Amitriptyline Grindeks - instructions for use, dose, side effects, contraindications

tablets 10 mg: lactose monohydrate 85.5 mg, corn starch 33.0 mg, povidone (polyvinylpyrrolidone) 5.0 mg, silicon dioxide 0.5 mg, magnesium stearate 1.0 mg; tablets 25 mg: lactose monohydrate 74.5 mg, corn starch 29.0 mg, povidone (polyvinylpyrrolidone) 5.0 mg, silicon dioxide 0.5 mg, magnesium stearate 1.0 mg;

shell:

tablets 10 mg - coloring Opadrai II blue 85 F 20753 (polyvinyl alcohol - 40,000%, titanium dioxide (E 171) - 24.360%, macrogol PEG 3000 - 20,200%, talcum - 14,800%, indigo carmine (E 132) - 0,084%, dye crimson (Ponso 4R) (E 124) 0.011%, quinoline yellow (E 104) 0.002%) 4.1 mg, carnauba wax - q.s.; tablets 25 mg - coloring Opadrai II yellow 85 F 22450 (polyvinyl alcohol - 40,000%, macrogol PEG 3000 - 20,200%, quinoline yellow (E 104) - 3,965%, talc - 14,800%, titanium dioxide (E 171) - 8,460%, dye sunset yellow (E 110) - 0.002%, indigo carmine (E 132) 0.001% ) - 4.1 mg, carnauba wax - q.s.

Description:

Tablets 10 mg - round biconvex tablets, covered with a film shell from light blue with a grayish shade to blue. On the site of the fault white or white with a yellowish tinge.

Tablets 25 mg - round biconvex tablets, covered with a film coating of yellow color. On the site of the fault white or white with a yellowish tinge.

Pharmacotherapeutic group:Antidepressant

ATX: & nbsp

N.06.A.A.09 Amitriptyline

Pharmacodynamics:

Amitriptyline is a tricyclic antidepressant from a group of indiscriminate inhibitors of neuronal capture of monoamines. Has a pronounced timoanaleptic and sedative effect.

The mechanism of antidepressant action of amitriptyline is associated with an increase in the content of norepinephrine and serotonin in the synaptic cleft. Accumulation of these neurotransmitters occurs as a result of inhibition of their re-uptake by membranes of presynaptic neurons. With prolonged use reduces the functional activity of beta-adrenergic and serotonin receptors in the brain, normalizes adrenergic and serotonergic transmission, restores the balance of these systems, disturbed in depressive states.

With anxiety-depressive states reduces anxiety, agitation and depressive manifestations.

Antidepressant effect develops within 2-3 weeks after the beginning of application. Amitriptyline possesses also m-cholinoblocking properties, causes blockade H₁-gistamines and αadrenoreceptors.

Pharmacokinetics:

Amitriptyline quickly and well absorbed from the gastrointestinal tract after oral administration.Bioavailability of amitriptyline 30-60%, its active metabolite nortriptyline - 46-70%. The maximum concentration in the blood plasma (Cmax) 0.04-0.16 μg / ml. Time to reach the maximum concentration (TCmah) after ingestion 2-7,7 hours. The volume of distribution is 5-10 l / kg. Effective therapeutic concentrations in the blood for amitriptyline - 50-250 ng / ml, for nortriptyline - 50-150 g / ml. Easily passes through the histohematetic barriers, including blood-brain barrier (including nortriptyline).

The concentrations of amitriptyline in tissues are higher than in plasma. The connection with plasma proteins is 96%.

Metabolised in the liver by isoenzymes CYP2C19, CYP2D6, has the effect of "first passage" (by demethylation, hydroxylation, N-oxidation) with the formation of active metabolites - nortriptyline, 10-hydroxyamitriptyline and inactive metabolites.

It is excreted by the kidneys (mainly in the form of glucuronides) - 80 %, partially intestines. The half-life (T1 / 2) of amitriptyline from the blood plasma is 10-26 hours, for nortriptyline - 18-44 hours. Complete excretion - within 7-14 days. In renal failure, the reduced clearance of metabolites can be associated with the cumulation of amitriptyline.

Amitriptyline penetrates the placental barrier, is excreted in breast milk in concentrations similar to plasma.

