Amitriptyline-Grindeks 10 mg 50 pcs film-coated tablets

Nosological classification (ICD-10)

• F10.3 Withdrawal state
• F20 Schizophrenia
• F29 Non-organic psychosis, unspecified
• F32 Depressive episode
• F33 Recurrent depressive disorder
• F41.2 Mixed anxiety and depressive disorder
• F50.2 Bulimia nervosa
• F60.3 Emotionally unstable personality disorder
• F90.0 Impaired activity and attention
• F91.9 Behavior disorder, unspecified
• F92.0 Depressive behavior disorder
• F98.0 Enuresis of inorganic nature
• G43.9 Migraine, unspecified
• G53.0 Neuralgia after herpes zoster (B02.2+)
• G62.9 Polyneuropathy, unspecified
• G63.2 Diabetic polyneuropathy (E10-E14+ with common fourth character .4)
• K25 Stomach ulcer
• K26 Duodenal ulcer
• M79.0 Rheumatism, unspecified
• M79.2 Neuralgia and neuritis, unspecified
• R51 Headache
• R52.1 Persistent, intractable pain
• R52.2 Other persistent pain
• R52.9 Pain, unspecified
• T14.4 Injury to nerve(s) of unspecified body area

Compound

Amitriptyline Zentiva tablets 25 mg No. 50

Amitriptyline Zentiva tablets 25mg No. 50
Amitriptyline Buy Amitriptyline in pharmacies
DOSAGE FORMS tablets 25mg film-coated tablets 25mg film-coated tablets 25mg

MANUFACTURERS

Zentiva a.s. (Slovakia)

GROUP Antidepressants - non-selective inhibitors of neuronal uptake

COMPOSITION The active substance is amitriptyline.

INTERNATIONAL NON-PROPENTED NAME Amitriptyline

SYNONYMS Amineurin, Amiptyline, Amitriptyline Grindeks, Amitriptyline Nycomed, Amitriptyline-Akos, Amitriptyline-Ferein, Amitriptyline hydrochloride, Vero-Amitriptyline, Saroten retard, Elivel

PHARMACOLOGICAL ACTION Antidepressant, anxiolytic, sedative. Inhibits the reuptake of neurotransmitters (norepinephrine, serotonin, etc.) by the presynaptic nerve endings of neurons, causes the accumulation of monoamines in the synaptic cleft and enhances postsynaptic impulses. 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. Blocks M-cholinergic and histamine receptors of the central nervous system. In anxiety-depressive conditions, it reduces anxiety, agitation and depressive symptoms. If you suddenly stop taking it after long-term treatment, withdrawal syndrome may develop. It is quickly and well absorbed from the gastrointestinal tract. The maximum concentration in the blood after oral administration is achieved after 2.0-7.7 hours. The antidepressant effect develops within 2-3 weeks after the start of treatment. Easily passes through histohematic barriers, including the blood-brain barrier, placental barrier, and penetrates into breast milk. It undergoes biotransformation in the liver. It is excreted by the kidneys within a few days.

INDICATIONS FOR USE Depression, depressive syndrome, schizophrenic psychoses, anxiety-depressive states of various origins, mixed emotional disorders, behavioral disorders, psychogenic anorexia, nocturnal enuresis (auxiliary treatment), severe pain of a neurogenic nature.

CONTRAINDICATIONS Hypersensitivity, glaucoma, epilepsy, prostatic hyperplasia, bladder atony, paralytic ileus, history of myocardial infarction, use of MAO inhibitors in the previous 2 weeks, pregnancy, lactation, children (up to 6 years).

SIDE EFFECTS Blockade of peripheral M-cholinergic receptors: dry mouth, urinary retention, constipation, blurred vision, accommodation, increased sweating. From the cardiovascular system: tachycardia, orthostatic hypotension, increased blood pressure, conduction disturbances. From the side of the central nervous system: drowsiness, dizziness, tremor. Allergic reactions: skin rash and others.

