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Amitriptyline solution for intravenous and intramuscular administration “Moscow endocrine plant. Amitriptyline Akos, solution for injection (ampoules) Amitriptyline instructions for use release form

The drug Amitriptyline is a synthetic drug that is used in medicine to treat various forms of neurosis. Prescribed for mild, moderate, severe depression, diagnosing nervous and phobic disorders. The drug belongs to the category of tricyclic antidepressants.

Description of the drug

Amitriptyline is a highly effective drug with a pronounced sedative, antiserotinic effect, thymoanaleptic, and anxiolytic properties. Belongs to the group of non-selective inhibitors of neuronal monoamine uptake. The antidepressant is produced by many pharmaceutical companies. Also known under the following trade names: Amirol, Triptisol, Elivel, Amizol.

Amitriptyline is available in pharmacies only with a doctor's prescription.

Amitriptyline is available in the form of tablets or pills for oral administration (orally), as well as a white crystalline powder or sterile solution for injection (for intramuscular administration).

The main active substance, regardless of the form of release of the antidepressant, is amitriptyline hydrochloride. The tablets contain 10 and 25 mg of the active ingredient (in one pill) and 20 mg of amitriptyline in each 2 ml ampoule of the injection solution.

The composition includes excipients that differ from manufacturer to manufacturer, namely: glucose, water in injections, and in pills - starch, MCC, lactose monohydrate, talc, starch, polyvinylpyrrolidone, magnesium stearate.

Store the medicine in a dry, cool place, protected from direct sunlight at a temperature of 6 to 24 degrees Celsius. Shelf life from the date of issue is three years.

Pharmacodynamics and mechanism of action

Amitriptyline, instructions for use indicate that this drug has a pronounced peripheral and central anticholinergic effect, which is due to its high affinity for m-cholinergic receptors.

The antidepressant effect of this drug is due to the suppression of neuronal reuptake of serotonin, norepinephrine, and dopamine by the membranes of presynaptic neurons. An increase in the amount of neurotransmitters improves the psychological and emotional state.

Amitriptyline reduces the severity of depressive symptoms, agitation, and eliminates feelings of anxiety in mild to moderate anxiety-depressive states.

The antidepressant has a sedative, alpha-adrenergic blocking effect. It has the properties of class-A antiarrhythmic drugs. In recommended therapeutic dosages, it inhibits and slows ventricular conduction, but in case of overdose, the medication can cause severe intraventricular block.

Important! It is worth noting that taking pharmacological drugs of this group has a so-called “antidepressive threshold”, which is manifested by the individual perception of the body. Therefore, the doctor selects a dosage that will reduce the uptake of neurotransmitters by 5-10 times, individually for each patient.

Otherwise, the antidepressant effect will not be achieved and side effects may occur.

A tricyclic antidepressant has a sedative, thymoleptic effect. It also has a sedative, antibulimic, antihistamine, and anticholinergic effect. With long-term use of the drug, the balance of systems disturbed due to depressive conditions is restored.

The drug Amitriptyline has an additional analgesic effect of central origin. Due to the blocking of H2-histamine receptors in the parietal cells (ventricular walls), an antiulcer effect is provided. In addition, the medication lowers body temperature and blood pressure during general anesthesia.

The maximum concentration of the drug in the bloodstream occurs after 3-12 hours. Metabolized in the liver, where it forms active and inactive metabolites. It is excreted from the body in urine. complete elimination takes one to two weeks.

The antidepressant effect is noted approximately three to four weeks from the start of drug use.

Indications for use

The antidepressant, frequency of administration, and duration of course are prescribed by the attending physician on an individual basis.

Indications:

depressive and anxiety states of various etiologies (endogenous, reactive);
moderate, mild, severe depression;
emotional disorders accompanied by behavioral disorders;
sleep disorders (insomnia);
schizophrenic psychoses;
chronic neurogenic pain:
phobias, panic attacks;
bulimic neuroses, psychogenic anorexia.

The antidepressant Amitriptyline is also used in pediatrics for the treatment of nocturnal enuresis in children, which is also caused by weakness of the bladder sphincter.

An antidepressant relieves headaches caused by migraines. The drug is prescribed for the treatment of gastrointestinal ulcers, and for the treatment of alcohol and drug addiction.

Instructions for use

According to the instructions, amitriptyline tablets should be taken after meals or during meals. Without chewing the pills, you need to drink plenty of water.

The initial daily dose of the drug is 50-75 mg, divided into two to three doses. Gradually increase the dosage to 150-200 mg per day to achieve the best effect. Sometimes the dose is increased to 300 mg or more (up to the maximum tolerated dose). In this case, the daily dose is divided into three doses, with most of the medication taken before bedtime.

Important! The dosage of any antidepressant should be increased gradually.

15-30 days after achieving the desired pronounced therapeutic effect, the dosage is gradually reduced. After improvement of the condition, the minimum daily dose may be 25-50 mg.
But a sharp decrease is unacceptable, since withdrawal syndrome may develop.

When treating childhood enuresis, amitriptyline is prescribed 10-25 mg at bedtime. The dose is calculated individually based on the recommendation of 2.5 mg per kg of child weight. For childhood depression, 1.5 mg per kg of body weight is prescribed.

Contraindications for use

Amitriptyline has many contraindications, so before use, carefully read the instructions for the medication.

Contraindications:

myocardial infarction;
chronic heart failure;
disruption of cardiac muscle conduction;
chronic liver pathologies, renal failure;
exacerbation of peptic ulcer;
blood diseases;
prostate hypertrophy;
pregnancy, lactation;
disturbances in the functioning of the urinary system.

Amitriptyline is strictly prohibited for use in children under six years of age. The antidepressant is used with caution for secondary glaucoma, bronchial asthma, epilepsy, intraocular hypertension, manic-depressive psychoses, inhibition of bone marrow hematopoiesis, urinary retention, thyrotoxicosis.

The drug is not prescribed to patients who have individual intolerance to the constituent components of the drug.

Side effects

If there are no contraindications to taking amitriptyline, or hypersensitivity of the body, if the dosage is observed, side effects rarely occur. Excessive abuse or non-compliance with the dose can provoke poisoning, intoxication, and a number of side effects.

In case of overdose note:

dizziness;
nausea, diarrhea, vomiting, heartburn;
instability of blood pressure;
allergic manifestations, itching, skin rash;
decreased libido;
epileptic seizures, convulsions, spasms;
impaired coordination of movements, disorientation in space;
tinnitus, severe headaches;
angioedema;
decreased visual function;
gastralgia;
constipation, intestinal obstruction;
difficulty urinating;
dry mouth;
darkening of the tongue;
increased excitability, irritability;
anemia of the mucous membranes;
changes in the circulatory formula;
increased intraocular pressure;
enlarged lymph nodes;
change in taste sensations.

Patients may experience nightmares, hallucinations, and sleep disturbances. The heart rate increases (tachycardia, arrhythmia), sweating increases, and the general temperature rises. Coma may occur.

If symptoms of overdose occur, consult a doctor immediately. To avoid serious complications, emergency medical attention is required. In case of individual intolerance, the course of treatment with amitriptyline is stopped. Patients are prescribed another antidepressant.

Before carrying out therapy, blood pressure levels must be monitored. Parenteral Amitriptyline is used only under the supervision of a physician in a hospital setting. In the first days of treatment, patients are advised to remain in bed.