Indications:

Endogenous depression and other depressive disorders.

Contraindications:

- Hypersensitivity to amitriptyline and / or any auxiliary substance of the drug,

- is incompatible with MAO inhibitors (there may be an increase in the frequency of periods of hyperpyrexia, severe seizures, hypertensive crises and death). A break in treatment between taking MAO inhibitors and amitriptyline should be at least 14 days! (see section "Interaction with other drugs"),

- myocardial infarction (acute and recovery period),

- blockade of intracardiac conduction (of any degree),

- arrhythmia,

- heart failure,

- severe renal or hepatic insufficiency,

- peptic ulcer of stomach and 12-типерстной intestines in a stage of an exacerbation,

- pyloric stenosis, paralytic ileus,

- atony of the bladder,

- acute alcohol intoxication,

- hyperplasia of the prostate,

- angle-closure glaucoma,

- acute intoxication with sleeping pills, analgesic and psychoactive drugs,

- the period of breastfeeding,

- deficiency of lactase, lactose intolerance, glucose-galactose malabsorption,

- It is not recommended for the treatment of depression in children and adolescents under the age of 18 years.

Carefully:

Зcardiovascular system abnormalities (stenocardia, arterial hypertension), oppression of bone marrow hematopoiesis, increased intraocular pressure, flat anterior chamber of the eye and acute angle of the eye chamber, stroke, hyperthyroidism, bladder hypotension, bipolar disorder and epilepsy (see " Special instructions "), schizophrenia (possible activation of psychosis), impaired liver or kidney function, bronchial asthma, pregnancy (especially III trimester), chronic alcoholism, old age.

If you have any of the listed diseases or conditions, always consult a doctor before taking the drug.

Pregnancy and lactation:

In experimental studies, the adverse effects of amitriptyline on the fetus have been identified, but strictly controlled clinical studies on the safety of its use in pregnancy have not been conducted.

Use amitriptyline during pregnancy should only be in cases where the intended benefit to the mother exceeds the potential risk to the fetus.

The drug should not be used in the III trimester of pregnancy, unless it is absolutely necessary. The use of large doses of tricyclic antidepressants in the third trimester of pregnancy can affect the newborn, including impaired behavior and neurological functions. In newborns, there are cases of drowsiness, as a result of the effect of amitriptyline, and urinary retention, as a result of the influence of nortriptyline (amitriptyline metabolite) if the drug was administered to women immediately before childbirth.

In order to avoid the development of the "cancellation" syndrome in newborns (manifested by shortness of breath, drowsiness, intestinal colic, increased nervous excitability, increase or decrease in blood pressure, tremor or spastic phenomena) Amitriptyline should be withdrawn gradually by starting a dose reduction at least 7 weeks before the expected delivery.

Amitriptyline penetrates into breast milk and may cause drowsiness in infants. Therefore, if treatment with amitriptyline is necessary for the mother, breast-feeding should be stopped.

Dosing and Administration:

The dose is selected individually.

Begin the treatment should be with the use of low doses with a subsequent gradual increase.

The dose is usually increased by taking the drug in the evening or before bedtime.

With maintenance therapy, the total daily dose can be taken once, preferably at bedtime.

The drug is taken orally, without chewing, during or immediately after a meal (to reduce irritation of the gastric mucosa).

Adults: the average daily or daily dose is 75 mg. The initial daily intake for oral administration is 25 mg 2 times a day. The dose should be increased gradually, increasing by 25 mg every other day, reaching - if necessary - doses of 150 mg / day (rarely up to 225-300 mg / day in a hospital).

After achieving a stable antidepressant effect after 2-4 weeks of treatment, a gradual slow reduction of the dose to a minimal effective dose is possible. If signs of depression appear, you must return to the previous dose. If the patient's condition does not improve within 3-4 weeks of treatment, further therapy with amitriptyline is impractical.

Aged people are more sensitive to the cholinolytic undesirable effects of amitriptyline.In this case, the recommended initial dose is 10 mg 2-3 times a day. Further increase in the dose should be carried out gradually, every other day, reaching - if necessary - doses of 50-100 mg / day. In some cases, the minimum effective dose in the elderly may be 10-50 mg / day.

Impaired renal function: patients with impaired renal function amitriptyline can be administered in usual doses.

