Amitriptyline 100mg (hundred Mg)tab

Amitriptyline is a tertiary amine tricyclic antidepressant (TCA). It primarily inhibits the reuptake of norepinephrine (NE) and serotonin (5-HT) into presynaptic neurons, thereby increasing their concentrations in the synaptic cleft. It also possesses significant anticholinergic (muscarinic receptor blockade), antihistaminic (H1 receptor blockade), and alpha-1 adrenergic blocking properties, which contribute to its side effect profile (e.g., sedation, dry mouth, orthostatic hypotension).

Serious 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 medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Fainting or changes in vision
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Weakness on one side of the body
Difficulty speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred vision
Chest pain or pressure
Rapid or irregular heartbeat
Confusion or difficulty focusing
Changes in behavior
Difficulty urinating
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Swelling
Shakiness
Seizures
Hallucinations (seeing or hearing things that are not there)
Abnormal sensations, such as burning, numbness, or tingling
Changes in sex drive
Difficulty getting or maintaining an erection
Swelling of the testicles
Enlarged breasts or nipple discharge
Severe constipation or stomach pain (which may be signs of a severe bowel problem)
Inability to sweat during physical activity or in warm temperatures
Sleep disturbances
Bad dreams
Ringing in the ears
Changes in tongue color
Excessive sweating
Joint pain
Hair loss

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Dizziness
Drowsiness
Fatigue
Weakness
Dry mouth
Headache
Anxiety
Feeling nervous or excitable
Changes in taste
Weight gain or loss
* Mouth sores

Reporting Side Effects

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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.

Please note that this is not an exhaustive list of all potential interactions. It is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist to ensure safe use. Do not start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so.

Important Warnings and Precautions

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

Caution with Daily Activities

Until you know how this medication affects you, avoid driving and other 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 suddenly 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 taper off the medication.

Monitoring Blood Sugar Levels

If you have diabetes (high blood sugar), closely monitor your blood sugar levels while taking this medication. Report any signs of high or low blood sugar to your doctor, including symptoms such as:

Breath that smells like fruit
Dizziness
Fast breathing
Fast heartbeat
Confusion
Sleepiness
Weakness
Flushing
Headache
Unusual thirst or hunger
Frequent urination
Shaking
Sweating

Interactions with Other Substances

Before using alcohol, marijuana, or other forms of cannabis, or prescription or over-the-counter medications that may cause drowsiness, consult 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 report any eye pain, changes in vision, or swelling and redness around the eye to your doctor.

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 while taking this medication.

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. Report any uncontrollable body movements or problems with your tongue, face, mouth, or jaw, such as:

Tongue sticking out
Puffing cheeks
Mouth puckering
* Chewing

to your doctor immediately.

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 using this medication during pregnancy or breastfeeding.

• Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation due to risk of serotonin syndrome)
• Cisapride (risk of QT prolongation and arrhythmias)
• Linezolid, Methylene Blue (non-selective MAOIs, risk of serotonin syndrome)
• Acute recovery phase of myocardial infarction

• Other CNS depressants (e.g., alcohol, benzodiazepines, opioids, sedatives, hypnotics) - additive CNS depression
• Anticholinergic agents (e.g., atropine, benztropine, diphenhydramine) - additive anticholinergic effects (severe constipation, urinary retention, delirium)
• QT-prolonging drugs (e.g., antiarrhythmics like quinidine, procainamide; antipsychotics like thioridazine, ziprasidone; certain antibiotics like moxifloxacin) - increased risk of ventricular arrhythmias
• Sympathomimetics (e.g., epinephrine, norepinephrine, phenylephrine) - enhanced pressor response, risk of hypertension/arrhythmias
• CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, bupropion) - increased amitriptyline plasma levels, increased risk of toxicity
• Thyroid hormones - increased risk of arrhythmias and CNS stimulation
• Guanethidine, Clonidine (antihypertensives) - may block antihypertensive effect

