSSU, incl. sinoatrial blockade.

- AV block II and III degree without artificial pacemaker.

- Severe bradycardia (heart rate - Variant angina (Prinzmetal angina).

- Pheochromocytoma (without the simultaneous use of alpha-blockers).

- Severe forms of peripheral circulation (including Raynaud's disease).

-. Hypokalemia.

- Hypovolemia.

- Severe renal impairment (creatinine clearance - Severe hepatic impairment.

- Concomitant use with flactaphenin, sultopride, antiarrhythmics, lithium preparations

- Children and adolescents under 18 years of age (efficacy and safety have not been established).

- Hypersensitivity to bisoprolol and other components of the drug.

- Hypersensitivity to hydrochlorothiazide and other sulfonamides.

Caution should be used in I-degree AV block, psoriasis, coronary heart disease, chronic heart failure in the decompensation stage, thyrotoxicosis, water-electrolyte disturbances (hyponatremia, hypokalemia, hypercalcemia), gout, as well as in elderly patients.

Use during pregnancy and lactation

It is not recommended to use Lodoz during pregnancy, since it contains a diuretic from the thiazide group.

It is currently unknown whether bisoprolol is excreted in breast milk. Diuretics from the thiazide group are excreted in breast milk. Breastfeeding during treatment with Lodoz is contraindicated.

Special instructions

Do not suddenly stop treatment, especially in patients with coronary artery disease. The dose is recommended to be reduced gradually over 2 weeks. If necessary, the appropriate therapy should be started at the same time to prevent angina attacks.

If it is necessary to administer the drug to patients with bronchial asthma or COPD, start treatment with a minimum initial dose. Functional breathing tests are recommended before starting therapy. If bronchospasm develops during therapy, beta-adrenergic agonists should be prescribed.

In patients with chronic heart failure, the drug should be prescribed with caution and under the supervision of a physician, in minimal doses.

It is necessary to reduce the dose of the drug for heart rate at rest. Given the negative dromotropic effect of beta-blockers, they should be prescribed with caution to patients with degree I AV block.

In patients with peripheral circulatory disorders (Raynaud’s disease), beta-blockers can exacerbate the course of the disease.

Patients with pheochromocytoma should not be prescribed Lodose until treatment with alpha-blockers. Need blood pressure control.

In elderly patients, treatment should begin with a low dose of the drug, careful monitoring of the patient's condition is necessary.

Patients taking Lodosis should be warned of the possibility of hypoglycemia and the need for regular monitoring of blood glucose levels. Bisoprolol may mask the symptoms of hypoglycemia (tachycardia, palpitations, and increased sweating).

During therapy with beta-blockers, an exacerbation of psoriasis is possible. Bisoprolol should be prescribed only if necessary.

If there is a history of anaphylactic reactions, regardless of the cause of their occurrence, especially when taking flactaphenin, or when carrying out desensitizing therapy, treatment with beta-blockers can exacerbate the occurrence of these reactions and cause the development of resistance to treatment with epinephrine (adrenaline) in normal doses.

Athletes should be informed that Lodoz contains an active substance that can give positive results when conducting doping tests.

Precautions associated with the use of hydrochlorothiazide: Before starting further regularly during therapy and monitoring the level of sodium in the blood is necessary. A decrease in sodium levels at the beginning of treatment may be asymptomatic, so regular monitoring is necessary. Particular attention is required in the presence of risk factors, for example, patients of senile age, patients with cirrhosis.

Control of potassium in the blood is necessary in patients at high risk, for example, in elderly patients, in patients receiving thiazide and thiazide-like diuretics, as well as in patients with cirrhosis, accompanied by edema, ascites, in patients with coronary artery disease or heart failure, increased QT interval.

Hypokalemia increases the risk of arrhythmias, toxicity of cardiac glycosides. The first determination of the level of potassium in the blood must be carried out during the first week of therapy with Lodoz.

Thiazide diuretics can reduce urinary calcium excretion, resulting in minor and temporary hypercalcemia. Temporary hypercalcemia may be associated with undiagnosed hyperparathyroidism. Before researching the function of the parathyroid glands, thiazide treatment must be discontinued.

Blood glucose control is required in patients with diabetes mellitus, especially in the case of hypokalemia.

In patients with hyperuricemia, the risk of developing gout attacks is increased: the dose of the drug must be selected individually.

Thiazide diuretics are effective for normal renal function or slightly reduced renal function (CC 220 μmol / L). In elderly patients, the serum creatinine content can be calculated taking into account the patient’s age, body weight and gender using the Cockroft formula: For men: QC (ml / min) = [140-age] x body weight (kg) / 72 x serum creatinine (mg / dl)

For women: obtained value x 0.85

Hypovolemia (loss of fluid and sodium) resulting from the use of diuretics at the beginning of therapy leads to a decrease in glomerular filtration, which leads to an increase in blood urea and creatinine in patients with normal function the kidneys.

Temporary impaired renal function occurs without consequences in patients with normal renal function. In patients with impaired renal function, an increase in existing disorders is possible.

In case of prescribing the drug with another antihypertensive agent, a dose reduction at the beginning of treatment is recommended.

Use in pediatrics: The efficacy and safety of the drug in children and adolescents under the age of 18 have not been established, therefore the use of the drug is contraindicated.

Influence on the ability to drive vehicles and control mechanisms: use with caution when driving and working with mechanisms due to the possibility of dizziness.

Composition

Yellow-coated film-coated tablets are round, biconvex, engraved in the shape of a heart on one side and numbers 2.5 on the other.

1 tab. bisoprolol hemifumarate (bisoprolol fumarate (2: 1)) 2.5 mg hydrochlorothiazide 6.25 mg

Excipients: magnesium stearate - 1.0 mg, crospovidone - 3.0 mg, corn starch - 6.75 mg, corn starch, pregelatinized - 6.75 mg, microcrystalline cellulose - 37.5 mg, calcium phosphate monosubstituted - 75.0 mg.