Impaired liver function: If liver function is impaired, caution should be exercised when selecting a dose of amitriptyline. It is desirable to determine the concentration of the drug in the blood serum.

Duration of treatment: The antidepressant effect of amitriptyline usually develops after 2-4 weeks of treatment. Duration of treatment is usually 6 months or more, incl. to prevent the recurrence of depression.

Cancel: the drug should be withdrawn gradually, because with sudden discontinuation after long-term treatment, especially in high doses, the development of the "withdrawal" syndrome is possible. Symptoms of withdrawal; headache, nausea, vomiting, diarrhea, malaise, sleep disorders, unusual dreams, agitation, motor anxiety, irritability and general poor health. These symptoms are not signs of drug dependence.

If you forget to take a dose

If you forget to take your daily dose, wait until the time for taking the next scheduled dose is right. Do not take a double dose instead of a single dose!

Side effects:

Very frequent (> 1/10); frequent (> 1/100, <1/10); infrequent (> 1/1000, <1/100), rare (> 1/10000, <1/1000); very rare (<1/10000).

Some of the undesirable reactions listed below (headache, tremor, decreased attention span, constipation, decreased libido) may also be symptoms of depression and tend to fade or disappear as the condition of a depressed patient improves.

organ systems	frequency		manifestations
From the nervous system	Often		Drowsiness, tremor, dizziness, headache
	often		decreased concentration of attention, a taste disorder (dysgeusia), paresthesia, extrapyramidal symptoms: ataxia, akathisia, parkinsonism, dystonic reactions, tardive dyskinesia, speech delay
	infrequently		convulsions
Mental disorders	Often		a state of confusion (in elderly patients, confusion may be manifested by anxiety, excitement, elements of hallucinatory delusional disorders), disorientation
	infrequently		weakening of cognitive abilities, hypomania, mania, anxiety, insomnia, nightmares
	rarely		aggression, delirium (in the elderly), hallucinations (in patients with schizophrenia)
	rarely		in the period of treatment with amitriptyline and soon after its termination - suicidal thoughts, suicidal behavior
From the side of the cardiovascular system	Often		palpitation, tachycardia, orthostatic hypotension
		often		atrioventricular block, violation of intraventricular conduction (change in ECG parameters: increase in intervals P-Q, Q-T, expansion of the complex QRS, signs of blockade of the bundle branch legs, nonspecific changes in the interval S-T or T wave, incl. in patients without heart disease), lowering blood pressure (BP)
		infrequently		arrhythmia, increased blood pressure
		rarely		myocardial infarction
From the digestive system		Often		dry mouth, constipation, nausea
		often		Atrophy of the gums, inflammation of the mouth, dental caries, burning sensation in the mouth
		infrequently		diarrhea, vomiting, edema of the tongue
		rarely		increased salivary glands, intestinal obstruction, hepatitis (including impaired liver function and cholestatic jaundice)
From the side of metabolism		Often		increased body weight, increased appetite
		rarely		loss of appetite
		rarely		syndrome of inadequate hypersecretion of antidiuretic hormone
From the side of the reproductive system		Often		weakening or increase of sexual desire
		often		in men - impotence, erectile dysfunction
		rarely		women - galactorrhea, delayed orgasm, loss of ability to achieve orgasm; in men - an increase in the size (swelling) of the testicles, delayed ejaculation, gynecomastia
From the urinary system		often		retention of urine
On the part of the organs of hematopoiesis		rarely		oppression of bone marrow function, agranulocytosis, leukopenia, thrombocytopenia, eosinophilia
From the sense organs		Often		reduction of visual acuity, violation of accommodation
		often		mydriasis
		infrequently		tinnitus, increased intraocular pressure
		rarely		loss of ability to accommodation, aggravation of narrow-angle glaucoma in the elderly
From the skin		Often		hyperhidrosis
		infrequently		skin rash, hives, angioedema
		rarely		alopecia, photosensitivity
General disorders		often		weakness
		infrequently		swelling of the face
		rarely		pyrexia
Laboratory indicators		often		ECG change: increasing the intervals P-Q, Q-T, expansion of the complex QRS, signs of blockade of the bundle branch legs, nonspecific changes in the interval S-T or T wave
		rarely		deviation from the norm of liver tests, increased activity of alkaline phosphatase, transaminase

Communication with the drug is not established: lupus-like syndrome (migratory arthritis, the appearance of antinuclear antibodies and a positive rheumatoid factor).

