Imipramine Pamoate 100mg Capsules
WARNING: Drugs like this one have raised the chance of suicidal thoughts or actions in children and young adults. The risk may be greater in people who have had these thoughts or actions in the past. All people who take this drug need to be watched closely. Call the doctor right away if signs like depression, nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.This drug is not approved for use in children. Talk with the doctor. @ COMMON USES: It is used to treat depression.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antidepressant
Pharmacologic Class
Tricyclic Antidepressant (TCA)
Pregnancy Category
Category C
FDA Approved
Mar 1959
DEA Schedule
Not Controlled
Overview
What is this medicine?
Imipramine Pamoate is a medication used to treat depression and sometimes panic disorder. It belongs to a class of drugs called tricyclic antidepressants. It works by helping to restore the balance of certain natural chemicals in the brain, which can improve mood and feelings of well-being. For children, it's sometimes used to treat bedwetting.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. If you experience drowsiness after taking this medication, consult your doctor, as they may need to adjust your dosage or the timing of when you take it. Continue taking your medication as directed by your doctor or healthcare provider, even if you're feeling well.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a secure location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Avoid taking two doses at the same time or taking extra doses. If you take your daily dose at bedtime and miss a dose, do not take the missed dose the next morning.
To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. If you experience drowsiness after taking this medication, consult your doctor, as they may need to adjust your dosage or the timing of when you take it. Continue taking your medication as directed by your doctor or healthcare provider, even if you're feeling well.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a secure location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Avoid taking two doses at the same time or taking extra doses. If you take your daily dose at bedtime and miss a dose, do not take the missed dose the next morning.
Lifestyle & Tips
- Avoid alcohol and other sedating medications, as imipramine can increase drowsiness.
- Be cautious when driving or operating machinery until you know how this medication affects you.
- Stand up slowly from a sitting or lying position to avoid dizziness due to blood pressure drops.
- Maintain good oral hygiene due to potential dry mouth.
- Stay hydrated to help with dry mouth and constipation.
- Avoid excessive sun exposure, as imipramine can increase sensitivity to sunlight.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Depression: Initially 75 mg/day in divided doses, gradually increased to 150-200 mg/day. Max 300 mg/day. Imipramine Pamoate is often dosed once daily.
Dose Range:
75 - 300 mg
Condition-Specific Dosing:
Depression:
Initial: 75 mg/day in divided doses or as a single bedtime dose (pamoate). Maintenance: 150-200 mg/day. Max: 300 mg/day.
Panic Disorder:
Initial: 25 mg/day, gradually increased to 75-150 mg/day. Max: 200 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Enuresis (6-12 years): Initial 25 mg at bedtime, max 50-75 mg at bedtime. Depression (adolescents): Initial 25-50 mg/day, gradually increased to 100 mg/day (max 150 mg/day for hospitalized adolescents).
Adolescent:
Depression: Initial 25-50 mg/day, gradually increased to 100 mg/day (max 150 mg/day for hospitalized adolescents).
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment generally required, but monitor for adverse effects.
Moderate:
Use with caution; consider lower doses and monitor plasma levels if available.
Severe:
Use with caution; consider lower doses and monitor plasma levels if available. Imipramine is extensively metabolized, so renal impairment has less impact on clearance of parent drug.
Dialysis:
Not significantly removed by dialysis. No specific supplemental dose needed, but use with caution due to potential accumulation of active metabolites.
Hepatic Impairment:
Mild:
Use with caution; consider lower initial doses.
Moderate:
Significant dose reduction required (e.g., 50% or more) due to extensive hepatic metabolism. Monitor closely for adverse effects.
Severe:
Contraindicated or not recommended due to high risk of toxicity and impaired metabolism.
Pharmacology
Mechanism of Action
Imipramine is a tricyclic antidepressant (TCA) that primarily inhibits the reuptake of norepinephrine (NE) and serotonin (5-HT) into presynaptic neurons, thereby increasing their concentrations in the synaptic cleft. It also has significant anticholinergic, antihistaminic, and alpha-1 adrenergic blocking properties.
