Amitriptyline Nicomed, 25 mg 50 pcs

Amitriptyline is a tricyclic antidepressant from the group of non-selective inhibitors of neuronal takeover of monoamines. It has a pronounced thymoanaleptic and sedative effect.

The mechanism of antidepressant action of amitriptyline is associated with inhibition of neuronal reuptake of catecholamines (noradrenaline, dopamine) and serotonin in CNS.

Amitriptyline is an antagonist of muscarinic cholinergic receptors in the CNS and in the periphery and has peripheral antihistamine (H1) and antiadrenergic properties.

It also causes antineuralgic (central analgesic), anti-ulcer and antibulemic effects and is effective in nocturnal urinary incontinence.

The antidepressant effect develops within 2-4 weeks after the start of use.

Indications

– Depression of any etiology. Particularly effective for anxiety-depressive states, due to the pronounced sedative effect. Does not cause aggravation of productive symptoms (delirium, hallucinations) unlike antidepressants with stimulating effect.
– Neurogenic pains of chronic character.
– Mixed emotional disorders and behavioral disorders, phobic disorders.
– Pediatric enuresis (except in children with hypotonic bladder).
– Psychogenic anorexia, bulimic neurosis.

Active ingredient

Composition

1 tablet contains amitriptyline hydrochloride (in terms of amitriptyline) 25 mg

How to take, the dosage

It is administered orally (during or after meals). The initial daily oral dose 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 portion of the dose is taken at night).

In severe depression that is resistant to therapy, the dose is increased to 300 mg or more, up to the maximum tolerated dose (maximum dose for outpatients is 150 mg/day). In these cases it is reasonable to start treatment with intramuscular or intravenous administration of the drug, using higher initial doses, accelerating the dosage escalation under control of the somatic condition.

After obtaining a persistent antidepressant effect, after 2-4 weeks the doses are gradually and slowly reduced to 50-100 mg/day and therapy is continued for at least 3 months. If there are signs of depression when the dose is 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 inadvisable.

Interaction

Amitriptyline increases the CNS depressant effect of the following drugs: neuroleptics, sedatives and hypnotics, anticonvulsants, analgesics, anesthetics, alcohol; it shows synergism in interaction with other antidepressants. Concomitant use of amitriptyline with neuroleptics and/or anticholinergic drugs may cause febrile temperature reaction, paralytic ileus.

Amitriptyline potentiates the hypertensive effects of catecholamines and other adrenostimulants, which increases the risk of cardiac rhythm disturbances, tachycardia, severe arterial hypertension, but inhibits the effects of drugs affecting the release of noradrenaline.

Amitriptyline may decrease the antihypertensive effect of guanethidine and drugs with a similar mechanism of action, as well as weaken the effect of anticonvulsants. Concomitant use of amitriptyline and anticoagulants – coumarin or indandion derivatives may increase anticoagulant activity of the latter. Concomitant use of amitriptyline and cimetidine may increase the plasma concentration of amitriptyline with possible development of toxic effects. Inducers of microsomal liver enzymes (barbiturates, carbamazepine) reduce plasma concentrations of amitriptyline.

Amitriptyline increases the effect of antiparkinsonian drugs, and other drugs that cause extrapyramidal reactions. Quinidine slows down the metabolism of amitriptyline. Concomitant use of amitriptyline with disulfiram and other acetaldehyde dehydrogenase inhibitors may provoke delirium. Estrogen-containing oral contraceptives may increase the bioavailability of amitriptyline; pimozide and probucol may increase cardiac arrhythmias.

Amitriptyline may increase glucocorticosteroid-induced depression; concomitant use with thyrotoxicosis medications increases the risk of agranulocytosis. Simultaneous use of amitriptyline with MAO inhibitors may be fatal. A break in treatment between MAO inhibitors and tricyclic antidepressants should be at least 14 days!

Special Instructions

Amitriptyline in doses above 150 mg/day lowers the seizure threshold, so the possibility of seizures in patients with a history of seizures and in those patients who are predisposed to it because of age or injury should be considered.

