Amitriptyline 25mg Tablets

Amitriptyline is a tricyclic antidepressant (TCA) that primarily inhibits the reuptake of norepinephrine and serotonin at the presynaptic neuronal membrane, thereby increasing the concentration of these neurotransmitters in the synaptic cleft. It also possesses significant anticholinergic, antihistaminic (H1 receptor blockade), and alpha-1 adrenergic blocking properties, which contribute to its side effect profile.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high or low blood pressure: severe headache, dizziness, fainting, or changes in vision
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision
Chest pain or pressure, rapid or irregular heartbeat
Confusion, difficulty focusing, or changes in behavior
Urination problems
Fever, chills, sore throat, unexplained bruising or bleeding, or extreme fatigue or weakness
Swelling, shakiness, or seizures
Hallucinations (seeing or hearing things that are not there)
Abnormal sensations, such as burning, numbness, or tingling
Changes in sex drive
Erectile dysfunction
Swelling of the testicles, enlarged breasts, or nipple discharge
Severe constipation or stomach pain, which may indicate a serious bowel problem
Inability to sweat during physical activity or in warm temperatures
Sleep disturbances, bad dreams, or ringing in the ears
Changes in tongue color
Excessive sweating
Joint pain or hair loss

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you are bothered by any of the following side effects or if they persist, contact your doctor:

Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Dizziness, drowsiness, fatigue, or weakness
Dry mouth
Headache
Anxiety or feeling nervous and excitable
Changes in taste
Weight gain or loss
Mouth sores

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
If you have recently had a heart attack.
If you have taken certain medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure.
If you are currently taking linezolid or methylene blue, as these medications can interact with this drug.
* If you are taking cisapride, as it is not recommended to use this medication in combination with this drug.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this drug before certain surgical procedures. If you need to stop taking this medication, your doctor will provide guidance on when to resume taking it after your surgery or procedure.

Caution with Daily Activities

Until you understand how this medication affects you, avoid driving and engaging in activities that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying down position. Be cautious when climbing stairs.

Stopping the Medication

Do not abruptly stop taking this medication without consulting your doctor, as this may increase the risk of withdrawal symptoms. If you need to stop taking this drug, your doctor will instruct you on how to gradually discontinue it.

Monitoring Blood Sugar Levels

If you have diabetes (high blood sugar), it is crucial to closely monitor your blood sugar levels. Inform your doctor if you experience symptoms of high or low blood sugar, such as fruity breath odor, dizziness, rapid breathing, rapid heartbeat, confusion, sleepiness, weakness, flushing, headache, unusual thirst or hunger, frequent urination, shaking, or sweating.

Interactions with Other Substances

Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, discuss the potential risks with your doctor.

Eye Problems

Some individuals may be at a higher risk of developing eye problems while taking this medication. Your doctor may recommend an eye exam to assess your risk. Immediately contact your doctor if you experience eye pain, changes in vision, or swelling and redness in or around the eye.

Sun Sensitivity

This medication may increase your risk of sunburn. Take precautions when exposed to sunlight, and inform your doctor if you experience excessive sunburn.

Heat and Fluid Loss

Be cautious in hot weather or during physical activity, and drink plenty of fluids to prevent dehydration.

Muscle Problems

There is a risk of developing a severe muscle condition called tardive dyskinesia, which may be irreversible. This risk is higher in individuals with diabetes, older adults, especially older females, and those taking higher doses or using the medication for an extended period. Contact your doctor immediately if you experience uncontrollable body movements or problems with your tongue, face, mouth, or jaw, such as tongue protrusion, cheek puffing, mouth puckering, or chewing.

Special Considerations

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

Pregnancy and Breastfeeding

Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Your doctor will discuss the potential benefits and risks of this medication to you and your baby.

• Monoamine Oxidase Inhibitors (MAOIs) - risk of serotonin syndrome, hyperpyretic crises, convulsions, and death. Allow at least 14 days between discontinuing MAOI and starting amitriptyline, and vice versa.
• Cisapride - risk of QT prolongation and arrhythmias.

