Amitriptyline tablets are taken for the following indications:
Severe depression, especially with characteristic signs of anxiety, agitation and sleep disorders. Depressive states in patients with schizophrenia - in combination with a neuroleptic to prevent exacerbations of hallucinations and paranoid mania. Chronic pain syndrome. Nocturnal enuresis in the absence of organic pathology.
Composition
Active ingredient: amitriptyline;
1 tablet contains amitriptyline 25 mg;
Excipients: lactose monohydrate, sugar; corn starch, gelatin; talc, calcium stearate, Opadry II white, containing titanium dioxide (E-171), talc, polyethylene glycol, polyvinyl alcohol Ponceau 4R (E-124), polyethylene glycol 6000.
Contraindication
Hypersensitivity to amitriptyline or any of the components of the drug.
Recent myocardial infarction. Any kind of blockage or heart rhythm disturbance, as well as coronary artery insufficiency.
Concomitant treatment with MAOIs (monoamine oxidase inhibitors) is contraindicated (see section “Interaction with other medicinal products and other types of interactions”).
Concomitant administration of amitriptyline and MAOIs may cause the development of serotonin syndrome (a combination of symptoms that include agitation, confusion, tremor, myoclonus, and hyperthermia).
Treatment with amitriptyline can be started 14 days after stopping irreversible non-selective MAOIs and at least 1 day after stopping the reversible drugs moclobemide and selegiline.
Treatment with MAOIs can be started 14 days after stopping amitriptyline.
Method of application
Treatment should be initiated at low doses and gradually increased with careful monitoring of clinical response and signs of drug sensitivity. Doses above 150 mg/day (up to 225 mg/day, and sometimes up to 300 mg/day) should be administered in a hospital setting.
Adults: initially 25 mg 3 times a day with a gradual increase if necessary by 25 mg every other day to 150 mg per day (occasionally up to 225-300 mg per day in a hospital setting).
The maintenance dose corresponds to the optimal therapeutic dose.
Application features
Pregnant women
Amitriptyline should not be prescribed during pregnancy unless the expected benefit to the patient outweighs the theoretical risk to the fetus.
Children
Amitriptyline can be prescribed to children from 7 years of age for the treatment of nocturnal enuresis, provided there is no organic pathology.
Drivers
Amitriptyline is a sedative drug. A patient receiving a psychotropic drug can be expected to experience impaired general attention and ability to concentrate, which makes driving and operating machinery dangerous and prohibits driving.
Overdose
Symptoms may appear slowly and insidiously, but sometimes sharply and suddenly. At first, drowsiness or agitation and hallucinations are observed. Anticholinergic symptoms are manifested by mydriasis, tachycardia, urinary retention, dryness of the mucous membranes and inhibition of intestinal motility. Convulsions, fever, sudden development of central nervous system depression are possible. Decreased consciousness progresses to a coma with respiratory depression.
Side effects
Amitriptyline can cause side effects similar to those seen with other tricyclic antidepressants. Some of the side effects listed below (headache, tremor, difficulty concentrating, constipation, and decreased libido) can also be symptoms of depression and usually improve as the depression improves.
Interaction
Antifungal agents such as fluconazole and terbinafine have been shown to increase serum concentrations of tricyclic antidepressants and increase associated toxicity. There have been reports of syncope and torsade de pointes-type arrhythmias.
Cimetidine and methylphenidate, as well as calcium channel blockers, increase plasma levels of tricyclic compounds and, consequently, toxicity.
Storage conditions
Store in the original packaging at a temperature not exceeding 25ºС.
Keep out of reach of children.
Shelf life - 4 years.
