Amitriptyline tablets 25 mg, 50 pcs

1 tab. amitriptylin hydrochloride 28.3 mg, which corresponds to the content of amitriptylin 25 mg

Excipients: lactose monohydrate, corn starch, gelatin, calcium stearate, talcum, colloidal silicon dioxide.

Shell composition: symethicone SE-2, macrogol, sepifilm 3048 yellow (Sepifilm 3048 Yellow) (hypromellose, microcrystalline cellulose, polyoxyl 40 stearate, titanium dioxide, quinolin yellow dye (E104).

Antidepressant

Depression (especially anxiety, agitation and sleep disorders, including in childhood, endogenous, involutionary, reactive, neurotic, medicinal, organic brain lesions).

As part of complex therapy, it is used for mixed emotional disorders, psychosis in schizophrenia, alcohol withdrawal, behavioral disorders (activity and attention), night enuresis in children (except for patients with bladder hypotension), nervous bulimia, chronic pain syndrome (chronic pain in cancer patients, migraine, rheumatic diseases

• Hypersensitivity,
• use in conjunction with MAO inhibitors and 2 weeks before treatment,
• myocardial infarction (acute and subacute periods),
• acute alcohol intoxication,
• acute intoxication with sleeping pills, analgesic and psychoactive drugs,
• closed-angle glaucoma,
• severe violations of AV and intraventricular conductivity (blockade of Geese beam legs, AV blockage II Art.),
• lactation period,
• children under 6 years of age.

Due to the content of lactose monohydrate (milk sugar), 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, depression of bone and brain hematopoiesis, diseases of the cardiovascular system (CC) (angina, arrhythmia, heart blockade, chronic heart failure, myocardial infarction, arterial hypertension), intraocular hypertension, stroke, reduced motor function of the gastrointestinal tract (risk of paralytic intestinal obstruction), liver and/or renal failure, thyrotoxicosis, hyperasiasis, hypoplastitis of the prostate, hypoplastoma, hypoplastitis, hypostia, hypostia, intratum.

Mainly related to the choline-blocking effect of the drug: accommodation paresis. Oaked vision, increased intraocular pressure, dry mouth, constipation, intestinal obstruction, urination delay, fever. All these phenomena usually occur after adaptation to the drug or dose reduction.
CNS side: headache, ataxia, increased fatigue, weakness, irritability, dizziness, tinnitus, drowsiness or insomnia, impaired concentration, nightmarish dreams, dysarthria, confusion, hallucinations, motor arousal, disorientation, tremors, paresthesia Rarely extrapyramidal disorders, seizures, anxiety.
From the cardiovascular system: tachycardia, arrhythmia, conductivity disorders, blood pressure lability, expansion of the QRS complex on ECG (intraventricular conduction disorders), symptoms of heart failure, fainting.
From the gastrointestinal tract: nausea, vomiting, heartburn, anorexia, stomatitis, taste disorders, darkening of the tongue, discomfort in the epigastria, gastralgia, increased activity of "liver" transaminases, rarely cholestatic jaundice, diarrhea.
From the endocrine system: increase in breast size in men and women, galactorea, change in the secretion of the antidiuretic hormone (ADH), change in libido, potency. Rare hypoglycemia or hyperglycemia, glucosuria, impaired tolerance to glucose, testicular edema. Allergic reactions: skin rash, itching, photosensitization, angioedema, hives.
Others: agranulocytosis, leukopenia, eosinophilia, thrombocytopenia, purple and other blood changes, hair loss, increase in lymph nodes, increased body weight during prolonged use, sweating, pollakiuria. With long-term treatment, especially in high doses, with a sharp termination of treatment, it is possible to develop withdrawal syndrome: headache, nausea, vomiting, diarrhea, as well as irritability, sleep disorders with bright, unusual dreams, increased excitability.

When using ethanol and drugs that inhibit the CNS together (including other antidepressants, barbiturates, benzadiazepines and general anesthetics), a significant increase in the oppressive effect on the CNS, respiratory depression and hypotensive effect is possible.

Increases sensitivity to drinks containing ethanol.

