Senor

Active material: Haloperidol
When ATH: N05AD01
CCF: Antipsychotic drug (anxiolytic)
When CSF: 02.01.01.02
Manufacturer: Sun Pharmaceutical Industries Ltd. (India)

DOSAGE FORM, STRUCTURE AND PACKAGING

Solution for the/m of oil clear, Coupling, colorless to pale yellow.

1 ml
galoperidola decanoate50 mg

Excipients: benzyl alcohol, sesame oil.

1 ml – vials of dark glass (5) – packs cardboard.

Solution for injection clear, colorless.

1 ml
haloperidol5 mg

Excipients: lactic acid, methylparaben, propyl, water d / and.

1 ml – vials of dark glass (5) – packs cardboard.

Pills1 tab.
haloperidol1.5 mg

10 PC. – aluminum strips (10) – packs cardboard.

Pills1 tab.
haloperidol5 mg

10 PC. – aluminum strips (10) – packs cardboard.

The pharmacological action of SENORMA

Antipsychotics (anxiolytic), butyrophenone derivative. Has expressed antipsihoticheskim effect, does postsinapticalkie dofaminove receptors in the mezolimbicheskih and mezokortikalnyh structures of the brain. High antipsihoticheskaja activity combined with a moderate sedative effect (in small doses renders activating effect) and expressed protivorvotnam action. Ekstrapiramidnye disorders, virtually no holinoblokirutego action. Sedative effect of Alpha-adrenergic blockade retikuliarna formations barrel brain; antiemetic effect – blockade of dopamine D2-receptors trigger a Vomitoxin Centre; gipotermicescoe effect galactorea – the blockade was dofamine receptors hypothalamus. The long reception accompanied by changes in the endocrine status, in the front lobe of pituitary prolactin production increases and decreases – gonadotroponah hormones. Haloperidol decanoate versus aminazin has a more lasting effect. Eliminates persistent personality changes, delirium, hallucinations, mania, enhances interest in the surrounding. Effective in patients, resistant to others. nejrolepticheskim HP. Has some aguirutee effect. From hyperactive children eliminates excess motor activity, behavioral disorders (impulsiveness, zatrudnennouu attention, aggressiveness). Therapeutic effect of prolonged form may continue to 6 Sun.

Senor – testimony

Psychosis (manic-depressive, epileptic, against the background of schizophrenia, alcoholic, drug, including “steroidal”), psychomotor agitation of various origins, delusions and hallucinations (paranoid state, acute psychosis), Tourette's disease, mental retardation, agitated depression, Huntington Gentingtona, long-term, persistent and resistant to therapy hiccup, nausea and vomiting during chemotherapy, zaikanie, breach of conduct in elderly and childhood (incl. giperreaguosti in children, children's autism), psychosomatic disorders.

SENORMA – Contraindications

Hypersensitivity, heavy oppression CNS function in the face of intoxication of xenobiotic, coma different Genesis, CNS disorders, accompanied by a pyramid or ekstrapiramidna symptoms (incl. Parkinson's disease), depression, vapors, pregnancy, lactation, childhood (to 3 years).C care. Urological diseases of the SSA (incl. angina, intracardiac conduction disorders, Q-T interval lengthening or predisposition to this – kaliopenia, the simultaneous use of etc. PM, that can cause the lengthening of the Q-T interval), epilepsy, zakrыtougolynaya glaucoma, liver and / or kidney failure, thyrotoxicosis (with the phenomena of thyrotoxicosis), Pulmonary-Cardiac and respiratory failure (incl. When COPD and acute infectious diseases), prostate hyperplasia with delay of urine, alcoholism.

