Imipramine 25mg Tablets

Imipramine is a tricyclic antidepressant (TCA) that primarily inhibits the reuptake of norepinephrine (NE) and serotonin (5-HT) into presynaptic neurons, thereby increasing the concentrations of these neurotransmitters in the synaptic cleft. It also possesses significant anticholinergic, antihistaminic (H1-receptor blocking), and alpha1-adrenergic blocking properties, which contribute to its side effect profile.

Important Side Effects to Report to Your Doctor Immediately

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, seek medical attention right away:

Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Confusion
Hallucinations (seeing or hearing things that are not there)
Sleep disturbances, including trouble sleeping or bad dreams
Erectile dysfunction or changes in sex interest
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Yellowing of the skin or eyes (jaundice)
Chest pain or pressure
Fast or abnormal heartbeat
Shortness of breath
Sudden weight gain or swelling in the arms or legs
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred eyesight
Ringing in the ears
Burning, numbness, or tingling sensations
Trouble controlling body movements
Twitching
Swallowing or speaking difficulties
Seizures
Severe constipation or stomach pain (may be signs of a bowel problem)
Trouble passing urine
Swelling
Mouth irritation or mouth sores
Enlarged breasts or nipple discharge
Swelling of the testicles
Hair loss

Monitoring for High or Low Blood Sugar

If you experience any of the following symptoms, contact your doctor, as they may be signs of high or low blood sugar:
Breath that smells like fruit
Dizziness
Fast breathing
Fast heartbeat
Confusion
Sleepiness
Weakness
Flushing
Headache
Unusual thirst or hunger
Frequent urination
Shaking or sweating

Eye Problems

Some people 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. If you experience any of the following symptoms, seek medical attention right away:
Eye pain
Changes in eyesight
Swelling or redness in or around the eye

Serotonin Syndrome

A rare but potentially life-threatening condition called serotonin syndrome may occur, especially if you are taking certain other medications. If you experience any of the following symptoms, seek medical attention immediately:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, stomach upset, or vomiting
Severe headache

Other Possible Side Effects

While many people may not experience any side effects or only minor ones, it is essential to report any of the following symptoms to your doctor if they bother you or persist:
Dizziness
Sleepiness
Fatigue
Weakness
Dry mouth
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Changes in taste
Stomach cramps
Weight gain or loss
Excessive sweating
Flushing
* Headache

Reporting Side Effects

If you have any 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 very high blood pressure.
If you are currently taking linezolid or methylene blue, as these medications can interact with this drug.
* If you are breastfeeding, as you should not breastfeed while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose 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, and will provide guidance on when to resume taking it after the surgery or procedure.

Caution with Daily Activities

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

Discontinuing the Medication

Do not stop taking this medication abruptly without consulting your doctor, as this may increase the risk of side effects. If you need to discontinue the medication, your doctor will provide instructions on how to gradually stop taking it.

Special Considerations

If you have diabetes (high blood sugar), closely monitor your blood sugar levels. Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may impair your actions, consult with your doctor.

Potential Side Effects and Interactions

It may take several weeks to experience the full effects of this medication. You may be more susceptible to sunburn, so avoid exposure to sunlight, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear to minimize your risk. In hot weather or during physical activity, drink plenty of fluids to prevent dehydration.

Monitoring and Precautions

Your doctor may recommend an electrocardiogram (ECG) before starting this medication and during treatment. If you are 65 years or older, use this medication with caution, as you may be more prone to side effects.

Pregnancy and Breastfeeding

If you are pregnant or plan to become pregnant, discuss the benefits and risks of taking this medication with your doctor.

• Monoamine Oxidase Inhibitors (MAOIs) - risk of serotonin syndrome, hyperpyrexia, convulsions, death. Allow 14 days washout period between MAOIs and imipramine.
• 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, scopolamine, antihistamines, antipsychotics) - additive anticholinergic effects (severe constipation, urinary retention, paralytic ileus, hyperpyrexia).
• Sympathomimetics (e.g., epinephrine, norepinephrine, phenylephrine, pseudoephedrine) - potentiated cardiovascular effects (hypertension, arrhythmias).
• QT-prolonging drugs (e.g., antiarrhythmics like quinidine, procainamide; certain antipsychotics like thioridazine; macrolide antibiotics; fluoroquinolones) - increased risk of ventricular arrhythmias, Torsades de Pointes.
• CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, cimetidine) - significantly increase imipramine and desipramine plasma concentrations, leading to increased toxicity.
• Thyroid hormones - increased risk of cardiac arrhythmias and toxicity.

