Vero-Amitriptyline - instructions for use, doses, side effects, contraindications

- sufficient amount to obtain a tablet weighing 200 mg: carboxymethyl starch sodium (primogel), lactose anhydrous (lactopress), microcrystalline cellulose, plastidone ES-630 (copovidone), povidone (polyvinylpyrrolidone), calcium stearate;

excipients for the shell:

- sufficient amount to obtain a coated tablet, 210 mg: Opadrai II [hypromellose (hydroxypropylmethylcellulose), titanium dioxide, lactose monohydrate, macrogol (polyethylene glycol 3350), aluminum varnish based on yellow sunset sun, iron oxide yellow, iron oxide red].

Description:

The tablets covered with a film cover of light orange color with a pinkish shade, round, biconcave.

Pharmacotherapeutic group:Antidepressant

ATX: & nbsp

N.06.A.A.09 Amitriptyline

Pharmacodynamics:

Amitriptyline is a tricyclic antidepressant (TCA) from a group of non-selective inhibitors of neuronal capture of monoamines.

Has a strong peripheral and central anticholinergic action due to high affinity for m-holinoretseptoram; strong sedative effect associated with affinity for H₁-histamine receptors, and αadrenoblocking action. The mechanism of antidepressant action is associated with an increase in the concentration of noradrenaline in synapses and / or serotonin in the central nervous system (CNS). Accumulation of these neurotransmitters occurs as a result of inhibition of their inverse capture by the membranes of presynaptic neurons. With prolonged use reduces the functional activity β-adrenergic and serotonin receptors of the brain, normalizes adrenergic and serotonergic transmission, restores the equilibrium of these systems, disturbed in depressive states. With anxiety-depressive states reduces anxiety, agitation and depressive manifestations. Does not inhibit the enzyme monoamine oxidase (MAO). Antidepressant effect develops within 2-3 weeks after the beginning of application.

Pharmacokinetics:

Suction

After oral administration amitriptyline quickly and completely absorbed from the gastrointestinal tract.

Distribution

The concentration of amitriptyline in the blood plasma of different patients varies significantly. The bioavailability of amitriptyline is about 50%. Amitriptyline to a large extent (95%) binds to blood plasma proteins. Time to reach the maximum concentration (TC_mOh) after oral administration - 4-8 hours, and the equilibrium concentration - about a week after the start of treatment. The volume of distribution is approximately 1085 l / kg. AND amitriptyline, and nortriptyline penetrate the placenta and are excreted in breast milk.

Metabolism

Amitriptyline is metabolized in the liver and to a large extent (about 50%) undergoes metabolism during primary passage through the liver. Wherein amitriptyline undergoes N-detylation of cytochrome P450 isoenzymes with the formation of an active metabolite - nortriptyline. AND amitriptyline, and nortriptyline also undergo in the liver hydroxylation. N-hydroxy and 10-hydroxymetabolite amitriptyline and 10-hydroxynortriptyline are also active. AND amitriptyline, and nortriptyline are conjugated to glucuronic acid, and these conjugates become inactive. The main factor determining renal clearance, and, correspondingly, the concentration in the blood plasma, is the rate of hydroxylation.

A small proportion of people have genetically determined delayed hydroxylation.

In patients with impaired liver function, the half-life of amitriptyline and nortriptyline in blood plasma is increased.

Excretion

The half-life (T_1/2) from the blood plasma - 9-46 hours for amitriptyline and 18-95 hours for nortriptyline. Displayed amitriptyline mainly by the kidneys and through the intestines in the form of metabolites. Only a small part of the accepted dose of amitriptyline is excreted through the kidneys unchanged.

In patients with impaired renal function, excretion of metabolites of amitriptyline and nortriptyline is slowed, although metabolism as such does not change.

Because of the association with blood proteins amitriptyline It is not removed from the blood plasma by hemodialysis.

Elderly patients

In elderly patients there is an increase in T_1/2and a decrease in the clearance of amitriptyline due to a decrease in metabolic rate.

