Amitriptyline: instructions for use
Each amitriptyline tablet contains an active substance – amitriptyline hydrochloride, 25 mg, and excipients: lactose, corn starch, calcium phosphate dibasic, gelatin, talc, magnesium stearate, silicon dioxide colloidal anhydrous, polyethylene glycol 6000, Opadry Blue (hydroxypropylmethyl-cellulose, (E 171), talc, polyethylene glycol, brilliant blue (E 133)).
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Indications for use
- severe depression, especially with characteristic signs of anxiety, agitation, and sleep disorders;
- nocturnal enuresis in children, provided there is no organic pathology.
- hypersensitivity to amitriptyline or to any of the components of this drug;
- angle-closure glaucoma;
- violation of urodynamics due to hypertrophy of the prostate gland or atony of the bladder;
- recent myocardial infarction, impaired conduction or heart rhythm, coronary artery insufficiency;
- simultaneous administration with MAO inhibitors, sultopride.
Before prescribing the drug, be sure to inform your doctor about the following changes in your health status:
- a tendency to develop orthostatic hypotension and sedation during treatment with amitriptyline;
- chronic constipation;
- prostatic hyperplasia;
- diseases of the cardiovascular system;
- hypothyroidism, taking thyroid hormone preparations;
- hepatic or renal failure.
When prescribing the drug, be sure to inform your doctor about taking any of the following medicines:
- Antihypertensive drugs – for the treatment of hypertension;
- Atropine and other atropine-like substances (sedative H1-histamine, antiparkin-conic, anticholinergic, antispasmodic atropine, disopyramide, phenothiazine antipsychotics) – for the treatment of allergies, Parkinson’s disease, eye diseases, mental disorders.
- Depressants of the central nervous system (morphine derivatives – analgesics, antitussive drugs; barbiturates, benzodiazepines; anxiolytics; sedative antidepressants (doxypine, myaserin, mirtazapine, trimipramine), antipsychotics; sedatives H1-antihistamines are central antidilts; – for pain relief, treatment of cough, depression, allergies, hypertension.
- Baclofen is a muscle relaxant.
- Beta-blockers (bisoprolol. Carvedilol, metoprolol) – for the treatment of heart disease.
The combination of amitriptyline with some drugs is undesirable, requires the supervision of a doctor and dose adjustment of drugs:
- Medicines containing alcohol.
- Clonidine, guanfacine – for the treatment of hypertension.
- Selective MAO inhibitors (moclobemide, toloxatone) – for the treatment of depression.
- Linezolid – for the treatment of infections.
- Alpha and beta sympathomimetics (epinephrine, norepinephrine, epinephrine, norepinephrine, systemic dopamine for parenteral administration).
- Antiepileptic drugs, including carbamazepine, valproic acid, valpromide – for the treatment of epilepsy.
- Antidepressants are selective serotonin reuptake inhibitors (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline).
- Alpha and beta – sympathomimetics (adrenaline, epinephrine as a local hemostatic and for subcutaneous / subbuccal injections).
- Phenothiazides (thioridazine) – for the treatment of mental disorders.
The combined use of the drug and the following medicines is contraindicated:
Non-selective monoamine oxidase inhibitors (MAOs) – for the treatment of depression, anxiety disorders and other diseases.
Sultoprid – for the treatment of mental disorders.
Pregnancy and lactation
Taking amitriptyline during pregnancy is possible under the supervision of a doctor only in cases where the expected benefit to the mother outweighs the possible risk to the fetus. If amitriptyline therapy is necessary to maintain the mental health of the mother, treatment with the drug in an effective dose can take place throughout pregnancy. Perhaps the manifestation in newborns of some side effects that appear in the first days of life and, as a rule, are short and mild. Be sure to warn the doctor about taking amitriptyline: monitoring and care for newborns is carried out taking into account the above effects.
Amitriptyline passes into breast milk. If necessary, treatment with the drug during lactation, breastfeeding must be interrupted.
Influence on the ability to drive vehicles and work with mechanisms.
A drug can reduce the ability to drive a car and other mechanisms, which must be taken into account.
Dosage and recommended doses
The dose of the drug is determined by the doctor. Take during or after meals with water. To improve sleep, the drug can be taken in the evening. The dose increase is usually carried out by taking the drug in the evening or at bedtime. With maintenance therapy, it is possible to take 1 time per day. Drug withdrawal is carried out gradually under the supervision of a doctor.
The risk on the tablet is intended solely to facilitate patient acceptance.
Depression. Treatment begins with low doses with their gradual increase under the close supervision of a doctor to evaluate the effectiveness and tolerability of therapy.