Compatibility with other drugs

The antidepressant Amitriptyline enhances the inhibitory effect on the central nervous system when interacting with hypnotics, sedatives, anticonvulsants, analgesics, and premedications.

The drug cannot be combined with alcohol or drugs, increasing their toxic effects on the body. During the entire treatment period, the consumption of any alcoholic beverages is strictly prohibited, as this can lead to very serious consequences, functional failures and disorders in the body. If you take alcohol and the drug at the same time, your heart rhythm is disturbed, your blood pressure increases, and paralytic obstruction occurs.

With the simultaneous use of amitriptyline with neuroleptics, an increase in general temperature and the development of paralytic intestinal obstruction are possible.

In combination with anticonvulsants and guanethidine, their therapeutic effect may be weakened. When used simultaneously, Amitriptyline increases the activity of anticoagulants. In combination with cimetidine, the concentration of amitriptyline in the bloodstream increases, which increases its toxic effect on the body as a whole.

The combination of amitriptyline with carbamazepine and barbiturates reduces the concentration of the antidepressant. When used with estrogen-based oral contraceptives, the bioavailability of the tranquilizer increases.

Amitriptyline can also increase depression caused by glucocorticosteroids.

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Compound

Amitriptyline dragees and tablets contain 10 or 25 mg of the active substance in the form amitriptyline hydrochloride.

Additional substances in the tablets are: microcrystalline cellulose, talc, lactose monohydrate, silicon dioxide, magnesium stearate, pregelatinized starch.

Additional substances in the dragees are: magnesium stearate, potato starch, talc, polyvinylpyrrolidone, lactose monohydrate.

1 ml of solution contains 10 mg of active substance. Additional substances are: hydrochloric acid (sodium hydroxide), dextrose monohydrate, water for infusion, sodium chloride, benzethonium chloride.

Release form

The drug is available in the form of tablets, dragees and solution.

Pharmacological action

Tricyclic antidepressant . Has a sedative, thymoleptic effect. It has an additional analgesic effect of central origin.

Pharmacodynamics and pharmacokinetics

MNN: Amitriptyline.

The drug reduces appetite, eliminates nighttime urinary incontinence, and has antiserotonin action. The drug has a strong central and peripheral anticholinergic effect. Antidepressant effect is achieved by increasing the concentration of serotonin in the nervous system and norepinephrine in synapses. Long-term therapy leads to a decrease in the functional activity of serotonin and beta-adrenergic receptors in the brain. Amitriptyline reduces the severity of depressive symptoms, agitation , anxiety during anxiety and depression . By blocking H2-histamine receptors in the stomach wall (parietal cells), an antiulcer effect is provided. The medication is able to reduce body temperature, the level during general anesthesia. The drug does not inhibit monoamine oxidases. The antidepressant effect appears after 3 weeks of therapy.

The maximum concentration of the substance in the blood occurs after a few hours, usually after 2-12. Excreted as metabolites in urine. Binds well to proteins.

Indications for use of Amitriptyline

What are tablets and solution usually prescribed for?

The drug is indicated for depression (agitation, anxiety, sleep disorders, alcohol withdrawal, with organic brain lesions, neurotic withdrawal), with behavioral disorders, mixed emotional disorders, nocturnal enuresis , chronic pain syndrome (with cancer, with postherpetic neuralgia ), for bulimia nervosa, for migraine (for prevention), for. Indications for the use of Amitriptyline in tablets and in other forms of release are the same.

Contraindications

According to the annotation, the medicine is not used if the main component is intolerant, if angle-closure glaucoma , acute intoxication with psychoactive, analgesic, hypnotics, and acute alcohol intoxication. The medication is contraindicated in breastfeeding, severe intraventricular conduction disorders, and antioventricular conduction disorders. With pathology of the cardiovascular system, with suppression of bone marrow hematopoiesis, manic-depressive psychoses , chronic alcoholism, decreased motor function of the digestive system, stroke, liver and kidney pathology, intraocular hypertension , urinary retention, prostatic hyperplasia, bladder hypotension, thyrotoxicosis, pregnancy, epilepsy Amitriptyline is prescribed with caution.

Side effects of Amitriptyline

Nervous system: agitation, hallucinations, fainting, asthenia, drowsiness, anxiety, hypomanic state, increased depression, depersonalization, motor restlessness, increased epileptic seizures, extrapyramidal syndrome , ataxia, myoclonus, paresthesia in the form of peripheral neuropathy, tremor of small muscles, headaches.

Anticholinergic effects: increased, blurred vision, mydriasis, dry mouth, tachycardia , difficulty urinating, paralytic ileus, delirium, confusion, decreased sweating.

Cardiovascular system: instability of blood pressure, intraventricular conduction disorders , arrhythmia, orthostatic hypotension , dizziness, palpitations, tachycardia.

Digestive tract: darkening of the tongue, diarrhea, changes in taste perception, vomiting, gastralgia, hepatitis, cholestatic jaundice.

Endocrine system: galactorrhea, hyperglycemia, decreased potency or increased libido, increased size of the mammary glands, gynecomastia, testicular swelling, syndrome of inappropriate ADH secretion, hyponatremia. Also noted hypoproteinemia , pollakiuria, urinary retention, enlarged lymph nodes, hyperpyrexia, swelling, tinnitus, hair loss.

When discontinuing the drug, unusual agitation, sleep disturbances, malaise, headache, diarrhea, nausea, unusual dreams, restlessness, irritability . When administered intravenously, a burning sensation, lymphangitis, thrombophlebitis, etc. are noted.

Reviews of the side effects of Amitriptyline are quite frequent. When using the drug, addiction may also occur.

Amitriptyline, instructions for use (Method and dosage)

The medicine is taken orally immediately after eating, without chewing, which ensures the least irritation of the stomach walls. The initial dosage is 25-50 mg at night for adults. Within 5 days, the amount of the drug is increased to 200 mg per day in 3 doses. If there is no effect within 2 weeks, the dose is increased to 300 mg.

Solutions are administered slowly intravenously and intramuscularly, 20-40 mg 4 times a day with a gradual transition to oral administration. The course of therapy is no more than 8 months. For prolonged headaches, for migraines, chronic pain syndrome of neurogenic origin, for migraines, 12.5-100 mg per day is prescribed.

Instructions for use of Amitriptyline Nycomed are similar. Before use, be sure to familiarize yourself with the contraindications for the drug.

Overdose

Manifestations from the outside nervous system: coma, stupor, increased drowsiness, anxiety, hallucinations, ataxia, epileptic syndrome, choreoathetosis , hyperreflexia, muscle tissue rigidity, confusion, disorientation, impaired concentration, psychomotor agitation.

Manifestations of an overdose of Amitriptyline from the side cardiovascular system: intracardiac conduction disturbance, arrhythmia, tachycardia, drop in blood pressure, shock, heart failure , rarely - cardiac arrest.

Also noted are oliguria, increased sweating, hyperthermia , vomiting, shortness of breath, depression of the respiratory system, cyanosis. Possible drug poisoning.

To avoid the negative consequences of an overdose, emergency gastric lavage and administration of cholinesterase inhibitors are required in case of severe anticholinergic manifestations. It is also required to maintain water and electrolyte balance, blood pressure levels, control over the functioning of the cardiovascular system, and carry out resuscitation and anticonvulsant measures if necessary. Forced diuresis , as well as hemodialysis have not proven effective in treating an overdose of Amitriptyline.