Patients with impaired hepatic function

Dysfunction of the liver can lead to a slowing of the metabolism of amitriptyline and increase its plasma concentrations.

Patients with impaired renal function

Renal failure does not affect the kinetics of the drug.

Indications:

Endogenous depression and other depressive disorders.

Contraindications:

- Hypersensitivity to amitriptyline and other components of the drug;

- intolerance to galactose, deficiency of lactose or glucose-galactose malabsorption;

- simultaneous use with monoamine oxidase (MAO) inhibitors and within 2 weeks after their cancellation;

- myocardial infarction (acute and recovery periods), atrioventricular and intraventricular conduction disorders (blockages of any degree), arrhythmias, heart failure, bradycardia, congenital syndrome of elongated QT, as well as simultaneous use with drugs that lead to lengthening of the interval QT;

- acute delirium;

- paralytic ileus, intestinal obstruction;

- pyloric stenosis;

- acute alcohol intoxication;

- acute intoxication with hypnotics, analgesics and psychoactive drugs;

- angle-closure glaucoma;

- hyperplasia of the prostate with a delay of urine;

- hypokalemia;

- children and adolescents under 18;

- pregnancy;

- the period of breastfeeding.

Carefully:

With convulsive disorders, chronic alcoholism, simultaneous reception with antipsychotic and hypnotics,diseases of the blood, bronchial asthma, oppression of bone marrow hematopoiesis, coronary heart disease, tachycardia, hyperthyroidism, decreased motor function of the gastrointestinal tract (risk of paralytic intestinal obstruction), prostatic hyperplasia, urination disorders, bladder hypotension, function disorders liver, renal dysfunction, schizophrenia (although it usually does not exacerbate productive symptoms), paranoid symptoms, bipolar (after withdrawal from the depressive phase), in persons prone to increased intraocular pressure (with a narrow angle of the anterior chamber), in persons with epilepsy in the anamnesis, in old age, concomitant reception with selective serotonin reuptake inhibitors (SSRIs) and selective serotonin and norepinephrine reuptake inhibitors (SIOPSiN).

Pregnancy and lactation:

The use of amitriptyline during pregnancy is not recommended. During pregnancy amitriptyline Should be used only if the intended benefit to the mother exceeds the potential risk to the fetus.The use of tricyclic antidepressants in high doses in the first and third trimester of pregnancy can adversely affect the psychophysical development of the newborn, including behavioral changes and neurological functions.

In the appointment of amitriptyline, pregnant women in newborns were drowsy, agitated and depressed breathing, and when nortriptyline (amitriptyline metabolite) was prescribed, urine retention. In the case of amitriptyline during pregnancy, especially in III trimester, it is necessary to warn the patient about the high risk of adverse effects on the fetus.

The use of amitriptyline during breast-feeding is not recommended, since the active substance penetrates into breast milk. It has been established that the ratio of amitriptyline concentrations "breast milk / blood plasma" is 0.4-1.5. A child who is breastfeeding by a mother receiving amitriptyline, undesirable reactions described in the "Side effect" section may occur.

If you need to take the drug should refrain from breastfeeding.

Dosing and Administration:

The dose is determined by the doctor individually for each patient, and should be strictly adhered to. Assign inside during or after a meal.

The initial daily intake with oral administration is 25-50 mg, divided into 2 doses during the day, or as a single dose 2 hours before bedtime. 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 depression, resistant to therapy, the dose is increased to 300 mg in a hospital (maximum dose for outpatients is 150 mg / day). In these cases, treatment is advisable to begin with intramuscular or intravenous administration of the drug, while using higher initial doses, accelerating the build-up of dosages under the control of the somatic state.

After obtaining a persistent antidepressant effect, after 2-4 weeks the doses gradually and slowly decrease. In case of signs of depression with decreasing doses, it is necessary to return to the previous dose. If the patient's condition does not improve within 3-4 weeks of treatment, then further therapy is impractical.

Duration of therapy

Treatment with antidepressants is symptomatic and should be long enough. The average duration of therapy is usually 6 months. and more in order to prevent relapse.

