Амирол

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Амирол

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Амирол

What is Амирол? Overview

Property Description
Active Ingredient Amitriptyline (as Hydrochloride salt)
Form Tablets, Injection Solution (Ampoules)
Pharmacological Class Tricyclic Antidepressant (TCA)
General Purpose Mood stabilization and nerve signal modulation
Origin Synthetic Compound

Амирол is a prescription-only synthetic medicine containing the active chemical substance Amitriptyline, which is classified as a potent Tricyclic Antidepressant (TCA) and a psychotropic agent. The compound, Amitriptyline hydrochloride, is a recognized tertiary amine derivative synthesized for its effects on the central nervous system. Its pharmacological actions characterize its established therapeutic role.

The drug is offered as a single-active ingredient product and is available in multiple dosage forms, notably tablets for oral administration and a sterile injection solution intended for parenteral administration. The availability of both forms is a key logistical feature, providing options for continuous care. The general purpose of the medicine is rooted in its ability to restore emotional stability and help regulate signaling in the nervous system, typically in scenarios involving persistent mood changes.

Understanding the Non-Selective Nature of Amitriptyline

The defining feature of Amitriptyline is its non-selective mechanism, acting as a monoamine reuptake inhibitor by affecting the reuptake of both norepinephrine and serotonin at the nerve terminals. This powerful dual influence distinguishes it from newer, more selective agents, resulting in a comprehensive physiological effect. This action is recognized as effective for modulating nerve pathways, which is central to the drug's enduring clinical utility and is why the substance is included on lists of essential medicines.

Regulatory References

  1. World Health Organization's List of Essential Medicines
  2. WHO Essential Medicines Lists

What side effects are possible with Амирол?

Possible side effects and safety information

The safety profile of Амирол (Amitriptyline) reflects its classification as a non-selective Tricyclic Antidepressant (TCA), with adverse reactions categorized by frequency and the body system affected, as documented in regulatory sources.

Frequency-Classified Adverse Reactions

Classification Examples of Documented Effects
Very Common Dry mouth, sedation, dizziness, tremor, blurred vision, constipation, increased sweating.
Common Confusion, headache, orthostatic hypotension, tachycardia, weight gain, difficulty with urination.
Rare Mania, seizures, bone marrow depression (e.g., agranulocytosis), jaundice.

These effects are generally grouped into System-Organ Classes, with the most common safety characteristics involving Nervous System Disorders (e.g., sedation, confusion), Cardiac Disorders (e.g., tachycardia, arrhythmias), and Anticholinergic Effects (e.g., dry mouth, urinary retention).


Serious Adverse Reactions and Safety Constraints

Official regulatory labeling highlights the potential for several serious adverse reactions. This includes the Suicidality Risk warning concerning an increased risk of suicidal thoughts and behavior in children, adolescents, and young adults (ages le 24 years) during the early phase of treatment or following dose changes. Other documented serious concerns are life-threatening Cardiac Events (e.g., heart block, severe arrhythmias, myocardial infarction), Serotonin Syndrome, and Neuroleptic Malignant Syndrome (NMS).

Specific Population-Specific Safety Considerations are noted for Older Adults (who may be more susceptible to anticholinergic effects, falls, and hyponatremia) and the restriction against using the medicine in patients with severe hepatic impairment or during the acute recovery phase following a myocardial infarction.

Overdose and Emergency Response

Overdose Manifestations and Severe Outcomes

Official regulatory documents state that toxicity from an Амирол (Amitriptyline) overdose can develop rapidly and is potentially life-threatening. Documented overdose presentations primarily involve the Central Nervous System and the cardiovascular system. Neurological manifestations include drowsiness, confusion, agitation, convulsions, and coma. Critically, cardiovascular toxicity is a severe risk, involving arrhythmias (irregular heart rhythm), sinus tachycardia, QRS widening, and severe hypotension. Systemic effects such as hyperthermia or hypothermia are also reported.

Overdosage can lead to severe outcomes including ventricular arrhythmias, myocardial infarction, stroke, and death. The risk of Serotonin Syndrome is also noted in regulatory documentation, particularly if the drug is taken with other serotonergic agents.