The treatment with amitriptyline in elderly patients should be carefully monitored and, with the use of minimal doses of the drug, increasing them gradually, in order to avoid the development of delirium disorders, hypomania and other complications. Patients with a depressive phase of TIR may progress to a manic phase.

While taking amitriptyline it is prohibited to drive vehicles, operate machinery and other types of work requiring high concentration, as well as alcohol intake.

Contraindications

– Heart failure in decompensation.
– Acute and recovery period of myocardial infarction.
– Cardiac conduction disorders.
– Severe arterial hypertension.
– Acute liver and kidney diseases, with marked functional disorders.
– Blood diseases.
– Acute peptic ulcer.
– Hypertrophy of the prostate.
– Bladder atony.
– Pylorostenosis, paralytic ileus.
– Concurrent treatment with MAO inhibitors (see. Interaction).
– Pregnancy, breastfeeding.
– Children under 6 (for oral administration).
– Children under 12 (for intravenous and intravenous administration).
– Hypersensitivity to amitriptyline.

Amitriptyline should be used with caution in patients with alcoholism, bronchial asthma, manic-depressive psychosis (MDP) and epilepsy (see Special Guidelines). It is also used with inhibition of bone marrow hematopoiesis, hyperthyroidism, angina and heart failure, closed-angle glaucoma, intraocular hypertension, schizophrenia (although usually there is no exacerbation of productive symptoms when taking it).

Side effects

Mainly related to the cholin-blocking effect of the drug: accommodation paresis. Blurred vision, increased intraocular pressure, dry mouth, constipation, intestinal obstruction, urinary retention, increased body temperature. All of these phenomena usually go away after adjusting to the drug or reducing the doses.

CNS side: Headache, ataxia, increased fatigue, weakness, irritability, dizziness, tinnitus, drowsiness or insomnia, impaired concentration, nightmares, dysarthria, confusion, hallucinations, motor agitation, disorientation, tremor, paresthesias, peripheral neuropathy, EEG changes. Rarely-extrapyramidal disorders, seizures, anxiety.

Cardiovascular system disorders: tachycardia, arrhythmia, conduction disorders, labile blood pressure, enlarged QRS complex on ECG (intraventricular conduction disorders), cardiac insufficiency symptoms, fainting.

Gastrointestinal disorders: nausea, vomiting, heartburn, anorexia, stomatitis, taste disorders, darkened tongue, discomfort in epigastrium, gastralgia, increased activity of liver transaminases, rarely cholestatic jaundice and diarrhea.

Endocrine system disorders: increase of breast size in men and women, galactorrhea, changes in secretion of antidiuretic hormone (ADH), changes in libido and potency. Rarely, hypo- or hyperglycemia, glucosuria, impaired glucose tolerance, testicular edema. Allergic reactions: skin rash, itching, photosensitization, angioedema, urticaria.

Other: agranulocytosis, leukopenia, eosinophilia, thrombocytopenia, purpura and other blood changes, hair loss, increased lymph nodes, weight gain with long-term use, sweating, pollakiuria. With long-term treatment, especially in high doses, abrupt discontinuation of treatment may lead to withdrawal syndrome: headache, nausea, vomiting, diarrhea, as well as irritability, sleep disorders with vivid, unusual dreams, increased excitability.

Overdose

Symptoms: drowsiness, disorientation, confusion, dilated pupils, increased body temperature, dyspnea, dysarthria, agitation, hallucinations, seizures, muscle rigidity, supra, coma, vomiting, arrhythmia, arterial hypotension, heart failure, respiratory depression.

Treatment: discontinuation of amitriptyline therapy, gastric lavage, fluid infusion, symptomatic therapy, maintenance of BP and water-electrolyte balance. Monitoring of cardiovascular activity (ECG) for 5 days is indicated, as relapse may occur after 48 hours or later. Hemodialysis and forced diuresis are of little use.

Similarities