Epidemiological studies, which were mainly conducted in patients aged 50 years and older, indicate an increased risk of bone fractures when using selective serotonin reuptake inhibitors and tricyclic antidepressants. The mechanism of action that increases this risk is not known.

If you experience any of the undesirable reactions described in the manual or if you notice any other undesirable phenomena, tell your doctor.

Overdose:

Symptoms. Symptoms of an overdose of amitriptyline may develop slowly or occur suddenly. In the first hours there are drowsiness or excitement, hallucinations and symptoms associated with the anticholinergic action of the drug: mydriasis, tachycardia, urinary retention, dry mucous membranes, weakened intestinal motility.Cramps, fever. In the future, a sharp suppression of the functions of the central nervous system, impaired consciousness, progressing to coma, and respiratory failure are possible.

Cardiac symptoms: arrhythmia (ventricular tachyarrhythmia, flutter and ventricular fibrillation). On the ECG, the characteristic changes are the lengthening of the interval PR, expansion of the complex QRS, interval lengthening QT, flattening or inverting the T wave, segment depression ST and a different degree of blockade of intracardiac conduction, which can cause cardiac arrest. Can develop heart failure, arterial hypotension, cardiogenic shock, metabolic acidosis and hypokalemia, confusion, anxiety, hallucinations and ataxia. A case of a lethal arrhythmia occurred 56 hours after an overdose of amitriptyline.

Treatment. The victim should be immediately taken to the hospital for symptomatic and maintenance therapy. It is necessary to wash the stomach and lavage, incl. in later terms after oral administration of the drug; The reception of activated carbon is 20-30 g every 4-6 hours during the first 24-48 hours after poisoning. A thorough monitoring of the patient's condition is necessary, includingin apparently uncomplicated cases. It is necessary to control the level of consciousness, heart rate, blood pressure and respiratory rate, at short intervals - the content of electrolytes and gases in the blood. To prevent stopping breathing, it is necessary to ensure airway patency with the help of artificial ventilation. ECG monitoring should be continued for 3-5 days.

With the expansion of the complex QRS, heart failure and ventricular arrhythmias, it can be effective to shift the pH of the blood to the alkaline side (administration of a sodium bicarbonate solution or hyperventilation) with the rapid administration of a hypertonic sodium chloride solution (100-200 mmol Na⁺). With ventricular arrhythmias, it is possible to use traditional antiarrhythmic drugs, for example, 50-100 mg of lidocaine (1-1.5 mg / kg) intravenously with further infusion at a rate of 1-3 mg / min.

If necessary, cardioversion and defibrillation are used. Circulatory insufficiency is corrected with the help of plasma substitutes, in severe cases - by infusing dobutamine (at first - at a rate of 2-3 μg / min with a further increase in dose depending on the effect).

Excitation and convulsions can be stopped with diazepam.

In metabolic acidosis, standard therapy should be started.

Dialysis is ineffective, as the concentration of amitriptyline in the blood is low.

The reactions to overdose in different patients vary significantly. Children are particularly prone to the occurrence of cardiotoxic phenomena and seizures. In adults, moderate or severe intoxication develops with amitriptyline at a dose of more than 500 mg, with a dose of about 1000 mg, a lethal outcome is possible.

Interaction:

Amitriptyline increases the effect on the central nervous system of the following medicines: neuroleptics, central and narcotic analgesics, sedatives and hypnotics, anticonvulsant drugs, anesthetics, and alcohol - it is possible to significantly increase the inhibitory effect on the central nervous system, respiratory depression and hypotensive effect.

Amitriptyline shows synergism when interacting with other antidepressants. However, simultaneous use of antidepressants of various classes can cause serious undesirable phenomena, including the development of serotonin syndrome. It is recommended to observe a period free from taking medication when moving from one classantidepressants to another.

Tricyclic antidepressants, including amitriptyline, are metabolized by isoenzyme CYP2D6 hepatic cytochrome P450. This isoenzyme in man has several isoforms. In addition, the metabolism of amitriptyline involves isoenzymes CYP2C19 and CYP3A.

