Imipramine Pamoate 75mg 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
Tricyclic Antidepressant (TCA)
Pharmacologic Class
Norepinephrine and Serotonin Reuptake Inhibitor (non-selective), Anticholinergic, Antihistaminic, Alpha-1 Adrenergic Blocker
Pregnancy Category
Category C
FDA Approved
Mar 1973
DEA Schedule
Not Controlled
Overview
What is this medicine?
Imipramine Pamoate is a medication used to treat depression and sometimes bedwetting in children. It works by helping to restore the balance of certain natural chemicals in the brain. It's a type of antidepressant called a tricyclic antidepressant (TCA).
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, 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 prescribed by your doctor or healthcare provider, even if you start feeling better.
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 have questions 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, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, 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 prescribed by your doctor or healthcare provider, even if you start feeling better.
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 have questions 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
- Take this medication exactly as prescribed, usually once daily at bedtime. Do not stop taking it suddenly without talking to your doctor, as this can cause withdrawal symptoms.
- Avoid alcohol and other CNS depressants (e.g., sedatives, pain medications) as they can increase drowsiness and other side effects.
- Be cautious when driving or operating machinery until you know how this medication affects you, as it can cause drowsiness, dizziness, or blurred vision.
- Avoid prolonged exposure to sunlight or tanning beds, as this medication can increase sensitivity to the sun. Use sunscreen and wear protective clothing.
- To relieve dry mouth, chew sugarless gum, suck on hard candy, or use saliva substitutes.
- Increase fluid and fiber intake to help with constipation, a common side effect.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Depression: Initial 75 mg once daily at bedtime; may increase to 150 mg once daily. Maintenance 75-150 mg once daily.
Dose Range:
75 - 200 mg
Condition-Specific Dosing:
Depression:
Initial 75 mg once daily at bedtime; may increase to 150 mg once daily. Max 200 mg once daily for outpatients, up to 300 mg for hospitalized patients.
Panic Disorder:
Initial 75 mg once daily at bedtime; may increase to 150 mg once daily. Max 200 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Nocturnal Enuresis (6-12 years): Initial 25 mg once daily 1 hour before bedtime; if no response in 1 week, increase to 50 mg. Max 75 mg once daily.
Adolescent:
Nocturnal Enuresis (>12 years): Initial 50 mg once daily 1 hour before bedtime; if no response in 1 week, increase to 75 mg. Max 75 mg once daily. Depression: Initial 25-50 mg once daily, gradually increase to 100-150 mg once daily.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, monitor for adverse effects.
Moderate:
Use with caution, consider lower doses and monitor for adverse effects.
Severe:
Use with caution, consider lower doses and monitor for adverse effects. Active metabolites may accumulate.
Dialysis:
Not significantly dialyzable. Use with caution, monitor for adverse effects.
Hepatic Impairment:
Mild:
Use with caution, consider lower doses.
Moderate:
Significant dose reduction required, monitor closely for adverse effects and plasma levels.
Severe:
Contraindicated or not recommended due to extensive hepatic metabolism and risk of accumulation.
Confidence:
Medium
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 the concentration 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.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (29-77%) due to extensive first-pass metabolism
Tmax:
6-12 hours (for pamoate extended-release formulation)
FoodEffect:
Food may slightly delay absorption but does not significantly affect the extent of absorption.
Distribution:
Vd:
10-20 L/kg (high)
ProteinBinding:
Approximately 90-95%
CnssPenetration:
Yes (readily crosses the blood-brain barrier)
Elimination:
HalfLife:
Imipramine: 10-20 hours; Desipramine: 15-30 hours
Clearance:
Approximately 0.5-1.5 L/kg/hr
ExcretionRoute:
Renal (approximately 80% as metabolites), Fecal (approximately 20%)
Unchanged:
Less than 5% (renal)
Pharmacodynamics
OnsetOfAction:
Antidepressant effects typically begin within 1-4 weeks; sedative effects may be immediate.
PeakEffect:
Full therapeutic effect may take 4-6 weeks.
DurationOfAction:
Due to long half-life, once-daily dosing is effective.
Confidence:
Medium
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 Pamoate 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 24 years of age; 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.
Side Effects
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, such as:
+ Trouble sleeping
+ 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
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
Abnormal sensations, such as:
+ Burning
+ Numbness
+ Tingling
Trouble controlling body movements
Twitching
Swallowing or speaking difficulties
Seizures
Severe constipation or stomach pain (may be signs of a bowel problem)
Urination difficulties
Swelling
Mouth irritation or mouth sores
Enlarged breasts or nipple discharge
Swelling of the testicles
Hair loss
Monitoring Blood Sugar Levels
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
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, contact your doctor immediately:
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. The risk may be higher if you take certain other medications. If you experience any of the following symptoms, contact your doctor right away:
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
Vomiting
Severe headache
Other Possible Side Effects
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following possible side effects:
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
If you experience any of these side effects or have concerns, contact your doctor or seek medical attention. You can also report side effects to the FDA at 1-800-332-1088 or https://www.fda.gov/medwatch.
