Galidor® (Halidor®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceBenzyclanBenzyclan
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  • Galidor®
    solution w / m in / in 
    EGIS ZAO Pharmaceutical Plant     Hungary
  • Galidor®
    pills inwards 
    EGIS ZAO Pharmaceutical Plant     Hungary
    • Dosage form: & nbspsolution for intravenous and intramuscular administration
    Composition:
    Each vial of 2 ml contains 50 mg of active substance bencyclane fumarate and auxiliary substances: sodium chloride for parenteral dosage forms and 8 mg Water for Injection to 2 ml.
    Description:Transparent colorless solution, odorless.
    Pharmacotherapeutic group:Spasmolytic agent
    ATX: & nbsp

    C.04.A.X.11   Benzyclan

    Pharmacodynamics:

    Benzyclan - myotropic antispasmodic with a pronounced vasodilating effect. The vasodilator effect of benzyclane is mainly due to its ability to block calcium channels, antiserotonin action, and to a lesser extent - with blockade of sympathetic ganglia. Besides, benzyclan has an antispasmodic effect on visceral musculature (gastrointestinal tract, urogenital organs, respiratory organs). The drug causes a slight increase in the heart rate. It is also known for its weak tranquilizing effect.

    Mechanism of action

    Benzyclan can cause dose-dependent suppression Na/K -dependent ATPase and platelet and erythrocyte aggregation, as well as increased erythrocyte elasticity. These effects are observed mainly in peripheral vessels, coronary arteries and cerebral vessels.

    Pharmacokinetics:

    The maximum concentration in the blood plasma is achieved in 2-8 hours (usually after 3 hours) after ingestion. Because of the metabolism of the first passage through the liver, the bioavailability of the drug after ingestion is 25-35%. Approximately 30 - 40% of the amount of bicyclic in the circulating blood is associated with plasma proteins, 30% with red blood cells, 10% with platelets; the free fraction is 20%. Metabolism is carried out in the liver, mainly along two routes: dealkylation gives a demethylated derivative, the rupture of the ester bond gives benzoic acid, which later turns into a hippuric acid. The bulk of the administered dose is excreted with the kidneys, mainly in the form of metabolites, but also in unchanged form (2-3%).

    A significant majority of metabolites (90%) are excreted unconjugated, and a small fraction is excreted in conjugated form (approximately 50% as a conjugate with glucuronic acid).

    The half-life is 6-10 hours; this parameter does not change in elderly patients, as well as in violation of the functions of the nights and liver. The total ground clearance is 40 l / h, the renal clearance is less than 1 l / h.

    Indications:

    Vascular diseases

    Diseases of peripheral vessels: Raynaud's disease, other diseases with acrocyanosis and spasm of blood vessels, as well as chronic obliterating diseases of the arteries.

    Diseases of cerebral vessels: in the complex therapy of acute and chronic cerebral ischemia.

    Elimination of spasm of internal organs

    Gastrointestinal diseases: gastroenteritis different etiology (especially infectious and inflammatory colitis, functional diseases of the colon, tenesmus, postoperative flatulence, cholecystitis, cholelithiasis, condition after cholecystectomy, motor disorders with dyskinesia of the sphincter of Oddi, ulcer of the stomach or duodenum - in combination with other medications.

    Urological syndromes: spasms and tenesmus of the bladder, concomitant therapy of urolithiasis (in combination with analgetics in renal colic),preparation for instrumental methods of research.

    Contraindications:

    Hypersensitivity to the active or any other component of the drug. Severe respiratory, renal or hepatic insufficiency.

    Decompensated heart failure, acute myocardial infarction, atrioventricular blockade.

    Epilepsy and other forms of spasmophilia.

    Recently suffered hemorrhagic stroke.

    Craniocerebral trauma (during the last 12 months).

    Pregnancy and lactation (see the section on pregnancy and lactation).
    Pregnancy and lactation:

    Pre-clinical data showed no embryotoxic or teratogenic effects. However, sufficient reliable studies on the use of the drug during pregnancy and lactation in humans have not been conducted. Therefore, the administration of the drug to patients in the first trimester of pregnancy is not recommended. During lactation, you should refrain from prescribing the drug, or decide whether to stop breastfeeding during treatment.