• CYP2C19 inhibitors (e.g., omeprazole, fluconazole) - increased amitriptyline plasma levels
• CYP1A2 inhibitors (e.g., cimetidine, fluvoxamine) - increased amitriptyline plasma levels
• Anticoagulants (e.g., warfarin) - potential for altered anticoagulant effect (monitor INR)
• Antihypertensives (other) - additive hypotensive effects
• Cholinergic agents (e.g., donepezil, rivastigmine) - antagonism of effects
• Tramadol - increased risk of seizures and serotonin syndrome

• Tobacco smoking (induces CYP1A2, may decrease amitriptyline levels)
• Grapefruit juice (inhibits CYP3A4, minor increase in levels)

• Worsening depression
• Suicidal thoughts or behavior
• Unusual changes in behavior (agitation, irritability, hostility, impulsivity)
• Anxiety, panic attacks
• Insomnia
• Dry mouth
• Constipation
• Blurred vision
• Urinary retention
• Dizziness or lightheadedness (especially upon standing)
• Sedation or drowsiness
• Weight gain
• Palpitations or irregular heartbeat
• Seizures
• Confusion or delirium (especially in elderly)

Amitriptyline is Pregnancy Category C. Studies in animals have shown an adverse effect on the fetus, but there are no adequate and well-controlled studies in humans. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to TCAs in the third trimester have developed withdrawal symptoms (e.g., respiratory distress, feeding difficulties, tremor, hypertonia, hypotonia, seizures).

Amitriptyline and its active metabolite nortriptyline are excreted into breast milk. The American Academy of Pediatrics considers amitriptyline to be a drug for which the effect on the nursing infant is unknown but may be of concern. Monitor the infant for sedation, poor feeding, and weight gain. Nortriptyline (the active metabolite) is generally preferred if a TCA is needed during lactation due to lower levels in milk and less sedation.

Not approved for depression in children <12 years due to limited efficacy data and Black Box Warning regarding increased risk of suicidality in children, adolescents, and young adults. Used off-label for neuropathic pain and migraine prophylaxis in children and adolescents, but requires careful risk-benefit assessment and close monitoring for adverse effects, especially suicidality. Lower doses and slow titration are essential.

Elderly patients are more sensitive to the anticholinergic, sedative, and hypotensive effects of amitriptyline. They are at increased risk for falls, confusion, urinary retention, and constipation. Start with lower doses (e.g., 10-25 mg/day) and titrate very slowly. Monitor closely for adverse effects, especially cardiovascular and CNS effects. Consider alternative agents if possible due to high anticholinergic burden.

• Amitriptyline is highly sedating; therefore, it is typically dosed at bedtime, which can also help with insomnia often comorbid with depression or pain.
• Its anticholinergic properties can be beneficial for patients with irritable bowel syndrome (IBS) with diarrhea-predominant symptoms or nocturnal enuresis (off-label).
• Due to its long half-life and active metabolite (nortriptyline), steady-state levels may take 1-2 weeks to achieve.
• Titrate dose slowly to minimize side effects, especially in elderly patients or those sensitive to anticholinergic effects.
• Patients should be warned about the potential for weight gain and advised on lifestyle modifications.
• Consider an ECG before initiation, especially in patients with pre-existing cardiac conditions or those over 40-50 years old, due to potential for QT prolongation and conduction abnormalities.
• Switching from an MAOI to amitriptyline (or vice versa) requires a 14-day washout period to prevent serotonin syndrome.

• SSRIs (e.g., fluoxetine, sertraline, escitalopram) for depression/anxiety
• SNRIs (e.g., venlafaxine, duloxetine) for depression/anxiety and neuropathic pain
• Other antidepressants (e.g., mirtazapine, bupropion)
• Gabapentin or Pregabalin for neuropathic pain
• Beta-blockers (e.g., propranolol) or CGRP inhibitors for migraine prophylaxis
• Cognitive Behavioral Therapy (CBT) or other psychotherapies for depression/anxiety
• Non-pharmacological pain management strategies (e.g., physical therapy, acupuncture)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, we encourage you to discuss them 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 seeking help, be prepared to provide details about the overdose, including the amount taken and the time it occurred.