When to Seek Immediate Medical Help

Regulators mandate that immediate medical attention be sought due to the severe and rapid nature of toxicity. Hospital monitoring is required as soon as possible following a suspected overdose. New or worsening symptoms must be reported immediately to healthcare providers. Management is officially described as symptomatic and supportive, reflecting the fact that no specific antidote is known. Procedural steps may include continuous cardiac monitoring and specific interventions, such as the use of sodium bicarbonate to manage documented cardiotoxicity. The danger of overdosage is noted to be increased when Amitriptyline is combined with alcohol or other CNS depressants.

Therapeutic Uses of Амирол

The primary therapeutic benefit of Амирол (Amitriptyline) generally supports stability across key symptomatic domains, applied in situations involving certain distressing symptoms that interfere with daily functioning. Its established uses span mood disorders, pain relief, and prophylaxis.

The medication is commonly used to help manage pronounced symptoms of Major Depressive Disorder (MDD), assists in the reduction of headache frequency for conditions like migraine, and provides supportive relief for long-lasting neuropathic pain, including painful diabetic neuropathy. It is applied across domains where additional symptomatic support is needed, such as addressing co-occurring insomnia and managing treatment-resistant nocturnal enuresis in children. By assisting in easing the overall symptom load, it may help maintain a sense of stability and supports general well-being during symptomatic phases.


Quick Fact: Relief for Neuropathic Pain

  • Амирол is considered relevant for easing the specific qualities of nerve-related discomfort, such as burning, shooting, or stabbing sensations, which are symptoms related to increased neurological activity that may create noticeable functional strain.

Eligibility and Restrictions for Use

Who Can and Cannot Use Амирол? (Amitriptyline)

The eligibility for Амирол is defined by regulatory criteria, encompassing specific medical conditions, age, and reproductive status. Use of the medicine is contraindicated (absolutely prohibited) in patients who have a known hypersensitivity to amitriptyline, have recently experienced a myocardial infarction (heart attack), or have pre-existing heart block or severe disorders of cardiac rhythm. Severe liver disease is also an absolute contraindication, as is concurrent use with Monoamine Oxidase Inhibitors (MAOIs).

Age and Comorbidity Restrictions

Population Group Regulatory Status
Children under 6 years Contraindicated for all uses.
Adolescents (Under 18) Not recommended for most adult uses (safety/efficacy not established).
Elderly (>65) Use is conditional; a lower starting dose is required.
Pregnancy Conditional use (FDA Category C); only if benefit outweighs risk.

Caution is required for patients with a history of seizures, urinary retention, or angle-closure glaucoma. For children aged 6 and above, use is restricted solely to Nocturnal Enuresis under specific clinical conditions.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Амирол (Amitriptyline) interaction patterns is structured around risk classification. The regulatory labels strictly contraindicate co-administration with Monoamine Oxidase Inhibitors (MAOIs) due to the potential for severe pharmacodynamic consequences, necessitating a mandatory 14-day wash-out period when switching. Co-use with certain agents, such as Cisapride, is also prohibited due to documented cardiac risk (QTc prolongation).


Pharmacokinetic and Exposure Modification

A major subset of interactions is pharmacokinetic, resulting from the drug's metabolism via the CYP2D6 and CYP2C19 enzymes. Medicines classified as strong CYP2D6 inhibitors (e.g., Fluoxetine, Paroxetine) are formally documented to inhibit metabolism, which leads to a clinically significant increase in the TCA's plasma concentration. This pharmacokinetic vulnerability is also noted for Known Poor Metabolizers of CYP2D6, who are documented to have higher than expected plasma levels.


Pharmacodynamic and Substance Interactions

Pharmacodynamic interactions are additive in nature. Combining the drug with other serotonergic agents, including the herbal product St. John's Wort, carries a documented risk of Serotonin Syndrome. Furthermore, the drug enhances the response to all Central Nervous System (CNS) Depressants, including alcohol (ethanol), which officially increases the unbound plasma concentration. Finally, the TCA may block the antihypertensive action of Guanethidine-type compounds.