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, such as:
+ Trouble sleeping
+ 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
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
Abnormal sensations, such as:
+ Burning
+ Numbness
+ Tingling
Trouble controlling body movements
Twitching
Swallowing or speaking difficulties
Seizures
Severe constipation or stomach pain (may be signs of a bowel problem)
Urination difficulties
Swelling
Mouth irritation or mouth sores
Enlarged breasts or nipple discharge
Swelling of the testicles
Hair loss
Monitoring Blood Sugar Levels
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
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, contact your doctor immediately:
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. The risk may be higher if you take certain other medications. If you experience any of the following symptoms, contact your doctor right away:
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
Vomiting
Severe headache
Other Possible Side Effects
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following possible side effects:
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
If you experience any of these side effects or have concerns, contact your doctor or seek medical attention. You can also report side effects to the FDA at 1-800-332-1088 or https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Worsening depression or new/worsening thoughts of self-harm or suicide, especially at the beginning of treatment or after a dose change.
- Unusual changes in behavior or mood (e.g., agitation, irritability, panic attacks, restlessness, aggression, insomnia, impulsivity, mania).
- Signs of a serious allergic reaction (e.g., rash, itching/swelling, severe dizziness, trouble breathing).
- Signs of heart problems (e.g., fast/irregular heartbeat, severe dizziness, fainting, chest pain).
- Signs of liver problems (e.g., persistent nausea/vomiting, dark urine, yellowing eyes/skin).
- Signs of blood problems (e.g., fever, sore throat, easy bruising/bleeding).
- Severe anticholinergic effects (e.g., inability to urinate, severe constipation, severe blurred vision, confusion, hallucinations).
- Seizures.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is crucial 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. Describe the allergic reactions you have 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.
* If you are breastfeeding, as you should not breastfeed while taking this medication.
This list is not exhaustive, and it is essential to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues 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 adjust the dosage of any medication without first consulting your doctor.
It is crucial 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. Describe the allergic reactions you have 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.
* If you are breastfeeding, as you should not breastfeed while taking this medication.
This list is not exhaustive, and it is essential to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues 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 adjust the dosage 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 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 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 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 protective clothing and eyewear to minimize your risk. In hot weather or during physical activity, drink plenty of fluids to prevent dehydration.
Monitoring and Testing
Your doctor may recommend 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 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 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 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 protective clothing and eyewear to minimize your risk. In hot weather or during physical activity, drink plenty of fluids to prevent dehydration.
Monitoring and Testing
Your doctor may recommend 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
- Severe dry mouth, blurred vision, dilated pupils
- Fast, irregular, or pounding heartbeat (tachycardia, arrhythmias)
- Low blood pressure (hypotension)
- Confusion, agitation, hallucinations
- Seizures
- Respiratory depression
- Urinary retention
- Hypothermia
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Overdose can be life-threatening, especially due to cardiac toxicity.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - risk of serotonin syndrome, hyperpyretic crisis, convulsions, death (allow 14 days washout)
- Cisapride - risk of QTc prolongation and arrhythmias
- Linezolid, Methylene Blue (IV) - risk of serotonin syndrome
Major Interactions
- QTc-prolonging drugs (e.g., 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, antihistamines, antipsychotics) - additive anticholinergic effects (severe constipation, urinary retention, delirium)
- Sympathomimetics (e.g., epinephrine, norepinephrine, phenylephrine) - potentiation of cardiovascular effects (hypertension, arrhythmias)
- CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, cimetidine) - increased imipramine plasma levels and toxicity
- Thyroid hormones - increased risk of arrhythmias and cardiovascular toxicity
Moderate Interactions
- CYP1A2 inhibitors (e.g., fluvoxamine) - increased imipramine plasma levels
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin) - increased imipramine plasma levels
- Antihypertensives (e.g., guanethidine, clonidine) - may antagonize antihypertensive effects
- Warfarin - increased anticoagulant effect (monitor INR)
- Nicotine - may decrease imipramine plasma levels
Minor Interactions
- Oral contraceptives - may alter imipramine metabolism
- St. John's Wort - may increase risk of serotonin syndrome
Monitoring
Baseline Monitoring
Electrocardiogram (ECG)
Rationale: To assess for pre-existing cardiac conduction abnormalities or risk factors for arrhythmias, especially in patients with cardiac disease or elderly.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC) with differential
Rationale: To assess for baseline blood dyscrasias (e.g., agranulocytosis, thrombocytopenia) which are rare but serious side effects.
Timing: Prior to initiation of therapy.
Liver Function Tests (LFTs)
Rationale: To assess for baseline hepatic impairment, as imipramine is extensively metabolized by the liver.
Timing: Prior to initiation of therapy.
Renal Function Tests (BUN, Creatinine)
Rationale: To assess for baseline renal impairment, as metabolites are renally excreted.
Timing: Prior to initiation of therapy.
Thyroid Function Tests (TSH)
Rationale: To rule out thyroid dysfunction, which can mimic or exacerbate psychiatric symptoms and affect TCA response.
Timing: Prior to initiation of therapy.