Isozyme CYP2D6 can be inhibited by various psychotropic drugs, for example, antipsychotics, serotonin reuptake inhibitors (except citalopram, a very weak inhibitor), as well as P-blockers and antiarrhythmics (procainamide, phenytoin, propafenone, esmolol, amiodarone). These drugs can inhibit the metabolism of tricyclic antidepressants and significantly increase their concentration in blood plasma.

Contraindicated mills:

Amitriptyline is incompatible with MAO inhibitors (because of the risk of developing a serotonin syndrome, including myoclonus, spasms during excitation, delirium and to whom). The use of amitriptyline can be started 2 weeks after the cancellation of the irreversible non-selective MAO inhibitor and the day after the reversal of the reversible inhibitor of moclobemide.

The use of MAO inhibitors can begin 2 weeks after the withdrawal of amitriptyline.

In either case, both the MAO inhibitor, and amitriptyline should be started with small doses, gradually increasing them depending on the effect.

Not recommended combinations:

Sympathomimetics: amitriptyline strengthens the effect on the cardiovascular system of epinephrine, ephedrine, isoprenaline, norepinephrine, dopamine and phenylephrine, used, for example, for anesthesia (local or general) or in the form of drops in the nose. Adrenoblockers: when used simultaneously with amitriptyline, the hypotensive effect of guanethidine, clonidine, betanidine, reserpine and methyldopa may be weakened.

M-holinoblokatory: tricyclic antidepressants can enhance the effect of m-cholinoblockers (eg, phenothiazine derivatives, antiparkinsonics, blockers H₁-gistaminovyh receptors, atropine, biperidena) on the organs of vision, central nervous system, intestine and bladder. It should avoid the simultaneous use of m-holinoblokatorov and amitriptyline in connection with an increased risk of development of adverse events, including paralytic intestinal obstruction and hyperpyrexia.

Simultaneous use of amitriptyline and phenothiazine derivatives, in addition, may increase the risk of malignant neuroleptic syndrome. Drugs capable of lengthening the interval QT - antiarrhythmic drugs (for example, quinidine), H1-histamine receptor blockers (for example, astemizole and terfenadine), some antipsychotics (in particular, pimozide and sertindole), anesthetics (isoflurane, droperidol), chloral hydrate, sotalol - when used in conjunction with amitriptyline may increase the risk of ventricular arrhythmias.

Antifungal drugs - eg, fluconazole and terbinafine - increase the concentration of amitriptyline in the serum and, in connection with this, increase its toxicity. Cases of fainting, fibrillation and fluttering of the ventricles were noted.

Lithium salts (lithium carbonate) interact with amitriptyline by an unknown mechanism; this interaction can enhance the toxicity of lithium: tremor, tonic-clonic convulsions, difficulty remembering, mismatched thinking, hallucinations, malignant neuroleptic syndrome.

Combinations requiring caution:

Means that depress the central nervous system: amitriptyline can enhance the inhibition of CNS functions caused by various psycho-depressants, for example, alcohol, hypnotics, sedatives and strong analgesics. Drugs that affect the activity of cytochrome P450 isoenzymes can alter the metabolism of amitriptyline and cause significant fluctuations in its plasma concentration.

Inducers of microsomal liver enzymes (barbiturates, carbamazepine, phenytoin, nicotine, rifampicin and oral contraceptives) increase metabolism of amitriptyline, reduce its concentration in the blood and, thus, weaken the antidepressant effect.

Cimetidine, methylphenidate and blockers of "slow" calcium channels increase the concentration of amitriptyline in the blood plasma, which can be accompanied by increased toxicity.

Amitriptyline and neuroleptics mutually suppress each other's metabolism, which can lead to a decrease in the convulsive threshold and the development of seizures. When combined, it may be necessary to adjust the dosage of these drugs.

Avoid simultaneous use of amitriptyline, neuroleptics and hypnotics (droperidol). When joint admission should exercise extreme caution.

Sucralfate weakens absorption of amitriptyline and can weaken its antidepressant effect.