Elderly patients (over 65 years of age)

In elderly patients, the recommended initial dose is 25 mg / day for 2 hours before bedtime. Further increase in the dose should be carried out gradually, every other day, reaching, if necessary, a dose of 75-100 mg / day.

Patients with impaired renal function

If there is a violation of kidney function, dose adjustment is not required.

Patients with impaired hepatic function

If the liver function is impaired and metabolism is slowed, the drug should be used with caution. Depending on the concentration of amitriptyline in the blood plasma, dose adjustment is possible.

Discontinuation of therapy

When discontinuing therapy, it is recommended to cancel the drug gradually over several weeks in order to avoid the development of the "withdrawal" syndrome.

Symptoms of cancellation: headache, nausea, vomiting, diarrhea, malaise, sleep disturbance, unusual dreams, agitation, motor anxiety, irritability and general poor health.These symptoms are not signs of drug dependence.

If you forget to take your daily dose, it is recommended to wait until the next time you take a schedule and take a single dose.

Repeated course of therapy

When appointing a second course of treatment with amitriptyline, the patient needs to undergo an additional general clinical examination.

Side effects:

The WHO classification was used to indicate the incidence of adverse events: very often (≥10%); often (≥1% and <10%); infrequently (≥0.1% and <1%); rarely (≥0.01% and <0.1%); very rarely (<0.01%); an unknown frequency (according to available data, it is not possible to determine the frequency of occurrence of a side effect).

Violations of the blood and lymphatic system: infrequently: oppression of bone marrow hematopoiesis, agranulocytosis, leukopenia, thrombocytopenia, eosinophilia.

Disorders of the psyche: often: disorientation, anxiety, agitation, irritability, psychosis, hallucinations, nightmares, impaired concentration.

Impaired nervous system: often: headache, fatigue, weakness, drowsiness,insomnia, tremor, paresthesia, ataxia, peripheral neuropathy; infrequently: extrapyramidal disorders (tardive dyskinesia, lubricated speech, increased convulsive readiness, convulsions).

Disorders from the side of the organ of vision: often: blurred vision, disturbance of accommodation;

Disturbances from the organ of hearing and balance: very often: dizziness, noise in the ears.

Heart Disease: very often: arrhythmia, cardiac conduction disorder, recorded only on the ECG, but not manifested clinically (prolongation of the QT interval, expansion of the QRS complex), extrasystole, palpitation, tachycardia; infrequent: heart failure (worsening of the existing cardiac dysfunction), nonspecific changes in ECG in patients not suffering from heart disease; very rarely: atrial fibrillation, ventricular fibrillation, asystole, myocardial infarction.

Vascular disorders: very often: orthostatic hypotension.

Disorders from the gastrointestinal tract: often: dryness of the oral mucosa, a taste disorder (bitter or salty taste in the mouth), a feeling of discomfort in the epigastrium,gastralgia, constipation, nausea, diarrhea, vomiting, heartburn, anorexia, stomatitis, darkening of the tongue, enlargement of the salivary glands; rarely: paralytic intestinal obstruction.

Disorders from the liver and bile ducts: infrequently: cholestatic jaundice.

Disturbances from the skin and subcutaneous tissue: very often: increased sweating; rarely: alopecia.

Disorders from the kidneys and urinary tract: often: urinary retention, delay in the onset of urination, pollakiuria.

Violations of the genitals and breast: often: violation of libido, potency, swelling of the testicles; infrequently: gynecomastia, galactorrhea.

Disorders from the endocrine system: infrequently: a change in the secretion of antidiuretic hormone (ADH); rarely: hypo- or hyperglycemia, glucosuria, impaired glucose tolerance.

Infringements from immune systems: infrequently: skin rash, itching, hives; rarely: photosensitivity, angioedema, edema of the face and lips.

Disorders from the metabolism and nutrition: infrequently: increase in body weight with prolonged use; rarely: hyperpyrexia, weight loss; frequency unknown: hyperkalemia.