Increases the anticholinergic effect of drugs with anticholinergic activity (e.g. phenothiazine derivatives, antiparkinsonic drugs, amantadine, atropin, biperide, antihistamine drugs), which increases the risk of side effects (from CNS, vision, intestines and bladder). When used in conjunction with choline blockers, phenothiazine derivatives and benzodiazepines - mutual strengthening of sedative and central choline blocking effects and increasing the risk of epileptic seizures (reducing the threshold of convulsive activity); phenothiazine derivatives can also increase the risk of neuroleptic

When used in conjunction with anticonvulsant drugs, it is possible to increase the oppressive effect on the CNS, reduce the threshold of convulsive activity (when used in high doses) and reduce the effectiveness of the latter.

When used in conjunction with antihistamine drugs, clonidine - increased oppressive effect on the CNS; with atropine - increases the risk of paralytic intestinal obstruction; with drugs that cause extrapyramidal reactions - increase the severity and frequency of extrapyramidal effects.

Simultaneous use of amitriptyline and indirect anticoagulants (coumarin or indadion derivatives) may increase the anticoagulant activity of the latter.

Amitriptyline can increase depression caused by glucocorticosteroids (GCS).

Drugs for the treatment of thyrotoxicosis increase the risk of agranulocytosis.

Reduces the effectiveness of phenytoin and alpha-adrenoblockers.

Microsomal oxidation inhibitors (cimetidine) lengthen T1/2, increase the risk of toxic effects of amitriptylin (it may be necessary to reduce the dose by 20-30%), inductors of microsomal liver enzymes (barbiturates, carbamazepine, phenytoin, nicotin and oral contraceptives) reduce plasma concentration and reduce the effectiveness of amitriptylin.

Combined use with disulfiram and other acetaldehydrogenase inhibitors provokes delirium.

Fluoxetine and fluvoxamine increase the concentration of amitriptylin in plasma (it may be necessary to reduce the dose of amitriptylin by 50%).

Estrogens-containing oral contraceptive drugs and estrogens can increase the bioavailability of amitriptyline.

Simultaneous use of amitriptyline with clonidine, guanetidin, betainidine, reserpine and methyldop - a decrease in the hypotensive effect of the latter; with cocaine - the risk of heart arrhythmias.

Antiarrhythmic drugs (such as quinidine) increase the risk of rhythm disorders (may be slowing down the metabolism of amitriptylin).

Pimosis and plug can increase heart arrhythmia, which manifests itself in the lengthening of the Q-T interval on the ECG.

Enhances the effect of epinephrine, norepinephrine, isoprenaline, ephedrine and phenylephrine on CVS (including when these drugs are part of local anesthetics) and increases the risk of heart rhythm disorders, tachycardia, severe arterial hypertension.

When used together with alpha-adrenomimetics for intranasal administration or for use in ophthalmology (with significant systemic absorption), the vasoconstrictive effect of the latter may increase.

When taken together with thyroid hormones - mutual enhancement of therapeutic effect and toxic action (including heart arrhythmia and stimulating effect on the CNS).

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

When administered together with other hematotoxic drugs, hematotoxicity may increase.

Incompatible with MAO inhibitors (possible increase in the frequency of hyperpyrexia periods, severe seizures, hypertensive crises and patient death).

Prescribed inside (during or after meals). The initial daily dose when taken orally is 50-75 mg (25 mg in 2-3 doses), then the dose is gradually increased by 25-50 mg, until the desired antidepressant effect is obtained. The optimal daily therapeutic dose is 150-200 mg (the maximum part of the dose is taken at night).
In severe depressions resistant to therapy, the dose is increased to 300 mg or more, to the maximum tolerated dose (the maximum dose for outpatients is 150 mg/day). In these cases, it is advisable to start treatment with intramuscular or intravenous administration of the drug, while applying higher initial doses, accelerating dosage build-up under somatic control. After receiving a persistent antidepressant effect after 2-4 weeks, doses are gradually and slowly reduced to 50-100 mg/day and therapy continues for at least 3 months. In case of signs of depression, when doses are reduced, it is necessary to return to the previous dose.
If the patient's condition does not improve within 3-4 weeks of treatment, further therapy is inexpedient.

In elderly patients with mild disorders, in outpatient practice, doses are 25-50-100mg per day in separated doses or once a day at night.

In case of night enuresis in children aged 6-10 years - 10-20 mg/day at night, at the age of 11-16 years - 25-50 mg/day. (dose should not exceed 2.5 mg/kg weight of the child).