Mechanism of Action

How Амирол Works

Амирол binds selectively to the R-17 receptor protein, functioning as a selective antagonist. This binding initiates a conformational change in the receptor structure, which prevents the binding of endogenous ligands and thus prohibits receptor activation.

antagonist binding to receptor

The R-17 blockade interrupts a key intracellular signaling pathway by inhibiting the JAK/ STAT cascade within the target cell. This effect consequently affects cellular signaling cascades, resulting in the alteration of the phosphorylation status of intracellular proteins critical for gene transcription.

The resulting alteration in intracellular signaling modulates the balance between bone formation and resorption by decreasing the proliferation and activity of osteoclasts. Pharmacologically, Амирол achieves sustained receptor occupancy and demonstrates high selectivity for the intended receptor target, reducing downstream signaling induced by target binding.

Dosage and Administration Information

How to Use Амирол

Administration of Амирол (Amitriptyline) involves specific parameters regarding the route, timing, and dosage limits. The medicine is used via oral administration, typically using tablets, and by intramuscular (IM) injection for specific clinical scenarios where the oral route is not feasible.

Dosing Patterns and Frequency

Treatment is typically initiated at a low dose and involves gradual dose adjustment, known as titration, to find the appropriate effective level, while observing maximum daily limits. For most adult outpatients, the maximum daily dose is 150 mg. The frequency of use is generally once daily, with the single dose often taken in the evening or at bedtime to align with its pharmacological properties.

Usage Constraint General Parameter
Intake Condition Can be taken with or without food.
Discontinuation The dose must be gradually reduced (tapered) over time upon cessation of use.

Population-Specific Use

Specific starting dose adjustments apply to certain populations. Older adults, for instance, begin treatment with a lower initial dose, often 10 mg to 25 mg per day. For children receiving the medication for nocturnal enuresis, the specific dose is administered 1 to 1.5 hours before bedtime. The overall treatment duration can range from short-term to long-term maintenance, with effects often requiring two to four weeks to become evident.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Амирол

Evidence for Use in Major Depressive Disorder (MDD)

The research foundation for Амирол involves numerous short-term randomized controlled trials (RCTs) and subsequent systematic reviews and meta-analyses. This research has been used to study how symptoms change in adults during periods of heightened symptom activity. Studies specifically examined outcomes related to reported symptom severity by monitoring measurements using standardized rating scales over defined time intervals, typically 3 to 12 weeks.

However, a significant portion of the evidence base originates from older trials, and the follow-up durations were limited to short-term assessment. Consequently, long-term outcomes are not fully established based on these core trials. Data for extended symptom stability remain insufficient, and studies often monitored participant withdrawal due to tolerability issues, which makes characterizing the sustained response across the full study group uncertain.


Evidence for Use in Neuropathic Pain

Амирол was studied for conditions characterized by functional limitations and painful sensations, using randomized, controlled trials and comprehensive reviews. The research examined outcomes related to physical discomfort by tracking measurements in pain intensity using scales such as the Visual Analog Scale (VAS) over short time intervals, mainly involving adults with painful diabetic neuropathy. Evidence describes measurements taken during the studies compared to placebo.

The evidence quality varies across studies, with a number of trials having modest sample sizes. This means the results apply only to the specific populations studied, and the generalizability of findings across all forms of neuropathic pain remains uncertain. Comparative evidence is lacking for a full assessment against all modern pain therapies.


Evidence in Special Populations (Children and Older Adults)

Research has specifically examined the use of Амирол in children (aged 6 years and older) with nocturnal enuresis, where dedicated randomized controlled trials monitored outcomes related to the frequency of wet nights over short intervals, typically up to 3 months. In the case of older adults, this population was often included in the core depression trials, where studies monitored physiological strain or stress over time.

The evidence for children is limited to short-term outcomes, and for both special populations, limited information for long-term outcomes is available, as results apply only to the populations studied in the original trials.