With the simultaneous use of valproic acid, the clearance of amitriptyline from the blood plasma decreases, which can lead to an increase in the concentration of amitriptyline and its metabolite, nortriptyline, which should be controlled concentrations of amitriptyline and nortriptyline in serum. You may need to reduce the dose of amitriptyline.

In the appointment of amitriptyline to patients receiving phenytoin, the concentration of the latter in the blood plasma should be monitored because of the increased risk of inhibition of its metabolism and, as a consequence, increased toxic effects (ataxia, hyperreflexia, nystagmus, tremor). At the same time, the therapeutic effect of amitriptyline should be monitored, since an increase in its dose may be required.

Drug preparations of St. John's wort reduce AUC₀_-₁₂hours and maximum concentration of amitriptyline in the blood plasma by about 20% due to activation hepatic metabolism of amitriptyline with isoenzyme CYP3A4. This combination can be used in clinical practice provided that the dose adjustment of amitriptyline depending on the results of measuring its concentration in the blood plasma.

With the simultaneous use of amitriptyline and anticoagulants (coumarin derivatives), it is possible to increase the anticoagulant activity of the latter.

Fluoxetine and fluvoxamine increase the concentration of amitriptyline in plasma (may require a decrease in the dose of amitriptyline by 50%).

Simultaneous use of amitriptyline with disulfiram and other acetal dehydrogenase inhibitors can provoke delirium.

Estrogen-containing oral contraceptive medications can increase the bioavailability of amitriptyline.

The use of cocaine while taking amitriptyline increases the risk of heart arrhythmia.

Amitriptyline may increase depression caused by glucocorticosteroids. Drugs for the treatment of thyrotoxicosis increase the risk of agranulocytosis.

When used simultaneously with thyroid hormones - the mutual enhancement of the therapeutic effect and toxic effects (cardiac arrhythmias and a stimulating effect on the central nervous system).

When used simultaneously with other hematotoxic drugs, it is possible to increase hematotoxicity.

Special instructions:

Before the start of treatment, it is necessary to control blood pressure (BP) (in patients with low or labile blood pressure it can be reduced to a greater extent).

Care must be taken when jumping to a vertical position from the "lying" or "sitting" position.

During the treatment in some cases, agranulocytosis may develop, and therefore control of peripheral blood is recommended, especially with an increase in body temperature, the development of influenza-like symptoms and tonsillitis.

With prolonged therapy with amitriptyline, monitoring of the functions of the cardiovascular system and the liver is necessary.

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 elderly patients and patients with diseases of the cardiovascular system, it is necessary to control the heart rate, blood pressure, ECG. On the ECG, the appearance of clinically insignificant changes (nonspecific changes in the interval S-T or T wave, moderate expansion of the complex QRS).

During the treatment with amitriptyline, alcohol should be excluded.

Cancel amitriptyline should be gradual, as with the sudden discontinuation of treatment after long-term treatment, especially in high doses, the development of the syndrome of "withdrawal" is possible.

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

Due to the m-cholinoblocking effect of amitriptyline, tearing can be reduced and the relative amount of mucus in the tear fluid can be increased, which can damage the corneal epithelium in patients using contact lenses.

Simultaneous use of other m-holinoblokatorov can enhance mholinoblokiruyuschee effect of amitriptyline.

Amitriptyline is prescribed no earlier than 14 days after the abolition of MAO inhibitors, starting with small doses (see section "Interaction with other drugs").

When the drug is used in high doses, the likelihood of developing cardiac rhythm disturbances and severe arterial hypotension increases.The development of such conditions is also possible with the use of conventional doses in patients with heart disease.

Amitriptyline at doses above 150 mg / day reduces the threshold of convulsive activity, therefore, one should take into account the risk of epileptic attacks in predisposed patients, as well as in the presence of other factors predisposing to the onset of convulsive syndrome, for example, in brain lesions of any etiology, simultaneous use of neuroleptics, refusal of ethanol (for patients with chronic alcoholism) or with the withdrawal of drugs with anticonvulsant properties, for example, benzodiazole ins.

Due to the high risk of suicidal actions with severe depression (which can persist until a significant remission is achieved), combinations of amitriptyline with drugs from the benzodiazepine group or neuroleptic medicines may be indicated at the beginning of treatment, and constant medical supervision is necessary.

