Haloperidol-Ferein - instructions for use, dose, side effects, contraindications

Pharmacodynamics:HALOPERIDOL-FEREIN® (haloperidol) neuroleptic, belonging to the derivatives of butyrofenone. Has a pronounced antipsychotic and antiemetic effect.

The effect of haloperidol is associated with blockade of central dopamine (D2) and alpha-adrenergic receptors in the mesocortical and limbic structures of the brain. Blockade of D2-receptors of the hypothalamus leads to a decrease in body temperature, galactorrhea, due to increased production of prolactin. The inhibition of dopamine receptors in the trigger zone of the vomiting center underlies the antiemetic effect. Interaction with the dopaminergic structures of the extrapyramidal system leads to extrapyramidal disorders.Expressed antipsychotic activity is combined with a mild sedative effect (in small doses it has an activating effect).

Potentiates the effect of hypnotics, drugs, analgesics and other drugs depressing the function of the central nervous system

Pharmacokinetics:The maximum concentration in the blood after intramuscular injection is reached after 20 minutes. Haloperidol 90% bound to plasma proteins, 10% is a free fraction. The ratio of concentration in erythrocytes to plasma concentration is 1:12.

The concentration of haloperidol in tissues is higher than in blood, the drug tends to accumulate in tissues.

Haloperidol is metabolized in the liver, the metabolite is not active.

Haloperidol is excreted by the kidneys (40%) and with feces (60%). The half-life from the plasma after intramuscular injection is -21 hours (17-25 hours), after intravenous 14 hours (10-19 hours).

Indications:- Coping and treatment of psychotic disorders of different etiologies.

- Premedication before surgery.

Contraindications:- Severe toxic oppression of the central nervous system and coma of any etiology.

- CNS diseases, accompanied by pyramidal and extrapyramidal disorders (Parkinson's disease, etc.).

- Hypersensitivity to butyrophenone derivatives.

- Pregnancy, the period of breastfeeding.

- Children under 3 years old.

Carefully:Caution must be exercised in cardiovascular diseases events decompensation, cardiac muscle conductivity; with severe diseases of the kidneys, liver and lungs.

Pregnancy and lactation:Contraindicated.

Dosing and Administration:For edema agitation haloperidol-FEREYN® in the first days intramuscularly administered at 2-5 mg 2-3 times a day, or intravenously at the same dosage (vial must be diluted in 10-15 ml of water for injection), the maximum daily dose of 60 mg . After achieving a stable sedative effect, they switch to taking the drug inside.

For elderly patients 0.5 - 1.5 mg (0,1-0, ZA ml), the maximum daily dose of - 5 mg (1 ml).

For children over 3 years old dose of 0.025-0.05 mg per day, divided into 2 admission. The maximum daily dose is 0.15 mg / kg.

The parenteral route of administration of haloperidol-FEREYN® should be under close medical supervision, especially in the elderly and children, the therapeutic effect should go to the reception of the drug inside.

Side effects:

CNS: paroxysmal and acute extrapyramidal disorders of varying severity. Most patients have transient akinetorhidic syndrome, oculogic crises, akathisia, dystonic phenomena. To stop these phenomena prescribe antiparkinsonic funds (cyclodol, etc.), symptomatic therapy.

The severity of extrapyramidal disorders is associated with a dose, often with a decrease in dose, they may decrease or disappear.

In a number of cases, signs of neurological disorders are observed when the drug is withdrawn after a long course of treatment, therefore, it should be canceled haloperidol gradually reducing the dose.

Possible development of neuroleptic malignant syndrome (NZS).

With long-term administration of haloperidol, it is possible to develop late dyskinesias, especially in elderly patients and patients with organic deficiency of the central nervous system, so doses for this category of patients should be reduced.

At the beginning of therapy, there may be lethargy, drowsiness, headache that occurs after the appointment of correctors.

The cardiovascular system: tachycardia, arterial hypotension, sometimes hypertension, changes in the ECG.

Blood: transient leukopenia or leukocytosis, anemia, lymphomonocytosis, rarely agranulocytosis.

Liver: possible dysfunction, jaundice.

Leather: toxicoderma, dry skin, photosensitization, hyperfunction of the sebaceous glands.

GIT: anorexia, dyspepsia, dry mouth, sometimes hypersalivation, nausea, vomiting. constipation, diarrhea.

Endocrine system: amenorrhea, frigidity, gynecomastia, galactorrhea, impotence.

Overdose:In case of an overdose of the drug, the appearance of acute neuroleptic reactions, listed above, is possible. Particularly should alarm the increase in body temperature, which may be one of the symptoms of malignant neuroleptic syndrome. In severe cases of overdose, various forms of impairment of consciousness, up to coma, can occur.

Measures of help: discontinuation of therapy with neuroleptics, appointment of correctors, intravenous diazepam, glucose solution, nootropics, B and C vitamins, symptomatic therapy.

Interaction:

Haloperidol potentiates the effects of antihypertensive drugs of central action, opioid analgesics, hypnotics, antidepressants, drugs for anesthesia, alcohol.

With simultaneous use with antiparkinsonian drugs (levodopa and others), the therapeutic effect of these agents may decrease because of the antagonistic effect on the dopaminergic structures.

Haloperidol can reduce the intensity of action of adrenaline and other sympathomimetics and cause a paradoxical decrease in blood pressure when they are used.

When combined with antiepileptic drugs, the doses of the latter should be increased, t. Haloperidol reduces the threshold of convulsive activity.

Haloperidol can reduce the effect of indirect anticoagulants, so when combined, the dose of the latter should be adjusted.

Haloperidol slows the metabolism of tricyclic antidepressants, which increases their plasma levels and increases toxicity.

With the simultaneous administration of haloperidol with fluoxetine and lithium, the risk of side effects on the central nervous system increases, especially extrapyramidal reactions.

With simultaneous administration with antihistamines, anticholinergic effects may be increased.

With the simultaneous use of tea or coffee, the effect of haloperidol may decrease.

Special instructions:

It is forbidden to drink alcohol when taking GALOPERIDOL-FERAIN®.

Effect on the ability to drive transp. cf. and fur:During the reception of GALOPERIDOL-FERAIN®, it is prohibited to drive vehicles, service mechanisms and other types of work that require increased concentration of attention.

Form release / dosage:Solution for intravenous and intramuscular injection 5 mg / 1 ml.

Packaging:1 ml per ampoule of neutral glass; 5 ampoules per contour cell package; 1-2 contour packs per pack with instructions for use.

Storage conditions:At a temperature of 15 to 25 ° C in a dark place. Keep out of the reach of children.

Shelf life:Shelf life 2 years.

Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N002933 / 01

Date of registration:15.12.2008 / 27.05.2015

Expiration Date:Unlimited

The owner of the registration certificate:BRYNTSALOV-A, CJSC BRYNTSALOV-A, CJSC Russia

Manufacturer: & nbsp

BRYNTSALOV-A, CJSC Russia

Information update date: & nbsp14.03.2017

Illustrated instructions

Instructions

Haloperidol-Ferein (Haloperidol-Ferein)