Laboratory and instrumental data: very rarely: increased activity of "liver" transaminases.

General disorders and disorders at the site of administration: very often: fatigue.

The withdrawal syndrome: after prolonged use with a sharp discontinuation of reception can occur such undesirable reactions as nausea, vomiting, diarrhea, headache, malaise, insomnia, unusual dreams, unusual arousal, irritability; after prolonged use with a gradual withdrawal - irritability, sleep disturbances, unusual dreams. These symptoms do not indicate the development of addiction to the drug.

There was reported the development of suicidal thoughts or behavior during treatment with amitriptyline or after its withdrawal.

Class-effect antidepressants:

Epidemiological studies that included patients over the age of 50 demonstrated an increased risk of fracture in people taking selective serotonin reuptake inhibitors (SSRIs) and tricyclic antidepressants (TCAs). The mechanism leading to an increased risk of fractures is unknown.

Overdose:

There is no specific antidote for the relief of symptoms of acute TCA poisoning.

In adults, taking more than 500 mg of the drug causes mild or severe intoxication. An overdose of amitriptyline (more than 1000 mg) can lead to death.There is a report of a fatal arrhythmia that occurred 56 hours after an overdose of amitriptyline.

Symptoms

Symptoms can develop slowly and imperceptibly, or abruptly and suddenly. During the first hours there is drowsiness or agitation, agitation and hallucinations.

Anticholinergic symptoms: mydriasis, tachycardia, urinary retention, dry mucous membranes, intestinal motility slowing, convulsions, fever, sudden CNS depression, lowering consciousness level down to coma, suppression of breathing.

Symptoms from the cardiovascular system: arrhythmias (ventricular tachyarrhythmia, cardiac arrhythmias of the torsade des pointes type, ventricular fibrillation). The ECG is characterized by prolongation of the PR interval, expansion of the QRS complex, prolongation of the QT interval, flattening or inversion of the T wave, depression of the ST segment and blockade of intracardiac conduction of various degrees, which can progress up to cardiac arrest. The expansion of the QRS complex usually correlates with the severity of toxic effects due to acute overdose. Heart failure, lowering blood pressure, cardiogenic shock.Metabolic acidosis, hypokalemia.

After awakening, confusion, excitement, hallucinations, and ataxia are again possible.

Treatment

Hospitalization (in the intensive care unit). Treatment is symptomatic and supportive. Probing and gastric lavage, even if after taking the drug inside a long time, with the prescription of activated charcoal. In case of severe intoxication, 1-3 mg of physostigmine intravenously should be administered. Since physostigmine salicylate is rapidly metabolized, it must be re-administered several times in the event of any life-threatening complication (arrhythmia, convulsions, deep coma). Careful observation, even if the case seems uncomplicated. Observation of the level of consciousness, pulse, arterial pressure and respiration. Frequent control of the level of electrolytes in blood serum and blood gases. The control of airway passages, if necessary, should be performed using intubation. To prevent possible stopping of breathing, it is recommended to use an artificial respiration device (IVF).Constant ECG monitoring and control of heart function for 3-5 days. When expanding the intervals QRS, heart failure and heart rhythm disturbances of the positive effect can be achieved by shifting the pH to the alkaline side (through the introduction of bicarbonate or mild hyperventilation) and by rapid infusion of hypertonic sodium chloride solution (100-200 mmol Na+). It is possible to use appropriate antiarrhythmics, for example, lidocaine in ventricular arrhythmias at a dose of 50-100 mg IV (1-1.5 mg / kg), then 1-3 mg / min by IV infusion.

Amitriptyline is not excreted by hemodialysis.

If necessary, cardioversion is performed, defibrillation. For the treatment of circulatory failure should use plasma substitutes, and in severe cases - infusion of dobutamine with an initial rate of 2-3 mcg / kg per minute with an increase in dose, depending on the response. With excitation and convulsions, diazepam can be used.

