Amitriptyline: 7 things you should know

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Medically reviewed by Carmen Fookes, BPharm. Last updated on Sep 9, 2022.

1. How it works

• Amitriptyline may be used to treat depression or off-label to relieve chronic pain, fibromyalgia, or insomnia.
• Experts are unsure exactly how amitriptyline works, although historically it was believed that amitriptyline’s effects in depression were due to its ability to rebalance chemicals in the brain, such as serotonin and/or norepinephrine. Studies confirm that amitriptyline is still effective for treating mood disorders, such as depression, even though the way it works is unknown. It is not known how amitriptyline works to relieve chronic pain, fibromyalgia, or insomnia.
• Amitriptyline belongs to a group of medicines known as tricyclic antidepressants.

2. Upsides

• May be used for the treatment of major depressive disorder (MDD).
• May be used off-label (this means it is not an FDA-approved indication; however it may be useful clinically) for the treatment of other conditions such as chronic pain, fibromyalgia, or insomnia. Amitriptyline may be used in addition to other treatments or where alternative treatments have not worked.
• Recommended on the WHO pain ladder for nerve-related pain unresponsive to opioid-like drugs (such as morphine).
• Generic amitriptyline is available.

3. Downsides

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Dry mouth, headache, constipation, diarrhea, and sexual dysfunction.
• May increase the risk of suicidal thoughts or behavior in young adults (similar to other antidepressants).
• May cause drowsiness and affect a person’s ability to drive or operate machinery; some people may develop tolerance to this effect.
• Risk of heart-related effects, muscle rigidity, tremor, seizures, increased sensitivity to light, weight gain or loss, hair loss, skin rash, and edema.
• Interaction or overdosage may cause serotonin syndrome (symptoms include agitation, hallucinations, fast heart rate, dizziness, muscle tremor, nausea, vomiting, diarrhea). Another rare syndrome, neuroleptic malignant syndrome (NMS) has been reported after starting or increasing the dose of amitriptyline. Symptoms include muscle rigidity, fever, mental status changes, a fast heart rate, and tremors.
• May cause withdrawal symptoms with abrupt discontinuation (symptoms include nausea, headache, sleep disturbance, and generalized tiredness). These are not indicative of addiction. Taper dosage off slowly under medical supervision. Rare instances of mania have been reported within 2 to 7 days following cessation of chronic treatment with tricyclic antidepressants, such as amitriptyline.
• May not be suitable for some people including those that are in the acute recovery phase following a myocardial infarction, undiagnosed bipolar disorder, a history of seizures, urinary retention, or angle-closure glaucoma. Do not use high dosages of amitriptyline in people with cardiovascular disease. Close supervision is recommended when giving to people with thyroid disease.
• May cause mild pupil dilation, which may trigger an episode of angle-closure glaucoma.
• May interact with several other drugs including those that are metabolized by hepatic enzymes CYP2D6 or other drugs that cause sedation or with anticholinergic side effects (such as dry mouth, urinary retention, blurred vision, constipation). Extremely high fever (hyperpyrexia) has been reported when amitriptyline has been administered with antipsychotics or anticholinergic drugs.
• Not approved for use in children.
• Do not use during pregnancy unless the benefits outweigh the risks. Amitriptyline has been shown to cross the placenta and there have been a few reports of adverse events, although a causal relationship has not been established.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

Amitriptyline is an effective antidepressant but it may cause drowsiness initially and a withdrawal syndrome with abrupt discontinuation. It may be used off-label to treat other conditions such as chronic pain, fibromyalgia, or insomnia.

5. Tips

• Take exactly as your doctor has prescribed. If amitriptyline makes you sleepy, talk to your doctor about taking higher dosages later in the afternoon or in the evening to minimize daytime sedation.
• Read the medication guide supplied by your pharmacy that tells you about amitriptyline. If you have any further questions, talk with your doctor or pharmacist.
• Do not stop suddenly as withdrawal symptoms may occur. Reducing the dosage slowly over weeks to months is recommended.
• Tell your doctor if your depression worsens or if you develop suicidal thoughts, particularly during the first few months of therapy. Also, monitor for serotonin syndrome.
• Report any unusual side effects to a doctor.
• May increase the risk of sunburn; protect yourself from the sun when outdoors.
• Do not take other medications with amitriptyline until first checking with your doctor or pharmacist that these are compatible.
• Tell your doctor if you are pregnant or intending to become pregnant, or breastfeeding.

6. Response and effectiveness

• Peak concentrations of amitriptyline are reached within 4 to 8 hours. Amitriptyline is metabolized to an active metabolite (nortriptyline) so the effects of amitriptyline are long-lasting. The antidepressant effect may take several weeks to develop.

7. Interactions

Medicines that interact with amitriptyline may either decrease its effect, affect how long it works for, increase side effects, or have less of an effect when taken with amitriptyline. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with amitriptyline include:

• anticoagulants (blood thinners), such as warfarin, or other drugs that have blood-thinning effects such as aspirin or NSAIDs
• anticonvulsants, such as phenytoin, phenobarbital, or primidone
• antipsychotics (such as butyrophenones, phenothiazines, or thioxanthenes) and atypical antipsychotics (eg, olanzapine, quetiapine, ziprasidone)
• any medication that may cause drowsiness, such as benzodiazepines (eg, diazepam, lorazepam), first-generation antihistamines (such as doxylamine or promethazine), metoclopramide, or opioids (such as codeine, morphine)
• aspirin
• bupropion
• buspirone
• cimetidine
• cisapride
• diuretics, such as furosemide
• disulfiram
• ipratropium
• lithium
• medications that may affect the heartbeat by prolonging the QT interval, such as amiodarone, encainide, flecainide, or pimozide
• medications that induce or inhibit CYP2D6 such as amiodarone, bupropion, or duloxetine
• other antidepressants, such as tricyclic antidepressants (eg, clomipramine), monoamine oxidase inhibitors (eg, isocarboxazid, phenelzine, and tranylcypromine), venlafaxine, and SSRIs (eg, paroxetine, sertraline)
• other medications that affect serotonin, such as amphetamines, fentanyl, lithium, tramadol, triptans (eg, almotriptan, eletriptan, or sumatriptan), or St. John’s Wort
• others, such as HIV medications (fosamprenavir, ritonavir), fluconazole, or procyclidine
• topiramate.