Interaction

Hypotensive effect respiratory depression , a depressant effect on the nervous system is observed with the joint prescription of medications that depress the functioning of the central nervous system: general anesthetics, benzodiazepines, barbiturates, antidepressants and others. The drug increases the severity of the anticholinergic effect when taken , antihistamines , biperiden, atropine, antiparkinsonian drugs, phenothiazine. The drug enhances the anticoagulant activity of indadione, coumarin derivatives, and indirect anticoagulants. There is a decrease in efficiency alpha blockers , phenytoin. , increase the concentration of the drug in the blood. The risk of developing epileptic seizures increases, and the central anticholinergic and sedative effects also increase when combined with benzodiazepines, phenothiazines, and anticholinergics. Simultaneous use methyldopa , betanidine, guanethidine, reduces the severity of their hypotensive effect. When taking cocaine, arrhythmia develops. Delirium develops when taking acetaldehydrogenase inhibitors. Amitriptyline enhances the effects on the cardiovascular system , norepinephrine, , isoprenaline. The risk of hyperpyrexia increases when taking antipsychotics and m-anticholinergics.

Terms of sale

Prescription or not? The medicine is not sold without a prescription.

Storage conditions

In a dry, dark place, out of reach of children, at a temperature of no more than 25 degrees Celsius.

Best before date

No more than 3 years.

Special instructions

Before carrying out therapy, monitoring blood pressure levels is mandatory. Parenteral Amitriptyline is administered exclusively under the supervision of a physician in a hospital setting. In the first days of treatment it is necessary to observe bed rest. A complete abstinence from ethanol intake is required. Abrupt refusal of therapy can cause withdrawal syndrome . The drug at a dose of more than 150 mg per day leads to a decrease in the threshold of convulsive activity, which is important to consider when developing epileptic seizures in patients with a predisposition. Possible development of hypomanic or manic states in persons with cyclical, affective disorders during the depressive phase. If necessary, treatment is resumed with small doses after relief of these conditions. Caution should be exercised when treating individuals taking thyroid hormone medications due to the possible risk of cardiotoxic effects. The medication can provoke the development of paralytic intestinal obstruction in elderly people, as well as those prone to chronic constipation. It is imperative to warn anesthesiologists about taking amitriptyline before performing local or general anesthesia. Long-term therapy provokes development. The need for riboflavin may increase. Amitriptyline passes into breast milk and causes increased drowsiness in infants. The medication affects driving.

The medicine is described in Wikipedia.

Amitriptyline and alcohol

Amitriptyline analogues

Level 4 ATX code matches:

Analogues of the drug are: Saroten And Amitriptyline Hydrochloride .

Amitriptyline is a synthetic drug that is used to treat depression, nervous disorders, psychogenic and other pathologies caused by psychological disorders. Belongs to tricyclic antidepressants.

Amitriptyline is produced by many pharmaceutical companies, both under the same trade name and under other names: Amirol, Triptisol, Elivel, Amizol, etc.

The active ingredient in all drugs is amitriptyline hydrochloride. Tablet forms are available containing 10 and 25 mg of the active ingredient per tablet, and injection forms contain 20 mg of amitriptyline in each ampoule (2 ml).

In addition to the active ingredient, the composition also contains auxiliary substances. They differ from one manufacturer to another. Most often, the injection solution contains glucose and water, and the tablets contain starch, MCC, lactose monohydrate, talc and magnesium stearate.

Pharmacological action and its mechanism

Amitriptyline has antidepressant, anticholinergic, antiulcer, antiserotinic, some analgesic, sedative, thymoleptic effects, and also eliminates enuresis.

The antidepressant effect of the drug is manifested due to its ability to suppress the reverse neuronal uptake of norepinephrine, serotonin and dopamine membranes of presynaptic neurons.

The accumulation of these neurotransmitters ensures an improvement in psychological state and the disappearance of signs of depression.

When using drugs in this group, the so-called “antidepressive threshold” must be taken into account. It manifests itself in individual perception of the drug, as a result of which for each patient it is necessary to select a dose of the drug that will reduce the uptake of neurotransmitters by 5-10 times.

If this is not achieved, then the antidepressant effect will not appear, but only nonspecific effects and side effects will be present. The antidepressant effect of treatment with the drug appears no earlier than after 2-3 weeks of continuous use.

Thanks to the demonstrated thymoleptic effect, there is an improvement in well-being and mood.

The anticholinergic effect is provided by a strong affinity for m-cholinergic receptors. Due to its affinity for H1-histamine receptors and its alpha-adrenergic blocking effect, the drug has a strong sedative effect.

The antiulcer effect of the drug is achieved due to its ability to block H2 receptors in gastric cells. In this case, there is an elimination of pain and acceleration of healing of ulcerative-erosive lesions of the gastrointestinal mucosa.

The analgesic effect of the drug is associated with an increase in the concentration of monoamines, in particular serotonin, in the central nervous system.

Elimination of urinary incontinence at night is provided by anticholinergic action, which increases the ability of the bladder to distend, as well as beta-adrenergic stimulation, which leads to increased sphincter tone.

The mechanism of action of the drug in the fight against bulimia has not yet been clarified. Amitriptyline is effective for people with and without depression.

Pharmacokinetics of the drug

Amitriptyline is well and quickly absorbed when it enters the gastrointestinal tract. The maximum content in the blood is observed after 2-6 hours, the half-life is about 10-26 hours. The active substance binds to blood proteins very well, almost 95%.

The drug is metabolized in the liver, forming active and inactive metabolites. The elimination of the drug is ensured by the kidneys. Complete elimination from the body occurs in 1-2 weeks.

The drug penetrates the histohematic and placental barriers, as well as into breast milk.

Indications for use

Indications for the use of Amitriptyline are as follows:

Contraindications for use

Amitriptyline has a large number of contraindications that significantly limit the possibility of its use; taking the medication is prohibited if:

myocardial infarction in the acute and recovery period;
acute liver diseases;
heart failure;
disorders of myocardial conduction functions;
hypertension;
exacerbations of gastric and duodenal ulcers;
impaired renal function;
prostate hypertrophy;
paralytic ileus;
pyrolytic stenosis;
atony of the bladder;
pregnancy;
breastfeeding;
children under 6 years of age (tablets) and 12 years of age (injection forms);
hypersensitivity to the components of the drug;
simultaneous use of MAO inhibitors, as well as with a break of less than 2 weeks after taking them.

Particular care should also be taken when using the medicine when:

alcoholism;
bronchial asthma;
inhibition of the hematopoietic process;
glaucoma;
schizophrenia;
manic-depressive psychosis;
intraocular hypertension.

How to take the medicine - scheme and dosage

Amitriptyline tablets are taken orally during or immediately after a meal.

The dosage of the drug is selected on a strictly individual basis. The initial daily dose is usually from 50 to 75 mg, divided into 2-3 doses.

The dose of the drug must be gradually increased until the best therapeutic effect is achieved. Usually it is enough to increase the intake to 150-200 mg per day, but in some cases it may be necessary to take 300 mg or more (up to the maximum tolerated dose). In this case, the daily dose is also divided into 3 doses, with most of the dose taken at night.

After 2 weeks to a month after achieving the required severity of the therapeutic effect, the dosage of the medication begins to be gradually reduced. Abruptly discontinuing the drug is prohibited due to the possible development of withdrawal syndrome.

If the symptoms of depression begin to return, then taking the medication in high doses is started again. The drug is discontinued (gradually) if there is no treatment success within a month of therapy. Elderly patients are advised not to exceed a daily dose of 100 mg.

