Imipramine Pamoate 125mg Capsules

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, 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 medical attention immediately:

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
Yellow 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
Seizures
Severe constipation or stomach pain (may indicate 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 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, contact your doctor immediately:

Eye pain
Changes in eyesight
Swelling or redness in or around the eye

Serotonin Syndrome: A Potentially Life-Threatening Condition

There is a risk of developing serotonin syndrome, a severe and potentially deadly condition, especially when taking certain other medications. If you experience any of the following symptoms, contact your doctor 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, upset stomach, 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 be aware of the following possible side effects:

Dizziness
Drowsiness
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

If you experience any of these side effects or any other symptoms that concern you, contact your doctor for advice. 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 conditions with your doctor and pharmacist. They will help 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 down position, and exercise caution when climbing stairs.

Stopping the Medication

Do not abruptly stop taking this medication 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 while taking this medication. 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.

Delayed Effects and Sun Sensitivity

It may take several weeks to experience the full effects of this medication. Additionally, you may be more susceptible to sunburn, so avoid exposure to sunlight, sunlamps, and tanning beds, and use protective measures such as sunscreen, clothing, and eyewear.

Heat and Fluid Loss

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

Medical Monitoring

Your doctor may require an electrocardiogram (ECG) before starting and during treatment with this medication. Discuss any concerns with your doctor.

Allergies and Age-Related Considerations

If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient. If you are 65 or older, use this medication with caution, as you may be more prone to side effects. Pregnant or planning to become pregnant? Discuss the benefits and risks of using this medication with your doctor.

• Monoamine Oxidase Inhibitors (MAOIs) - risk of serotonin syndrome, hyperpyretic crises, convulsions, death. Allow 14 days washout between MAOIs and imipramine.
• Linezolid, Methylene Blue (IV) - risk of serotonin syndrome.

• QT-prolonging drugs (e.g., Class IA and III antiarrhythmics, antipsychotics, macrolide antibiotics, fluoroquinolones) - increased risk of arrhythmias.
• 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, delirium).
• Sympathomimetics (e.g., epinephrine, norepinephrine, phenylephrine) - potentiation of cardiovascular effects (hypertension, arrhythmias).
• Serotonergic drugs (e.g., SSRIs, SNRIs, triptans, tramadol, St. John's Wort) - increased risk of serotonin syndrome.
• CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, cimetidine) - increased imipramine and desipramine plasma levels, leading to toxicity.
• Thyroid hormones - increased risk of cardiac arrhythmias and toxicity.

• Antihypertensives (e.g., guanethidine, clonidine) - imipramine may antagonize their effects, leading to loss of blood pressure control.
• Oral anticoagulants (e.g., warfarin) - increased anticoagulant effect due to inhibition of metabolism.
• Cimetidine - increased imipramine levels.
• Barbiturates, Carbamazepine, Phenytoin (CYP inducers) - decreased imipramine levels.
• Disulfiram - may inhibit imipramine metabolism.

• Nicotine - may decrease imipramine levels.
• Grapefruit juice - may inhibit CYP3A4, potentially increasing imipramine levels.

• Orthostatic hypotension (dizziness upon standing)
• Anticholinergic effects (dry mouth, blurred vision, constipation, urinary retention)
• Sedation or drowsiness
• Cardiac symptoms (palpitations, chest pain, shortness of breath, fainting)
• Changes in mood or behavior (agitation, irritability, anxiety, panic attacks, insomnia, impulsivity, worsening depression, suicidal thoughts)
• Seizures
• Fever, sore throat (agranulocytosis, rare)
• Yellowing of skin/eyes, dark urine (hepatic dysfunction, rare)

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Imipramine crosses the placenta. Neonatal withdrawal symptoms (e.g., respiratory distress, cyanosis, irritability, feeding difficulties, seizures, hypertonia/hypotonia, tremor) have been reported with third-trimester exposure.

Imipramine and its active metabolite, desipramine, are excreted into breast milk. The American Academy of Pediatrics considers imipramine to be a drug for which the effect on the nursing infant is unknown but may be of concern. Use with caution; monitor infant for sedation, poor feeding, and weight gain. Consider alternative agents with more established safety profiles during lactation.

Generally not recommended as first-line for depression due to the Black Box Warning regarding increased risk of suicidality in children, adolescents, and young adults. Approved for nocturnal enuresis in children ≥6 years (imipramine HCl), but the pamoate form is less commonly used for this indication. Close monitoring for adverse effects, especially cardiac and behavioral changes, is crucial if used.

Elderly patients are more sensitive to the anticholinergic, sedative, and hypotensive effects of imipramine. Start with lower doses and titrate slowly. Increased risk of orthostatic hypotension, falls, confusion, urinary retention, and constipation. ECG monitoring is particularly important due to increased risk of cardiac conduction abnormalities. Consider lower target plasma levels.

• Imipramine pamoate is a sustained-release formulation, allowing for once-daily dosing, typically at bedtime to mitigate sedation.
• Therapeutic drug monitoring (TDM) of imipramine and desipramine plasma levels is often useful, especially in cases of non-response, suspected toxicity, or in special populations (elderly, hepatic/renal impairment).
• Due to its anticholinergic properties, imipramine can exacerbate conditions like benign prostatic hyperplasia (BPH), narrow-angle glaucoma, and paralytic ileus.
• Orthostatic hypotension is a common and potentially dangerous side effect, especially in the elderly. Advise patients to rise slowly.
• Imipramine has a narrow therapeutic index, and overdose can be life-threatening, primarily due to cardiac toxicity (arrhythmias, conduction delays) and CNS effects (seizures, coma).
• Withdrawal symptoms (e.g., nausea, vomiting, dizziness, headache, anxiety, agitation, sleep disturbances) can occur if discontinued abruptly. Taper dose gradually over several weeks.
• While effective, TCAs like imipramine are generally not first-line for depression due to their side effect profile and higher toxicity in overdose compared to newer antidepressants (SSRIs, SNRIs).

• Selective Serotonin Reuptake Inhibitors (SSRIs) e.g., fluoxetine, sertraline, escitalopram
• Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) e.g., venlafaxine, duloxetine
• Atypical Antidepressants e.g., bupropion, mirtazapine
• Other Tricyclic Antidepressants (TCAs) e.g., amitriptyline, nortriptyline, desipramine
• Monoamine Oxidase Inhibitors (MAOIs) e.g., phenelzine, tranylcypromine (reserved for refractory depression)
• Psychotherapy (e.g., Cognitive Behavioral Therapy, Interpersonal Therapy)
• Electroconvulsive Therapy (ECT) for severe or refractory depression
• Transcranial Magnetic Stimulation (TMS)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information. Please read this guide carefully and review it again whenever you refill your prescription. If you have any questions or concerns about this medication, don't 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. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.