Amitriptyline 10mg Tablets

Amitriptyline is a tertiary amine tricyclic antidepressant (TCA) that primarily inhibits the reuptake of norepinephrine and serotonin at presynaptic neuronal membranes, 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 (e.g., sedation, dry mouth, orthostatic hypotension). Its active metabolite, nortriptyline, is a secondary amine TCA with a more selective norepinephrine reuptake inhibition 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 experience any of the following symptoms, contact your doctor or seek medical attention immediately:

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 yellowing of the skin or 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 excessive 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 (may indicate a 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 experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Dizziness, drowsiness, fatigue, or weakness
Dry mouth
Headache
Anxiety or nervousness
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, it is essential to inform your doctor about the following:

Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Be sure to describe the symptoms you experienced as a result of the allergy.
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 take this medication concurrently.

It is crucial to note that this is not an exhaustive list of all potential drug interactions or health concerns that may affect your ability to take this medication safely. Therefore, it is vital to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. This will enable your healthcare team to verify that it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or modify the dosage of any medication without first consulting your doctor.

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 discontinue this medication, your doctor will provide instructions on how to gradually stop taking 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, consult 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 the sun, 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 uncontrolled 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 years 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 benefits and risks of this medication for you and your baby.

• Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of each other) - risk of serotonin syndrome, hyperpyretic crisis, convulsions, death.
• Cisapride - increased risk of QT prolongation and arrhythmias.
• Linezolid, Methylene Blue (IV) - risk of serotonin syndrome.

• Other CNS depressants (e.g., alcohol, benzodiazepines, opioids, sedatives, hypnotics) - additive CNS depression.
• Anticholinergic agents (e.g., atropine, benztropine, diphenhydramine, oxybutynin) - additive anticholinergic effects (severe constipation, urinary retention, delirium).
• QT-prolonging drugs (e.g., antiarrhythmics like quinidine, procainamide, amiodarone, sotalol; antipsychotics like thioridazine, ziprasidone; macrolide antibiotics; fluoroquinolones) - increased risk of ventricular arrhythmias.
• Serotonergic drugs (e.g., SSRIs, SNRIs, triptans, tramadol, fentanyl, St. John's Wort) - increased risk of serotonin syndrome.
• CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, bupropion) - increased amitriptyline and nortriptyline plasma concentrations.
• Sympathomimetics (e.g., epinephrine, norepinephrine, phenylephrine, pseudoephedrine) - potentiated pressor response, risk of hypertension and arrhythmias.

• Thyroid hormones - increased risk of cardiac arrhythmias.
• Cimetidine - increased amitriptyline levels.
• Oral contraceptives - may increase or decrease TCA levels.
• Antihypertensives (e.g., guanethidine, clonidine) - may antagonize antihypertensive effect.
• Barbiturates - may decrease TCA levels due to enzyme induction.

• Not readily available for minor interactions, focus on major/moderate due to safety profile.

• Worsening depression
• Suicidal thoughts or behavior (especially in young adults)
• Unusual changes in behavior or mood (e.g., agitation, irritability, anxiety, panic attacks, insomnia, impulsivity, aggression, mania/hypomania)
• Dry mouth
• Blurred vision
• Constipation
• Urinary retention
• Dizziness or lightheadedness (especially upon standing)
• Sedation or drowsiness
• Tachycardia or palpitations
• Confusion or delirium (especially in elderly)
• Seizures
• Muscle stiffness or tremors

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Neonates exposed to TCAs in the third trimester may develop withdrawal symptoms (e.g., respiratory distress, feeding difficulties, irritability, tremors).

L3 (Moderately safe). Amitriptyline and its active metabolite, nortriptyline, are excreted into breast milk. While levels in milk are generally low, monitor breastfed infants for sedation, poor feeding, and weight gain. Nortriptyline may be preferred due to lower levels in milk and less sedative effects.

Not approved for depression in pediatric patients due to increased risk of suicidal thoughts and behaviors (Black Box Warning). However, it is commonly used off-label for neuropathic pain and migraine prophylaxis in children and adolescents, typically at lower doses. Close monitoring for adverse effects, especially suicidality, is crucial.

Elderly patients are more sensitive to the anticholinergic, sedative, and orthostatic hypotensive effects of amitriptyline. Start with lower doses (e.g., 10 mg at bedtime) and titrate slowly. Increased risk of falls, confusion, and cardiac conduction abnormalities. Avoid in patients with dementia due to anticholinergic burden. Consider nortriptyline (the active metabolite) as an alternative due to a more favorable side effect profile.

• Amitriptyline is a highly effective TCA, but its side effect profile (anticholinergic, sedation, orthostatic hypotension) often limits its use, especially in the elderly.
• The 10mg dose is typically used for neuropathic pain, migraine prophylaxis, or as a sleep aid, rather than for depression, where higher doses are usually required.
• Due to its long half-life and sedative properties, it is usually dosed once daily at bedtime.
• Full antidepressant effects may take several weeks to manifest, but pain/sleep benefits can be seen sooner.
• Always screen for suicidal ideation, especially in younger patients, and educate patients/caregivers on warning signs.
• Avoid abrupt discontinuation to prevent withdrawal symptoms (e.g., nausea, headache, malaise, vivid dreams, irritability).

• Other TCAs (e.g., Nortriptyline, Imipramine, Desipramine, Doxepin)
• SSRIs (e.g., Fluoxetine, Sertraline, Paroxetine, Citalopram, Escitalopram) for depression.
• SNRIs (e.g., Venlafaxine, Duloxetine) for depression and neuropathic pain.
• Other agents for neuropathic pain (e.g., Gabapentin, Pregabalin, Duloxetine).
• Other agents for migraine prophylaxis (e.g., Beta-blockers, Topiramate, CGRP inhibitors).

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information about its use. 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, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.

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. This information will help healthcare professionals provide you with the most appropriate care and treatment.