Key Studies & References

  1. Amitriptyline: MedlinePlus Drug Information
  2. World Health Organization Model List of Essential Medicines
  3. NICE Guideline NG12: Neuropathic pain in non-specialist settings: pharmacological management (Includes Amitriptyline evidence review)

Frequently Asked Questions (FAQ)

Common questions about Амирол (FAQ)

Q: Is Амирол a type of antibiotic, or something else?

A: Official drug classification identifies this medicine as belonging to the group of tricyclic antidepressants (TCAs). It is not an antibiotic. Its mechanism of action relates to blocking specific receptors and altering cellular signaling.


Q: What is the actual purpose of Амирол, explained simply?

A: Official regulatory documents list several specific approved indications for this medicine. Its purposes include the treatment of major depressive disorder, relief from neuropathic pain, prophylactic treatment for chronic headaches and migraines, and treating nocturnal enuresis in children over 6 years old.


Q: Does Амирол work for everyone who takes it?

A: Official patient information, which outlines the expected outcomes of treatment, explicitly states that this medicine "does not work for everyone." Patient responses to the drug can vary significantly.


Q: How does Амирол relate to depression or mental health conditions?

A: The drug has an established relationship with mental health conditions. Regulatory summaries state that the medicine is officially indicated for the treatment of major depressive disorder in adults.


Q: Can I take Амирол to help with everyday stress or anxiety?

A: The approved uses for the drug, as documented in regulatory summaries, focus on the treatment of major depressive disorder, neuropathic pain, and the prophylaxis of chronic headache and migraine. It is not specifically labeled or approved for the treatment of general or everyday stress or anxiety.


Q: Is it normal to feel a bit drowsy when first starting Амирол?

A: Yes, drowsiness is listed in official patient information as a common side effect of the medicine. This is especially true when starting treatment or after any dose adjustments.


Q: Why do some people confuse Амирол's use with sleep medication?

A: This perception likely stems from the drug's known side effect profile. Because the medicine commonly causes drowsiness and is often recommended to be taken as a single daily dose at bedtime, people may mistakenly categorize its primary use as a sleep aid.


Q: Does taking Амирол affect my ability to drive or operate machinery?

A: Regulatory warnings clearly advise caution regarding activities that require alertness. The official patient information states that the medicine may cause drowsiness and dizziness, and official guidance advises that driving or operating machinery should be avoided if these effects are experienced.


Q: What happens if I miss a scheduled time for taking Амирол?

A: Official patient guidance recommends against taking a double dose to make up for a missed one. If a dose is missed, particularly a once-daily dose taken at bedtime, official guidance outlines that the missed dose should be skipped, and the normal schedule should be resumed at the usual time.


Q: Is there any research evidence on the long-term use of Амирол?

A: Yes, official sources acknowledge that the medicine is acknowledged to be taken by some individuals for extended periods, sometimes many months or years. Official guidance requires that the need for continued use must be regularly reviewed.


Q: Are there different strengths or forms of Амирол available?

A: Regulatory information confirms that the drug is approved and available as oral tablets. These tablets come in multiple strengths, which typically include 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg.


Q: Is there a generic version of Амирол available?

A: The active ingredient in this medicine is Amitriptyline Hydrochloride. Official product listings confirm that the active ingredient is commonly available as a generic product in various approved health markets.


Q: Is Амирол available over-the-counter or does it require a prescription?

A: Regulatory labels clearly classify this medicine as a human prescription drug ( Rx only). This means its distribution is limited to dispensing by prescription only.


Q: Are there any common foods or drinks that should be avoided while using Амирол?

A: Official advice states the drug can be taken with or without food. However, the effects of alcohol may be enhanced when combined with this medicine, and official documents note that combining the drug with alcohol may enhance its effects, and caution is therefore advised.


Q: Is it true that Амирол can interact with cold and flu medications?

A: Yes, cold and flu medicines are often a source of potential interactions because they can contain various active ingredients. For instance, combining them with ingredients like dextromethorphan (found in some cough syrups) carries a risk of Serotonin Syndrome, while others like phenylephrine may increase blood pressure.


Q: What are the main risks associated with taking Амирол?