May enhance the effects of alcohol and the effects of other CNS depressants. Avoid drinking alcohol or taking illegal or recreational drugs while taking amitriptyline.

Note that this list is not all-inclusive and includes only common medications that may interact with amitriptyline. You should refer to the prescribing information for amitriptyline for a complete list of interactions.

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References

• Amitriptyline. Revised 11/2021. Major Pharmaceuticals. https://www.drugs.com/pro/amitriptyline.html

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use amitriptyline only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2023 Drugs.com. Revision date: September 9, 2022.

Medical Disclaimer

Side effects, dosage, uses and more

1. Amitriptyline oral tablet is available as a generic drug. It’s not available as a brand-name drug.
2. Amitriptyline comes only as a tablet you take by mouth.
3. Amitriptyline oral tablet is used to help relieve symptoms of depression.

Amitriptyline is a prescription drug. It comes as a tablet you take by mouth.

Amitriptyline oral tablet is not available as a brand-name drug. It’s only available as a generic drug. Generic drugs typically cost less than brand-name drugs.

Why it’s used

Amitriptyline is used to help relieve symptoms of depression.

How it works

Amitriptyline belongs to a class of drugs called tricyclic antidepressants. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

Amitriptyline works on your central nervous system to increase the level of certain chemicals in your brain, which improves your depression.

Amitriptyline can cause dizziness and drowsiness during the first few hours after you take it. If you notice drowsiness while you take this drug, your doctor may have you take your dose at bedtime.

Amitriptyline can also cause other side effects.

More common side effects

The more common side effects of amitriptyline can include:

• confusion
• numbness and tingling in your arms and legs
• headache
• constipation or diarrhea
• blurred vision
• skin rash
• swelling of your face and tongue
• nausea
• unexpected weight gain or loss
• dizziness
• dry mouth

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Heart attack. Symptoms can include:
  • chest pain
  • shortness of breath
  • pain or pressure in your chest or upper body
• Stroke. Symptoms can include:
  • weakness in one part or side of your body
  • slurred speech
• Seizures
• Withdrawal (if you suddenly stop taking this drug). Symptoms can include:
  • headache
  • nausea
  • trouble sleeping
  • depression
  • mood swings
• Increases or decreases in blood sugar
• Suicidal thoughts or actions
• Orthostatic hypotension (sudden drop in blood pressure when standing)

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare professional who knows your medical history.

Amitriptyline oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk with your doctor or pharmacist.

Examples of drugs that can cause interactions with amitriptyline are listed below.

Drugs you should not take with amitriptyline

Taking certain drugs with amitriptyline may cause serious side effects. You should not take these drugs and amitriptyline at the same time. Examples of these drugs include:

• Monoamine oxidase inhibitors (MAOIs). Examples of these drugs include:
  • phenelzine
  • tranylcypromine
  • selegiline

Using an MAOI with amitriptyline can lead to seizures or even death. Do not take an MAOI within two weeks of stopping amitriptyline, unless told to do so by your doctor. Also, do not start taking amitriptyline if you stopped taking a MAOI in the last two weeks, unless told to do so by your doctor. If you aren’t sure whether any of the drugs you take is an MAOI, ask your doctor or pharmacist.

• Quinidine. Taking this drug with amitriptyline could increase the amount of amitriptyline in your body. This could lead to dangerous side effects.

Drugs that cause more negative effects

Taking amitriptyline with certain drugs raises your risk of negative effects. Examples of these drugs include:

• Topiramate. Taking this drug with amitriptyline could increase the amount of amitriptyline in your body. This raises your risk of side effects. Your doctor may adjust your dosage of amitriptyline if you take it with topiramate.
• Sertraline, fluoxetine, and paroxetine. These drugs can increase the dangerous side effects of amitriptyline.
• Cimetidine. Taking this drug with amitriptyline could increase the amount of amitriptyline in your body. This raises your risk of side effects.
• Anticholinergic drugs. Examples include diphenhydramine, oxybutynin, solifenacin, and olanzapine. Taking these drugs with amitriptyline raises your risk of side effects such as fever, especially during hot weather.
• Neuroleptic drugs. Examples include clozapine, risperidone, and haloperidol. Taking these drugs with amitriptyline raises your risk of side effects such as fever, especially during hot weather.

All possible dosages and drug forms may not be included here. Your dosage, drug form, and how often you take the drug will depend on:

• your age
• the condition being treated
• the severity of your condition
• other medical conditions you have
• how you react to the first dose

Forms and strengths

Generic: Amitriptyline

• Form: oral tablet
• Strengths: 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg

Dosage for depression

Adult dosage (ages 18–64 years)

• Typical starting dosage: 75 mg per day, usually in divided doses.
• Dosage increases: Your doctor will slowly increase your dosage if needed.
• Maximum dosage: 150 mg per day.
• Alternative dosage regimen: Start with 50 to 100 mg at bedtime. This may be increased by 25 or 50 mg as needed in the bedtime dose, for a total of 150 mg per day.

Child dosage (ages 12–17 years)

Typical starting dosage: 10 mg three times a day with 20 mg at bedtime, for a total of 50 mg per day.

Child dosage (ages 0–11 years)

It hasn’t been confirmed that amitriptyline is safe and effective for use in children younger than 17 years.

Senior dosage (ages 65 years and older)

The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects.

Your doctor may start you on a lowered dose or a different dosing schedule. This can help keep levels of this drug from building up too much in your body.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.

When to call the doctor

Call your doctor if you notice worsening depression or suicidal thoughts. Also call your doctor right away if you become pregnant while taking this drug.

