Amitriptyline nycomed pills 25mg №50

Active ingredient and dosage form

Coated tablets:
1 pill contains Amitriptyline hydrochloride (in terms of amitriptyline) 10. 25 mg;
50 pieces in a package.

Pharmacology

Amitriptyline is a tricyclic antidepressant from the group of non-selective inhibitors of the neuronal uptake of monoamines. It has a pronounced thymoanaleptic and sedative effect.
The mechanism of the antidepressive action of amitriptyline is associated with the inhibition of the reverse neuronal capture of catecholamines (noradrenaline, dopamine) and serotonin in the central nervous system.
Amitriptyline is an antagonist of muscarinic cholinergic receptors in the central nervous system and on the periphery, has peripheral antihistamine (H1) and antiadrenergic properties. It also causes anti-neuralgia (central analgesic), anti-ulcer and anti-bacterial action, effective for bedwetting.
Antidepressant effect develops within 2-4 weeks. after the start of the application.

Indications and usage

- Depression of any etiology. Especially effective in anxiety-depressive states, due to the severity of the sedative effect. It does not cause exacerbation of productive symptoms (delusions, hallucinations), unlike antidepressants with a stimulating effect.
- Neurogenic pain of a chronic nature.
- Mixed emotional and behavioral disorders, phobic disorders.
- Children's enuresis (with the exception of children with hypotonic bladder).
- Psychogenic anorexia, bulimic neurosis.

Contraindications

- heart failure in the stage of decompensation.
- Acute and recovery period of myocardial infarction.
- Violations of the conduction of the heart muscle.
- Severe arterial hypertension.
- Acute diseases of the liver and kidneys, with severe dysfunction.
- Blood diseases.
- Peptic ulcer of the stomach and duodenal ulcer in the acute stage.
- Prostatic hypertrophy.
- Atony of the bladder.
- Pyloric stenosis, paralytic intestinal obstruction.
- Simultaneous treatment with MAO inhibitors (see Interaction).
- Pregnancy, breastfeeding period.
- Children under 6 years old (for oral administration),
- Children under 12 years old (for the / m and / in the introduction),
- Hypersensitivity to amitriptyline.
Amitriptyline should be used with caution in patients suffering from alcoholism, people with asthma, manic-depressive psychosis (MDP) and epilepsy (see. Special instructions), the oppression of bone marrow hematopoiesis, hyperthyroidism, angina and heart failure, angle-closure glaucoma, ocular hypertension, schizophrenia (although when it is taken, there is usually no exacerbation of productive symptoms).

Dosage and administration
Assign inside (during or after a meal). The initial daily dose for oral administration is 50-75 mg (25 mg in 2-3 doses), then the dose is gradually increased by 25-50 mg, to obtain the desired antidepressant effect. The optimal daily therapeutic dose is 150-200 mg (the maximum part of the dose is taken at night).
With severe depressionresistant to therapy, the dose is increased to 300 mg or more, to the maximum tolerated dose (the maximum dose for outpatients 150 mg / day). In these cases, treatment is advisable to start with intramuscular or intravenous administration of the drug, while applying a higher initial dose, accelerating the buildup of dosages under the control of the somatic condition. After obtaining a persistent anti-depressive effect after 2-4 weeks, the dose is gradually and slowly reduced to 50-100 mg / day and therapy is continued for at least 3 months. In the case of signs of depression at lower doses, you must return to the previous dose.
If the patient's condition does not improve within 3-4 weeks of treatment, then further therapy is inappropriate.

In elderly patients with mild disorders, in outpatient practice, doses are 25-50-100 mg per day in divided doses or 1 time per day for the night.

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

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

With severe depressionresistant to therapy: intramuscularly or intravenously (administered slowly!) administered at a dose of 10-20-30 mg up to 4 times a day, the dose should be increased gradually, the maximum daily dose of 150 mg; after 1-2 weeks, go to the drug intake.
Children over 12 years and older people lower doses are administered and they are increased more slowly.
If the patient's condition does not improve within 3-4 weeks of treatment, then further therapy is inappropriate.