• Antihypertensives (e.g., guanethidine, clonidine, reserpine) - imipramine may antagonize their hypotensive effects.
• Oral anticoagulants (e.g., warfarin) - potential for increased anticoagulant effect (monitor INR).
• Barbiturates - may decrease imipramine plasma levels due to enzyme induction.
• Nicotine - may decrease imipramine plasma levels due to enzyme induction.

• Not available (interactions are generally categorized as significant due to TCA's narrow therapeutic index and side effect profile)

• Worsening depression
• Emergence or worsening of suicidal thoughts or behavior
• Unusual changes in behavior (e.g., agitation, irritability, anxiety, panic attacks, insomnia, impulsivity, aggression, akathisia, hypomania, mania)
• Dry mouth
• Constipation
• Blurred vision
• Urinary retention
• Dizziness or lightheadedness (especially on standing)
• Sedation or drowsiness
• Tremor
• Palpitations or irregular heartbeat
• Seizures
• Confusion or disorientation (especially in elderly)

Category D. Imipramine crosses the placenta. Use during pregnancy is generally not recommended unless the potential benefit justifies the potential risk to the fetus. Neonatal withdrawal symptoms (e.g., respiratory distress, cyanosis, irritability, tremors, seizures, feeding difficulties) have been reported following third-trimester exposure.

L3 (Moderately Safe). Imipramine and its active metabolite desipramine are excreted into breast milk. While levels are generally low, monitor the infant for adverse effects such as sedation, poor feeding, irritability, or poor weight gain. Use with caution, especially in preterm or neonates.

Approved for nocturnal enuresis in children aged 6 years and older. Not approved for depression in pediatric patients due to the black box warning regarding increased risk of suicidality in children, adolescents, and young adults. Use for depression is off-label and generally discouraged in favor of safer alternatives. Close monitoring for behavioral changes and suicidality is crucial if used.

Elderly patients are more sensitive to the anticholinergic, sedative, and cardiovascular (e.g., orthostatic hypotension, cardiac conduction abnormalities) side effects of imipramine. Start with lower doses (e.g., 25-50 mg/day) and titrate slowly. Monitor closely for adverse effects, especially cognitive impairment, falls, and cardiac issues. Plasma levels may be higher due to reduced metabolism and clearance.

• Imipramine has significant anticholinergic side effects (dry mouth, constipation, blurred vision, urinary retention), which can be particularly problematic in elderly patients.
• Cardiovascular effects, including orthostatic hypotension, tachycardia, and conduction abnormalities (e.g., QRS widening, QT prolongation), are dose-dependent and require careful monitoring, especially in patients with pre-existing cardiac disease.
• Therapeutic drug monitoring (TDM) of combined imipramine and desipramine plasma levels can be useful to guide dosing, assess adherence, and investigate toxicity or lack of response.
• Due to its sedative properties, imipramine is often dosed at bedtime, which can also help mitigate orthostatic hypotension during the day.
• Withdrawal symptoms (e.g., nausea, vomiting, dizziness, headache, anxiety, agitation, sleep disturbances) can occur if discontinued abruptly; taper dose gradually over several weeks.
• Imipramine has a narrow therapeutic index, making careful dosing and monitoring essential.

• Other Tricyclic Antidepressants (TCAs): Amitriptyline, Nortriptyline, Doxepin, Desipramine (active metabolite of imipramine)
• Selective Serotonin Reuptake Inhibitors (SSRIs): Fluoxetine, Sertraline, Paroxetine, Citalopram, Escitalopram
• Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs): Venlafaxine, Duloxetine, Desvenlafaxine
• Atypical Antidepressants: Bupropion, Mirtazapine, Trazodone
• Other treatments for nocturnal enuresis: Desmopressin, behavioral therapy (e.g., bedwetting alarms)
• Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)

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, which is a valuable resource that provides important information about its use. It is crucial to read this guide carefully and review it again whenever you receive a refill of your medication. 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, immediate action is necessary. Call your local poison control center or seek medical attention right away. 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.