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FDA warning: Suicidal thoughts and behavior

• This drug has a black box warning. This is the most serious warning from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients about drug effects that may be dangerous.
• Amitriptyline can increase the risk of suicidal thoughts and behavior, especially in children, adolescents, and young adults. People of all ages who are started on antidepressant therapy should be watched closely for signs of changes in behavior or worsening depression.

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Worsening depression warning

You might experience an initial worsening of your depression, thoughts of suicide, and behavioral changes when you first start taking amitriptyline. This risk may last until the drug starts working for you.

Withdrawal symptoms warning

If you’ve been taking this medication for a long time, you should not stop taking it suddenly. Stopping it suddenly may cause side effects such as nausea, headache, and tiredness. Do not stop taking this drug without talking with your doctor. They will tell you how to slowly lower your dosage over time.

Allergy warning

This drug can cause a severe allergic reaction. Symptoms can include:

• skin rash or hives
• trouble breathing
• swelling of your face or tongue

If you develop these symptoms, call 911 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

Alcohol interaction warning

The use of drinks that contain alcohol while taking amitriptyline raises your risk of serious side effects, including extreme drowsiness.

Warnings for people with certain health conditions

For people with heart disorders: Taking this drug could cause heart problems, such as irregular heart rhythm, heart attack, and stroke. Do not take this drug if you’re recovering from a recent heart attack.

For people with bipolar disorder: Before starting you on treatment with antidepressants such as amitriptyline, it’s important for your doctor to check your risk of bipolar disorder. Your doctor should do this because a major depressive episode is usually the first symptom noticed in people with bipolar disorder. This drug should not be used in people with bipolar disorder.

For people with a history of seizures: Taking this drug raises your risk of seizures. If you have a history of seizures, your doctor will monitor you closely while you’re taking this drug. If you have a seizure while taking this drug, stop taking it and call your doctor right away.

For people with a history of glaucoma or increased eye pressure: Taking this drug could increase the pressure in your eyes. If you have a history of glaucoma or increased eye pressure, your doctor will monitor you closely while you’re taking this drug.

For people who have schizophrenia: This drug can worsen certain symptoms of schizophrenia. If you have this condition, let your doctor know before starting this drug.

For people who have urinary retention (difficulty emptying your bladder completely): Taking this drug can worsen urinary retention. If you have this condition, let your doctor know before starting this drug.

Warnings for other groups

For pregnant women: Talk with your doctor if you’re pregnant or plan to become pregnant. Research in animals has shown adverse effects to the fetus when the mother takes the drug. There haven’t been enough studies done in humans to be certain how the drug might affect the fetus. This drug should only be used if the potential benefit justifies the potential risk

For women who are breastfeeding: Amitriptyline passes into breast milk and may cause side effects in a child who is breastfed. Talk with your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication.

For seniors: The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects. These side effects include fast heart rate, difficulty urinating, constipation, dry mouth, and blurred vision.

For children: It has not been confirmed that this drug is safe and effective for use in children younger than 12 years. Use of this drug in children must balance the potential risks with the clinical need.

Amitriptyline oral tablet is used for long-term treatment. It comes with risks if you don’t take it as prescribed.

If you stop taking the drug suddenly or don’t take it at all: If you don’t take amitriptyline, your depression may worsen. If you stop taking this medication suddenly you may have withdrawal side effects such as nausea, headache, and tiredness.

If you miss doses or don’t take the drug on schedule: Your medication may not work as well or may stop working completely. For this drug to work well, a certain amount needs to be in your body at all times.

If you take too much: You could have dangerous levels of the drug in your body. Symptoms of an overdose of this drug can include:

• irregular heart rhythm
• severely low heart rate
• convulsions
• hallucinations
• confusion
• stiff muscles

If you think you’ve taken too much of this drug, call your doctor or seek guidance from the American Association of Poison Control Centers at 1-800-222-1222 or through their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

What to do if you miss a dose: Take your dose as soon as you remember. But if you remember just a few hours before your next scheduled dose, take only one dose. Never try to catch up by taking two doses at once. This could result in dangerous side effects.

How to tell if the drug is working: Over time you should notice an improvement in your symptoms of depression. This can take more than a month.

Keep these considerations in mind if your doctor prescribes amitriptyline for you.

General

• You can take amitriptyline with or without food.
• You can cut or crush the tablet.

Storage

• Store amitriptyline at room temperature between 68°F and 77°F (20°C and 25°C). It can be kept for brief periods between 59°F and 86°F (15°C and 30°C).
• Keep this drug away from light.
• Don’t store this drug in moist or damp areas, such as bathrooms.

Refills

A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

• Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
• Don’t worry about airport X-ray machines. They can’t hurt your medication.
• You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled container with you.
• Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Clinical monitoring

Your doctor will monitor your mental health while you take this drug. Be sure to tell your doctor about any unusual changes in your behavior and mood.

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk with your doctor about other drug options that may work for you.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Amitriptyline coated tablets 25 mg: instructions, price, analogues | film-coated tablets Lekhim

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• Pharmacological properties
• Readings
• Contraindications
• Interaction with other medicinal products and other forms of interaction
• Dosage and Administration
• Overdose
• Adverse reactions
• Expiry date
• Storage conditions
• Diagnosis
• Recommended analogues
• Trade names

Composition:

active substance: amitriptyline;

1 tablet contains amitriptyline hydrochloride in terms of amitriptyline 25 mg;

excipients: lactose monohydrate; microcrystalline cellulose, croscarmellose sodium, hypromellose, magnesium stearate, anhydrous colloidal silicon dioxide, polyethylene glycol 6000, titanium dioxide (E 171), talc, polysorbate 80, carmoisine (E 122).

Dosage form

Coated tablets.

Basic physical and chemical properties: round-shaped, film-coated tablets, from light pink to pink, with top and bottom convex surfaces. On the fault, under a magnifying glass, you can see the core, surrounded by one continuous layer.

Pharmacotherapeutic group

Antidepressants. Non-selective monoamine reuptake inhibitors. ATX code N06A A09.

Pharmacological properties

Pharmacodynamics.