• QT-prolonging drugs (e.g., Class IA and III antiarrhythmics, antipsychotics, macrolide antibiotics, fluoroquinolones) - increased risk of torsades de pointes.
• CNS depressants (e.g., alcohol, benzodiazepines, opioids, sedatives, hypnotics) - additive CNS depression.
• Anticholinergic agents (e.g., atropine, scopolamine, antihistamines, antipsychotics) - additive anticholinergic effects (e.g., severe constipation, urinary retention, blurred vision, delirium).
• Sympathomimetics (e.g., epinephrine, norepinephrine, phenylephrine) - potentiation of cardiovascular effects (hypertension, arrhythmias).
• CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, cimetidine) - increased amitriptyline plasma concentrations, leading to increased risk of adverse effects.
• Thyroid hormones - increased risk of cardiac arrhythmias and toxicity.

• Antihypertensives (e.g., guanethidine, clonidine) - amitriptyline may antagonize the hypotensive effects.
• Anticoagulants (e.g., warfarin) - potential for increased anticoagulant effect (monitor INR).
• Cimetidine - increased amitriptyline levels.
• Disulfiram - may inhibit amitriptyline metabolism.
• Barbiturates - may decrease amitriptyline levels due to enzyme induction.

• Oral contraceptives - may alter amitriptyline metabolism.
• Nicotine - may decrease amitriptyline levels.

• Worsening depression
• Suicidal thoughts or behavior
• Anxiety, agitation, panic attacks
• Insomnia
• Irritability, hostility, aggressiveness
• Impulsivity
• Akathisia (restlessness)
• Hypomania or mania
• Orthostatic dizziness or lightheadedness
• Palpitations, chest pain
• Dry mouth
• Blurred vision
• Constipation
• Urinary retention
• Sedation or drowsiness
• Confusion or delirium (especially in elderly)
• Seizures
• Fever, sore throat, unusual bleeding/bruising (signs of hematologic dyscrasias)

Category D. Amitriptyline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are reports of adverse effects in neonates (e.g., withdrawal symptoms, respiratory distress, CNS depression) when TCAs are used in the third trimester.

L3 (Moderately safe). Amitriptyline and its active metabolite, nortriptyline, are excreted into breast milk. While levels are generally low, monitor the infant for sedation, poor feeding, weight gain, and anticholinergic effects (e.g., constipation, urinary retention). Nortriptyline may be preferred due to lower levels in milk and less sedating effects.

Not approved for depression in children under 12 years due to limited efficacy and safety data. Black Box Warning regarding increased risk of suicidality in children, adolescents, and young adults. Used off-label for neuropathic pain and migraine prophylaxis, and approved for nocturnal enuresis in specific age groups. Close monitoring for adverse effects and suicidality is crucial.

Elderly patients are more sensitive to the anticholinergic, sedative, and hypotensive effects of amitriptyline. They are at increased risk for orthostatic hypotension, falls, confusion, and urinary retention. Start with lower doses (e.g., 10-25 mg at bedtime) and titrate slowly. Nortriptyline, a less sedating and anticholinergic TCA, may be preferred in this population.

• Amitriptyline is a highly sedating TCA, making it useful for patients with insomnia or for once-daily bedtime dosing.
• Its anticholinergic and alpha-1 adrenergic blocking effects contribute significantly to its side effect profile (dry mouth, constipation, blurred vision, orthostatic hypotension).
• Often used off-label for chronic neuropathic pain (e.g., diabetic neuropathy, postherpetic neuralgia), migraine prophylaxis, and tension headaches at lower doses than those used for depression.
• Therapeutic effects for depression may take 2-4 weeks to manifest, while pain relief may be seen sooner (days to weeks).
• Due to its cardiac effects (QT prolongation, conduction delays), it should be used with caution in patients with pre-existing cardiac disease or those taking other QT-prolonging drugs.
• Plasma levels of amitriptyline and nortriptyline can be monitored, especially in cases of suspected toxicity, non-response, or significant drug interactions.
• Withdrawal symptoms (e.g., nausea, vomiting, dizziness, headache, malaise, sleep disturbance, irritability) can occur if discontinued abruptly; taper dose gradually.

• For Depression: Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs), Atypical Antidepressants (e.g., Bupropion, Mirtazapine).
• For Neuropathic Pain: Gabapentin, Pregabalin, Duloxetine, Venlafaxine, Carbamazepine.
• For Migraine Prophylaxis: Beta-blockers (e.g., Propranolol), Topiramate, CGRP inhibitors, OnabotulinumtoxinA.
• For Insomnia: Trazodone, Mirtazapine, Z-drugs (e.g., Zolpidem), Benzodiazepines (short-term).

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.

In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.