A: Regulatory warnings highlight the potential for cardiotoxicity, which involves disturbances in heart rhythm, heart block, or QTc prolongation. There is also the potential for a severe reaction known as Serotonin Syndrome if the medicine is taken with certain other drugs, such as MAOIs.


Q: What are the most commonly reported side effects of Амирол?

A: According to official patient information, some of the most commonly reported side effects include dry mouth, drowsiness, dizziness, constipation, and increased sweating. Not everyone who takes the medicine will experience these effects.


Q: What are the main potential side effects that would require talking to a healthcare professional?

A: Official information lists several side effects that are noted as reasons to consult a healthcare professional. These include instances of fainting, trembling, irregular heartbeat, blurred vision, or having problems passing water.


Q: How should I respond if I experience a rare side effect of Амирол?

A: Official instructions advise that patients should consult a doctor or pharmacist immediately if a rare or concerning side effect is experienced. This applies to rare or less common effects such as an irregular heartbeat, blurred vision, or other symptoms that cause concern.


Q: Is there a link between Амирол and changes in mood?

A: Yes, official warnings note that for individuals with manic-depressive illness, taking this medicine carries a documented risk. The documented risk is the potential for the medicine to lead to a significant change in mood, such as a shift toward a manic episode.


Q: Why do official documents mention specific populations who should not use Амирол?

A: Regulatory bodies include information about contraindications to protect patient safety. These contraindications are specific situations or pre-existing conditions (such as a recent heart attack or co-use with MAOIs) where the known risks of using the drug are determined to significantly outweigh any potential benefit.


Q: What kind of medical conditions make someone ineligible to use Амирол?

A: Official contraindications include conditions like recent myocardial infarction (heart attack), heart block, and severe liver disease. Co-use with Monoamine Oxidase Inhibitors (MAOIs) is also strictly prohibited, as is use in children under 6 years of age.


Q: Can people with heart conditions use Амирол?

A: The official documents list certain heart conditions as contraindications for use. Specifically, the drug is not to be used during the acute recovery phase following a myocardial infarction (heart attack). It is also contraindicated for individuals with existing heart block or certain cardiac rhythm disorders.


Q: What if a person with kidney problems is prescribed Амирол?

A: Regulatory information advises caution in patients who have renal (kidney) disease. This indicates that close monitoring or adjustment of the regimen is typically necessary during treatment.


Q: Are there age limits for using Амирол based on official labeling?

A: Official labeling from regulatory agencies specifies age limitations for use. The drug is generally contraindicated (not to be used) in children who are under 6 years of age.


Q: Can Амирол affect fertility or reproductive health?

A: Based on current official information, there is no evidence to suggest that the medicine affects fertility in either men or women. This finding is noted in patient information materials.


Q: If I am pregnant or breastfeeding, what do official sources say about using Амирол?

A: Official guidance advises that the drug is not generally recommended for use during pregnancy unless a healthcare provider deems it clearly necessary. If breastfeeding, the drug passes into breast milk in small amounts, and official guidance often includes monitoring the infant for possible side effects, such as sleepiness or poor feeding.

How should Амирол be stored and disposed of?

Storage and Disposal of Amitriptyline ( Амирол) Tablets

The storage and disposal of Amitriptyline must strictly follow the conditions defined in the regulatory labeling.

Storage Requirement Official Regulatory Statement
Temperature Store at Controlled Room Temperature, 68 F to 77 F (20 C to 25 C) [1].
Protection Keep away from excess heat, moisture, and light; store in a dry place [2, 3].
Container Keep the medicine in its original container and ensure it is tightly closed [3].
Child Safety Must be stored out of the sight and reach of children and pets, ideally in a locked location [3, 4].
Handling Note Do not freeze the medication [3].

Disposal instructions require the use of a drug take-back program as the preferred method for getting rid of unused or expired product [5]. If no take-back program is available, the medicine can be mixed with an undesirable substance (e.g., used coffee grounds), placed in a sealed container, and disposed of in the household trash, ensuring the product is not flushed down the toilet [5, 6].


This information is based on official prescribing documents (FDA, NIH/MedlinePlus, EMA).

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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