Interaction:

Pharmacodynamic interaction

Joint use with serotonergic active substances (such as selective serotonin and noradrenaline reuptake inhibitors (SIOZsin), SSRIs, monoamine oxidase inhibitors (MAO), lithium preparations, triptans, tramadol, linezolid, L-tryptophan, preparations of St. John's wort) can cause the development of serotonin syndrome.

MAO inhibitors

Simultaneous reception of amitriptyline and monoamine oxidase (MAO) inhibitors can cause serotonin syndrome (agitation, confusion, tremor, myoclonus, hyperthermia are possible). Amitriptyline can be appointed 14 days after cessation of treatment by irreversible MAO inhibitors and at least 1 day after discontinuation of therapy with a reversible MAO inhibitor of type A - moclobemide. MAO inhibitors can be prescribed 14 days after the end of amitriptyline intake.

SSRIs

Caution should be exercised when amitriptyline is used together with SSRIs (fluoxetine, fluvoxamine). Their simultaneous administration leads to an increase in the concentration of amitriptyline in blood plasma due to inhibition of the isoenzyme CYP2D6, involved in the metabolism of TCAs. Patients receiving such therapy should be under strict medical supervision because of the risk of developing toxic reactions.

Anticholinergic drugs

Since TCAs, including amitriptyline, can enhance the effect of anticholinergic drugs on the organs of vision, the central nervous system, the intestines and the bladder,avoid their simultaneous use because of the risk of developing paralytic intestinal obstruction.

When taking TCAs in combination with anticholinergic drugs or antipsychotics, especially in hot weather, the development of hyperexia is possible.

Sympathomimetics

Amitriptyline can enhance the effect of epinephrine, norepinephrine, ephedrine, isoprenaline, phenylephrine and phenylpropanolamine on the cardiovascular system. Therefore, do not use anesthetics, decongestants and other drugs containing these substances, along with amitriptyline.

Drugs that reduce sympathetic activity

Amitriptyline may reduce the hypotensive effect of guanethidine, betanidine, reserpine, clonidine and methyldopa. At simultaneous admission TCA it is necessary to correct hypotensive therapy.

Drugs that depress the central nervous system

When used simultaneously with blockers H₁-gistaminovyh receptors, clonidine, alcohol and barbiturates may increase the inhibitory effect on the central nervous system. Amitriptyline can enhance the effects of other drugs that depress the central nervous system.

Drugs that extend the QT interval

Simultaneous reception of amitriptyline and drugs that extend the interval QT: antiarrhythmics (quinidine), antihistamines (astemizole and terfenadine), some neuroleptics (especially pimozide and sertindole), cisapride, halofantrine and sotalol - increases the risk of ventricular arrhythmia.

Antifungal drugs

Antifungal drugs, such as fluconazole and terbinafine, increase the concentration of tricyclic antidepressants in serum and, accordingly, their toxicity. Possible syncope and development of paroxysms of ventricular tachycardia (torsade de pointes).

Barbiturates and inducers of microsomal liver enzymes

Barbiturates and other inducers of microsomal liver enzymes, for example rifampicin and carbamazepine can enhance the metabolism of TCAs, and as a result, reduce the concentration of TCAs in the blood plasma and reduce their effectiveness.

Cimetidine and methylphenidate, as well as blockers of "slow" calcium channels

With simultaneous use with cimetidine, methylphenidate and blockers of "slow" calcium channels, it is possible to slow the metabolism of amitriptyline, increase its concentration in the blood plasma and develop toxic effects.

Neuroleptics

When co-administered with neuroleptics, it should be borne in mind that TCAs and neuroleptics mutually inhibit each other's metabolism, reducing the threshold of convulsive readiness.

Indirect anticoagulants

With the simultaneous use of amitriptyline and indirect anticoagulants (coumarin derivatives or indadion), an increase in anticoagulant activity of the latter is possible.

Glucocorticosteroid agents

Amitriptyline may increase depression caused by glucocorticosteroids (GCS).

Anticonvulsants

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

Antithyroid drugs

Because of the risk of developing arrhythmias, special care should be taken when prescribing amitriptyline to patients with thyroid hyperthyroidism or to patients receiving antithyroid drugs.

