Albertor Long - instructions for use, dose, side effects, contraindications

Active substanceButylamine hydroxypropoxyphenoxymethyl methyl oxadiazoleButylamine hydroxypropoxyphenoxymethyl methyl oxadiazole

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Albertor®

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OBNINSKAYA CHEMICAL - PHARMACEUTICAL COMPANY, CJSC Russia

Albertor® Long

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OBNINSKAYA CHEMICAL - PHARMACEUTICAL COMPANY, CJSC Russia

Proxodolol®

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Proxodolol®

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SYNTHESIS, OJSC Russia

Dosage form: & nbsp

film-coated tablets, prolonged action

Composition:

One tablet, film-coated, prolonged action contains:

active substance: - butylamine hydroxypropoxyphenoxymethyl methyl oxadiazole hydrochloride (proxodolol) -0.12 g;

Excipients: microcrystalline cellulose, hypromellose (METHOCEL®), hypromellose (BENECEL®), silicon dioxide colloid (aerosil), calcium stearate;

shell composition: Opadrai II (series 85): partially hydrolysed polyvinyl alcohol, macrogol-3350, titanium dioxide E 171, talc.

Description:The tablets covered with a cover of white color, round, biconcave. Two layers are visible on the cross-section. The inner layer is white or almost white.

Pharmacotherapeutic group: Alpha- and beta-blocker

ATX: & nbsp

S.01.E.X Other antiglaucoma drugs

C.07.A.G. Alpha-, beta-blockers

Pharmacodynamics:

Butilaminogidroksipropoksifenoksimetil metiloksadiazol - beta1- and beta2-adrenergic blocker with alpha-1-adrenoblokiruyuschey activity, has antihypertensive, antianginal and antiarrhythmic action. The drug interacts with alpha1 and beta-adrenoreceptors and does not interact with angiotensin II receptors and vasopressin.

Antihypertensive effect is provided by a decrease in cardiac output, stroke volume of the heart and a decrease in the total peripheral vascular resistance.

Antianginal effect of the drug due to a decrease in myocardial oxygen demand (due to lower energy costs hearts), as well as the redistribution of regional (coronary) myocardial blood flow to ischemic lesions.

The mechanism of the antiarrhythmic action is associated with the elimination of arrhythmogenic sympathetic effects on cardiac conduction system, braking heterogeneous automaticity and speed of excitation through the atrioventricular (AV) node, increasing the refractory period, slowing the heart rate (HR).

The tone of the bronchi in connection with the blockade of beta2-adrenergic receptors is increased.

The hypotensive effect after taking the drug inside is observed after 30 minutes and remains for 12-24 hours. The therapeutic efficacy in coronary heart disease (CHD) is manifested by a decrease in the number of angina attacks and a decrease in the demand for nitroglycerin.

Conducted toxicological studies indicate a low toxicity and a high safety profile. The drug does not have a mutagenic and carcinogenic effect, does not affect reproductive function, does not have immunotoxic and allergenic properties, does not have a local irritant effect.

Pharmacokinetics:The maximum concentration of butylamine hydroxypropoxyphenoxymethyl methyl oxadiazole in blood plasma is observed 4 hours after ingestion of 120 mg (1 tablet) of the drug. Bioavailability is 2.2%. Apparent volume of distribution after ingestion of 120 mg (1 tablet) is 245 liters, half-life (T_1/2) is 5.1 hours, the clearance is -35.3 l / h. When administered for 5 days to 120 mg per day increase in the concentration of unchanged butylamine hydroxypropoxyphenoxymethyl methyl oxadiazole in blood plasma is not observed. Butylamine hydroxypropoxyphenoxymethyl methyl oxadiazole and its metabolites are excreted by the kidneys and through the intestine.

Indications:

- Arterial hypertension (in monotherapy and / or in combination with other antihypertensive drugs);

- ischemic heart disease (prevention of attacks of stable angina).

Contraindications:Hypersensitivity to any of the components of the drug; chronic obstructive pulmonary disease, bronchial asthma; chronic heart failure, bradycardia (heart rate less than 60 beats / min), AV blockade of II and III degree, cardiogenic shock, arterial hypotension (systolic pressure (BP) less than 100 mmHg); pregnancy, lactation; age to 18 years (efficacy and safety not established).

Carefully:AV blockade of I degree, angina of Prinzmetal, peptic ulcer of stomach and duodenum, diabetes mellitus (danger of masking hypoglycemia), occlusive diseases of peripheral vessels, marked violations of liver and kidney function.

Pregnancy and lactation:Albertor® Long is contraindicated for use during pregnancy. It is not known whether it penetrates into breast milk butylaminohydroxypropoxyphenoxymethyl methyl oxadiazole. If you need to use Albertor® Long during lactation, breastfeeding should be discontinued.

Dosing and Administration:

Inside whole, not liquid and squeezed liquid, regardless of food intake.

Arterial hypertension and ischemic heart disease

Treatment is started with a dose of 120 mg (1 tablet of the drug Albertus Long daily, in the morning). With insufficient therapeutic effect, the dose can be increased to 240 mg (2 tablets per day, divided into two doses in the morning and in the evening). The maximum daily dose is 240 mg.

