Lodoz pills 2.5mg + 6.25mg №30

Dosage form

Pills

Composition

Tablets, coated yellow film; round, biconvex, engraved with a heart on one side and the number "2.5" on the other, contain: Bisoprolol hemifumarate (bisoprolol fumarate (2: 1)) 2.5 mg, Hydrochlorothiazide 6.25 mg.

Excipients: Magnesium stearate, Crospovidone, Corn starch, Pregelatinized corn starch, Microcrystalline cellulose, Calcium phosphate monosubstituted.

Shell composition: Polysorbate 80 VS, Iron oxide yellow, Macrogol 400, Titanium dioxide, Hypromellose 2910/3, Hypromellose 2910/6.

Packing

In the blister of 10 tablets. In packing 3 blisters.

Mechanism of action

Lodoz - combined antihypertensive drug.

Bisoprolol is a highly selective beta1-blocker without sympathomimetic and membrane stabilizing activity. The mechanism of action of bisoprolol in arterial hypertension is associated primarily with a decrease in the level of renin in the blood plasma 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 ingredients of this combination was observed. Efficacy for the treatment of mild and moderate 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 Lodoz is reduced by 2-4 times.

Indications and usage

Arterial hypertension mild and moderate severity.

Contraindications

- Severe forms of bronchial asthma, COPD.
- Chronic heart failure in the stage of decompensation, not amenable to drug therapy.
- Cardiogenic shock.
- SSS, including sinoatrial blockade.
- AV block II and III degree without artificial pacemaker.
- Severe bradycardia (HR - Variable angina (Prinzmetal's angina).
- Pheochromocytoma (without the simultaneous use of alpha-blockers).
- Severe forms of impaired peripheral circulation (including Raynaud's disease).
- Arterial hypotension.
- Hypokalemia.
- Hypovolemia.
- Severe renal dysfunction (creatinine clearance - Severe abnormal liver function.
- Simultaneous use with flaktafenin, sultoprid, antiarrhythmic drugs, 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.

It should be used with caution in AV block I degree, psoriasis, IHD, chronic heart failure in the decompensation stage, thyrotoxicosis, water and electrolyte disorders (hyponatremia, hypokalemia, hypercalcemia), gout, as well as in elderly patients.

Pregnancy and Breastfeeding

It is not recommended to use Lodoz during pregnancy because 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 the drug Lodoz is contraindicated.

Dosage and administration

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

The initial dose corresponds to 1 pill (2.5 mg of bisoprolol / 6.25 mg of hydrochlorothiazide) 1 time / In case of insufficient efficacy of treatment, the dose is increased to 1 pill (5 mg of bisoprolol / 6.25 mg of hydrochlorothiazide) 1 time / If necessary, the dose can be increased to 1 pill (10 mg of bisoprolol / 6.25 mg hydrochlorothiazide) 1 time /
In patients with impaired liver function or moderate renal dysfunction (CC> 30 ml / min), a dose change is not required.

Adverse reactions

From the side of the central nervous system: sleep disorders, depression; possible - fatigue, fatigue, dizziness, headache (may occur at the beginning of treatment and usually go away during the first or second week of treatment).
Cardiovascular: bradycardia, impaired AV conduction, exacerbation of chronic heart failure, orthostatic hypotension.
Respiratory: bronchospasm in patients with asthma or COPD in history.
Gastrointestinal: nausea, vomiting, diarrhea, constipation, hepatitis, jaundice, increased AST and ALT activity.
Urogenital: reversible increase in serum creatinine and urea.
Musculoskeletal system: feeling of cold and numbness of the limbs, muscle weakness, cramps.
Special senses: hearing impairment, decreased production of the lacrimal glands (it is necessary to take into account patients using contact lenses), impaired vision.
Metabolism: hypertriglyceridemia, hypercholesterolemia, hyperglycemia, glycosuria, hyperuricemia, impaired water-electrolyte state, metabolic alkalosis.
Hemic and lymphatic: leukopenia, thrombocytopenia.
Dermatologic: beta-blockers can cause or aggravate 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.

