Aminazine solution for injection 25mg / ml, 2ml No. 10

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BIDL3180370
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Expiration Date: 11/2025

Russian Pharmacy name:

Аминазин раствор для инъекций 25мг/мл, 2мл №10

Aminazine solution for injection 25mg / ml, 2ml No. 10

Use strictly as directed by your doctor to avoid complications!

In psychiatric practice : psychomotor agitation and psychotic states in schizophrenic patients; manic agitation in manic-depressive psychosis and other mental illnesses of various origins accompanied by fear, anxiety, and insomnia; for mood disorders and psychopathies in psychotic disorders in patients with epilepsy and organic diseases of the central nervous system to ease the state of abstinence in alcoholism and substance abuse.

In therapeutic neurological and surgical practice, Aminazin is used to relieve psychomotor agitation; as an antiemetic (including during surgery) a means to enhance the action of analgesics for persistent pain in diseases accompanied by an increase in muscle tone (after cerebrovascular accidents, etc.) to soothe hiccups to lower body temperature in anesthesiology as part of the so-called 'lytic mixtures' ...

The drug is administered intramuscularly and intravenously as a 25% solution (25 mg / ml).

For intramuscular administration, dilute with 2-5 ml of 025-05% solution of novocaine (procaine) or 09% sodium chloride solution. The solution is injected deep into the muscle.

For intravenous administration, the required amount of solution is diluted with 20 ml of 5% dextrose solution or 09% sodium chloride solution. Enter slowly over 5 minutes under the control of blood pressure.

With intramuscular administration, the daily dose usually does not exceed 600 mg. The course of treatment is from 2 weeks to 2-4 months or more. Until the end of the course of treatment, the dose of the drug is gradually reduced (by 25-50 mg per day).

With pronounced psychomotor agitation, convulsive syndrome, vomiting, a single initial dose for intramuscular administration is 100-150 mg. To relieve acute excitement, Aminazin is administered into a vein in doses of 50-75 mg (2-3 ml of a 25% solution) 1-2 times a day.

Higher doses of Aminazine for adults intravenously: single - 100 mg daily - 250 mg intramuscularly: single - 150 mg daily - 1000 mg.

For children, Aminazin is prescribed depending on age: from 3 years of age and older intramuscularly at 055 mg / kg or 15 mg / m2 of body surface, if necessary, every 6-8 hours.

Children under 5 years of age (body weight up to 23 kg) - should not be administered more than 40 mg / day from 5 to 12 years (body weight 23-46 kg) - 75 mg / day.

Weakened and elderly patients, depending on age, are prescribed up to 300 mg / day.

To stop psychomotor agitation in violation of cerebral circulation, attacks of hiccups and indomitable vomiting, Aminazin is used as part of the so-called 'lytic mixtures' containing 1-2 ml of a 25% solution of Aminazin 2 ml of a 25% solution of diprazine or 2 ml of a 2% solution of diphenhydramine 1 ml 2 % solution of promedol. The mixture is administered intravenously or intramuscularly 1-2 times a day.

1 ml of solution contains:

active substance : chlorpromazine hydrochloride in terms of 100% substance (aminazine) - 25.0 mg;

auxiliary substances : anhydrous sodium sulfite - 1.0 mg, sodium disulfite - 1.0 mg, ascorbic acid - 2.0 mg, sodium chloride - 6.0 mg, water for injection - up to 1.0 ml.

- Increased individual sensitivity;

- chronic heart failure (decompensation);

- arterial hypotension;

- pronounced suppression of the function of the central nervous system and coma of any etiology;

- head injury;

- progressive systemic diseases of the brain and spinal cord;

- pregnancy lactation period

- children's age (up to 6 months).

Carefully:

Active alcoholism (increased likelihood of developing hepatotoxic reactions) pathological changes in blood counts (impaired blood formation) breast cancer (progression of tumor growth and resistance to treatment with endocrine and cytostatic drugs) angle-closure glaucoma prostatic hyperplasia with clinical manifestations hepatic and / or renal failure; diseases accompanied by an increased risk of thromboembolic complications; Parkinson's disease epilepsy myxedema chronic diseases accompanied by respiratory failure (especially in children) a history of Reye's syndrome (increased risk of hepatotoxicity in children and adolescents); cachexia vomiting (the antiemetic effect of phenothiazines can mask vomiting associated with an overdose of other drugs) elderly age.