Amitriptyline is a tricyclic antidepressant. Amitriptyline is a tertiary amine that occupies a central place among tricyclic antidepressants, since it is approximately equally active in vivo as an inhibitor of the uptake of serotonin and norepinephrine by presynaptic nerve endings. The main metabolite of the compound, nortriptyline, is a relatively stronger inhibitor of norepinephrine reuptake, but also blocks serotonin reuptake. Amitriptyline has fairly strong anticholinergic, antihistaminergic and sedative properties and also potentiates the effects of catecholamines.

Inhibition of rapid eye movement (REM) sleep is considered a sign of antidepressant activity. Tricyclic antidepressants, like selective serotonin reuptake inhibitors and monoamine oxidase inhibitors (MAOIs), inhibit the REM phase and increase deep slow-wave sleep.

Amitriptyline improves pathologically depressed mood.

Due to its sedative action, amitriptyline is of particular importance in the treatment of depression accompanied by anxiety, agitation, restlessness and sleep disturbances. The antidepressant effect usually develops after 2-4 weeks of therapy, while the sedative effect does not decrease.

The analgesic effect of the drug is not related to the antidepressant, since analgesia occurs much earlier than any mood changes, and often as a result of taking a much lower dose than is necessary to produce mood changes.

Pharmacokinetics.

Absorption. Oral administration of the drug in tablets causes the achievement of the maximum level in the blood serum after approximately 4 hours (t _max = 3. 89 ± 1.87 h; range 1.03–7.98 h). After oral administration of 50 mg, mean C _max = 30.95 ± 9.61 ng/mL, range 10.85–45.7 ng/mL (111.57 ± 34.64 nmol/L; range 39.06 –164.52 nmol/l). The mean absolute oral bioavailability is 53% (F _abs = 0.527 ± 0.123; range 0.219–0.756).

Distribution . Plasma protein binding is about 95%. Amitriptyline and its main metabolite, nortriptyline, cross the placental barrier.

Biotransformation. Metabolism of amitriptyline occurs mainly by demethylation (CYP2C19, CYP3A) and hydroxylation (CYP2D6) followed by conjugation with glucuronic acid. At the same time, metabolism is characterized by genetically determined polymorphism. The main active metabolite is the secondary amine nortriptyline. Nortriptyline is a more potent norepinephrine reuptake inhibitor than serotonin reuptake inhibitor, while amitriptyline is equally successful at inhibiting both neurotransmitter reuptake. Further metabolites (cis- and trans-10-hydroxyamitriptyline, as well as cis- and trans-10-hydroxy-nortriptyline) are characterized by a profile identical to that of nortriptyline with a significantly lower potency. Demethylnortriptyline and amitriptyline-N-oxide are present in plasma only in small amounts, and the latter of them is completely devoid of activity. All metabolites have less anticholinergic activity than amitriptyline and nortriptyline. In plasma, the total content of 10-hydroxynortriptyline dominates in a quantitative ratio, however, most metabolites are contained in a conjugated state.

Elimination. The elimination half-life (t _½β ) of amitriptyline after oral administration is approximately 25 hours (24.65 ± 6.31 hours, range 16.49–40.36 hours). The mean systemic clearance (Cl _s ) is 39.24 ± 10.18 l/g, range 24.53–53.73 l/g.

Excretion occurs mainly in the urine. Excretion of unchanged amitriptyline by the kidneys is negligible (about 2%).

In breastfeeding mothers, amitriptyline and nortriptyline pass into breast milk in small amounts. The ratio of concentration in milk and blood serum in women is 1: 2. The estimated daily amount (amitriptyline + nortriptyline) supplied to an infant is about 2% of the mother’s dose of amitriptyline in relation to the child’s body weight (in mg / kg).

Stable total plasma levels of amitriptyline and nortriptyline are achieved in most patients within 1 week. In this state, the plasma level is present during the day approximately equally with amitriptyline and nortriptyline during treatment using the usual tablets of the drug 3 times a day.

Elderly patients have a longer half-life due to less intensive metabolism.

Liver damage can limit hepatic absorption resulting in higher plasma levels.

Renal insufficiency does not affect the kinetics of the drug.

Polymorphism . The metabolism of the drug depends on genetic polymorphism (isoenzymes CYP2D6 and CYP2C19).

Pharmacokinetic/pharmacodynamic relationship . Therapeutic plasma concentration in major depressive disorders is 100-250 ng / ml (≈ 370-925 nmol / l) (together with amitriptyline and nortriptyline). Levels above 300–400 ng/mL are associated with an increased risk of cardiac conduction problems such as QRS prolongation or atrioventricular block (AV block).

Clinical characteristics

Indications

Severe depression, especially with characteristic signs of anxiety, agitation and sleep disturbance.

Depressive conditions 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.

Contraindications

Hypersensitivity to amitriptyline or any of the components of the drug.

Recent myocardial infarction. Any kind of blockade or disturbance of the heart rhythm, as well as insufficiency of the coronary arteries.

Simultaneous treatment with MAOIs (monoamine oxidase inhibitors) is contraindicated (see section “Interaction with other medicinal products and other types of interactions”).

Co-administration of amitriptyline and MAOIs may cause the development of serotonin syndrome (a combination of symptoms that include agitation, confusion, tremors, 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.

Interaction with other drugs and other types of interactions

Pharmacodynamic interactions

Contraindicated combinations

MAO inhibitors (non-selective and also selective A [moclobemide] and B [selegiline]) – risk of “serotonin syndrome” (see section “Contraindications”).

Undesirable combinations

Sympathomimetics: amitriptyline may enhance the cardiovascular effects of adrenaline, ephedrine, isoprenaline, norepinephrine, phenylephrine and phenylpropanolamine.

Adrenergic neuron blockers: tricyclic antidepressants may interfere with the antihypertensive effects of guanethidine, betanidine, reserpine, clonidine and methyldopa. It is recommended that the entire antihypertensive regimen be reviewed when treated with tricyclic antidepressants.