Special notes

Do not suddenly stop treatment, especially in patients with coronary artery disease. It is recommended to reduce the dose gradually over 2 weeks.If necessary, you should simultaneously begin an appropriate therapy to prevent attacks of angina pectoris.
If it is necessary to administer the drug to patients with asthma or COPD, the treatment should be started with the minimum initial dose. Before starting therapy, it is recommended to conduct functional respiratory tests. If bronchospasm develops during therapy, beta-adrenomimetics should be prescribed.
Patients with chronic heart failure should be prescribed the drug with caution and under the supervision of a physician, in minimal doses.
It is necessary to reduce the dose of the drug at heart rate at rest. Given the negative dromotropic effect of beta-blockers, they should be prescribed with caution in patients with AV-blockade I degree.
In patients with peripheral circulatory disorders (Raynaud's disease), beta-blockers may cause exacerbation of the disease.
Patients with pheochromocytoma should not be given Lodoz until treatment with alpha-blockers is performed. Need to control blood pressure.
In elderly patients, treatment should begin with a low dose of the drug, careful monitoring of the patient’s condition is necessary.
Patients taking Lodoz should be warned about 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, exacerbation of the course of psoriasis is possible. Bisoprolol should be administered only when necessary.
With indications of Anaphylactic reactions in history, regardless of the cause of their occurrence, especially when taking floctaphenin, or during desensitization therapy, treatment with beta-adrenergic blockers can aggravate the occurrence of these reactions and cause the development of resistance to treatment with epinephrine (adrenaline) in usual 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 control of sodium levels in the blood is necessary. Reduction of sodium at the beginning of treatment may be asymptomatic, so regular monitoring is necessary. Special attention is required in the presence of risk factors, for example, patients of old age, patients with cirrhosis of the liver.
It is necessary to control potassium in the blood of high-risk patients, 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, extended QT interval.
Hypokalemia increases the risk of arrhythmias, the 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 Lozodom.
Thiazide diuretics can reduce urinary calcium excretion, which leads to minor and temporary hypercalcemia. Temporary hypercalcemia may be associated with undiagnosed hyperparathyroidism. Before the study of the function of the parathyroid glands, treatment with thiazides should be discontinued.
It is necessary to control blood glucose levels 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 in normal kidney function or slightly reduced kidney function (QC 220 µmol / L). In elderly patients, the content of serum creatinine can be calculated based on the age, body weight and sex of the patient according to Cockroft's formula:
For men:
QC (ml / min) = [140-age] x body weight (kg) / 72 x serum creatinine (mg / dL)
For women: the obtained value is 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 urea and creatinine levels in patients with normal renal function.
Temporary impaired renal function occurs without consequences in patients with normal renal function.In patients with impaired renal function, it is possible to enhance existing disorders.
In the case of the appointment of the drug with another antihypertensive agent is recommended to reduce the dose at the beginning of treatment.
Use in pediatrics: The efficacy and safety of the drug in children and adolescents under the age of 18 years have not been established, therefore, the use of the drug is contraindicated.
Influence on ability to drive motor transport and control mechanisms: use with caution when driving and working with mechanisms in connection with the possibility of dizziness.

The drug is contraindicated for use in combination with floctafenin, sultoprid.
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).
It is required to use the drug with the use of baklofen drugs, high doses of salicylates, drugs,causing hypopotassemia - amphotericin (in / in the introduction) and mineralocorticoid (system use), tetracosactids, laxatives; cardiac glycosides, hyperkalemia-causing diuretics (amiloride, canrenone, spironolactone, triamterene); ACE inhibitors, Metformin .
Perhaps greater hypotensive action while the use of tricyclic antidepressants (including imipramine), neuroleptics, calcium channel blockers slow dihydropyridine derivatives (including Amlodipine , felopidin, lacidipine, Nifedipine , nicardipine, nimodipine, nitrendipine).
Application of Lodoz simultaneously with tricyclic antidepressants, incl. MAO inhibitors , as well as neuroleptics, 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 hypotensive action.
When co-administered with mefloquine, bradycardia may develop.
When administered jointly with calcium preparations may develop hypercalcemia.
When administered jointly with cyclosporine, an increase in serum creatinine is possible.
The weakening of the hypotensive action of Lodoz is possible with simultaneous administration with GCS (for systemic use), NSAIDs and tetracosactide.

Symptoms: excessive decrease in blood pressure, bradycardia.In newborns from mothers who received treatment with beta-blockers, may develop an overdose, manifested by decompensation of cardiac activity.
Treatment: in the case of severe bradycardia or an excessive decrease in blood pressure, the following drugs are injected into / in: atropine 1-2 mg; glucagon at a dose of 1 mg is slowly bolus and then, if necessary, in the form of an infusion at a dose of 1-10 mg / h; then, if necessary, either epinephrine (adrenaline) at a dose of 15-85 µg is administered, the administration can be repeated, its total amount should not exceed 300 µg, or dopamine at a dose of 2.5-10 µg / kg / min.
In case of overdose in newborns, manifested by decompensation of cardiac activity, glucagon is prescribed at the rate of 0.3 mg / kg; epinephrine (adrenaline) and dobutamine (usually in high doses) must be monitored in the ICU of newborns. Prolonged treatment is carried out under the supervision of a specialist).

The drug should be stored out of reach of children at a temperature of 18 ° to 25 ° C.

3 years