Trade name of the drug

Aminazin

International non-proprietary name

Chlorpromazine

Dosage form

solution for intravenous and intramuscular administration

Composition

1 ml of solution contains:

active substance : chlorpromazine hydrochloride in terms of 100% substance (aminazine) - 25.0 mg;

auxiliary substances : anhydrous sodium sulfite - 1.0 mg, sodium disulfite - 1.0 mg, ascorbic acid - 2.0 mg, sodium chloride - 6.0 mg, water for injection - up to 1.0 ml.

Description

Transparent colorless or slightly colored liquid.

Pharmacotherapeutic group

Antipsychotic (neuroleptic)

ATX code

N05AA01

Pharmacodynamics:

An antipsychotic agent (neuroleptic), a phenothiazine derivative with an aliphatic side chain. It has a pronounced antipsychotic sedative antiemetic vasodilating (alpha-adrenergic blocking) moderate M-anticholinergic and also a weak hypothermic effect soothes hiccups; has a local irritating effect.

The antipsychotic effect is due to the blockade of the dopamine D2 receptors of the mesolimbic and mesocortical systems. The antipsychotic effect is manifested in the elimination of the productive symptoms of psychosis (delusions of hallucinations). It suppresses various types of psychomotor agitation and reduces psychotic fear of aggressiveness.

The sedative effect is due to the blockade of adrenergic receptors of the reticular formation of the brain stem. One of the main features of Aminazine (in comparison with other phenothiazines) is the presence of a pronounced sedative effect, manifested by suppression of conditioned reflex activity (primarily motor defensive reflexes), a decrease in spontaneous motor activity, relaxation of skeletal muscles, a decrease in sensitivity to endogenous and exogenous stimuli with preserved consciousness.

The onset of sedation 15 minutes after intramuscular injection of the drug.

The antiemetic effect is due to the blockade of dopamine D2 receptors in the trigger zone of the vomiting center; hypothermic action - blockade of dopamine receptors of the hypothalamus.

Aminazine reduces capillary permeability, lowers blood pressure, has a weak antihistamine effect. Has a local irritating effect.

Pharmacokinetics:

Well and quickly absorbed after intramuscular injection. The maximum concentration in blood plasma after intramuscular administration is achieved in 1-2 hours. The connection with blood plasma proteins is 90-99%. It is quickly excreted from the bloodstream and accumulates unevenly in various organs. Easily penetrates the blood-brain barrier, while its concentration in the brain exceeds the concentration in plasma. There is no direct correlation between plasma concentration and therapeutic effect.

It has a 'first pass' effect through the liver where the drug is extensively metabolized as a result of oxidation (30%), hydroxylation (30%) and demethylation (20%). Pharmacological activity is possessed by hydroxylated metabolites which are inactivated by binding with glucuronic acid or by further oxidation with the formation of inactive sulfoxides.

It is excreted by the kidneys and with bile. The half-life is 15-30 hours. About 20% of the taken dose is excreted per day. 1-6% of the dose is excreted by the kidneys unchanged. Traces of metabolites can be detected in urine 12 months or more after stopping treatment. Due to the high binding to proteins, it is practically not excreted during hemodialysis.

Indications:

Use strictly as directed by your doctor to avoid complications!

In psychiatric practice : psychomotor agitation and psychotic states in schizophrenic patients; manic agitation in manic-depressive psychosis and other mental illnesses of various origins accompanied by fear, anxiety, and insomnia; for mood disorders and psychopathies in psychotic disorders in patients with epilepsy and organic diseases of the central nervous system to ease the state of abstinence in alcoholism and substance abuse.

In therapeutic neurological and surgical practice, Aminazin is used to relieve psychomotor agitation; as an antiemetic (including during surgery) a means to enhance the action of analgesics for persistent pain in diseases accompanied by an increase in muscle tone (after cerebrovascular accidents, etc.) to soothe hiccups to lower body temperature in anesthesiology as part of the so-called 'lytic mixtures' ...

Contraindications:

- Increased individual sensitivity;

- chronic heart failure (decompensation);

- arterial hypotension;

- pronounced suppression of the function of the central nervous system and coma of any etiology;

- head injury;

- progressive systemic diseases of the brain and spinal cord;

- pregnancy lactation period

- children's age (up to 6 months).

Carefully:

Active alcoholism (increased likelihood of developing hepatotoxic reactions) pathological changes in blood counts (impaired blood formation) breast cancer (progression of tumor growth and resistance to treatment with endocrine and cytostatic drugs) angle-closure glaucoma prostatic hyperplasia with clinical manifestations hepatic and / or renal failure; diseases accompanied by an increased risk of thromboembolic complications; Parkinson's disease epilepsy myxedema chronic diseases accompanied by respiratory failure (especially in children) a history of Reye's syndrome (increased risk of hepatotoxicity in children and adolescents); cachexia vomiting (the antiemetic effect of phenothiazines can mask vomiting associated with an overdose of other drugs) elderly age.