Pharmacokinetics
Absorption:
Bioavailability:
29-77% (highly variable due to first-pass metabolism)
Tmax:
1-2 hours (imipramine), 2-8 hours (desipramine)
FoodEffect:
Food may delay absorption but does not significantly affect the extent of absorption.
Distribution:
Vd:
10-20 L/kg (large volume of distribution)
ProteinBinding:
86-95% (primarily to alpha-1 acid glycoprotein and albumin)
CnssPenetration:
Yes
Elimination:
HalfLife:
9-24 hours (imipramine), 12-54 hours (desipramine)
Clearance:
Not available (highly variable due to extensive metabolism)
ExcretionRoute:
Primarily renal (approximately 80% as metabolites), fecal (approximately 20%)
Unchanged:
<5% (imipramine), <1% (desipramine)
Pharmacodynamics
OnsetOfAction:
Antidepressant effects typically begin within 1-4 weeks; sedative effects may be immediate.
PeakEffect:
Antidepressant effects: 2-4 weeks.
DurationOfAction:
Due to long half-life, effects persist for 24 hours, allowing once-daily dosing for pamoate.
Safety & Warnings
BLACK BOX WARNING
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of imipramine or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Imipramine is not approved for use in pediatric patients with MDD.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you experience 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.
Although rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you experience 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.
Seek Immediate Medical Attention If You Experience:
- Worsening depression, suicidal thoughts or behavior, or unusual changes in mood/behavior (especially at the beginning of treatment or with dose changes).
- Severe dizziness or fainting (signs of orthostatic hypotension).
- Fast, pounding, or irregular heartbeat.
- Difficulty urinating or severe constipation.
- Blurred vision or eye pain.
- Fever, sore throat, or other signs of infection (may indicate blood problems).
- Seizures.
- Confusion, hallucinations, or delirium (especially in older adults).
- Muscle stiffness, high fever, sweating, confusion, fast or irregular heartbeat (signs of Serotonin Syndrome or Neuroleptic Malignant Syndrome).
Before Using This Medicine
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 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.
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 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.
Precautions & Cautions
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 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 stop taking this medication abruptly without consulting your doctor, as this may increase the risk of side effects. If you need to stop taking this drug, your doctor will instruct you on how to gradually discontinue 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 cause drowsiness, 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.
Medical Monitoring
Your doctor may require you to undergo an electrocardiogram (ECG) before starting this medication and during treatment. If you are allergic to tartrazine (FD&C Yellow No. 5), a component of some products, inform your doctor.
Special Populations
If you are 65 years or older, use this medication with caution, as you may be more prone to side effects. Pregnant women or those planning to become pregnant should discuss the benefits and risks of using this medication with their doctor.
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 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 stop taking this medication abruptly without consulting your doctor, as this may increase the risk of side effects. If you need to stop taking this drug, your doctor will instruct you on how to gradually discontinue 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 cause drowsiness, 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.
Medical Monitoring
Your doctor may require you to undergo an electrocardiogram (ECG) before starting this medication and during treatment. If you are allergic to tartrazine (FD&C Yellow No. 5), a component of some products, inform your doctor.
Special Populations
If you are 65 years or older, use this medication with caution, as you may be more prone to side effects. Pregnant women or those planning to become pregnant should discuss the benefits and risks of using this medication with their doctor.