In case of severe severe depression, the drug is taken intravenously or intramuscularly at a dose of 10-40 mg up to 4 times a day.

The maximum permissible daily dose is 150 mg. After 1-2 weeks, injections should be gradually replaced with the tablet form of the drug.

To get rid of chronic neurogenic pain, the drug is taken at a dose of 12.5-100 mg per day.

For the treatment of childhood enuresis, the drug is prescribed 10-25 mg at bedtime. The dose is calculated individually based on the recommendation of 2.5 mg per kg of child weight.

For childhood depression, 1.5 mg per kg of body weight is prescribed.

Cases of overdose

Excessive use of Amitriptyline may result in an overdose. Since everyone has a different sensitivity threshold to the drug, it is impossible to accurately say the amount of the drug that will provoke this condition.

In case of overdose, the following are observed: disorientation, shortness of breath, fever, dizziness, dilated pupils, disturbances of consciousness, arrhythmia, increased drowsiness, hypotension, respiratory depression, hallucinations, agitation, convulsions, coma.

If any symptoms of overdose occur, stop taking the drug immediately and contact a medical facility for help. Gastric lavage, normalization of water-electrolyte balance and blood pressure, and symptomatic therapy are carried out.

Monitoring the state of the cardiovascular system for at least 5 days is very important, since the attack may recur after 48 hours or more.

Side effect

Amitriptyline, when taken in large quantities, causes numerous side effects. Taking it can provoke the development of problems with almost all organs and systems.

Due to blocking of m-cholinergic receptors, it can:

increase intraocular pressure;
dry mouth occurs;
impaired vision;
delayed urination;
constipation and intestinal obstruction occur;
sweating increases;
accommodation paresis develops;
body temperature rises.

These side effects usually disappear after getting used to the drug or as a result of reducing the dose.

Other side effects caused by the complex manifestation of all the actions of the drug are also possible:

With long-term use of high doses of the drug, cardiotoxicity is likely to develop.

Separately, it should be noted the symptoms characteristic of withdrawal syndrome: increased excitability, diarrhea, nausea, headaches, vomiting, irritability, sleep disturbances with unusual dreams.

Special instructions

Amitriptyline reduces attention and causes drowsiness. Because of this, its use is not recommended when driving, as well as performing work that requires increased concentration.

Drug and alcohol

While using Amitriptyline, drinking alcohol is strictly prohibited, as this can lead to serious consequences.

This is explained by the similarity of the mechanisms of action of the drug and alcohol, which is expressed in the mutual strengthening of the effect on the body and the most pronounced toxic effect.

With the simultaneous use of alcohol and medication, the temperature and blood pressure may rise significantly, the heart rhythm may be disturbed, and paralytic obstruction may occur.

In addition, due to the inhibitory effect on the respiratory center, breathing may be impaired until it stops completely and death occurs.

Also, the simultaneous use of alcohol and Amitriptyline has a very negative effect on the liver and kidneys. Toxic liver necrosis and severe renal dysfunction may develop.

Other important nuances

It is prohibited to take the drug if there are serious dysfunctions of these organs.

The use of the drug during pregnancy and lactation is prohibited. Tablets are taken from the age of 6 years, and an injection solution - from 12 years.

Practical application experience

Amitriptyline is a fairly old drug, so there are a sufficient number of reviews about it from both doctors and patients. For the most part they are positive, but there are also nuances.

A word from the experts

Amitriptyline is one of the most effective antidepressants. When taking it, patients experience an improvement in mood almost after the first doses, and after a week of treatment, an increase in self-esteem is observed.

After a full course of treatment, one can note the disappearance of nightmares, improved sleep quality and the disappearance of suicidal tendencies.

take only as prescribed by a doctor;

carefully read the instructions before starting treatment and keep them throughout the entire treatment period;

do not exceed recommended doses;

Increase the dose gradually;

Under no circumstances should it be taken simultaneously with alcohol.

Pros and cons based on reviews and practical experience

high efficiency;
affordable price.

many contraindications and side effects;
prescription sales.

Purchasing the drug and its analogues

Average price of Amitriptyline in pharmacies:

table 25 mg No. 50 – 29 -60 rubles;
table 10 mg No. 50 – 20-50 rubles;
2ml ampoules No. 10 – 25-67 rubles.

The drug is dispensed from pharmacies strictly according to a doctor's prescription.

Quite a lot of Amitriptyline analogs are produced that have a similar active ingredient: Vero-Amitriptyline, Nycomed Damilena maleinate, Saroten retard, Elivel, Amizol, Elivel, Amirol.

In some cases, it is possible to replace it with a drug of the same pharmacological group: Clofranil, Doxepin, etc. Such a replacement of drugs can only be carried out by the attending physician.

Detailed instructions for use are published on this page. Amitriptyline. The available dosage forms of the drug are listed (tablets and dragees 10 mg and 25 mg, injections in ampoules), as well as its analogues. Information is provided on the side effects that Amitriptyline can cause and on interactions with other medications. In addition to information about the diseases for the treatment and prevention of which the drug is prescribed (depression, anxiety, psychosis, migraine), administration algorithms, possible dosages for adults and children are described in detail, and the possibility of use during pregnancy and breastfeeding is clarified. The abstract for Amitriptyline is supplemented with reviews from patients and doctors. Interaction of the drug with alcohol.

Instructions for use and dosage

Administered orally, without chewing, immediately after meals (to reduce irritation of the gastric mucosa).

Adults

For adults with depression, the initial dose is 25-50 mg at night, then the dose can be gradually increased, taking into account the effectiveness and tolerability of the drug, to a maximum of 300 mg per day in 3 divided doses (the largest part of the dose is taken at night). When a therapeutic effect is achieved, the dose can be gradually reduced to the minimum effective, depending on the patient's condition. The duration of the course of treatment is determined by the patient’s condition, the effectiveness and tolerability of the therapy and can range from several months to 1 year, and if necessary, more. In old age with mild disorders, as well as with bulimia nervosa, as part of complex therapy for mixed emotional disorders and behavioral disorders, psychoses in schizophrenia and alcohol withdrawal, a dose of 25-100 mg per day (at night) is prescribed, after achieving a therapeutic effect, switch for the minimum effective dose - 10-50 mg per day.

For the prevention of migraines, with chronic pain syndrome of a neurogenic nature (including prolonged headaches), as well as in the complex therapy of gastric and duodenal ulcers - from 10-12.5-25 to 100 mg per day (maximum part of the dose taken at night).

Children

For children as an antidepressant: from 6 to 12 years old - 10-30 mg per day or 1-5 mg/kg per day in fractions, in adolescence - up to 100 mg per day.

For nocturnal enuresis in children 6-10 years old - 10-20 mg per day at night, 11-16 years old - up to 50 mg per day.

Release forms

Tablets 10 mg and 25 mg.

Dragee 25 mg.

Solution for intravenous and intramuscular administration (injections in injection ampoules).

Amitriptyline- antidepressant (tricyclic antidepressant). It also has some analgesic (of central origin), antiserotonin effect, helps eliminate bedwetting and reduces appetite.

It has a strong peripheral and central anticholinergic effect due to its high affinity for m-cholinergic receptors; strong sedative effect associated with affinity for H1-histamine receptors and alpha-adrenergic blocking effect.

It has the properties of a class IA antiarrhythmic drug; like quinidine in therapeutic doses, it slows down ventricular conduction (in overdose it can cause severe intraventricular block).