Typically, the dose is 75-150 mg per day, higher doses are used in a hospital setting. The average daily dose in adults is usually 75 mg (25 mg 3 times a day). After 3 weeks of effective treatment, the daily dose can be individually reviewed.
In children, the effective daily dose is not more than 1 mg / kg of body weight.
Antidepressant treatment is symptomatic. The duration of treatment is about 6 months in order to prevent relapse.
Nocturnal enuresis in children. The doses of amitriptyline used in enuresis are lower than in the treatment of depression. The daily dose in children aged 6 to 10 years with a body weight of 25 kg or more is 25 mg per day (1 tablet), from 11 to 16 years old – 25 – 50 mg per day (1-2 tablets). The drug is taken before bedtime. The duration of therapy is not more than 3 months.
Special categories of patients. In patients over the age of 65, the initial dose should be reduced (to 50% of the minimum). The daily dose can be divided into several doses or taken once before bedtime. If necessary, the dose is increased gradually, under close medical supervision due to the possibility of serious side effects in this category of patients (fainting, confusion). In case of impaired liver and kidney function, careful selection of an individual dose is recommended, which can be reduced in comparison with patients with normal function of these organs.
If the number of tablets per day you have taken exceeds the amount recommended by your doctor or your child swallowed the tablets, consult a doctor immediately or call an ambulance! Stop taking the medicine immediately! Overdose symptoms are likely to be manifested by dry mouth, accommodation disorders, tachycardia, heart rhythm disturbance, decreased blood pressure, increased sweating, and urination retention. Confusion, coma. As first aid, carry out the following activities: gastric lavage, intake of activated carbon suspension, laxatives, maintaining body temperature, monitoring blood pressure, ECG.
If you forget to take the next dose of the drug on time. Take the pill as soon as you remember about it, making sure that there is a time gap before taking the next dose. If there is not enough time before taking the next dose, take as directed by your doctor. Do not take a double dose if you miss the next dose!
Possible adverse reactions
Amitriptyline can cause adverse reactions similar to those that occur when taking other tricyclic antidepressants. Some of the following side effects (headache, tremors, impaired attention, constipation, and decreased libido) may also be symptoms of depression and worsen as the depression stops.
- dry mouth, constipation, disturbances of accommodation, tachycardia, increased sweating, urinary retention;
- orthostatic hypotension, decreased sexual function;
- drowsiness or sedation, tremor, an attack of seizures in predisposed individuals, confusion, loss of consciousness, dysarthria;
- risk of developing suicidal behavior / thoughts, mood changes with the appearance of a manic episode, manifestations of anxiety;
- weight gain;
- violation of conduction and heart rhythm (in high doses);
- breast enlargement, the allocation of milk from the mammary glands;
- allergic skin reactions;
- an increase in the number of eosinophils, a decrease in the number of leukocytes and platelets in the blood.
Adverse reactions in elderly patients. Patients 50 years of age and older were found to have an increased risk of bone fractures when taking selective serotonin reuptake inhibitors or tricyclic antidepressants. The mechanism of this side effect is not clear.
Depression is associated with an increased risk of suicidal behavior, auto-aggression and suicide. Such a risk can exist until a stable remission is reached and occur spontaneously during the entire course of therapy, especially in the early stages of remission or when the dosage is changed. When treating with antidepressants, it is necessary to carefully monitor your condition, especially at the beginning of therapy: changes in mood, behavior, clinical deterioration and / or the appearance of suicidal thoughts, the development of side effects. Ask your loved ones to help you assess your condition during treatment. In case of any change in condition, doubts about his assessment, please consult a doctor or tell relatives!
If insomnia or nervousness appears at the beginning of treatment, it is recommended to consult a doctor to reduce the dose of the drug and conduct the necessary symptomatic treatment.
Patients suffering from manic-depressive disorders may worsen the course of the disease. The reception of amitriptyline must be stopped, consult a doctor for appropriate treatment.
In patients with epilepsy while taking amitriptyline, a decrease in the seizure threshold is possible. With the development of seizures, taking amitriptyline must be stopped. Consult a doctor for appropriate treatment.
When you stop taking the drug, there are rare signs of withdrawal syndrome (headache, malaise, nausea, anxiety, sleep disturbances), to prevent which a gradual (over several weeks) dose reduction is necessary with careful monitoring of the condition.
The drug is used with caution in elderly patients.
Due to the presence of lactose in the medicinal product, the drug is contraindicated in persons with congenital galactosemia, impaired glucose and galactose absorption, or lactose deficiency.
Store in a place protected from moisture and light at a temperature not exceeding 25 ° C.
Keep out of the reach of children.
50 tablets per polymer jar or 10 tablets per blister. One jar or 5 blister packs together with a leaflet are placed in a pack of cardboard.