Overdose Information
Overdose Symptoms:
- Severe drowsiness or coma
- Confusion, agitation, hallucinations
- Seizures
- Fast, irregular, or pounding heartbeat (arrhythmias)
- Low blood pressure (hypotension)
- Dilated pupils
- Dry mouth, blurred vision
- Urinary retention
- Hypothermia or hyperthermia
- Respiratory depression
- Cardiac arrest
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Overdose can be life-threatening.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - risk of serotonin syndrome, hyperpyretic crises, convulsions, death (allow 14 days washout period)
- Cisapride - risk of QT prolongation and arrhythmias
- Thioridazine - risk of QT prolongation and arrhythmias
Major Interactions
- Other CNS depressants (e.g., alcohol, benzodiazepines, opioids, sedatives) - increased CNS depression
- Anticholinergic agents (e.g., atropine, scopolamine, antihistamines) - increased anticholinergic effects (e.g., severe constipation, urinary retention, blurred vision, delirium)
- Sympathomimetics (e.g., epinephrine, norepinephrine, phenylephrine) - potentiated pressor response
- QT-prolonging drugs (e.g., antiarrhythmics, antipsychotics, fluoroquinolones) - increased risk of arrhythmias
- CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine) - increased imipramine plasma levels and toxicity
- Thyroid hormones - increased risk of cardiac arrhythmias and toxicity
Moderate Interactions
- Antihypertensives (e.g., guanethidine, clonidine) - reduced antihypertensive effect
- Cimetidine - increased imipramine plasma levels
- Oral contraceptives - may increase or decrease imipramine levels
- Nicotine - may decrease imipramine levels
- St. John's Wort - increased risk of serotonin syndrome
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Electrocardiogram (ECG)
Rationale: To assess for pre-existing cardiac conduction abnormalities or QT prolongation, as TCAs can cause cardiac effects.
Timing: Prior to initiation of therapy, especially in patients with cardiac disease or elderly.
Blood Pressure (BP) and Heart Rate (HR)
Rationale: To establish baseline and monitor for orthostatic hypotension and tachycardia.
Timing: Prior to initiation.
Complete Blood Count (CBC) with differential
Rationale: To assess for baseline blood dyscrasias, as TCAs can rarely cause agranulocytosis or neutropenia.
Timing: Prior to initiation.
Liver Function Tests (LFTs)
Rationale: To assess for baseline hepatic impairment, as imipramine is extensively metabolized by the liver.
Timing: Prior to initiation.
Renal Function (BUN, Creatinine)
Rationale: To assess for baseline renal impairment, though less critical for parent drug clearance, important for overall patient health.
Timing: Prior to initiation.
Thyroid Function Tests (TFTs)
Rationale: To rule out thyroid dysfunction which can mimic or exacerbate psychiatric symptoms and interact with TCAs.
Timing: Prior to initiation.
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: Regularly, especially during dose titration and in elderly patients.
Target: Maintain within normal limits; monitor for orthostatic changes.
Action Threshold: Significant orthostatic drop (>20 mmHg systolic or >10 mmHg diastolic) or persistent tachycardia (>100 bpm) may require dose adjustment or discontinuation.
Electrocardiogram (ECG)
Frequency: Periodically, especially in elderly patients or those with cardiac risk factors, and with dose increases.
Target: Normal sinus rhythm, QTc <450 ms (men), <470 ms (women).
Action Threshold: New onset arrhythmias, significant PR/QRS/QTc prolongation (e.g., QTc >500 ms or increase >60 ms from baseline) warrant immediate evaluation and dose adjustment/discontinuation.
Mental Status and Clinical Response
Frequency: Weekly during initial titration, then monthly or as clinically indicated.
Target: Improvement in depressive symptoms, reduction in panic attacks.
Action Threshold: Lack of response after adequate trial, worsening symptoms, emergence of suicidality, or new psychiatric symptoms.
Adverse Effects (e.g., anticholinergic, sedation)
Frequency: Regularly, especially during initial therapy.
Target: Tolerable level of side effects.
Action Threshold: Intolerable side effects warrant dose adjustment or alternative therapy.
Plasma Imipramine/Desipramine Levels (Therapeutic Drug Monitoring)
Frequency: Consider for non-responders, patients with severe side effects, suspected non-adherence, or drug interactions.
Target: Imipramine + Desipramine: 150-300 ng/mL (for depression).
Action Threshold: Levels outside therapeutic range may indicate need for dose adjustment or investigation of adherence/interactions.
Complete Blood Count (CBC) with differential
Frequency: Periodically, especially if patient develops fever, sore throat, or other signs of infection.
Target: Normal cell counts.
Action Threshold: Significant leukopenia, neutropenia, or agranulocytosis warrants immediate discontinuation.