Anticholinergics: tricyclic antidepressants may increase the effects of these drugs on the eyes, central nervous system, intestines and bladder; simultaneous use with them should be avoided due to an increased risk of paralytic ileus, hyperpyrexia.

Drugs that cause prolongation of the QT interval of the electrocardiogram, including antiarrhythmic drugs (quinidine), antihistamines (astemizole and terfenadine), some antipsychotic drugs (particularly pimozide and sertindole), cisapride, halofantrine and sotalol increase the likelihood of ventricular arrhythmias when taken together with tricyclic antidepressants.

Antifungal agents such as fluconazole and terbinafine cause an increase in serum concentrations of tricyclic antidepressants in the blood serum and the severity of concomitant toxicity. There were cases of syncope and arrhythmias of the torsade de pointes type.

Combinations requiring special caution

Central nervous system (CNS) depressants: Amitriptyline may increase the sedative effects of alcohol, barbiturates and other CNS depressants.

Pharmacokinetic interactions

Tricyclic antidepressants, including amitriptyline, are metabolized by the hepatic cytochrome P450 isoenzyme CYP2D6. CYP2D6 is characterized by polymorphism in the population, and its activity can be suppressed by many psychotropic drugs, as well as other drugs, for example: neuroleptics, serotonin reuptake inhibitors, with the exception of citalopram (which is a very weak isoenzyme inhibitor), β-adrenergic receptor blockers, and antiarrhythmic drugs . Also involved in the metabolism of amitriptyline isoenzyme CYP2C19and CYP3A.

Barbiturates, as well as other enzyme stimulants, such as rifampicin and carbamazepine, can increase metabolism and thus cause a decrease in plasma levels of tricyclic antidepressants and a decrease in the antidepressant effect.

Cimetidine and methylphenidate, as well as calcium channel blocking drugs, increase plasma levels of tricyclic compounds and therefore toxicity.

Tricyclic antidepressants and antipsychotics mutually inhibit each other’s metabolism; this can lead to a decrease in the seizure threshold and the appearance of seizures. Doses of these drugs may need to be adjusted.

Antifungals such as fluconazole and terbinafine increased serum levels of amitriptyline and nortriptyline. In the presence of ethanol, free plasma concentrations of amitriptyline and nortriptyline concentrations increased.

Application features.

Amitriptyline should not be administered simultaneously with MAOIs (see sections “Contraindications” and “Interaction with other medicinal products and other types of interactions”).

When using high doses of the drug, the likelihood of developing cardiac arrhythmias and severe arterial hypotension increases. The development of such conditions is also possible with the use of conventional doses in patients with pre-existing heart disease.

Amitriptyline should be used with caution in patients with convulsive disorders, urinary retention, prostatic hypertrophy, hyperthyroidism, paranoid symptoms, and severe liver or cardiovascular disease.

Depression is associated with an increased risk of suicide. Such a risk may exist up to the achievement of a stable remission and arise spontaneously during the course of therapy. Since improvement may not occur during the first few weeks of treatment or longer, patients should be closely monitored until such improvement occurs. It is known from general clinical experience that the risk of suicide increases in the early stages of recovery. Patients with a history of suicidal events or suicidal thoughts prior to treatment are at greater risk of suicide or suicide attempts and should be closely monitored during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressants in adult patients with psychiatric disorders showed an increased risk of suicidal behavior with antidepressants compared with placebo in patients under 25 years of age. Careful monitoring of patients, in particular those at high risk, should accompany drug therapy, especially at the start and after dose changes. Patients (and caregivers) should be warned to monitor for any clinical deterioration, suicidal behavior, thoughts, and unusual changes in behavior and seek medical attention if these symptoms are present.

Particular attention is needed when prescribing amitriptyline to patients with hyperthyroidism or those taking thyroid hormone preparations, since cardiac arrhythmias may develop.

Elderly patients are particularly susceptible to the development of postural hypotension during treatment with amitriptyline.

In patients suffering from manic-depressive disorders, the transition of the disease to the manic phase is possible; from the moment the manic phase of the disease begins, the patient must stop therapy with amitriptyline.

The use of amitriptyline for the depressive component of schizophrenia may increase psychotic symptoms. Amitriptyline should be administered in combination with neuroleptics.

Patients with a rare condition of shallow depth and narrow anterior chamber angle may provoke acute glaucoma attacks due to pupillary dilatation.

The use of anesthetics during therapy with tri-/tetracyclic antidepressants increases the risk of arrhythmias and arterial hypotension. If possible, amitriptyline should be discontinued a few days before surgery. If urgent surgery is unavoidable, it is imperative to inform the anesthesiologist about the treatment with amitriptyline.

Like other psychotropic drugs, amitriptyline is able to change the body’s sensitivity to insulin and glucose, which requires correction of antidiabetic therapy in patients with diabetes mellitus; in addition, a depressive illness, in fact, can be manifested by changes in the balance of glucose in the patient’s body.

Cases of hyperpyrexia have been reported with the use of tricyclic antidepressants when administered simultaneously with anticholinergic or neuroleptic drugs, especially in hot weather.

Abrupt discontinuation of therapy after prolonged treatment may cause withdrawal symptoms such as headache, malaise, insomnia and irritability. These symptoms are not signs of drug addiction.

Amitriptyline should be used with caution in patients taking selective serotonin reuptake inhibitors (SSRIs).

Excipients : tablets of the drug contain lactose monohydrate. Patients with rare hereditary problems of galactose sensitivity, lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

The medicinal product contains carmoisine (E 122), which may cause allergic reactions.

Use during pregnancy or lactation.

Amitriptyline should not be used during pregnancy unless the expected benefit to the patient outweighs the theoretical risk to the fetus. Administration of high doses of tricyclic antidepressants during the third trimester of pregnancy may cause neurobehavioral disturbances in newborns. In neonates, only drowsiness has been reported as a result of exposure to amitriptyline and urinary retention as a result of exposure to nortriptyline (a metabolite of amitriptyline) when the drug was administered to pregnant women before delivery.