Side effects of SENORMA

From the nervous system: headache, insomnia or drowsiness (especially at the beginning of treatment), status anxiety, anxiety, excitation, fears, akathisia, euphoria or depression, lethargy, epilepsy, development of a paradoxical reaction – aggravation of psychosis and hallucinations; long-term treatment – extrapyramidal disorder, incl. pozdnyaya dyskinesia (luck and puckering of the lips, bombast, fast and cherveobraznye language movement, uncontrolled chewing movements, uncontrolled movements of arms and legs), tardive dystonia (rapid blinking or eyelid spasms, unusual facial expression or body position, uncontrolled motion curved neck, trunk, hands and feet) and neirolepticeski Malignant Syndrome (difficulty breathing or shortness of breath, tachycardia, arrhythmia, hyperthermia, increased or decreased blood pressure, increased perspiration, urinary incontinence, muscle rigidity, seizures, loss of consciousness).

From the CCC: when used in high doses – decrease in blood pressure, orthostatic hypotension, Arrhythmia, tachycardia, ECG changes (Q-T interval extension, signs of atrial and ventricular flicker).

From the digestive system: when used in high doses – decreased appetite, dry mouth, giposalivaciâ, nausea, vomiting, diarrhea or constipation, abnormal liver function, until the development of jaundice.

From the side of hematopoiesis: rarely – Temporary leukopenia or leukocytosis, agranulocytosis, eritropenia and tendency to monocitozu.

With the genitourinary system: urinary retention (when prostatic hyperplasia), peripheral edema, pain in breast, gynecomastia, hyperprolactinemia, menstrual disorders, reduced potency, increased libido, priapism.

From the senses: Cataract, retinopathy, blurred vision.

Allergic reactions: maculopapular skin changes and akneobraznye, photosensitivity, rarely – bronchospasm, laringospazm.

Laboratory findings: giponatriemiya, Hyper- or hypoglycemia.

Other: alopecia, the increase in body mass index. Overdose. Symptoms: muscle stiffness, tremor, drowsiness, decrease in blood pressure, sometimes – increased blood pressure. In severe cases, – coma, respiratory depression, shock.

Treatment: ingestion – gastric lavage, Activated carbon. When oppression breath – IVL. To improve circulation in/in introducing or plasma albumin, norepinephrine. Epinephrine in these cases apply strictly prohibited! Reduce symptoms extrapiramidale – Central and holinoblokatora anti-parkinsonian N04 HP. Dialysis nyeeffyektivyen.

Dosage and administration SENORMA

Inside, during or after a meal, squeezed full (240 ml) a glass of water or milk, initial dose for adults – 0.5-5 mg 2-3 once a day. If necessary dose gradually increased to achieve the desired therapeutic effect (average – to 10-15 mg, for chronic forms of schizophrenia – to 20-60 mg). The maximum dose – 100 mg / day. Duration of treatment – 2-3 Months. Reduce the dose slowly, maintenance doses – 5-10 mg / day. Elderly or debilitated patients early treatment appoint inwards, by 0.5-2 mg 2-3 once a day. Babies 3-12 years (or weighing 15-40 kg) in psychotic disorders – inside, 0.05 mg / kg / day 2-3 divided doses; If necessary, given the endurance dose increase to 0.5 mg 1 times during 5-7 days until the total dose 0.15 mg / kg / day. When non-psychotic behavior violations, Tourette's disease – inside, initially 0.05 mg / kg / day 2-3 divided doses, then increase the dose 0.5 mg 1 once every 5-7 days before 0.075 mg / kg / day. Childhood autism – inside, 0.025-0.05 mg / kg / day. If no effect for 1 MO treatment is not recommended to continue. In acute conditions and in the cases, When oral administration is not possible, – w / w or w / o. At “indomitable” rvote – by 1.5-2 mg 2 once a day. The average dose for a/m – 2-5 mg, the interval between wvedeniami – 4-8 no. In acute psychosis – 5-10 mg in/in or/m. The specified dose can be administered again 1-2 times at intervals of 30-40 minutes to obtain the desired effect. The maximum daily dose – 100 mg. In acute alcoholic psychosis – I /, 5-10 mg; with the poor spend an additional infusion dose 10-20 mg at a speed of not more than 10 mg / min. Solution for injection, containing galoperidola decanoate, strictly/m, by 25 mg every 15-30 days, If necessary, increase the dose to 100-150 mg (the interval between doses and adjust the dose at intervals of not less than 1 Months).