The mechanism of antidepressant action is associated with an increase in the concentration of norepinephrine and/or serotonin in the central nervous system (CNS) (decreasing their reabsorption).

The accumulation of these neurotransmitters occurs as a result of inhibition of their reuptake by the membranes of presynaptic neurons. With long-term use, it reduces the functional activity of beta-adrenergic and serotonin receptors in the brain, normalizes adrenergic and serotonergic transmission, and restores the balance of these systems, disturbed during depressive states. In anxiety-depressive conditions, it reduces anxiety, agitation and depressive symptoms.

The mechanism of antiulcer action is due to the ability to have a sedative and m-anticholinergic effect. Efficacy for bedwetting appears to be due to anticholinergic activity leading to increased bladder distensibility, direct beta-adrenergic stimulation, alpha-adrenergic agonist activity leading to increased sphincter tone, and central blockade of serotonin uptake. It has a central analgesic effect, which is believed to be associated with changes in the concentration of monoamines in the central nervous system, especially serotonin, and an effect on endogenous opioid systems.

The mechanism of action in bulimia nervosa is unclear (may be similar to that in depression). A clear effect of the drug on bulimia has been shown in patients both without depression and in its presence, while a decrease in bulimia can be observed without a concomitant weakening of depression itself.

During general anesthesia, it reduces blood pressure and body temperature. Does not inhibit monoamine oxidase (MAO).

The antidepressant effect develops within 2-3 weeks after the start of use.

Pharmacokinetics

Absorption is high. Passes (including nortriptyline, a metabolite of amitriptyline) through histohematic barriers, including the blood-brain barrier, placental barrier, and penetrates into breast milk. Excreted by the kidneys (mainly in the form of metabolites) - 80% in 2 weeks, partly with bile.

Indications

depression (especially with anxiety, agitation and sleep disorders, including in childhood, endogenous, involutional, reactive, neurotic, medicinal, with organic brain damage);
as part of complex therapy it is used for mixed emotional disorders, psychoses in schizophrenia, alcohol withdrawal, behavioral disorders (activity and attention), nocturnal enuresis (except for patients with bladder hypotension), bulimia nervosa, chronic pain syndrome (chronic pain in cancer patients, migraine, rheumatic diseases, atypical pain in the face, postherpetic neuralgia, post-traumatic neuropathy, diabetic or other peripheral neuropathy), headaches, migraines (prevention), gastric and duodenal ulcers.

Contraindications

hypersensitivity;
use together with MAO inhibitors and 2 weeks before starting treatment;
myocardial infarction (acute and subacute periods);
acute alcohol intoxication;
acute intoxication with sleeping pills, analgesics and psychoactive drugs;
angle-closure glaucoma;
severe disturbances of AV and intraventricular conduction (bundle branch block, AV block 2 degrees);
lactation period;
children under 6 years of age;
galactose intolerance;
lactase deficiency;
glucose-galactose malabsorption.

Special instructions

Caution is required when suddenly moving to a vertical position from a lying or sitting position.

During the treatment period, the use of ethanol should be avoided.

Prescribed no earlier than 14 days after discontinuation of MAO inhibitors, starting with small doses.

If you suddenly stop taking it after long-term treatment, withdrawal syndrome may develop.

Amitriptyline in doses above 150 mg per day reduces the threshold of convulsive activity (the risk of epileptic seizures in predisposed patients should be taken into account, as well as in the presence of other factors predisposing to the occurrence of convulsive syndrome, for example, brain damage of any etiology, simultaneous use of antipsychotic drugs (neuroleptics) ), during the period of withdrawal from ethanol or withdrawal of medications with anticonvulsant properties, for example, benzodiazepines). Severe depression is characterized by a risk of suicidal actions, which can persist until significant remission is achieved. In this regard, at the beginning of treatment, a combination with drugs from the group of benzodiazepines or antipsychotic drugs and constant medical supervision (entrust trusted persons with the storage and dispensing of drugs) may be indicated. In children, adolescents and young adults (under 24 years of age) with depression and other mental disorders, antidepressants, compared with placebo, increase the risk of suicidal thoughts and suicidal behavior. Therefore, when prescribing amitriptyline or any other antidepressants in this category of patients, the risk of suicide should be weighed against the benefits of their use. In short-term studies, the risk of suicide did not increase in people over 24 years of age, but it decreased slightly in people over 65 years of age. During treatment with antidepressants, all patients should be monitored for early detection of suicidal tendencies.

In patients with cyclic affective disorders during the depressive phase, manic or hypomanic states may develop during therapy (reducing the dose or discontinuing the drug and prescribing an antipsychotic drug is necessary). After relief of these conditions, if indicated, treatment in low doses can be resumed.

Due to possible cardiotoxic effects, caution is required when treating patients with thyrotoxicosis or patients receiving thyroid hormone preparations.

In combination with electroconvulsive therapy, it is prescribed only under the condition of careful medical supervision.

In predisposed patients and elderly patients, it can provoke the development of drug-induced psychoses, mainly at night (after discontinuation of the drug, they disappear within a few days).

May cause paralytic ileus, primarily in patients with chronic constipation, the elderly, or those forced to bed rest.

Before performing general or local anesthesia, the anesthesiologist should be warned that the patient is taking amitriptyline.

Due to the anticholinergic effect, there may be a decrease in tear production and a relative increase in the amount of mucus in the tear fluid, which can lead to damage to the corneal epithelium in patients using contact lenses.

With long-term use, an increase in the incidence of dental caries is observed. The need for riboflavin may be increased.

Animal reproduction studies have shown adverse effects on the fetus, and there are no adequate and well-controlled studies in pregnant women. In pregnant women, the drug should be used only if the expected benefit to the mother outweighs the potential risk to the fetus.

Children are more sensitive to acute overdose, which should be considered dangerous and potentially fatal to them.

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Side effect

blurred vision;
mydriasis;
increased intraocular pressure (only in persons with a local anatomical predisposition - a narrow angle of the anterior chamber);
drowsiness;
fainting conditions;
fatigue;
irritability;
anxiety;
disorientation;
hallucinations (especially in elderly patients and patients with Parkinson's disease);
anxiety;
mania;
memory impairment;
decreased ability to concentrate;
insomnia;
"nightmare" dreams;
asthenia;
headache;
ataxia;
increased frequency and intensification of epileptic seizures;
changes in the electroencephalogram (EEG);
tachycardia;
feeling of heartbeat;
dizziness;
orthostatic hypotension;
arrhythmia;
lability of blood pressure (decrease or increase in blood pressure);
dry mouth;
constipation;
nausea, vomiting;
heartburn;
gastralgia;
increased appetite and body weight or decreased appetite and body weight;
stomatitis;
change in taste;
diarrhea;
darkening of the tongue;
increase in size (swelling) of the testicles;
gynecomastia;
increase in the size of the mammary glands;
galactorrhea;
decreased or increased libido;
decreased potency;
skin rash;
photosensitivity;
angioedema;
hives;
hair loss;
tinnitus;
swelling;
hyperpyrexia;
swollen lymph nodes;
urinary retention.

Drug interactions

When ethanol (alcohol) is used together with drugs that depress the central nervous system (including other antidepressants, barbiturates, benzodiazepines and general anesthetics), a significant increase in the depressant effect on the central nervous system, respiratory depression and hypotensive effect is possible. Increases sensitivity to drinks containing ethanol (alcohol).