The drug passes into breast milk in low concentrations, so its effect on the infant at therapeutic doses is unlikely. The dose received by the child is about 2% of the mother’s dose relative to the child’s weight (in mg / kg). Breast-feeding may be continued during amitriptyline therapy if clinically necessary, but monitoring of the infant is recommended, especially in the first 4 weeks after birth.

The ability to influence the reaction rate when driving vehicles or operating other mechanisms.

Amitriptyline is a sedative drug. In a patient receiving a psychotropic drug, one can expect a violation of general attention and the ability to concentrate, which causes danger and prohibition to drive a car and work with mechanical equipment.

Dosage and administration

Depression.

Treatment should be initiated at low doses and gradually increased while closely monitoring clinical response and signs of drug sensitivity. Doses of more than 150 mg per day (up to 225 mg per day, and sometimes up to 300 mg per day) should be used in a hospital setting.

Adults: initially 25 mg 3 times a day, gradually increased if necessary by 25 mg every other day up 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.

Patients over 65 years of age: Treatment should be started at approximately half the recommended dose, using the appropriate dosage form of amitriptyline, gradually increasing every second day as needed to 100–150 mg daily. An additional dose should usually be taken in the evening. The maintenance dose corresponds to the optimal therapeutic dose.

Duration of therapy. 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. Patients with recurrent (unipolar) depression may need maintenance therapy for several years to prevent new episodes.

Chronic pain syndrome.

Adults. Take 25 mg in the evening first. The dose can be gradually increased according to the effect of therapy up to a maximum dose of 100 mg in the evening.

For elderly patients, treatment should begin at approximately half the recommended dose.

Nocturnal enuresis.

Children 7–12 years old 25 mg, over 12 years old 50 mg 30 minutes to 1 hour before bed.

Duration of therapy – no more than 3 months.

Decreased renal function: patients with impaired renal function can be given amitriptyline at the usual doses.

Decreased liver function: it is recommended to carefully select the dose and, if possible, determine the content of the drug in the blood serum.

Method of application: dose increase is usually carried out by taking the drug in the evening or at bedtime. With maintenance therapy, the total daily dose can be taken as a single dose, mainly at bedtime. Tablets should be swallowed whole, without chewing and with water.

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

Children.

Amitriptyline is not recommended for the treatment of depression in children and adolescents due to insufficient safety and efficacy data. Treatment with amitriptyline is associated with a risk of cardiovascular adverse events in all age groups.

Amitriptyline can be given to children 7–12 years of age for the treatment of nocturnal enuresis in the absence of organic pathology.

Overdose

Symptoms: symptoms may appear slowly and disguised, but at times abruptly and suddenly. At first, drowsiness or excitement and hallucinations are observed. Anticholinergic symptoms are manifested by mydriasis, tachycardia, urinary retention, dry mucous membranes and inhibition of intestinal motility. Convulsions, fever, sudden development of suppression of the central nervous system are possible. Decreased consciousness progresses to a coma with suppression of respiratory function.

From the side of the cardiovascular system: arrhythmias (ventricular tachyarrhythmias, flutter-flicker, ventricular fibrillation). The ECG typically shows a prolonged PR interval, QRS widening, QT prolongation, T-wave widening or inversion, ST-segment depression, and varying degrees of heart block up to and including cardiac arrest. Widening of the QRS complex usually correlates well with the severity of toxicity after acute overdose. Develops heart failure, arterial hypotension, cardiogenic shock. Increases metabolic acidosis, hypokalemia. After awakening, confusion, agitation, hallucinations, and ataxia are again possible.

Treatment: hospitalization (intensive care unit). Treatment is symptomatic and supportive. Tube gastric emptying and lavage are indicated, even late after oral administration, as well as activated charcoal. Careful monitoring of the condition is mandatory, even if the case is obviously not severe. Assess the state of consciousness, the nature of the pulse, the value of blood pressure and respiratory function; at short intervals, carry out the determination of the content of electrolytes and blood gases. Maintain airway patency by intubation if necessary. In general, treatment with forced ventilation is recommended to prevent possible respiratory arrest. Continuous ECG monitoring should be carried out for 3-5 days. With the expansion of the QRS interval, heart failure and ventricular arrhythmias, it can be effective to change the blood pH to the alkaline side (prescription of a bicarbonate solution or hyperventilation) with the rapid introduction of hypertonic sodium chloride solution (100-200 mmol Na ⁺ ). For ventricular arrhythmias, traditional antiarrhythmic agents may be used, such as lidocaine 50–100 mg (1–1.5 mg/kg) IV followed by infusion at a rate of 1–3 mg/min.

Use pacing and defibrillation as needed. Correct circulatory failure with plasma substitutes and, in severe cases, with dobutamine infusion (initially at a rate of 2–3 μg/kg/min) with increasing dose depending on the effect. Excitement and convulsions can be stopped with diazepam.

Overdose sensitivity is predominantly individual. Children are especially prone to the development of cardiotoxicity and seizures.

In adults, doses greater than 500 mg can cause moderate to severe intoxication, while doses of about 1000 mg have been lethal.

Adverse reactions

Amitriptyline may cause side effects similar to those that occur with other tricyclic antidepressants. Some of the side effects listed below (headache, tremors, difficulty concentrating, constipation, and decreased libido) may also be symptoms of depression and usually improve as the depression improves.

On the part of the immune system : allergic reactions

On the part of the blood and lymphatic system : bone marrow depression, agranulocytosis, leukopenia, eosinophilia, thrombocytopenia.

From the side of metabolism : decreased appetite.

From the side of the psyche : state of confusion, decreased libido, hypomania, mania, anxiety, insomnia, nightmares, delirium (in elderly patients), hallucinations (in patients with schizophrenia), suicidal thoughts or behavior *.

From the nervous system : drowsiness, tremor, dizziness, headache, attention disorders, dysgeusia, paresthesia, ataxia, convulsions.

On the part of the organs of vision : accommodation disorders, mydriasis, increased intraocular pressure.