Shell composition: Polysorbate 80 VS - 0.035 mg, yellow iron oxide - 0.089 mg, macrogol 400 - 0.280 mg, titanium dioxide - 0.891 mg, hypromellose 2910/3 - 1.1025 mg, hypromellose 2910/6 - 1.1025 mg.

Dosage and administration of

Lodosis is recommended to be taken in the morning (during meals). Tablets should be swallowed whole with a small amount of liquid and not chewed.

The initial dose corresponds to 1 tablet (2.5 mg bisoprolol / 6. 25 mg of hydrochlorothiazide) 1 time / In case of insufficient treatment effectiveness, increase the dose to 1 tablet (5 mg of bisoprolol / 6.25 mg of hydrochlorothiazide) 1 time / If necessary, the dose can be increased to 1 tablet (10 mg of bisoprolol / 6.25 mg of hydrochlorothiazide) 1 time /

In patients with impaired liver function or moderate impaired renal function (CC> 30 ml / min), a dose change is not required.

Side effects of the

From the central nervous system: sleep disturbances, depression are possible - fatigue, fatigue, dizziness, headache (can occur at the beginning of treatment and usually disappear during the first or second week of treatment).

From the cardiovascular system: bradycardia, impaired AV conduction, exacerbation of the course of chronic heart failure, orthostatic hypotension.

From the respiratory system: bronchospasm in patients with asthma or COPD in history.

From the digestive system: nausea, vomiting, diarrhea, constipation, hepatitis, jaundice, increased activity of AST and ALT.

From the urinary system: reversible increase in serum creatinine and urea.

From the musculoskeletal system: a feeling of cold and numbness of the extremities, muscle weakness, cramps.

On the part of the sensory organs: hearing impairment, decreased production of the lacrimal glands (it is necessary to consider patients using contact lenses), visual impairment.

From the side of metabolism: hypertriglyceridemia, hypercholesterolemia, hyperglycemia, glucosuria, hyperuricemia, disturbance of the water-electrolyte state, metabolic alkalosis.

From the hemopoietic system: leukopenia, thrombocytopenia.

Dermatological reactions: beta-blockers can cause or exacerbate the course of psoriasis or cause psoriasis-like rashes, alopecia.

Other: impotence, allergic rhinitis.

The drug is usually well tolerated. Side effects are described in less than 10% of cases.

Drug Interactions

The drug is contraindicated for use in combination with flactafenin, sultopride.

The drug is not recommended for use in combination with amiodarone, lithium, or with agents that can initiate arrhythmias (astemizole, bepridil, erythromycin, halofantrine, pentamidine, sparfloxacin, terfenadine, vincamycin).

Caution is required when using the drug with baclofen, inhaled halogenated general anesthetics, slow calcium channel blockers (bepridil, diltiazem, verapamil), antiarrhythmic drugs (propafenone, quinidine, hydroquinidine, disopyramide), insulin, urea preparations, lidocaine, iodine-containing contrast agents, anti-cholinesterase drugs, high doses of amyocalcimesal iv) and mineralocorticoids (systemic use), tetracosactide, laxatives, cardiac glycosides, diuretics, causing hyperkalemia (amiloride, canrenone, spironolactone, triamterene) ACE inhibitors, metformin.

It is possible to enhance the hypotensive effect with the simultaneous use of tricyclic antidepressants (including imipramine), antipsychotics, dihydropyridine derivatives of slow calcium channels (including amlopidine, felopidine, lacidipine, nifedipine, nicardipine, nimodipine, nitrendipine).

The use of Lodose simultaneously with tricyclic antidepressants, including MAO inhibitors, as well as antipsychotics, is not a contraindication. At the same time, their combined use should be taken into account, since it may be necessary to reduce the dose of the antihypertensive agent due to the additive antihypertensive effect.

When co-administered with mefloquine, bradycardia may develop.

When co-administered with calcium preparations, hypercalcemia may develop.

When combined with cyclosporine, an increase in serum creatinine is possible.

It is possible to weaken the hypotensive effect of Lodosa with simultaneous administration with GCS (for systemic use), NSAIDs and tetracosactide.

Overdose

Symptoms: excessive decrease in blood pressure, bradycardia. Newborns from mothers receiving beta-blockers may develop an overdose manifested by cardiac decompensation.

Treatment: in the case of severe bradycardia or excessive decrease in blood pressure, the following drugs are administered: atropine at a dose of 1-2 mg glucagon at a dose of 1 mg slowly bolus and then, if necessary, in the form of infusion at a dose of 1-10 mg / h, if necessary. enter either epinephrine (adrenaline) at a dose of 15-85 mcg, the introduction can be repeated, its total amount should not exceed 300 mcg, or dopamine at a dose of 2.5-10 mcg / kg / min.

Glucagon at the rate of 0.3 mg / kg epinephrine (adrenaline) and dobutamine (usually in high doses) should be monitored in the OIT of newborns in the case of an overdose in neonates manifested by cardiac decompensation. Long-term treatment is carried out under the supervision of a specialist.

Storage conditions

The product should be stored out of the reach of children at temperatures between 18 ° and 25 РC.

Shelf life

3 years.

dosage form

tablets

Possible product names

Vazaprostan lyoph. d / in. 60mkg N10 Germany

LODOZ 0.0025 + 0.00625 N30 TABLE P / O

LODOZ 0.0025 + 0.00625 N30 TABLE P / FILM / SHELL

LODOZ 2.5MG. + 6.25MG. No. 30 TAB.

Lodoz 2.5mg + 6.25mg Tab. p / o X30

Merck Sante, France

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