Increases the anticholinergic effect of drugs with anticholinergic activity (for example, phenothiazine derivatives, antiparkinsonian drugs, amantadine, atropine, biperiden, antihistamines), which increases the risk of side effects (from the central nervous system, vision, intestines and bladder). When used together with anticholinergic blockers, phenothiazine derivatives and benzodiazepines, there is a mutual enhancement of the sedative and central anticholinergic effects and an increased risk of epileptic seizures (lowering the threshold of convulsive activity); Phenothiazine derivatives may also increase the risk of neuroleptic malignant syndrome.

When used together with anticonvulsants, it is possible to enhance the inhibitory effect on the central nervous system, reduce the threshold of convulsive activity (when used in high doses) and reduce the effectiveness of the latter.

When used together with antihistamines, clonidine - increased inhibitory effect on the central nervous system; with atropine - increases the risk of paralytic intestinal obstruction; with drugs that cause extrapyramidal reactions - an increase in the severity and frequency of extrapyramidal effects.

With the simultaneous use of amitriptyline and indirect anticoagulants (coumarin or indadione derivatives), the anticoagulant activity of the latter may increase. Amitriptyline may enhance depression caused by glucocorticosteroids (GCS). Medicines used to treat thyrotoxicosis increase the risk of developing agranulocytosis. Reduces the effectiveness of phenytoin and alpha-blockers.

Inhibitors of microsomal oxidation (cimetidine) prolong T1/2, increase the risk of developing toxic effects of amitriptyline (a dose reduction of 20-30% may be required), inducers of microsomal liver enzymes (barbiturates, carbamazepine, phenytoin, nicotine and oral contraceptives) reduce plasma concentrations and reduce the effectiveness of amitriptyline.

Combined use with disulfiram and other acetaldehydrogenase inhibitors provokes delirium.

Fluoxetine and fluvoxamine increase plasma concentrations of amitriptyline (a 50% reduction in amitriptyline dose may be required).

With the simultaneous use of amitriptyline with clonidine, guanethidine, betanidine, reserpine and methyldopa - a decrease in the hypotensive effect of the latter; with cocaine - the risk of developing cardiac arrhythmias.

Antiarrhythmic drugs (such as quinidine) increase the risk of developing rhythm disturbances (possibly slowing down the metabolism of amitriptyline).

Pimozide and probucol may increase cardiac arrhythmias, which is manifested by prolongation of the QT interval on the ECG.

It enhances the effect of epinephrine, norepinephrine, isoprenaline, ephedrine and phenylephrine on the cardiovascular system (including when these drugs are part of local anesthetics) and increases the risk of developing heart rhythm disturbances, tachycardia, and severe arterial hypertension.

When co-administered with alpha-adrenergic agonists for intranasal administration or for use in ophthalmology (with significant systemic absorption), the vasoconstrictor effect of the latter may be enhanced.

When taken together with thyroid hormones, there is a mutual enhancement of the therapeutic effect and toxic effects (including cardiac arrhythmias and a stimulating effect on the central nervous system).

M-anticholinergic drugs and antipsychotic drugs (neuroleptics) increase the risk of developing hyperpyrexia (especially in hot weather).

When co-administered with other hematotoxic drugs, increased hematotoxicity is possible.

Incompatible with MAO inhibitors (increased frequency of periods of hyperpyrexia, severe convulsions, hypertensive crises and patient death are possible).

Analogues of the drug Amitriptyline

Structural analogues of the active substance:

Amizol;
Amirol;
Amitriptyline Nycomed;
Amitriptyline AKOS;
Amitriptyline Ferein;
Amitriptyline hydrochloride;
Apo Amitriptyline;
Vero Amitriptyline;
Saroten retard;
Tryptisol;
Elivel.

Use in children

Contraindicated for children under 6 years of age.

In children, adolescents and young adults (under 24 years of age) with depression and other mental disorders, antidepressants, compared with placebo, increase the risk of suicidal thoughts and suicidal behavior. Therefore, when prescribing amitriptyline or any other antidepressants in this category of patients, the risk of suicide should be weighed against the benefits of their use

Use during pregnancy and breastfeeding

In pregnant women, the drug should be used only if the expected benefit to the mother outweighs the potential risk to the fetus.

Passes into breast milk and may cause drowsiness in nursing infants. To avoid the development of withdrawal syndrome in newborns (manifested by shortness of breath, drowsiness, intestinal colic, increased nervous excitability, increased or decreased blood pressure, tremor or spastic phenomena), amitriptyline is gradually discontinued at least 7 weeks before the expected birth.

microcrystalline cellulose - 40 mg, lactose monohydrate (milk sugar) - 40 mg, pregelatinized starch - 25.88 mg, colloidal silicon dioxide (aerosil) - 400 mcg, talc - 1.2 mg, magnesium stearate - 1.2 mg.
microcrystalline cellulose - 100 mg, lactose monohydrate (milk sugar) - 100 mg, pregelatinized starch - 64.7 mg, colloidal silicon dioxide (aerosil) - 1 mg, talc - 3 mg, magnesium stearate - 3 mg.

Pharmacological action

Antidepressant (tricyclic antidepressant). It also has some analgesic (of central origin), antiserotonin effect, helps eliminate bedwetting and reduces appetite.
It has a strong peripheral and central anticholinergic effect due to its high affinity for m-cholinergic receptors; strong sedative effect associated with affinity for H1-histamine receptors and alpha-adrenergic blocking effect.
It has the properties of a class IA antiarrhythmic drug; like quinidine in therapeutic doses, it slows down ventricular conduction (in overdose it can cause severe intraventricular block).
The mechanism of antidepressant action is associated with an increase in the concentration of norepinephrine and/or serotonin in the central nervous system (CNS) (decreasing their reabsorption).
The accumulation of these neurotransmitters occurs as a result of inhibition of their reuptake by the membranes of presynaptic neurons. With long-term use, it reduces the functional activity of beta-adrenergic and serotonin receptors in the brain, normalizes adrenergic and serotonergic transmission, and restores the balance of these systems, disturbed during depressive states. In anxiety-depressive conditions, it reduces anxiety, agitation and depressive symptoms.
The mechanism of antiulcer action is due to the ability to have a sedative and m-anticholinergic effect. Efficacy for bedwetting appears to be due to anticholinergic activity leading to increased bladder distensibility, direct beta-adrenergic stimulation, alpha-adrenergic agonist activity leading to increased sphincter tone, and central blockade of serotonin uptake. It has a central analgesic effect, which is believed to be associated with changes in the concentration of monoamines in the central nervous system, especially serotonin, and an effect on endogenous opioid systems.
The mechanism of action in bulimia nervosa is unclear (may be similar to that in depression). A clear effect of the drug on bulimia has been shown in patients both without depression and in its presence, while a decrease in bulimia can be observed without a concomitant weakening of depression itself.
During general anesthesia, it reduces blood pressure and body temperature. Does not inhibit monoamine oxidase (MAO).
The antidepressant effect develops within 2-3 weeks after the start of use.

Indications for use

Depression (especially with anxiety, agitation and sleep disorders, including in childhood, endogenous, involutional, reactive, neurotic, drug-induced, with organic brain damage).
As part of complex therapy, it is used for mixed emotional disorders, psychoses in schizophrenia, alcohol withdrawal, behavioral disorders (activity and attention), nocturnal enuresis (except for patients with bladder hypotension), bulimia nervosa, chronic pain syndrome (chronic pain in cancer patients, migraine, rheumatic diseases, atypical pain in the face, postherpetic neuralgia, post-traumatic neuropathy, diabetic or other peripheral neuropathy), headaches, migraines (prevention), gastric and duodenal ulcers.