Pregnancy and lactation:

Aminazine penetrates the placental barrier, excreted in breast milk, has a teratogenic effect, prolongs labor. Use during pregnancy is contraindicated. If it is necessary to use the drug during lactation, breastfeeding should be discontinued for the duration of treatment.

Method of administration and dosage:

The drug is administered intramuscularly and intravenously as a 25% solution (25 mg / ml).

For intramuscular administration, dilute with 2-5 ml of 025-05% solution of novocaine (procaine) or 09% sodium chloride solution. The solution is injected deep into the muscle.

For intravenous administration, the required amount of solution is diluted with 20 ml of 5% dextrose solution or 09% sodium chloride solution. Enter slowly over 5 minutes under the control of blood pressure.

With intramuscular administration, the daily dose usually does not exceed 600 mg. The course of treatment is from 2 weeks to 2-4 months or more. Until the end of the course of treatment, the dose of the drug is gradually reduced (by 25-50 mg per day).

With pronounced psychomotor agitation, convulsive syndrome, vomiting, a single initial dose for intramuscular administration is 100-150 mg. To relieve acute excitement, Aminazin is administered into a vein in doses of 50-75 mg (2-3 ml of a 25% solution) 1-2 times a day.

Higher doses of Aminazine for adults intravenously: single - 100 mg daily - 250 mg intramuscularly: single - 150 mg daily - 1000 mg.

For children, Aminazin is prescribed depending on age: from 3 years of age and older intramuscularly at 055 mg / kg or 15 mg / m2 of body surface, if necessary, every 6-8 hours.

Children under 5 years of age (body weight up to 23 kg) - should not be administered more than 40 mg / day from 5 to 12 years (body weight 23-46 kg) - 75 mg / day.

Weakened and elderly patients, depending on age, are prescribed up to 300 mg / day.

To stop psychomotor agitation in violation of cerebral circulation, attacks of hiccups and indomitable vomiting, Aminazin is used as part of the so-called 'lytic mixtures' containing 1-2 ml of a 25% solution of Aminazin 2 ml of a 25% solution of diprazine or 2 ml of a 2% solution of diphenhydramine 1 ml 2 % solution of promedol. The mixture is administered intravenously or intramuscularly 1-2 times a day.

Side effects:

At the beginning of treatment, drowsiness, dizziness, dry mouth, decreased appetite, constipation, accommodation paresis, moderate orthostatic hypotension, tachycardia, sleep disorders, difficulty in urinating, decreased potency, frigidity, allergic reactions from the skin and mucous membranes (photosensitization, angioedema of the face and extremities); less often - a sharp decrease in blood pressure.

With prolonged use in high doses (05-15 g / day) - extrapyramidal disorders (dyskinesias - paroxysmal spasms of the muscles of the neck of the tongue of the bottom of the oral cavity akinetic phenomena akathisia hyperkinesis tremor and autonomic disorders) phenomena of mental indifference depression of a delayed reaction to external irritations cholestatic jelly cardiac arrhythmias lympho- and leukopenia anemia agranulocytosis hypercoagulation amenorrhea galactorrhea hyperprolactinemia gynecomastia nausea vomiting diarrhea oliguria skin pigmentation lens and corneal opacity; in isolated cases - convulsions (antiparkinsonian drugs are used as correctors - tropacin trihexyphenidil and others;dyskinesias are stopped by subcutaneous injection of 2 ml of a 20% solution of caffeine-sodium benzoate and 1 ml of 01% solution of atropine) neuroleptic malignant syndrome.

Local reactions: with intramuscular administration, infiltrates may occur with intravenous administration - phlebitis when in contact with the skin and mucous membranes - tissue irritation.

When taking neuroleptics of the phenothiazine series, there have been cases of sudden death (including possibly caused by cardiac causes); can lengthen the QT interval - the risk of developing ventricular arrhythmias (especially against the background of the initial bradycardia, hypokalemia of prolonged QT).

Overdose:

Symptoms : areflexia or hyperreflexia blurred vision of mydriasis dry mouth hyperpyrexia or hypothermia muscle rigidity vomiting respiratory depression may develop pulmonary edema;

cardiotoxic effect (development of circulatory failure arterial hypotension shock rhythm disturbance (tachycardia change in the QRS wave ventricular fibrillation asystole);

neurotoxic effect (agitation; confusion of consciousness, convulsions, disorientation, drowsiness, stupor or coma).