Symptom Monitoring
- Orthostatic dizziness
- Blurred vision
- Dry mouth
- Constipation
- Urinary retention
- Sedation/drowsiness
- Tachycardia
- Tremor
- Confusion/delirium (especially in elderly)
- Worsening depression or suicidality
- Agitation/restlessness
- Seizures
- Fever, sore throat, signs of infection (for blood dyscrasias)
Special Patient Groups
Pregnancy
Use during pregnancy should only be considered 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, cyanosis, apnea, seizures, feeding difficulties, hypotonia, hypertonia, tremor, irritability, constant crying).
Trimester-Specific Risks:
First Trimester:
Limited data, but some studies suggest a possible association with congenital malformations, though not consistently proven. Risk appears low.
Second Trimester:
Generally considered safer than first trimester, but still category C. Monitor for fetal growth.
Third Trimester:
Risk of neonatal withdrawal symptoms and persistent pulmonary hypertension of the newborn (PPHN) has been reported with other antidepressants, and theoretically possible with TCAs.
Lactation
Imipramine and its active metabolite desipramine are excreted into breast milk. The American Academy of Pediatrics considers imipramine to be compatible with breastfeeding, but caution is advised. Monitor the infant for sedation, poor feeding, and weight gain.
Infant Risk:
L3 (Moderate risk). Monitor for drowsiness, irritability, poor feeding, and weight gain. Consider therapeutic drug monitoring in the infant if concerns arise.
Pediatric Use
Not approved for Major Depressive Disorder in pediatric patients due to increased risk of suicidality (Black Box Warning). Approved for nocturnal enuresis in children 6 years and older. Use with caution and close monitoring for adverse effects, especially cardiac and behavioral changes.
Geriatric Use
Elderly patients are more sensitive to the anticholinergic, sedative, and orthostatic hypotensive effects of imipramine. Start with lower doses (e.g., 25-50 mg/day) and titrate slowly. Monitor closely for confusion, delirium, urinary retention, constipation, and cardiac effects (ECG monitoring is crucial). Plasma levels may be higher due to reduced metabolism and clearance.
Clinical Information
Clinical Pearls
- Imipramine Pamoate is a long-acting formulation, often dosed once daily, typically at bedtime due to its sedative effects.
- Therapeutic effects for depression may take 2-4 weeks to become apparent; patients should be advised of this delay.
- Orthostatic hypotension is a common and potentially serious side effect, especially in the elderly. Advise patients to rise slowly.
- Anticholinergic side effects (dry mouth, constipation, blurred vision, urinary retention) are prominent. Manage with supportive care (e.g., sugar-free candies, fiber, adequate hydration).
- Cardiac conduction abnormalities (e.g., QTc prolongation, widened QRS) can occur, especially at higher doses or in susceptible individuals. ECG monitoring is important.
- Imipramine has a narrow therapeutic index; therapeutic drug monitoring (TDM) of imipramine and desipramine levels can be useful for guiding therapy, especially in non-responders or those with side effects.
- Abrupt discontinuation can lead to withdrawal symptoms (e.g., nausea, vomiting, dizziness, headache, anxiety, sleep disturbances). Taper dose gradually over several weeks.
Alternative Therapies
- Other Tricyclic Antidepressants (TCAs): Amitriptyline, Nortriptyline, Desipramine, Doxepin
- Selective Serotonin Reuptake Inhibitors (SSRIs): Fluoxetine, Sertraline, Paroxetine, Citalopram, Escitalopram
- Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs): Venlafaxine, Duloxetine, Desvenlafaxine
- Atypical Antidepressants: Bupropion, Mirtazapine, Trazodone
- For nocturnal enuresis: Desmopressin, Oxybutynin
Cost & Coverage
Average Cost:
Varies widely, typically $20-$100+ per 30 capsules (100mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. 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 essential 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 clarification.
In the event of a suspected overdose, immediately contact 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 quantity, and the time it was taken.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is essential 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 clarification.
In the event of a suspected overdose, immediately contact 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 quantity, and the time it was taken.