Suicidal ideation/behavior assessment
Rationale: To establish baseline risk, especially in children, adolescents, and young adults.
Timing: Prior to initiation of therapy.
Routine Monitoring
Electrocardiogram (ECG)
Frequency: Periodically, especially in patients with pre-existing cardiac disease, elderly, or at higher doses.
Target: Normal PR, QRS, QTc intervals (QTc < 450 ms for males, < 470 ms for females)
Action Threshold: Significant QTc prolongation (>500 ms or >60 ms increase from baseline), new arrhythmias, or conduction abnormalities warrant dose reduction or discontinuation.
Plasma Imipramine and Desipramine Levels (Therapeutic Drug Monitoring - TDM)
Frequency: After 5-7 days of stable dosing, then periodically as needed (e.g., if no response, suspected toxicity, or drug interactions).
Target: Combined imipramine + desipramine: 150-300 ng/mL (for depression)
Action Threshold: Levels above therapeutic range may indicate toxicity; levels below may indicate non-adherence or inadequate dosing.
Blood Pressure and Heart Rate
Frequency: Regularly, especially during dose titration and in patients at risk for orthostatic hypotension or tachycardia.
Target: Within patient's normal range
Action Threshold: Significant orthostatic hypotension, persistent tachycardia, or hypertension warrant intervention.
Mental Status and Clinical Response
Frequency: Weekly during initial titration, then monthly or as clinically indicated.
Target: Improvement in target symptoms (e.g., mood, anxiety, sleep, appetite)
Action Threshold: Worsening depression, emergence of suicidal ideation, mania/hypomania, or severe adverse effects.
Adverse Effects (e.g., anticholinergic, CNS, GI)
Frequency: At each visit, especially during initial therapy.
Target: Tolerable side effect profile
Action Threshold: Intolerable side effects (e.g., severe dry mouth, blurred vision, urinary retention, constipation, sedation, dizziness) may require dose adjustment or alternative therapy.
Symptom Monitoring
- Worsening depression
- Emergence or worsening of suicidal thoughts or behaviors
- Unusual changes in behavior (e.g., agitation, irritability, aggression, panic attacks, insomnia, impulsivity, akathisia, hypomania, mania)
- Cardiac symptoms (e.g., palpitations, dizziness, syncope, chest pain)
- Anticholinergic effects (e.g., severe dry mouth, blurred vision, urinary retention, constipation)
- Neurological symptoms (e.g., seizures, tremors, ataxia)
- Signs of liver dysfunction (e.g., jaundice, dark urine, persistent nausea/vomiting)
- Signs of blood dyscrasias (e.g., fever, sore throat, unusual bleeding/bruising)
Special Patient Groups
Pregnancy
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, tremors, seizures, feeding difficulties) have been reported with third-trimester exposure.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally not associated with major congenital malformations. However, caution is advised.
Second Trimester:
No specific increased risks identified beyond general antidepressant use.
Third Trimester:
Risk of neonatal withdrawal syndrome (poor adaptation syndrome) if exposed late in pregnancy. Monitor neonate for symptoms.
Lactation
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, and weight gain. Use with caution, or consider alternative therapies with better safety profiles during lactation.
Infant Risk:
Low to moderate risk (L3). Monitor for sedation, irritability, poor feeding, and weight gain.
Pediatric Use
Black Box Warning for increased risk of suicidality in children, adolescents, and young adults. Approved for nocturnal enuresis in children 6 years and older. Use for depression in pediatric populations requires careful risk-benefit assessment and close monitoring.
Geriatric Use
Elderly patients are more sensitive to the anticholinergic, sedative, and cardiovascular (e.g., orthostatic hypotension, arrhythmias) side effects of imipramine. Start with lower doses and titrate slowly. Monitor ECG, blood pressure, and for cognitive impairment. Imipramine is on the Beers List as a potentially inappropriate medication in older adults due to its strong anticholinergic and sedative properties and risk of orthostatic hypotension.
Clinical Information
Clinical Pearls
- Imipramine Pamoate is an extended-release formulation, allowing for once-daily dosing, typically at bedtime due to its sedative effects.
- Therapeutic drug monitoring (TDM) of imipramine and desipramine plasma levels can be useful, especially in cases of non-response, suspected toxicity, or drug interactions.
- Due to its anticholinergic properties, imipramine can exacerbate conditions like benign prostatic hyperplasia (BPH), narrow-angle glaucoma, and severe constipation.
- TCA overdose is a medical emergency and can be fatal, primarily due to cardiac arrhythmias and seizures. Always prescribe the smallest effective quantity, especially for patients at risk of overdose.
- Withdrawal symptoms (e.g., nausea, vomiting, dizziness, headache, anxiety, agitation, sleep disturbances) can occur if discontinued abruptly; taper dose gradually.
- Patients should be advised about the delayed onset of antidepressant effects (weeks) and the importance of continued adherence despite initial side effects.
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 (off-label), Behavioral therapy (e.g., enuresis alarms)
Cost & Coverage
Average Cost:
$30 - $100 per 30 capsules (75mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (preferred generic)
General Drug Facts
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 about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.