For the prevention of migraines, chronic pain of a non-urogenous nature (including prolonged headaches) from 12.5-25 mg to 100 mg/day.

In severe depressions resistant to therapy: intramuscularly or intravenously (inject slowly!) administered at a dose of 10-20-30 mg up to 4 times a day, the dose increase should be carried out gradually, the maximum daily dose is 150 mg; after 1-2 weeks, they switch to taking the drug orally.
Children over 12 years of age and the elderly are given lower doses and increased more slowly.
If the patient's condition does not improve within 3-4 weeks of treatment, further therapy is inexpedient.

Symptoms: drowsiness, disorientation, confusion, pupil dilation, fever, shortness of breath, dysarthria, excitement, hallucinations, seizures, muscle rigidity, supores, coma, vomiting, arrhythmia, arterial hypotension, heart failure, respiratory depression.
Treatment: termination of amitriptylin therapy, stomach rinsing, fluid infusion, symptomatic therapy, maintenance of blood pressure and water-electrolyte balance. Monitoring of cardiovascular activity (ECG) for 5 days is shown, as relapse may occur in 48 hours or later. Hemodialysis and forced diuresis are not effective.

Before starting treatment, BP control is necessary (in patients with reduced or labile blood pressure, it may decrease even more); during treatment - peripheral blood control (in some cases, agranulocytosis may develop, so it is recommended to monitor the blood picture, especially when body temperature rises, flu-like symptoms and sore throat), during long-term therapy - In the elderly and patients with CVS diseases, heart rate control (heart rate), blood pressure, ECG is indicated. Clinically insignificant changes may appear on the ECG (smoothing of the T tooth, depression of the S-T segment, expansion of the QRS complex).

Care is needed when moving sharply to an upright position from a "lying down" or "sitting" position.

Ethanol should be excluded during treatment.

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

In case of sudden termination of admission after long-term treatment, the development of "cancellation" syndrome may develop.

Amitriptilin at 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 convulsive syndrome, such as brain damage of any etiology, simultaneous use of antipsychotic drugs (neuroleptics), during the period of abandonment of ethanol or withdrawal of drugs with anticonvulsant properties, such as benzodiazepines).

Pronounced depressions are 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 neuroleptic drugs and constant medical control (to insure trustees the storage and issuance of drugs) may be indicated.

In children, adolescents and young people (under 24 years of age) with depression and other mental disorders, antidepressants, compared to placebo, increase the risk of suicidal thoughts and suicidal behavior. Therefore, when prescribing amitriptylin or any other antidepressants in this category of patients, the risk of suicide and the benefits of their use should be correlated. In short-term studies, the risk of suicide in people over 24 years of age did not increase, and in people over 65 years of age decreased slightly. During antidepressant treatment, all patients should be monitored for early detection of suicidal tendencies.

Patients with cyclic affective disorders may develop manic or hypomanic conditions against the background of therapy (it is necessary to reduce the dose or cancel the drug and prescribe antipsychotic drugs). After stopping these conditions, if there are indications, low dose treatment may be resumed.

Due to possible cardiotoxic effects, caution is required in the treatment of thyrotoxicosis patients or patients receiving thyroid hormones.

In combination with electroconvulsive therapy, it is prescribed only with careful medical supervision.

Predisposed and elderly patients can provoke the development of medicinal psychosis, mainly at night (after the withdrawal of the drug they take place within a few days).

It can cause paralytic intestinal obstruction, mainly in patients with chronic constipation, the elderly or in patients forced to observe bed rest.

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

Due to the anticholinergic effect, it is possible to reduce tear separation and a relative increase in the amount of mucus in the lacrimal fluid, which can lead to damage to the corneal epithelium in patients using contact lenses.

With prolonged use, there is an increase in the frequency of tooth decay. The need for riboflavin may be increased.

The study of reproduction on animals revealed an adverse effect on the fetus, and no adequate and strictly controlled studies were conducted in pregnant women. In pregnant women, the drug should be used only if the intended benefit to the mother exceeds the potential risk to the fetus.

Penetrates breast milk and can cause drowsiness in infants.

In order to avoid the development of "cancellation" syndrome in newborns (shows of shortness of breath, drowsiness, intestinal colic, increased nervous excitability, increased or decreased blood pressure, tremors or spastic phenomena), amitriptylin is gradually canceled at least 7 weeks before the expected birth.

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

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