From the side of the hearing and vestibular apparatus : tinnitus.

From the side of the cardiovascular system : palpitations, tachycardia, atrioventricular blockade, blockade of the legs of the conduction system, ECG abnormalities (prolongation of the QT interval and the QRS complex), arrhythmia, orthostatic hypotension, arterial hypertension.

From the gastrointestinal tract : dry mouth, constipation, nausea, diarrhea, vomiting, swelling of the tongue, salivary gland enlargement, paralytic ileus.

From the side of the liver and biliary tract : jaundice, disturbances in the functional state of the liver, increased activity of blood alkaline phosphatase and transaminases.

Skin and subcutaneous tissue disorders : hyperhidrosis, rashes, urticaria, facial edema, alopecia, photosensitivity reactions.

Renal and urinary disorders : urinary retention.

From the side of the reproductive system and mammary glands : erectile dysfunction, gynecomastia.

General disorders : fatigue, pyrexia.

Other manifestations : weight gain, weight loss.

* Cases of suicidal thoughts or behavior have been reported during treatment or immediately after discontinuation of treatment with amitriptyline (see section “Peculiarities of use”).

Epidemiological studies, mainly conducted in patients over the age of 50, have shown an increased risk of bone fractures in patients receiving SSRIs and tricyclic antidepressants (TCAs). The mechanism by which this risk develops is unknown.

Shelf life

3 years.

Storage conditions

Store in the original container at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging

10 tablets in a blister. 5 blisters in a cardboard box.

10 tablets in a blister. 100 blisters in a cardboard box.

Dispensing category

By prescription.

Producer

PrJSC Tekhnolog.

Location of the manufacturer and its address of the place of business

Ukraine, 20300, Cherkasy region, Uman city, Staraya proreznaya street, 8.

Bipolar affective disorder, current episode of mild or moderate depression	ICD F31.3
Huntington’s disease	ICD G10
Delusional disorder	ICD F22. 0
Vasomotor cranialgia	ICD G44.2
Moderate depressive episode	ICD F32.1
Other depressive episodes	ICD F32.8
Other organic disorders of personality and behavior due to disease, trauma and brain dysfunction	ICD F07.8
Other recurrent depressive disorders	ICD F33.8
Migraine with aura [classic migraine]	ICD G43.1
Multi-infarct dementia	ICD F01.1
Trigeminal neuralgia	ICD G50.0
Neurasthenia (neurasthenic neurosis)	ICD F48.0
Organic mood disorder (affective)	ICD F06. 3
Acute stress reaction	ICD F43.0
Paranoid schizophrenia	ICD F20.0
Post-traumatic stress disorder	ICD F43.1
Post-schizophrenic depression	ICD F20.4
Recurrent depressive disorder, current mild episode	ICD F33.0
Recurrent depressive disorder, current episode moderate	ICD F33.1
Schizoaffective disorder, mixed type	ICD F25.2

film-coated tablets, 25 mg

Analogs

Choice of description form

Dosage

coated tablets

10 mg

25 mg

coated tablets

10 mg

25 mg

All forms of release, dosages, registration certificates, drug manufacturers, drug characteristics

Amitriptyline-Ferein ^® (coated tablets, 10 mg) 01/14/2003

Contents

• Active substance
• ATX
• Nosological classification (ICD-10)
• Pharmacological group
• Dosage form
• Compound
• Description of the dosage form
• Pharmacokinetics
• Pharmacodynamics
• Pharmacological properties
• Pharmaco-therapeutic group
• Indications
• Contraindications
• Dosage and administration
• Side effects
• Interaction
• Overdose
• special instructions
• Release form
• Terms of dispensing from pharmacies
• Storage conditions
• Best before date
• Reviews

Active ingredient

Amitriptyline* (Amitriptyline*)

ATX

N06AA09 Amitriptyline

Nosological classification (ICD-10)

ICD-10 code list

• F32 Depressive episode
• F50. 0 Anorexia nervosa
• F60.3 Emotionally unstable personality disorder
• F91 Conduct disorders
• F98.0 Inorganic enuresis
• R52.2 Other persistent pain

Pharmacological group

Antidepressants

Dosage form

Coated tablets.

Composition

Each coated tablet contains:

28 Excipients:

Contains kernels – microcrystalline cellulose, croscarmellose sodium, aerosil, magnesium stearate;

Shell composition: hydroxypropyl methylcellulose, polyethylene glycol-6000, titanium dioxide, indigo carmine for a dosage of 0.01 g (10 mg) or hydroxypropyl methylcellulose, polyethylene glycol-6000, titanium dioxide, tropeolin O for a dosage of 0.025 (25 mg).

Description of dosage form

Film-coated tablets, blue (for a dosage of 0.01 g) or yellow (for a dosage of 0.025 g). The cross section shows two layers.

Pharmacokinetics

Absorption is high. With oral administration of amitriptyline, maximum plasma concentrations are reached within 4-8 hours. Its bioavailability is from 33 to 62%. Time to reach maximum concentration (C _{ma x} ) after oral administration 2.0–7.7 hours. The volume of distribution is 5–10 l/kg. Effective therapeutic concentrations in the blood of amitriptyline are 50-250 ng / ml, for nortriptyline (its active metabolite) 50-150 ng / ml. Passes through the blood-brain barrier (including nortriptyline).

Tissue concentrations of amitriptyline are higher than those in plasma. Communication with plasma proteins 92–96%.

Metabolized in the liver (by demethylation, hydroxylation) with the formation of active metabolites – nortriptyline, 10-hydroxy-amitriptyline and inactive metabolites.

Plasma half-life of 10 to 28 hours for amitriptyline and 16 to 80 hours for nortriptyline. It is excreted mainly in the urine. Complete elimination within 7 days.

Amitriptyline crosses the placental barrier, is excreted in breast milk at concentrations similar to plasma.

Pharmacodynamics

The mechanism of antidepressant action of amitriptyline is associated with the inhibition of neuronal reuptake of catecholamines (norepinephrine, dopamine) in the CNS. Amitriptyline is a muscarinic cholinergic receptor antagonist in the CNS and in the periphery. It also has peripheral antihistamine (H1) and antiadrenergic properties.

