Halidorum

Halidorum – myotropic spasmolytic drug of the expressed vazodilatiruyushchy action.

Form of release and structure

Dosage forms of Halidorum:

• Tablets: round, white or grayish-white color, with a light characteristic smell, a facet and an engraving of HALIDOR on one of the flat parties (on 50 pieces in bottles of dark glass, in a cardboard pack 1 bottle);
• Solution for intramuscular (in oil) and intravenous (in/in) introductions: inodorous transparent colourless liquid (in ampoules on 2 ml, in a blister strip packaging on 5 ampoules; in a cardboard pack on 2 packagings or in a cardboard box on 10 packagings).

Active agent – Bencyclanum fumarates:

• 1 tablet – 100 mg;
• 1 ampoule – 50 mg.

Excipients:

• Tablets: polyvinyl acetate, potato starch, magnesium stearate, silicon dioxide colloid anhydrous, carbomer 934 P, talc, sodium carboxymethylstarch (type A);
• Solution: sodium chloride for parenteral dosage forms, water for injections.

Indications to use

Use of Halidorum is shown for treatment of vascular diseases:

• Peripheral vessels: pathologies with a Crocq's disease and a vasospasm, a Raynaud's disease and chronic obliterating diseases of arteries;
• Brain vessels: chronic and acute cerebral ischemia (as a part of complex treatment).

Drug is appointed for elimination of a spasm of internals:

• Gastrointestinal pathologies: as a part of a combination therapy of a peptic ulcer of a stomach and a duodenum, colitis – infectious and inflammatory, a gastroenteritis of various etiology, especially infectious. Cholecystitis, a state after a cholecystectomia, cholelithiasis, disturbances of motility at dyskinesia of a sphincter of Oddi. Functional pathologies of a large intestine, postoperative meteorism, tenesmus;
• Urological syndromes: the accompanying therapy of an urolithiasis (at renal colic – in combination with analgetics), tenesmus and spasms of a bladder.

In urology Halidorum is also applied to preparation for tool methods of a research.

Contraindications

Contraindications to use of Halidorum are:

• Heavy liver and renal failure;
• Heavy respiratory insufficiency;
• Epilepsy and other forms of a spasmophilia;
• The hemorrhagic stroke which is had recently;
• Craniocereberal injury (within the last year);
• Dekompensirovanny heart failure;
• Atrioventricular block;
• Acute myocardial infarction;
• Age up to 18 years;
• Period of pregnancy and breastfeeding;
• Hypersensitivity to drug components.

Route of administration and dosage

Halidorum in the form of tablets should be accepted inside. In the form of solution – in a look in/in injections or infusions and deep injections in oil.

The doctor appoints a course of treatment and a dosage form of drug individually, considering clinical indications and a condition of the patient.

The recommended dosing at treatment of vascular diseases:

• Tablets – on 100 mg 3 times a day within 2-3 months. The daily dose should not exceed 400 mg. A break between courses – 2-3 months;
• Solution – on 100 mg 2 times a day. 100 mg (4 ml) of drug need to be parted in 100-200 ml 0,9% of aqueous solution of sodium chloride and in/in kapelno to enter during 1 h.

Dosing for a spasmolysis of internals:

• Tablets – 100-200 mg once, the maximum daily dose – 400 mg. A maintenance therapy – on 100 mg 3 times a day within 3-4 weeks, then – 2 times a day. Drug is accepted before disappearance of symptoms of a disease, usually by 1-2 months;
• Solution – in acute cases: on 100-200 mg (4-8 ml) in the way in a slow injection or 50 mg (2 ml) – deeply in oil. For in/in introductions drug part 0,9% of aqueous solution of sodium chloride in 10-20 ml. A course of treatment 2-3 weeks, then, in case of need, transfer the patient to reception of tablets.

Side effects

Use of Halidorum can cause the following side effects:

• From the central nervous system (CNS): dizziness, headache, concern, disturbances of gait and/or dream, tremor, dysmnesias, sleeplessness. Seldom – the passing confused condition of consciousness, a hallucination, epileptiform attacks. Very seldom – symptoms of focal defeat of TsNS;
• From the alimentary system: sense of fulness, dryness in a mouth, nausea, an abdominal pain, vomiting, increase in activity of hepatic transaminases in blood serum;
• From cardiovascular system: sometimes – an atrial and ventricular tachyarrhythmia (especially at simultaneous administration of other proaritmogenny drugs);
• Others: increase in body weight, febricula, leukopenia, allergic reactions. Seldom – at in introduction there can be thrombophlebitis.

Special instructions

The daily dose of Halidorum should not exceed 150-200 mg at treatment in combination with cardiac glycosides, and also with the means oppressing functions of a myocardium or causing a hypopotassemia.

Parenteral administration of drug is contraindicated to the patients with a severe form of cardiovascular or respiratory insufficiency having predisposition to a collapse; prostatauxe; ischuria.

In case of prolonged use of drug it is recommended at least, than 1 time in 2 months to conduct laboratory researches of rheological properties of blood.

At parenteral use periodically it is necessary to change places of injections since drug can cause damage of an endothelium of vessels and thrombophlebitis.

At the beginning of use of Halidorum it is necessary to observe extra care at control of vehicles and performance of potentially dangerous types of activity.

Medicinal interaction

At a combination to sympathomimetics the probability of development of atrial and ventricular tachyarrhythmias, tachycardias increases.

At simultaneous use with anesthetics and the sedative drugs Halidorum strengthens their oppressing action on TsNS.

At a concomitant use with drugs of a foxglove the risk of arrhythmia from possible overdose of cardiac glycosides increases.

It is necessary to be careful at a combination with the quinidine and medicines reducing potassium level in blood (including cardiac glycosides and diuretics) as summation of proaritmogenny effects is possible.

In case of co-administration with Halidorum of beta adrenoblockers, it is necessary to consider contrast of chronotropic effects – positive at Bencyclanum and negative at beta adrenoblockers.

Drug can strengthen effect of blockers of calcium channels and other anti-hypertensive drugs.

Simultaneous use with the means causing side effects in the form of a spasmophilia can promote increase in these effects twice.

It is necessary to consider a possibility of strengthening of braking of aggregation of thrombocytes at a combination to acetylsalicylic acid.

Terms and storage conditions

Drug should be stored in the place, unavailable to children, at a temperature of 15-25 °C.

Period of validity:

• Tablets – 5 years;
• Solution – 3 years.