Amitriptyline (amityptilline) hydrochloride tablets 25 mg. №25

Amitriptyline (amityptilline) hydrochloride tablets 25 mg. №25

$8.20

Manufacturer: Ukraine

Amitriptyline is a tricyclic antidepressant and analgesic.

Its anticholinergic properties prevent re-uptake and therefore inactivation of norepinephrine and serotonin at nerve receptors, and potentiate the action of norepinephrine and serotonin in the brain. This is the action of amitriptyline.

The mechanism of action also includes blocking of sodium, potassium and N-methyl-D-aspartate (NMDA) ion channels at the level of the central and spinal cord. Norepinephrine action, sodium channel blocking, and NMDA are mechanisms that are involved in the suppression of neuropathic pain, the prevention of chronic tension-type headache, and the prevention of migraine. The analgesic effect of amitriptyline is not related to its antidepressant properties.

Tricyclic antidepressants have varying degrees of affinity for muscarinic and histamine H1 receptors.

Antidepressant and analgesic effects usually appear after 2-4 weeks of therapy, while the sedative effect does not decrease.

Category:

Description

Ingredients

active ingredient : amitriptyline;

1 tablet contains amitriptyline hydrochloride 25 mg;

excipients: corn starch lactose monohydrate, cellulose microcrystalline silicon dioxide colloidal magnesium stearate.

Dosage form

Pills.

Basic physical and chemical properties: white tablets with a flat surface and a chamfer.

Pharmacotherapeutic group

Antidepressants. ATX code N06A A09.

Pharmacodynamics

Amitriptyline is a tricyclic antidepressant and analgesic.

Its anticholinergic properties prevent re-uptake and therefore inactivation of norepinephrine and serotonin at nerve receptors, and potentiate the action of norepinephrine and serotonin in the brain. This is the action of amitriptyline.

The mechanism of action also includes blocking of sodium, potassium and N-methyl-D-aspartate (NMDA) ion channels at the level of the central and spinal cord. Norepinephrine action, sodium channel blocking, and NMDA are mechanisms that are involved in the suppression of neuropathic pain, the prevention of chronic tension-type headache, and the prevention of migraine. The analgesic effect of amitriptyline is not related to its antidepressant properties.

Tricyclic antidepressants have varying degrees of affinity for muscarinic and histamine H1 receptors.

Antidepressant and analgesic effects usually appear after 2-4 weeks of therapy, while the sedative effect does not decrease.

Indications

  • Major depressive disorder.
  • neuropathic pain.
  • Prevention of chronic tension headache.
  • Prevention of migraine.
  • Nocturnal enuresis in children aged 11 years and older in the absence of organic pathology.

Contraindications

  • Hypersensitivity to amitriptyline or to an excipient of the drug.
  • Recent myocardial infarction. Any kind of blockade or disturbance of the rhythm of the heart, as well as insufficiency of the coronary arteries.
  • Simultaneous treatment with the use of monoamine oxidase inhibitors (MAOIs) is contraindicated.
  • The simultaneous appointment of amitriptyline and MAOIs can cause the development of serotonin syndrome (a combination of symptoms such as anxiety, confusion, tremor, myoclonus and hyperthermia).
  • Treatment with amitriptyline can be started 14 days after discontinuation of non-reversible non-selective MAOIs and at least 1 day after discontinuation of the reversible drugs moclobemide and selegiline.
  • Treatment with MAOIs can begin 14 days after stopping amitriptyline.
  • Severe liver disease.
  • Age up to 11 years.

Directions

Major depressive disorder

Treatment should be initiated at low doses and gradually increased while closely monitoring clinical response and signs of drug sensitivity.

Adults

Initially 25 mg 2 times a day (50 mg per day). If necessary, the dose can be increased by 25 mg every other day to 150 mg per day, divided into two doses.

The maintenance dose corresponds to the lowest effective dose.

Patients over 65 years of age and patients with cardiovascular disease

Initially 25 mg per day.

The daily dose can be increased to 100-150 mg per day, divided into two doses, depending on the individual patient response and tolerability.

Doses above 100 mg should be used with caution.

The maintenance dose corresponds to the lowest effective dose.

Children

Amitriptyline hydrochloride should not be used for the treatment of major depressive disorder in children and adolescents (under 18 years of age), since the safety and efficacy of the drug in this age group of patients have not been established.

Duration of therapy

The antidepressant effect usually develops within 2-4 weeks. Treatment with antidepressants is symptomatic and should therefore be continued for an appropriate period of time, usually up to 6 months after recovery, to prevent relapse. In patients with recurrent (unipolar) depression, maintenance therapy may be required for several years to prevent new episodes.

Neuropathic pain, prophylactic treatment of chronic tension headache, and prophylactic treatment of migraine in adults

The dose is titrated individually for each patient to ensure adequate analgesia and tolerability of adverse reactions to the drug. In general, the lowest effective dose should be used for the shortest time necessary to treat symptoms.

adults

Recommended doses – 25-75 mg per day, in the evening. Doses above 100 mg should be used with caution.

The initial dose is 25 mg taken in the evening. The dose can be increased by 25 mg every 3-7 days, provided normal tolerability.

The dose can be taken once a day or divided into two doses. A single dose above 75 mg is not recommended.

Patients over 65 years of age and patients with cardiovascular disease

The recommended starting dose is 25 mg in the evening.

Doses above 75 mg should be used with caution.

The dose may be increased according to individual patient response and tolerability.

Children

Amitriptyline should not be used for the treatment of neuropathic pain, preventive treatment of chronic tension headache and migraine in children and adolescents (under 18 years of age), since the safety and efficacy of the drug in this age group of patients have not been established.

Duration of treatment

neuropathic pain

Treatment is symptomatic, so it should be continued for an appropriate period of time. In many patients, therapy can last several years. Regular monitoring of the need to continue treatment is recommended.

Prophylactic treatment of chronic tension headache and prophylactic treatment of migraine in adults.

Treatment should be continued for a certain period of time. Regular monitoring of the need to continue treatment is recommended.

Nocturnal enuresis

Children

Recommended doses for children aged 11 years and older: 25-50 mg per day.

The dose should be increased gradually.

The drug is taken 1-1.5 hours before bedtime.

Before starting therapy with amitriptyline, an ECG should be done to rule out long QT interval syndrome.

Duration of treatment

The maximum period of treatment should not exceed 3 months.

If a repeat course of treatment with amitriptyline is necessary, a physical examination should be carried out every 3 months.

When stopping treatment, the dose of amitriptyline should be reduced gradually.

Impaired kidney function

Patients with impaired renal function can be prescribed Amitriptyline hydrochloride in normal doses.

Liver dysfunction

Careful selection of the dose and, if possible, determination of the content of the drug in the blood serum is recommended.

Cytochrome P450 CYP2D6 inhibitors

Depending on the individual response of the patient, a reduction in the dose of amitriptyline may be considered in the case of simultaneous use of a strong inhibitor of CYP2D6 (for example, bupropine, kinidine, fluoxetine, paroxetine).

Known slow metabolisers of CYP2D6 or CYP2C19

Patients with a known slow metabolism of CYP2D6 or CYP2C19 may have elevated plasma concentrations of amitriptyline and its active metabolite nortriptyline. Perhaps a reduction of 50% of the recommended initial dose.

Application method

The drug is taken orally.

Amitriptyline hydrochloride tablets should be swallowed with water.

Termination of treatment

If treatment is discontinued, the dose should be gradually reduced over several weeks.

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