Side effects:

From the cardiovascular system: severe bradycardia, excessive reduction in blood pressure, violation of peripheral circulation (Raynaud's syndrome), blockade of the legs of the bundle, AV blockade.

From the gastrointestinal tract: dryness of the oral mucosa, gastralgia, nausea.

From the nervous system: headache, dizziness, asthenia, increased fatigue.

From the immune system: allergic reactions (local or generalized exanthema, urticaria).

Other: bronchospasm, increased contractility of myometrium, increased sweating, chills.

Overdose:

Symptoms: marked decrease in blood pressure (systolic blood pressure less than 80 mm Hg), pronounced bradycardia (less than 50 beats / min), cardiogenic shock, cardiac arrest.

Treatment: rinse the stomach, enter Activated carbon, give the patient a horizontal position (legs raise above the level of the head) and carry out measures to restore the volume of circulating blood:

- with a pronounced decrease in blood pressure, intravenous administration of plasma-substituting solutions (in the absence of pulmonary edema), vasoconstrictor (epinephrine, norepinephrine, dopamine or dobutamine)

- with severe bradycardia-intravenous injection of atropine or dobutamine.

Interaction:

With the simultaneous use of the drug with other antihypertensive agents (beta-blockers or alpha1-adrenergic blockers, sympatholytic drugs, diuretics, slow calcium channel blockers, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists, hypotensive action may be enhanced.Arterial hypotension is also potentiated by inhibitors of microsomal liver enzymes (cimetidine), hydralazine, monoamine oxidase inhibitors (MAO).

Simultaneous use with cardiac glycosides, methyldopa, reserpine and guanfacin, (BCC) (verapamil, diltiazem), amiodarone and other antiarrhythmic drugs increases the risk of developing or aggravating bradycardia, AV blockade, up to cardiac arrest.

Means for general anesthesia increase the negative inotropic and hypotensive effect, increasing the risk of bradycardia and arterial hypotension. When combined, prolongs the effect of nondepolarizing muscle relaxants and the anticoagulant effect of coumarins.

Beta-adrenomimetics, aminophylline, cocaine, estrogens, non-steroidal anti-inflammatory drugs (including indomethacin) weaken the hypotensive effect.

Tri- and tetracyclic antidepressants, antipsychotics (antipsychotics), antipsychotics ethanol, sedatives and hypnotics increase the symptoms of central nervous system depression with simultaneous application.

Special instructions:

When taking Albertor® Long, you need control of heart rate and blood pressure, periodic ECG monitoring.If against the background of a constant intake of the medication, the heart rate is less than 55 bpm, and the systolic blood pressure is less than 100 mm Hg, the dose should be reduced or the drug should be withdrawn.

It is not recommended simultaneous use with MAO inhibitors due to possible significant enhancement of the hypotensive effect, a break in treatment after taking MAO inhibitors should be at least 14 days.

When therapy with Albitor® Long ischemic heart disease in order to prevent the development of severe bradycardia, the dose should be selected individually and increased gradually within 2-5 days. In connection with this, titration of the short-acting drug form of butylaminohydroxypropoxyphenoxymethyl methyloxadiazole hydrochloride - with the preparation of Albertor®, tablets of 10 and 40 mg. Treatment should be started with 1 tablet (10 mg) 3-4 times a day (30-40 mg per day), with good tolerability, the dose is gradually increased (by 10-20 mg / day), reaching a daily dose of 80 mg (in any convenient for titration of a combination of tablets of 10 mg and 40 mg of Albertor), after which they switch to taking Almostor Long in a daily dose of 120 mg.

If you cancel treatment with Albitor® Long, the dose should be gradually reduced within 10-14 days. Patients with ischemic heart disease should be under close medical supervision during this period. In the case of Albertor® Long, 1 tablet 2 times a day (maximum daily dose of 240 mg) reduces the intake of 1 tablet of the drug Albertor® Long per day (therapeutic dose 120 mg). Then, if necessary, it is possible to further reduce the daily dose of the drug Albertor® in the dosage form of tablets 10 and 40 mg: the dose is reduced starting from 80 mg / day, after which the dose is gradually reduced by (10-20 mg / day), to a minimal therapeutic doses of 30-40 mg / day (1 tablet (10 mg) - 3-4 times a day).

Effect on the ability to drive transp. cf. and fur:Use with caution when driving vehicles and performing work that requires increased concentration.

Form release / dosage:

Tablets, film-coated, prolonged action, 120 mg.

Packaging:

For 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

1, 2 or 3 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

Storage conditions:In dry, the dark place at a temperature of no higher than 25 ° C.Keep out of the reach of children.

Shelf life:2 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-009127/10

Date of registration:31.08.2010 / 13.05.2015

Expiration Date:Unlimited

The owner of the registration certificate:OBNINSKAYA CHEMICAL - PHARMACEUTICAL COMPANY, CJSC OBNINSKAYA CHEMICAL - PHARMACEUTICAL COMPANY, CJSC Russia

Manufacturer: & nbsp

VALENTA PHARMACEUTICS, JSC Russia

Information update date: & nbsp14.07.2017

Illustrated instructions

Instructions

Albertor® Long (Albetor® Long)