Treatment:

With arrhythmia - intravenous administration of phenytoin 9-11 mg / kg with circulatory failure - cardiac glycosides with a pronounced decrease in blood pressure - intravenous administration of fluids or vasopressor drugs such as norepinephrine phenylephrine (avoid prescribing alpha and beta adrenomimetics such as epinephrine because paradoxical lowering blood pressure due to blockade of alpha-adrenergic receptors with chlorpromazine) with convulsions - diazepam (avoid prescribing barbiturates due to possible subsequent depression of the central nervous system and respiratory depression) with parkinsonism - diphenyltropine diphenhydramine.

Control of the function of the cardiovascular system for at least 5 days, the function of the central nervous system of respiration; measurement of body temperature; consultation of a psychiatrist. Dialysis is ineffective.

Interaction:

Aminazine weakens the vasoconstrictor effect of ephedrine.

May mask some manifestations of ototoxicity (tinnitus dizziness) of ototoxic drugs, especially antibiotics.

Reduces the antiparkinsonian effect of levodopa (due to the induced blockade of dopamine receptors) as well as the effects of the amphetamines clonidine and guanethidine.

It enhances the anticholinergic effects of other drugs, while its own antipsychotic effect may decrease.

With the simultaneous use of Aminazine with a chemical structure related to prochlorperazine, an overdose and prolonged loss of consciousness may occur. Compatible with other antipsychotic drugs, anxiolytics and antidepressants.

Long-term combination with analgesics and antipyretics is undesirable (hyperthermia may develop).

With simultaneous use with other drugs that have a depressing effect on the central nervous system (drugs for general anesthesia, anticonvulsants, narcotic analgesics, ethanol and drugs containing it, barbiturates and other hypnotics anxiolytics (tranquilizers) and others), it is possible to increase and lengthen the deprimating effect as well as suppression breathing. Prescribing in conjunction with tricyclic antidepressants maprotiline or monoamine oxidase inhibitors increases the risk of developing neuroleptic malignant syndrome.

With drugs for the treatment of thyrotoxicosis, it increases the risk of developing agranulocytosis.

With other drugs causing extrapyramidal reactions, Aminazin increases the frequency and severity of extrapyramidal disorders.

— гипотензивными препаратами усиливает выраженность снижени¤ артериального давлени¤ в ортостазе.

јнтациды противопаркинсонические препараты лити¤ могут нарушать всасывание јминазина.

vепатотоксичные лекарственные средства при совместном применении с јминазином повышают риск развити¤ токсического вли¤ни¤ на печень.

Ќа фоне лечени¤ јминазином следует избегать введени¤ эпинефрина (из-за возможности извращени¤ эффекта эпинефрина и дальнейшего снижени¤ артериального давлени¤).

—редства угнетающие костномозговое кроветворение увеличивают риск миелосупрессии.

ќсобые указани¤:

¬о врем¤ лечени¤ необходимо следить за показател¤ми артериального давлени¤ пульсом регул¤рно контролировать функции печени почек и крови.

¬о избежание резкого снижени¤ артериального давлени¤ после внутримышечного или внутривенного введени¤ процедуру провод¤т в положении больного 'лежаФ; после применени¤ препарата больные должны оставатьс¤ в положении 'лежаФ не менее 15-2 ч (резкий переход в вертикальное положение может вызвать ортостатический коллапс). Ѕольные не должны подвергатьс¤ ультрафиолетовому облучению поскольку препарат может вызывать фотосенсибилизацию.

¬ период лечени¤ следует не допускать применени¤ этанола.

Ќеобходимо исключать возможность попадани¤ препарата на кожу и слизистые оболочки.

¬ли¤ние на способность управл¤ть трансп. ср. и мех.:

јминазин нельз¤ назначать во врем¤ работы водител¤м транспортных средств и люд¤м професси¤ которых требует повышенной концентрации внимани¤ и быстроты психомоторных реакций.

‘орма выпуска/дозировка:

Solution for intravenous and intramuscular administration of 25 mg / ml.

Packaging:

In ampoules of 1 ml 2 ml 5 ml or 10 ml. 10 ampoules together with instructions for use and a knife for opening ampoules or an ampoule scarifier in a cardboard box or 5 or 10 ampoules in a blister strip packaging.

1 or 2 blister packs with instructions for use and a knife for opening ampoules or an ampoule scarifier in a cardboard box.

When packing ampoules with a break ring or a break point, the ampoule opening knife or ampoule scarifier is not inserted.

Storage conditions:

In a dark place at a temperature of 5 to 25 ? C.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date stated on the package.

Vacation conditions

On prescription

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