Directions for use

Administered orally, without chewing, immediately after meals (to reduce irritation of the gastric mucosa).
Adults
For adults with depression, the initial dose is 25-50 mg at night, then gradually the dose can be increased taking into account the effectiveness and tolerability of the drug to a maximum of 300 mg/day. in 3 doses (the largest part of the dose is taken at night). When a therapeutic effect is achieved, the dose can be gradually reduced to the minimum effective, depending on the patient's condition. The duration of the course of treatment is determined by the patient’s condition, the effectiveness and tolerability of the therapy and can range from several months to 1 year, and if necessary, more. In old age with mild disorders, as well as with bulimia nervosa, as part of complex therapy for mixed emotional disorders and behavioral disorders, psychosis with schizophrenia and alcohol withdrawal, a dose of 25-100 mg/day is prescribed. (at night), after achieving a therapeutic effect, switch to the minimum effective doses - 10-50 mg/day.
For the prevention of migraines, with chronic pain syndrome of a neurogenic nature (including prolonged headaches), as well as in the complex therapy of gastric and duodenal ulcers - from 10-12.5-25 to 100 mg/day. (the maximum dose is taken at night).
Children
For children as an antidepressant: from 6 to 12 years old - 10-30 mg/day. or 1-5 mg/kg/day. fractionally, in adolescence - up to 100 mg/day.
For nocturnal enuresis in children 6-10 years old - 10-20 mg/day. at night, 11-16 years - up to 50 mg/day.
In pregnant women, the drug should be used only if the expected benefit to the mother outweighs the potential risk to the fetus.

Contraindicated for children under 6 years of age.
In children, adolescents and young adults (under 24 years of age) with depression and other mental disorders, antidepressants, compared with placebo, increase the risk of suicidal thoughts and suicidal behavior. Therefore, when prescribing amitriptyline or any other antidepressants in this category of patients, the risk of suicide should be weighed against the benefits of their use

Interaction

When ethanol is used together with drugs that depress the central nervous system (including other antidepressants, barbiturates, benzadiazepines and general anesthetics), a significant increase in the depressant effect on the central nervous system, respiratory depression and hypotensive effect is possible. Increases sensitivity to drinks containing ethanol.
Increases the anticholinergic effect of drugs with anticholinergic activity (for example, phenothiazine derivatives, antiparkinsonian drugs, amantadine, atropine, biperiden, antihistamines), which increases the risk of side effects (from the central nervous system, vision, intestines and bladder). When used together with anticholinergic blockers, phenothiazine derivatives and benzodiazepines, there is a mutual enhancement of the sedative and central anticholinergic effects and an increased risk of epileptic seizures (lowering the threshold of convulsive activity); Phenothiazine derivatives may also increase the risk of neuroleptic malignant syndrome.
When used together with anticonvulsants, it is possible to enhance the inhibitory effect on the central nervous system, reduce the threshold of convulsive activity (when used in high doses) and reduce the effectiveness of the latter.
When used together with antihistamines, clonidine - increased inhibitory effect on the central nervous system; with atropine - increases the risk of paralytic intestinal obstruction; with drugs that cause extrapyramidal reactions - an increase in the severity and frequency of extrapyramidal effects.
With the simultaneous use of amitriptyline and indirect anticoagulants (coumarin or indadione derivatives), the anticoagulant activity of the latter may increase. Amitriptyline may enhance depression caused by glucocorticosteroids (GCS). Medicines used to treat thyrotoxicosis increase the risk of developing agranulocytosis. Reduces the effectiveness of phenytoin and alpha-blockers.
Inhibitors of microsomal oxidation (cimetidine) prolong T1/2, increase the risk of developing toxic effects of amitriptyline (a dose reduction of 20-30% may be required), inducers of microsomal liver enzymes (barbiturates, carbamazepine, phenytoin, nicotine and oral contraceptives) reduce plasma concentrations and reduce the effectiveness of amitriptyline.
Combined use with disulfiram and other acetaldehydrogenase inhibitors provokes delirium.
Fluoxetine and fluvoxamine increase plasma concentrations of amitriptyline (a 50% reduction in amitriptyline dose may be required).
Estrogen-containing oral contraceptives and estrogens may increase the bioavailability of amitriptyline.
With the simultaneous use of amitriptyline with clonidine, guanethidine, betanidine, reserpine and methyldopa - a decrease in the hypotensive effect of the latter; with cocaine - the risk of developing cardiac arrhythmias.
Antiarrhythmic drugs (such as quinidine) increase the risk of developing rhythm disturbances (possibly slowing down the metabolism of amitriptyline).
Pimozide and probucol may increase cardiac arrhythmias, which is manifested by prolongation of the QT interval on the ECG.
It enhances the effect of epinephrine, norepinephrine, isoprenaline, ephedrine and phenylephrine on the cardiovascular system (including when these drugs are part of local anesthetics) and increases the risk of developing heart rhythm disturbances, tachycardia, and severe arterial hypertension.
When co-administered with alpha-adrenergic agonists for intranasal administration or for use in ophthalmology (with significant systemic absorption), the vasoconstrictor effect of the latter may be enhanced.
When taken together with thyroid hormones, there is a mutual enhancement of the therapeutic effect and toxic effects (including cardiac arrhythmias and a stimulating effect on the central nervous system).
M-anticholinergic drugs and antipsychotic drugs (neuroleptics) increase the risk of developing hyperpyrexia (especially in hot weather).
When co-administered with other hematotoxic drugs, increased hematotoxicity is possible.
Incompatible with MAO inhibitors (increased frequency of periods of hyperpyrexia, severe convulsions, hypertensive crises and patient death are possible).

Side effect

Associated with the anticholinergic effect of the drug: blurred vision, accommodation paralysis, mydriasis, increased intraocular pressure (only in persons with a local anatomical predisposition - a narrow anterior chamber angle), tachycardia, dry mouth, confusion (delirium or hallucinations), constipation, paralytic intestinal tract obstruction, difficulty urinating.
From the central nervous system: drowsiness, fainting, fatigue, irritability, anxiety, disorientation, hallucinations (especially in elderly patients and patients with Parkinson's disease), anxiety, psychomotor agitation, mania, hypomania, memory impairment, decreased ability to concentrate, insomnia, nightmares, asthenia; headache; dysarthria, tremor of small muscles, especially the arms, hands, head and tongue, peripheral neuropathy (paresthesia), myasthenia gravis, myoclonus; ataxia, extrapyramidal syndrome, increased frequency and intensification of epileptic seizures; changes in the electroencephalogram (EEG).
From the cardiovascular system: tachycardia, palpitations, dizziness, orthostatic hypotension, nonspecific changes in the electrocardiogram (ECG) (S-T interval or T wave) in patients without heart disease; arrhythmia, blood pressure lability (decrease or increase in blood pressure), intraventricular conduction disturbances (widening of the QRS complex, changes in the P-Q interval, bundle branch block).
From the gastrointestinal tract: nausea, heartburn, gastralgia, hepatitis (including impaired liver function and cholestatic jaundice), vomiting, increased appetite and body weight or decreased appetite and body weight, stomatitis, changes in taste, diarrhea, darkening of the tongue.
From the endocrine system: increase in size (swelling) of the testicles, gynecomastia; increase in the size of the mammary glands, galactorrhea; decreased or increased libido, decreased potency, hypo- or hyperglycemia, hyponatremia (decreased vasopressin production), syndrome of inappropriate secretion of antidiuretic hormone (ADH). Allergic reactions: skin rash, itching, photosensitivity, angioedema, urticaria.
Other: hair loss, tinnitus, edema, hyperpyrexia, swollen lymph nodes, urinary retention, pollakiuria.
With long-term treatment, especially in high doses, if it is abruptly stopped, withdrawal syndrome may develop: nausea, vomiting, diarrhea, headache, malaise, sleep disturbances, unusual dreams, unusual agitation; with gradual withdrawal after long-term treatment - irritability, restlessness, sleep disturbances, unusual dreams.
The connection with taking the drug has not been established: lupus-like syndrome (migratory arthritis, the appearance of antinuclear antibodies and positive rheumatoid factor), impaired liver function, ageusia.

