Halidorum

Галидор Drug photo

The description is actual on 01.08.2014

  • Latin name: Halidor
  • ATH code: C04AX11
  • Active ingredient: Bencyclanum (Bencyclane)
  • Producer: EGIS PHARMACEUTICALS, Plc (Hungary)

Structure

Each tablet of the drug Halidorum contains 100 mg of a fumarat of Bencyclanum, and also excipients: potato starch, polyvinyl acetate, magnesium stearate, carbomer 934 P, sodium carboxymethylstarch (type A), colloid anhydrous silicon dioxide and talc.

The drug Halidorum in the form of solution for intramuscular and intravenous administration contains 25 mg on 1 ml of solution, 50 mg of a fumarat of Bencyclanum on a capsule. At solution there are also excipients: 8 mg of sodium chloride (in dosage forms for parenteral administration) and to 2 ml of water for injections.

Release form

The medicine is issued in two forms:

  • White or grayish-white tablets, a round form, flat, on them are a facet, an engraving of "HALIDOR" on one of the parties of a tablet, there is a slight characteristic smell. Tablets on 50 pieces are put in the bottles made of dark glass. Each bottle is placed in a cardboard pack.
  • Halidorum pricks — solution for intravenous and intramuscular administration has an appearance of the transparent, colourless, not having a smell liquid. Solution is on sale in ampoules (volume of each 2 ml). On 5 ampoules place in blister strip packagings, and put blister strip packagings on 2 pieces in cardboard packs or on 10 in cardboard boxes.

Pharmacological action

Halidorum is a myotropic spasmolysant, has the expressed vazodilatiruyushchy (vasodilating) action.

Also drug can cause some increase in heart rate, have small tranquilizing effect.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Bencyclanum has vasodilating effect generally thanks to the ability to block calcium channels, to have antiserotoninovy effect, and somewhat – property to create blockade sympathetic gangliyev. Also Bencyclanum is capable to cause dozozavisimy suppression of Na+/K+-dependent Atfaza, decrease in aggregation of some blood cells (thrombocytes and erythrocytes) and to increase elasticity of erythrocytes. Such effects are generally observed in coronary arteries, peripheral vessels and vessels of a brain.

Except described above, Bencyclanum has spasmolytic effect on visceral muscles (muscles of urinary tract, a digestive tract, respiratory bodies).

Pharmacokinetics

After reception of Halidorum inside Bencyclanum is soaked up from a digestive tract quickly and almost completely. The maximum concentration in a blood plasma of the person who accepted drug is usually reached in 3 hours (but this interval can have duration from 2 to 8 watch) after intake. As there is an effect of "the first passing" through a liver, as a result bioavailability of a medicine at intake is equal to 25-35%.

In the circulating blood Bencyclanum is distributed approximately in such proportions:

  • 30-40% of all amount of substance contact proteins of plasma;
  • 30% — contact erythrocytes;
  • 10% — with thrombocytes;
  • 20%. - free fraction.

The metabolism of drug occurs in a liver. During metabolic processes there is dealkylation which as a result gives demetilirovanny derivative, or radio communication therefore the benzoic acid which in the subsequent turns into hippuric acid is formed is terminated.

Half-life lasts from 6 to 10 hours. The medicine generally with urine as inactive metabolites is removed, but it can be removed also in not changed look (no more than 2-3%). The most part of metabolites (about 90%) is brought out of an organism in not conjugated look, and the insignificant part is removed in the conjugated look (from it about 50% are in a species of the conjugate formed with glucuronic acid).

Indications to use of Halidorum

There is a lot of indications to use of Halidorum. It is appointed at:

  • diseases of peripheral vessels – at a Raynaud's disease, other diseases at which a Crocq's disease also the vasospasm often develops, at chronic obliterating diseases of arteries;
  • diseases of brain vessels: uses in complex therapy, both at acute, and at a chronic form of cerebral ischemia;
  • emergence of spasms of internals;
  • gastrointestinal diseases — a gastroenteritis of a different etiology (especially at infectious), infectious and inflammatory colitis, functional diseases of a large intestine, tenesmus, a postoperative meteorism, cholecystitis, cholelithiasis, a state after carrying out a cholecystectomia, disturbance of motility at dyskinesia of a sphincter of Oddi, ulcer a stomach disease and a duodenum (apply as a part of the carried-out combination therapy);
  • urological syndromes: spasms and tenesmus of a bladder, the accompanying therapy of an urolithiasis (appoint in combination with the anesthetizing drugs at renal colic);
  • to preparation for the tool methods of research applied in urology.

Contraindications

For use of drug refer to contraindications:

  • heavy respiratory insufficiency;
  • renal failure (at heavy degree of insufficiency);
  • heavy liver failure;
  • dekompensirovanny heart failure;
  • acute myocardial infarction;
  • AV blockade;
  • Bouveret's supraventricular or acute ventricular disease;
  • epilepsy and other forms of a spasmophilia;
  • recently had hemorrhagic stroke;
  • craniocereberal injuries (their existence within the last year);
  • pregnancy;
  • breastfeeding period;
  • age till 18 flyings;
  • hypersensitivity to the making drug components.