Avoid simultaneous use of amitriptyline, neuroleptics and hypnotics (droperidol).If simultaneous reception is necessary, extreme caution should be exercised.

When using amitriptyline for the purpose of treating the depressive component of schizophrenia, it is possible to increase psychotic symptoms - in this case amitriptyline it is advisable to appoint in combination with neuroleptics.

In patients with a depressive phase of bipolar disorder, manic or hypomanic conditions may develop on the background of therapy (dose reduction or drug withdrawal is necessary). After stopping these conditions, treatment in low doses can be resumed.

In patients receiving three / tetracyclic antidepressants concomitantly with local and general anesthetics, the risk of arrhythmia and a drop in blood pressure may be increased.

It is recommended to cancel amitriptyline before performing surgical operations. In case of emergency operations, the anesthetist should be informed of the use of amitriptyline.

Care must be taken when treating amitriptyline with thyrotoxicosis patients and patients receiving thyroid hormone preparations, in connection with the risk of cardiac arrhythmia.

In combination with electroconvulsive therapy amitriptyline appointed only under the condition of careful medical supervision.

In predisposed patients and elderly patients amitriptyline can provoke the development of drug psychoses, mainly at night (after the drug is withdrawn for several days).

Amitriptyline can cause paralytic intestinal obstruction, mainly in patients with chronic constipation, the elderly or in patients who are obliged to comply with bed rest.

Patients should inform their dentist about taking amitriptyline. Dryness in the mouth can lead to a change in the mucous membrane of the mouth, inflammation, burning sensation and tooth decay. It is recommended to have a regular check-up at the dentist. Probably the increase in demand for riboflavin.

The intake of amitriptyline can alter the body's tolerance to insulin and glucose, which requires correction of antidiabetic therapy in patients with diabetes mellitus. The state of depression can also affect glucose metabolism.

There have been reports of hyperpyrexia on the background of the use of tricyclic antidepressants when given concomitantly withanticholinergic or neuroleptic medicines, especially in hot weather.

AMITRIPTYLIN GRINDEX tablets contain lactose, therefore the drug is contraindicated for patients with a rare congenital intolerance to galactose, a deficiency of lactase or malabsorption of glucose-galactose.

The AMITRIPTYLIN GRINDEX tablets contain dyes that can cause allergic reactions.

Suicide / suicidal thoughts or clinical worsening of the course of the disease Depression is accompanied by an increased risk of suicide. This risk persists until a significant remission is achieved and can occur spontaneously throughout the course of therapy. Since the antidepressant effect develops only a few weeks from the start of treatment, the patient's condition should be carefully monitored until clinical improvement is achieved. It is possible to increase suicide risk in the early stages of recovery.

We need constant medical supervision of patients with suicidal thoughts and suicidal attempts in history, incl. on the background of therapy. Storage and dispensing of medicines to such patients must be carried out by authorized representatives. Amitriptyline (like other antidepressants) can itself increase the incidence of suicide in persons under 24 years of age. Therefore, when amitriptyline is administered to patients younger than 24 years should be related to the risk of suicide and the benefits of using an antidepressant. In short-term studies in people over 24 years of age, the risk of suicide did not increase, but in people older than 65 years, it declined slightly.

Any depressive disorder in itself increases the risk of suicide, so during treatment with antidepressants, all patients should be monitored for early detection of disorders or behavioral changes, as well as suicidal tendencies.

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

During the treatment period, amitriptyline is prohibited from driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions, as well as alcohol intake.

Form release / dosage:

Tablets film-coated 10 mg and 25 mg.

Packaging:

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

For 5 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

Storage conditions:

Store in a dry, dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

4 years.

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

Terms of leave from pharmacies:On prescription

Registration number:П N012794 / 01

Date of registration:16.01.2012 / 26.11.2012

Expiration Date:Unlimited

The owner of the registration certificate:GRINDEX, JSC GRINDEX, JSC Latvia

Manufacturer: & nbsp

GRINDEX, AO Latvia

Representation: & nbspGrindeks Rus, Open CompanyGrindeks Rus, Open CompanyRussia

Information update date: & nbsp13.09.2017

Illustrated instructions

Instructions

Amitriptyline Grindeks (Amitriptyline Grindex)