    Dosing and Administration:

    Solution for intravenous injection (after dilution) or infusion.

    Vascular diseases

    Infusion: In vascular diseases, the drug can be used in a daily dose of 200 mg divided into 2 infusions. 100 mg (4 ml) of the drug is diluted in 100 - 200 ml of isotonic solution NaCl. The drug is administered intravenously-drip for 1 hour 2 times a day.

    Elimination of spasm of internal bodies

    Injections: In acute cases, 2-4 ampoules are slowly injected into the vein (4-8 ml) of the preparation diluted with saline to 10 - 20 ml or deep intramuscularly 2 ml.

    The course of treatment is 2-3 weeks, if necessary, with the subsequent transfer of the patient to taking Halidor tablet.

    Side effects:

    Gastrointestinal: dry mouth, abdominal pain, feeling full, nausea, vomiting.

    Central nervous system: anxiety, headache, dizziness, gait disturbance, tremor, insomnia, memory disorders, rarely - transient confusion, hallucinations, very rarely - symptoms of focal CNS lesion.

    Cardiovascular: sometimes atrial or ventricular tachyarrhythmia can occur (especially when combined with other pro-arrhythmogenic drugs).

    Laboratory indicators: a transient increase in the activity of aspartate aminotransferase and alamine aminotransferase, a decrease in the number of white blood cells.

    Others: general malaise, weight gain, allergic reactions, rarely thrombophlebitis with intravenous administration.

    Overdose:

    Symptoms: increased heart rate, lower blood pressure, predisposition to collapse, urinary incontinence, drowsiness, anxiety, and in severe cases - epileptiform convulsive seizures. A significant overdose can cause tonic and clonic convulsions.

    Treatment: The specific antidote is not known. In case of an overdose, symptomatic treatment should be used. To treat convulsive seizures, it is recommended to use benzodiazepines. Data on the possible excretion of bcyclical by dialysis are not available.

    Interaction:

    Care should be taken when combining with the following:

    - anesthetics and sedatives - their effects can be enhanced;

    - sympathomimetics - because of the risk of atrial and ventricular tachyarrhythmias;

    - means, reducing the level of potassium blood - because of the possible summation proaritmogenic effects;

    - drugs foxglove - increases the risk of arrhythmias with an overdose of digitalis;

    - beta-blockers - due to the opposite of chronotropic effects (negative for beta-blockers andpositive in bcyclical), it may be necessary to select a beta-blocker dosage;

    - calcium channel blockers and other antihypertensive drugs - because of the possibility of enhancing their effect;

    - drugs, causing side effects in the form of spasmophilia - because of the possibility of summation of these effects;

    - Aspirin - due to increased inhibition of platelet aggregation.

    Special instructions:

    Places of injection should be periodically changed, tk. the drug can cause damage to the vascular endothelium and thrombophlebitis.

    It should refrain from parenteral administration of the drug to patients with severe cardiovascular or respiratory failure predisposed to collapse, as well as prostatic hypertrophy and urinary retention (the degree of delay increases with relaxation of the bladder muscles).

    With prolonged therapy with benzyclan it is recommended to conduct regular laboratory tests (at least once every 2 months).

    Effect on the ability to drive transp. cf. and fur:

    At the beginning of the course of treatment, driving vehicles and performing work with an increased risk of accidents requires special care.

    Form release / dosage:
    Solution for intravenous and intramuscular injection 25 mg / ml.
    Packaging:2 ml in an ampoule with a break point and two code rings (blue lower ring and yellow upper ring), 5 ampoules in a planar cell package (pallet), 2 contourcell packs in a cardboard bundle along with instruction for use or 10 contour packagings in a cardboard box, sealed with a label together with instructions for use.
    Storage conditions:

    Store at a temperature of 15-25 ° C out of the reach of children.

    Shelf life:

    3 years. Do not use after the date indicated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N012430 / 01
    Date of registration:31.08.2010 / 09.10.2014
    Expiration Date:Unlimited
    The owner of the registration certificate:EGIS ZAO Pharmaceutical Plant EGIS ZAO Pharmaceutical Plant Hungary
    Manufacturer: & nbsp
    Representation: & nbspEGIS ZAO Pharmaceutical Plant EGIS ZAO Pharmaceutical Plant Hungary
    Information update date: & nbsp12.03.2017
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