INTERACTIONS Incompatible with MAO inhibitors. Enhances the effect of compounds that depress the central nervous system, sympathomimetics, antiparkinsonian drugs, weakens the effect of antihypertensive and anticonvulsant drugs. Barbiturates and carbamazepine reduce, and cimetidine increases plasma concentrations.

METHOD OF APPLICATION AND DOSAGE Orally, without chewing, after meals, for adults in the initial dose - 25 mg 2-4 times a day. The maximum doses for outpatient treatment are up to 150 mg per day, in a hospital - up to 300 mg per day, in elderly patients - up to 100 mg per day. For children, as an antidepressant: from 6 to 12 years old - 10-30 mg or 1-5 mg/kg per day in fractions, in adolescence - 10 mg 3 times a day, for the treatment of nocturnal enuresis for children under 6 years old - 10 mg per night, 6-10 years - 10-20 mg per day, 11-16 years - 25-50 mg per day.

OVERDOSE Symptoms: hallucinations, convulsions, coma, cardiac conduction disturbances, extrasystole, gastric arrhythmias, hypothermia. Treatment: gastric lavage, taking an activated carbon suspension, laxatives, maintaining body temperature, monitoring the function of the cardiovascular system for at least 5 days; for severe anticholinergic symptoms (hypotension, arrhythmia, coma) - 0.5-2 g of physostigmine intramuscularly or intravenously.

SPECIAL INSTRUCTIONS Should not be prescribed to manic patients and patients with suicidal tendencies. Use with caution for ischemic heart disease, arrhythmias, heart failure. During treatment, you should avoid drinking alcohol, as well as avoid activities that require increased attention and speed of reactions.

STORAGE CONDITIONS: In a dry place, protected from light. List B.

Directions for use and doses

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/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, psychoses in schizophrenia and alcohol withdrawal, prescribed in a dose of 25–100 mg/day (at night), after achieving a therapeutic effect, switch for the minimum effective dose - 10–50 mg/day.

For the prevention of migraine, 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 (maximum dose 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 in fractions, 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 old - up to 50 mg/day.

Amitriptyline (Amixid, Sarotene)

Clinical and pharmacological group

Antidepressant

Indications

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.

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.

Carefully. 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.

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 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 dose - 10-50 mg/day.

For the prevention of migraine, for 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.

Side effects

Associated with the anticholinergic effect of the drug: blurred vision, paralysis of accommodation, 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 PQ 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, motor 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.

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, intracardiac conduction disturbances, 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.

Drug interactions

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).

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 ST 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, it is possible that withdrawal syndrome may develop 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 childbirth

Use in childhood

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 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

For impaired renal function

Use with caution in case of renal failure.

For liver dysfunction

Use with caution in case of liver failure.

Use in old age

Use with caution in elderly people.

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

Conditions
for dispensing from pharmacies
The drug is dispensed with a prescription.

Storage conditions and periods

Store the drug in a dry place, protected from light, at a temperature not exceeding 25°C. Keep out of the reach of children.

Release form, composition and packaging

Pills

from white to white with a slightly yellowish tint, flat-cylindrical in shape, with a chamfer; Light marbling is allowed.

Excipients:

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.

10 pieces. — cellular contour packages (1) — cardboard packs. 10 pieces. — contour cell packaging (2) — cardboard packs. 10 pieces. — cellular contour packages (3) — cardboard packs. 10 pieces. — contour cell packaging (4) — cardboard packs. 10 pieces. — contour cell packaging (5) — cardboard packs. 100 pieces. — polymer jars (1) — cardboard packs.

Pills

from white to white with a slightly yellowish tint, flat-cylindrical in shape, with a chamfer and a notch; Light marbling is allowed.

Excipients:

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.

10 pieces. — cellular contour packages (1) — cardboard packs. 10 pieces. — contour cell packaging (2) — cardboard packs. 10 pieces. — cellular contour packages (3) — cardboard packs. 10 pieces. — contour cell packaging (4) — cardboard packs. 10 pieces. — contour cell packaging (5) — cardboard packs. 100 pieces. — polymer jars (1) — cardboard packs.