Side effects

From some systems of a human body manifestation of side effect of drug is possible:

  • Alimentary system: emergence of dryness in a mouth, an abdominal pain, sense of fulness, nausea, vomitings, loss of appetite, diarrheas is possible, in blood serum activity of hepatic transaminases can increase.
  • Central nervous system: there is a probability of emergence of concern, dizziness, headache, disturbance of gait, a tremor, sleep disorders, sleeplessnesses, dysmnesias; the passing confused conditions of consciousness, emergence of epileptiform attacks, hallucinations are seldom observed; in isolated cases symptoms of focal defeats of the central nervous system appeared.
  • Cardiovascular system: development of an atrial and ventricular tachyarrhythmia is sometimes observed (its probability especially increases at joint introduction of Halidorum with other proaritmogenny drugs).
  • Except the listed above side effects, emergence of a febricula, increase in body weight, development of a leukopenia, allergic reactions is possible; thrombophlebitis at intravenous administration is occasionally shown.

Application instruction of Halidorum (Way and dosage)

At vascular diseases

Inside medicine is taken on 100 mg by 3 times a day within 2 or 3 months. The maximum dose which can be accepted inside per day – 400 mg (tablet). Between courses of administration of drug it is necessary to do an interval from 2 to 3 months.

In the form of intravenous infusions drug accept in a dose 200 mg (per day). The daily dose is divided into 2 introductions. Before carrying out infusion, 100 mg (contains in 4 ml of solution for intravenous and intramuscular administration) drug need to be parted in 100-200 ml of isotonic solution of sodium chloride, and then to enter intravenously kapelno for 1 hour, it is necessary to do it 2 times a day.

At a spasm of internals

Inside appoint 100-200 mg of drug for once, but no more, than 400 mg per day.

In case of carrying out a maintenance therapy Halidorum is appointed on 100 mg 3 times a day for 3 or 4 weeks, then on 100 mg by 2 times a day. Duration of treatment is defined for each person individually and depends on when disease symptoms disappear. As a rule, this period lasts no more than 1-2 months.

At use in acute cases the drug is administered intravenously according to the application instruction of pricks Halidorum — slowly in number of 100-200 mg (these are 4-8 ml of solution) or it is intramusculary deep in number of 50 mg of drug (2 ml of solution). Before intravenous administration the necessary dose of solution is parted with isotonic solution of sodium chloride to 10-20 ml. Length of a course of treatment makes the 2nd silt 3 weeks, then, if necessary, the patient is transferred to reception of Halidorum inside.

Overdose

At overdose of drug heart rate increases, arterial pressure goes down, the collapse, disturbances of functions of kidneys can develop, to appear an urine incontience, the condition of drowsiness, concern is characteristic, in hard cases emergence of epileptiform convulsive attacks is possible. At considerable overdose there can be tonic and clonic spasms.

At overdose symptomatic therapy is carried out. If a large number of tablets was accepted, it is necessary to carry out a gastric lavage. In case of convulsive attacks recommend use of benzodiazepines. The specific antidote was not found yet. Data on whether it is possible to remove Bencyclanum by means of a dialysis, no.

Interaction

Simultaneous use of Halidorum with some drugs can lead to side effects. Therefore it is necessary to be careful at a combination to such drugs:

  • Anesthetics and sedative drugs – such combination increases the oppressing influence of Halidorum on the central nervous system.
  • Sympathomimetics – simultaneous use increases risk of development in the patient of tachycardia, atrial or ventricular tachyarrhythmias.
  • The drugs reducing potassium level in blood (diuretics and cardiac glycosides belong to such drugs) and quinidine – there can be summation of proaritmogenny effects.
  • Foxglove drugs — increase risk of development of arrhythmia in case of overdose by cardiac glycosides.
  • Beta adrenoblockers — there is a need to adjust a beta adrenoblocker dose as these drugs render opposite chronotropic effects (at beta adrenoblockers a negative effect, and at Bencyclanum — positive).
  • Blockers of calcium channels and other anti-hypertensive drugs – strengthening of effect is possible.
  • The medicines causing side effects in the form of a spasmophilia – the probability of summation of similar effects appears.
  • Acetylsalicylic acid – can strengthen braking of aggregation of thrombocytes.

Terms of sale

Medicine is sold only according to the recipe.

Storage conditions

Drug needs to be stored in the place unavailable to children, in temperature conditions from 15 °C to 25 °C.

Period of validity

Tablets are suitable 5 years. Solution for injections is good 3 years.

Special instructions

At the beginning of a course of administration of drug it is necessary to observe big care when driving cars and other vehicles, and also at any other types of activity which can be potentially dangerous.

Analogs of Halidorum

Coincidence on the ATH code of the 4th level:

Analogs of Halidorum are such drugs as Bencyclanum, Bencyclanum Fumarates, Vinoksin of MV, Dibazolum, Dibazol-darnitsa, Duzofarm, Papazolum, Enelbin 100 Retard.

Zdravzona

  • Halidorum solution for injections 25mg/ml 2 ml No. 10 ampulyegis
  • Halidorum of 100 mg No. 50 tabletkiegis

Drugstore of IFC

  • Halidorum tbl 100 mg No. 50, Egisvengriya
  • Halidorum solution for in 25mg/ml 2 ml No. 10, Egisvengriya
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BIOSPHERE

  • Halidorum of 50 mg / 2 ml No. 10 solution for in.amp.
  • Halidorum of 100 mg No. 50 of table.
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Section: Cardiovascular
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