Adverse reactions

Mainly associated with the anticholinergic effect of the drug: accommodation paresis. Blurred vision, increased intraocular pressure, dry mouth, constipation, intestinal obstruction, urinary retention, fever. All these phenomena usually disappear after adaptation to the drug or reduction of doses.
From the side of the central nervous system: headache, ataxia, fatigue, weakness, irritability, dizziness, tinnitus, drowsiness or insomnia, impaired concentration, nightmares, dysarthria, confusion, hallucinations, motor agitation, disorientation, tremor, paresthesia, peripheral neuropathy, changes in EEG. Rare extrapyramidal disorders, convulsions, anxiety.
Cardiovascular: tachycardia, arrhythmia, conduction disturbance, blood pressure lability, expansion of the QRS complex on the ECG (violation of intraventricular conduction), symptoms of heart failure, fainting.
From the digestive tract: nausea, vomiting, heartburn, anorexia, stomatitis, taste disorders, darkening of the tongue, epigastric discomfort, gastralgia, increased activity of liver transaminases, rarely cholestatic jaundice, diarrhea.
On the part of the endocrine system: increase in the size of the mammary glands in men and women, galactorrhea, changes in the secretion of antidiuretic hormone (ADH), changes in libido, potency. Rarely hypo- or hyperglycemia, glycosuria, impaired glucose tolerance, testicular edema. Allergic reactions: skin rash, itching, photosensitivity, angioedema, urticaria.
Other: agranulocytosis, leukopenia, eosinophilia, thrombocytopenia, purpura and other blood changes, hair loss, swollen lymph nodes, weight gain with prolonged use, sweating, pollakiuria. With long-term treatment, especially in high doses, with a sharp cessation of treatment, the development of withdrawal syndrome is possible: headache, nausea, vomiting, diarrhea, as well as irritability, sleep disturbance with vivid, unusual dreams, increased excitability.

Symptoms: drowsiness, disorientation, confusion, dilated pupils, fever, shortness of breath, dysarthria, agitation, hallucinations, seizures, muscle rigidity, supor, coma, vomiting, arrhythmia, hypotension, heart failure, respiratory depression.
Treatment: cessation of therapy with amitriptyline, gastric lavage, fluid infusion, symptomatic therapy, maintenance of blood pressure and water-electrolyte balance. The monitoring of cardiovascular activity (ECG) for 5 days is shown, because relapse may occur after 48 hours and later. Hemodialysis and forced diuresis are not very effective.

Drug interactions

Amitriptyline enhances the depressant effect on the central nervous system of the following drugs: antipsychotics, sedatives and hypnotics, anticonvulsants, analgesics, anesthetics, alcohol; shows synergism when interacting with other antidepressants. When combined use of amitriptyline with neuroleptics, and / or anticholinergic drugs, a febrile temperature reaction may occur, paralytic intestinal obstruction. Amitriptyline potentiates the hypertensive effects of catecholamines and other adrenostimulants, which increases the risk of developing heart rhythm disorders, tachycardia, severe arterial hypertension, but inhibits the effects of drugs affecting the release of norepinephrine. Amitriptyline can reduce the antihypertensive effect of guanethidine and drugs with a similar mechanism of action, as well as weaken the effect of anticonvulsants. With the simultaneous use of amitriptyline and anticoagulants - derivatives of coumarin or indandione, an increase in the anticoagulant activity of the latter is possible. With simultaneous administration of amitriptyline and cimetidine, it is possible to increase the plasma concentration of amitriptyline with the possible development of toxic effects.Inductors of liver microsomal enzymes (barbiturates, carbamazepine) reduces plasma concentrations of amitriptyline. Amitriptyline enhances the action of anti-parkinsonian drugs, and other drugs that cause extrapyramidal reactions. Quinidine slows down amitriptyline metabolism. The combined use of amitriptyline with disulfiram and other acetaldehyde dehydrogenase inhibitors can provoke delirium. Estrogen-containing oral contraceptives may increase the bioavailability of amitriptyline; pimozide and probucol may enhance cardiac arrhythmias. Amitriptyline may exacerbate depression caused by glucocorticosteroids; co-administration with drugs for the treatment of thyrotoxicosis increases the risk of agranulocytosis. Simultaneous use of amitriptyline with MAO inhibitors can be fatal. A break in treatment between taking MAO inhibitors and tricyclic antidepressants should be at least 14 days!

Amitriptyline in doses above 150 mg / day reduces the threshold of seizure activity, so you should consider the possibility of convulsive seizures in patients with those in history, and in the category of patients who are prone to this because of age or injury. Treatment with amitriptyline in old age should be carried out under close monitoring and, with the use of minimum doses of the drug, increasing them gradually, in order to avoid the development of delirious disorders, hypomania and other complications. Patients with a depressive phase of MDP may enter the manic stage. While taking amitriptyline, it is prohibited to drive vehicles, maintain machinery and other types of work that require high concentration of attention, as well as drinking alcohol.

In a dry, dark place, out of the reach of children, at a temperature of 15 to 25 ° C.

- 2 years