Simultaneous reception of amitriptyline and drugs for the treatment of thyrotoxicosis increases the risk of agranulocytosis.

Holinblockers, phenothiazines and benzodiazepines

When combined with holinoblokatorami, phenothiazines and benzodiazepines, mutual strengthening of sedative and central cholinoblocking effects and the risk of epileptic seizures (lowering the threshold of convulsive activity) is possible.

Oral contraceptives

Estrogen-containing oral contraceptive medications and estrogens can increase the bioavailability of amitriptyline. To restore efficacy or reduce activity, it may be necessary to reduce the dose or estrogen, or amitriptyline. However, it may be necessary and cancellation of the drug.

Inhibitors of acetaldehyde dehydrogenase

Co-administration with disulfiram and other acetaldehyde dehydrogenase inhibitors may increase the risk of developing psychotic conditions and confusion.

Phenytoin

TCAs can increase the serum concentration of phenytoin and, accordingly, increase the risk of its toxic effects (ataxia, hyperreflexia, nystagmus, tremor).

St. John's wort perforated

Simultaneous use of amitriptyline and preparations containing St. John's Wort,can lead to increased metabolism of amitriptyline and a decrease in the maximum serum concentration of amitriptyline by 20%, due to the induction of its metabolism by isoenzyme CYP3A4 of the liver. Theoretically, an increased risk of developing a serotonin syndrome is possible.

Lithium

With the simultaneous use of lithium drugs and tricyclic antidepressants, the risk of psychotic symptoms and toxic complications from the central nervous system may increase, even against the background of therapeutic concentrations of lithium in blood plasma. The cases of mania, myoclonus, tremor, tonic-clonic seizures, memory disorders, confusion, disorganization of thinking, hallucinations, serotonin syndrome and malignant neuroleptic syndrome, which began several days after the onset of combination therapy, were mostly required in most cases to abolish therapy or TCAs, or lithium preparations. Elderly patients are particularly prone to the occurrence of such reactions.

Special instructions:

Depression is accompanied by an increased risk of suicidal thoughts, self-harm and suicide (suicidal events).This risk persists until the state of significant improvement. Since the improvement may not occur during the first few weeks of treatment or longer, patients should be carefully monitored until such an improvement occurs. In clinical practice, an increased risk of suicide in the early stages of recovery is widespread.

Other psychiatric conditions that are prescribed for amitriptyline, may also be accompanied by an increased risk of suicidal events. In addition, these conditions may accompany a major depressive disorder. Therefore, when treating patients with other psychiatric conditions, the same precautions should be followed as in the treatment of patients with major depressive disorder.

It is known that patients with a history of suicide-related events or who have a significant degree of suicidal thinking prior to starting treatment have a greater risk of suicidal thoughts or suicidal actions and should be carefully observed during treatment. Meta-analysis of placebo-controlled trials of antidepressants with adult patients with psychiatric disordershas demonstrated an increased risk of suicidal behavior in patients younger than 25 years of age who are receiving antidepressants compared to the placebo group.

Careful monitoring of patients, especially those at high risk, should accompany drug therapy, especially in its early stages and after dose changes. It is necessary to alert patients (and those who care for them) about the need to monitor any clinical deterioration, suicidal behavior or suicidal thoughts, unusual behavioral changes, and seek medical advice immediately if these symptoms appear.

Caution should be exercised when using amitriptyline in patients receiving inhibitors or isoenzyme inducers CYP3A4 systems of cytochrome P450.

The drug Vero-amitriptyline contains lactose. Patients with rare congenital conditions accompanied by galactose intolerance, lactase deficiency or glucose-galactose malabsorption, this medication should not be taken.

Amitriptyline should not be given to children and adolescents under the age of 18 due to insufficient data on the efficacy and safety of TCAs in this group of patients.

The use of amitriptyline in patients of all age groups is associated with a risk of side effects from the cardiovascular system.