Pharmacological properties

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

Pharmacotherapeutic group

Antidepressant

Indications

Depression of any etiology. Due to the severity of the sedative effect, it is especially effective in anxiety and depressive states.

Mixed emotional and behavioral disorders, phobic disorders.

Pediatric enuresis (excluding children with hypotonic bladder).

Psychogenic anorexia, bulimic neurosis.

Chronic neurogenic pain, for the prevention of migraine.

Contraindications

Heart failure in the stage of decompensation.

Acute and recovery period of myocardial infarction.

Conduction disorders 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 duodenum in the acute stage.

Prostate hypertrophy.

Bladder atony.

Pyloric stenosis, paralytic ileus.

Simultaneous treatment with MAO inhibitors (see Interactions).

Pregnancy, breastfeeding period.

Children under 6 years of age.

Hypersensitivity to Amitriptyline.

Amitriptyline should be used with caution in persons suffering from alcoholism, bronchial asthma, manic-depressive psychosis (MDP) and epilepsy (see Special Instructions), oppression of bone marrow hematopoiesis, hyperthyroidism, angina pectoris and heart failure, as well as angle-closure glaucoma and intraocular hypertension.

Dosage and administration

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Assign 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 part of the dose is taken at night). In severe depression resistant to therapy, the dose is increased to 300 mg or more, up to the maximum tolerated dose (the maximum dose for outpatients is 150 mg / day). In these cases, it is advisable to start treatment with intramuscular or intravenous administration of the drug, while using higher initial doses, accelerating the increase in dosages under the control of the somatic condition.

After a sustained antidepressant effect is obtained after 2-4 weeks, doses are gradually and slowly reduced. In the event of signs of depression with a decrease in doses, it is necessary to 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 – maximum, in divided doses or 1 time per day at night.

For enuresis, children over 6 years of age 12.5–25 mg at bedtime (dose not to exceed 2.5 mg/kg of child’s weight).

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

Side effects

Mainly related to anticholinergic action of the drug: blurred vision, paresis of accommodation, increased intraocular pressure, dry mouth, stool retention, intestinal obstruction, urinary retention, fever. All these phenomena usually disappear after adaptation to the drug or dose reduction.

From the side of the central nervous system: fatigue, irritability, dizziness, drowsiness, confusion, hallucinations, motor agitation, disorientation, tremor, ataxia, insomnia, nightmares, headache, peripheral neuropathy, EEG changes. Rarely – extrapyramidal disorders, increased anxiety.

From the side of the cardiovascular system: tachycardia, conduction disorders, orthostatic arterial hypotension, expansion of the QRS complex on the ECG, symptoms of heart failure.

From the gastrointestinal tract: nausea, vomiting, anorexia, stomatitis, taste disturbances, darkening of the tongue, epigastric discomfort, increased activity of “liver” transaminases, rarely cholestatic jaundice.

From the endocrine system: gynecomastia, galactorrhea, changes in the secretion of antidiuretic hormone (ADH), decreased libido, potency. Rarely – hyperglycemia, glucosuria, impaired glucose tolerance.

Allergic reactions: skin rash, itching, photosensitivity, angioedema.

Other: agranulocytosis and other blood changes, hair loss, swollen lymph nodes, weight gain with prolonged use, sweating, pollakiuria.

With long-term treatment, especially at high doses, with an abrupt cessation of treatment, withdrawal symptoms may develop: headache, nausea, vomiting, etc.

Interactions

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Amitriptyline increases CNS depression with the following drugs: antipsychotics, sedatives and hypnotics, anticonvulsants, central and narcotic analgesics, anesthetics, alcohol.

Co-administration of Amitriptyline with neuroleptics and/or anticholinergics may cause a febrile temperature reaction, paralytic ileus.

Amitriptyline potentiates the hypertensive effects of catecholamines but inhibits the effects of drugs that affect the release of norepinephrine.

Amitriptyline may reduce the antihypertensive effect of guanethidine and drugs with a similar mechanism of action.

With the simultaneous use of Amitriptyline and anticoagulants – coumarin derivatives, an increase in the anticoagulant activity of the latter is possible.

Simultaneous administration 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 enhances the effect of antiparkinsonian drugs.

Quinidine slows down the metabolism of Amitriptyline.

Co-administration of amitriptyline with disulfiram and other acetaldehyde dehydrogenase inhibitors may cause delirium.

Simultaneous use of Amitriptyline with MAO inhibitors can be fatal. The break in treatment between taking MAO inhibitors and tricyclic antidepressants should be at least 14 days!

Overdose

Drowsiness, disorientation, confusion, dilated pupils, fever, shortness of breath, dysarthria, agitation, hallucinations, seizures, muscle rigidity, stupor, coma, vomiting, arrhythmia, arterial hypotension, heart failure, angina breathlessness .

Relief measures: discontinuation of amitriptyline therapy, gastric lavage, fluid infusion, symptomatic therapy, maintenance of blood pressure and fluid and electrolyte balance. Monitoring of cardiovascular activity (ECG) is shown for 5 days, tk. relapse can occur after 48 hours or later. Hemodialysis and forced diuresis are not very effective.

Special instructions

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

Amitriptyline treatment in the elderly should be carried out under careful somatic control and with the use of minimal doses of the drug, increasing them gradually, in order to avoid the development of delirious disorders, hypomania and other complications.

Patients in the depressive phase of MDP may progress to the manic phase.

While taking Amitriptyline, it is forbidden to drive vehicles, maintain machinery and other types of work that require increased concentration of attention, as well as drinking alcohol.

Presentation

10, 20 tablets in a blisters; 1, 2, 3, 4, 5 blisters in a pack; 40, 50 tablets in orange glass jars or jars and glass jars for medicines; 40, 50, 60, 100 tablets in plastic containers or vials; 1 jar, bottle, plastic container or bottle in a pack.