Cautions

During therapy patients should regularly monitor the ECG, blood formula, “hepatic” tests. Injecting haloperidol must be carried out under the close supervision of a physician (especially in older patients and children), When the therapeutic effect should go to ingesting. With the development of tardive dyskinesia recommended a gradual reduction of the dose (pending the complete abolition of the preparation). Use caution when performing heavy physical work, taking a hot bath (It is possible to develop heat stroke due to suppression of the Central and peripheral thermoregulation in the hypothalamus). During treatment should not take “cold and flu” OTC HP (Perhaps increased anticholinergic effects and the risk of heat stroke). Should protect exposed skin from excessive solar radiation due to increased risk of photosensitivity. Treatment ceased gradually to avoid syndrome “cancel”. Protivorvotnoe effect may mask the symptoms of drug toxicity and complicate the diagnosis of conditions, the first symptom of which is the nausea. When mixing concentrated solution for admission into levels with coffee, tea or lithium citrate syrup free haloperidol may precipitate. Before assigning the extended form, you must first translate the patient with any others. neiroleptika on haloperidol (Prevention of unexpected sensitivity to galoperidolu). Noted, What dose for children 6 mg/day are causing additional improvement in human behavior and ticks. During the period of treatment must be careful when driving and other lesson. potentially hazardous activities, require high concentration and speed of psychomotor reactions.

Interaction SENORMA

Increases the severity of oppressive influence on the central nervous system ethanol, tricyclic antidepressants, Opioid analgesics, barbiturates and tranquilizers HP, funds for general anesthesia. Reinforces the effect of peripheral m-holinoblokatorov and most gipotenziveh funds (reduces activity guanetidina due to crowding him out of Alpha adrenergic neurons and suppress his capture these neurons). Stops metabolism tricyclic antidepressants and MAO inhibitors, This increases the (mutually) their sedative effect and toxicity. Together with the use of bupropion reduces epileptic threshold and increases the risk of large seizures. Reduces the effect protivosudorozhnykh funds (lowering convulsant threshold aminazin). Ters sossoudossouerveshchee the dopamine, phenylephrine, norepinephrine, ephedrine and epinephrine (Alpha-adrenergic blockade aminazin, that could lead to distortion and epinephrine action paradoxical decrease in HELL). Reduces effect protivoparkinsonicheskih funds (antagonistic effect on CNS structures dofaminergicakie). Modifies (may increase or decrease) the effect of anticoagulants. Reduces effect bromokriptina (You may need a dose adjustment). When applying with metildopoj increases the risk of developing mental disorders (incl. disorientation in space, slowdown and difficulty thinking processes). Amphetamines reduce antipsihoticescoe effect galoperidola, which in turn reduces their psihostimuliruty effect (aminazin Alpha-adrenergic blockade). Anticholinergic, antihistamines (I generation) and anti-parkinsonian N04 HP may reinforce m-holinoblokirtee effect of haloperidol and reduced his antipsihoticescoe effect (may require dose adjustment). A long appointment of carbamazepine, barbiturates, etc.. induction mikrosomalnogo oxidation reduces the concentration of plasma levels. In combination with drugs Li + (especially in high doses) the development of encephalopathy (can cause irreversible nejrointoksikaciju) and strengthening of extrapyramidal symptoms. Together with fluoxetine increases the risk of side effects of the central nervous system, particularly extrapyramidal reactions. In an application with drugs, cause extrapyramidal reactions, increases the frequency and severity of jestrapiramidnyh disorders. The use of strong tea or coffee (especially in large quantities) reduces the effect of haloperidol.

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