When high doses are used, it is possible to develop heart rhythm disturbances and a severe decrease in blood pressure. In patients suffering from heart disease, these phenomena can occur when the usual dose is prescribed.

With the development of the manic state amitriptyline should be canceled.

Hyperglycemia / Diabetes mellitus

Epidemiological studies have revealed an increased risk of developing diabetes in depressed patients receiving TCAs. Thus, patients with an established diagnosis of diabetes mellitus or risk factors for diabetes, who take amitriptyline, should undergo an appropriate examination with the determination of the glucose content in the blood.

In patients with diabetes mellitus, treatment with amitriptyline may alter the action of insulin and the concentration of glucose in the blood, so an adjustment of the dose of insulin and / or oral hypoglycemic drugs may be required.

The use of anesthetics during a course of treatment with three / tetracyclic antidepressants may increase the risk of arrhythmia and lowering blood pressure.It should be possible to stop taking amitriptyline several days before surgery. In case of urgent surgical intervention, the anesthetist should be warned about the patient's treatment with the drug.

During the treatment should be excluded from drinking alcohol.

After a long period of use, a sharp cessation of therapy in some patients can lead to a "cancellation" syndrome. To avoid its occurrence, gradual abolition of amitriptyline for several weeks is recommended.

Treatment with amitriptyline in old age should be carefully controlled, with minimum doses of the drug and gradually increased, in order to avoid the development of delirious disorders, hypomania and other complications.

In patients using contact lenses, reducing the formation of tears and accumulation of mucous secretions, due to the m-holinoblokiruyuschey action of TCAs, can lead to damage to the epithelium of the cornea. Due to the anticholinergic effect of amitriptyline, an attack of increased intraocular pressure is possible.Dryness of the oral mucosa can lead to changes on its surface, inflammatory reactions, burning sensation and caries. Regular visits to the dentist are recommended. When TCAs are used in combination with other serotonergic drugs, serotonin syndrome may occur. The syndrome caused by excess serotonin can lead to a fatal outcome and includes the following symptoms: neuromuscular excitation (muscle twitching, hyperreflexia, myoclonus, rigidity), vegetative changes (hyperthermia, tachycardia, changes in blood pressure, increased sweating, tremors, flushing of skin , dilated pupils, diarrhea), changes in mental state (anxiety, agitation, confusion, coma).

Due to the administration of amitriptyline, the development of agranulocytosis is possible.

Amitriptyline should be used with extreme caution in patients with convulsive disorders and history of epilepsy, since amitriptyline reduces the threshold of convulsive readiness, which may lead to a decrease in the effectiveness of treatment with antiepileptic drugs.This group of patients has an increased risk of developing convulsive seizures amitriptyline.

Epidemiological studies involving patients over the age of 50 demonstrated an increased risk of fracture in individuals taking SSRIs and TCAs. The mechanism leading to an increased risk of fractures is unknown.

Before starting treatment with amitriptyline, the patient needs to correct hypokalemia.

Effect on the ability to drive transp. cf. and fur:

During the reception of amitriptyline it is prohibited to drive vehicles, as well as maintenance of mechanisms and performance of other types of work that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Film-coated tablets, 25 mg.

Packaging:

For 10 tablets in a planar cell packaging made of polyvinylchloride film and aluminum foil printed lacquered.

For 50 tablets in a bank of light-protective glass with a triangular corolla type BTS, ukuporennoy cover stretched with a sealing element or in a can of polymer.

Each jar or 5 contour squares together with instructions for use in a pack of cardboard.

Storage conditions:

In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-001867/10

Date of registration:11.03.2010 / 12.10.2015

Expiration Date:Unlimited

The owner of the registration certificate:VEROPHARM SA VEROPHARM SA Russia

Manufacturer: & nbsp

VEROPHARM SA Russia

Representation: & nbspVEROPHARM, AO VEROPHARM, AO Russia

Information update date: & nbsp03.02.2017

Illustrated instructions

Instructions

Vero-Amitriptyline (Vero-Amitriptyline)