Contraindications

Hypersensitivity, use in conjunction with MAO inhibitors and 2 weeks before treatment, myocardial infarction (acute and subacute periods), acute alcohol intoxication, acute intoxication with hypnotics, analgesics and psychoactive drugs, angle-closure glaucoma, severe AV and intraventricular conduction disorders (branch block His bundle, AV block II stage), lactation period, children under 6 years of age.
Due to the content of lactose monohydrate (milk sugar) in the tablets, the drug should not be taken by patients with rare hereditary diseases such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
With caution. Amitriptyline should be used with caution in persons with alcoholism, bronchial asthma, schizophrenia (possible activation of psychosis), bipolar disorder, epilepsy, suppression of bone marrow hematopoiesis, diseases of the cardiovascular system (CVS) (angina pectoris, arrhythmia, heart block, chronic heart failure, myocardial infarction, arterial hypertension), intraocular hypertension, stroke, decreased motor function of the gastrointestinal tract (GIT) (risk of paralytic ileus), liver and/or renal failure, thyrotoxicosis, prostatic hyperplasia, urinary retention, hypotension bladder, during pregnancy (especially the first trimester), in old age.

Overdose

Symptoms
From the central nervous system: drowsiness, stupor, coma, ataxia, hallucinations, anxiety, psychomotor agitation, decreased ability to concentrate, disorientation, confusion, dysarthria, hyperreflexia, muscle rigidity, choreoathetosis, epileptic syndrome.
From the cardiovascular system: decreased blood pressure, tachycardia, arrhythmia, impaired intracardiac conduction, ECG changes (especially QRS) characteristic of intoxication with tricyclic antidepressants, shock, heart failure; in very rare cases - cardiac arrest.
Other: respiratory depression, shortness of breath, cyanosis, vomiting, hyperthermia, mydriasis, increased sweating, oliguria or anuria.
Symptoms develop 4 hours after an overdose, reach a maximum after 24 hours and last 4-6 days. If an overdose is suspected, especially in children, the patient should be hospitalized.
Treatment: for oral administration: gastric lavage, intake of activated charcoal; symptomatic and supportive therapy; for severe anticholinergic effects (lowering blood pressure, arrhythmia, coma, myoclonic epileptic seizures) - administration of cholinesterase inhibitors (the use of physostigmine is not recommended due to the increased risk of seizures); maintaining blood pressure and water-electrolyte balance. Monitoring of cardiovascular functions (including ECG) for 5 days (relapse may occur after 48 hours or later), anticonvulsant therapy, artificial pulmonary ventilation (ALV) and other resuscitation measures are indicated. Hemodialysis and forced diuresis are ineffective.

Special instructions

Before starting treatment, blood pressure monitoring is necessary (in patients with low or labile blood pressure, it may decrease even more); during the treatment period - control of peripheral blood (in some cases, agranulocytosis may develop, and therefore it is recommended to monitor the blood picture, especially with an increase in body temperature, development of flu-like symptoms and sore throat), during long-term therapy - control of the functions of the cardiovascular system and liver. In the elderly and patients with cardiovascular diseases, monitoring of heart rate, blood pressure, and ECG is indicated. Clinically insignificant changes may appear on the ECG (smoothing of the T wave, depression of the S-T segment, widening of the QRS complex).
Caution is required when suddenly moving to a vertical position from a lying or sitting position.
During the treatment period, the use of ethanol should be avoided.
Prescribed no earlier than 14 days after discontinuation of MAO inhibitors, starting with small doses.
If you suddenly stop taking it after long-term treatment, withdrawal syndrome may develop.
Amitriptyline in doses above 150 mg/day. reduces the threshold of convulsive activity (the risk of epileptic seizures in predisposed patients should be taken into account, as well as in the presence of other factors predisposing to the occurrence of convulsive syndrome, for example, brain damage of any etiology, simultaneous use of antipsychotic drugs (neuroleptics), during the period of abstinence from ethanol or withdrawal of medications with anticonvulsant properties, such as benzodiazepines). Severe depression is characterized by a risk of suicidal actions, which can persist until significant remission is achieved. In this regard, at the beginning of treatment, a combination with drugs from the group of benzodiazepines or antipsychotic drugs and constant medical supervision (entrust trusted persons with the storage and dispensing of drugs) may be indicated. In children, adolescents and young adults (under 24 years of age) with depression and other mental disorders, antidepressants, compared with placebo, increase the risk of suicidal thoughts and suicidal behavior. Therefore, when prescribing amitriptyline or any other antidepressants in this category of patients, the risk of suicide should be weighed against the benefits of their use. In short-term studies, the risk of suicide did not increase in people over 24 years of age, but it decreased slightly in people over 65 years of age. During treatment with antidepressants, all patients should be monitored for early detection of suicidal tendencies.
In patients with cyclic affective disorders during the depressive phase, manic or hypomanic states may develop during therapy (reducing the dose or discontinuing the drug and prescribing an antipsychotic drug is necessary). After relief of these conditions, if indicated, treatment in low doses can be resumed.
Due to possible cardiotoxic effects, caution is required when treating patients with thyrotoxicosis or patients receiving thyroid hormone preparations.
In combination with electroconvulsive therapy, it is prescribed only under the condition of careful medical supervision.
In predisposed patients and elderly patients, it can provoke the development of drug-induced psychoses, mainly at night (after discontinuation of the drug, they disappear within a few days).
May cause paralytic ileus, primarily in patients with chronic constipation, the elderly, or those forced to bed rest.
Before performing general or local anesthesia, the anesthesiologist should be warned that the patient is taking amitriptyline.
Due to the anticholinergic effect, there may be a decrease in tear production and a relative increase in the amount of mucus in the tear fluid, which can lead to damage to the corneal epithelium in patients using contact lenses.
With long-term use, an increase in the incidence of dental caries is observed. The need for riboflavin may be increased.
Animal reproduction studies have shown adverse effects on the fetus, and there are no adequate and well-controlled studies in pregnant women. In pregnant women, the drug should be used only if the expected benefit to the mother outweighs the potential risk to the fetus.
Passes into breast milk and may cause drowsiness in nursing infants. To avoid the development of withdrawal syndrome in newborns (manifested by shortness of breath, drowsiness, intestinal colic, increased nervous excitability, increased or decreased blood pressure, tremor or spastic phenomena), amitriptyline is gradually discontinued at least 7 weeks before the expected birth.
Children are more sensitive to acute overdose, which should be considered dangerous and potentially fatal to them.
During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.