Imipramine 10mg Tablets
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 all children. Talk with the doctor to be sure that this drug is right for your child. @ COMMON USES: It is used to treat depression.It is used to help prevent bedwetting in children.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antidepressant
Pharmacologic Class
Tricyclic Antidepressant (TCA); Norepinephrine and Serotonin Reuptake Inhibitor
Pregnancy Category
Category D
FDA Approved
Sep 1959
DEA Schedule
Not Controlled
Overview
What is this medicine?
Imipramine 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 belongs to a group of medicines called tricyclic antidepressants.
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, discuss it with 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. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to explore drug take-back programs 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, discuss it with 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. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to explore drug take-back programs 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, due to potential for dizziness or blurred vision.
- To relieve dry mouth, chew sugarless gum, suck on hard candy, or use saliva substitutes.
- To prevent constipation, increase fiber intake, drink plenty of fluids, and consider a stool softener if needed.
- Stand up slowly from a sitting or lying position to avoid dizziness from orthostatic hypotension.
- Do not stop taking this medication suddenly without consulting your doctor, as it can lead to withdrawal symptoms.
- Protect yourself from the sun, as imipramine can increase sensitivity to sunlight.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Depression: Initial 25-75 mg/day in divided doses or at bedtime, gradually increased to 150-300 mg/day. 10mg is typically an initial very low dose for sensitive patients or specific conditions.
Dose Range:
25 - 300 mg
Condition-Specific Dosing:
Depression:
Initial 25-75 mg/day, maintenance 150-300 mg/day.
Panic Disorder:
Initial 10-25 mg/day, gradually increase to 75-150 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Nocturnal Enuresis (6-12 years): 25-50 mg at bedtime; (over 12 years): 50-75 mg at bedtime. Depression (adolescents): Initial 25-50 mg/day, gradually increase to 100-150 mg/day.
Adolescent:
Depression: Initial 25-50 mg/day, gradually increase to 100-150 mg/day. Nocturnal Enuresis: 50-75 mg at bedtime.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but monitor for adverse effects.
Moderate:
Use with caution; consider lower initial doses and slower titration. Monitor for adverse effects.
Severe:
Use with caution; consider lower initial doses and slower titration. Monitor for adverse effects. Imipramine and its metabolites are primarily eliminated renally.
Dialysis:
Not well studied. Imipramine is highly protein-bound, so dialysis is unlikely to be effective for removal. Use with extreme caution and monitor closely.
Hepatic Impairment:
Mild:
Use with caution; consider lower initial doses and slower titration.
Moderate:
Use with caution; significant dose reduction may be necessary due to extensive hepatic metabolism. Monitor plasma levels if possible.
Severe:
Contraindicated or not recommended due to extensive hepatic metabolism and risk of accumulation and toxicity.
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 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.
Pharmacokinetics
Absorption:
Bioavailability:
29-77% (highly variable due to extensive first-pass metabolism)
Tmax:
Imipramine: 1-2 hours; Desipramine (active metabolite): 2-8 hours
FoodEffect:
Food may slightly delay absorption but does not significantly affect bioavailability.
Distribution:
Vd:
10-20 L/kg
ProteinBinding:
>90%
CnssPenetration:
Yes
Elimination:
HalfLife:
Imipramine: 6-20 hours; Desipramine: 12-76 hours
Clearance:
Not available (highly variable)
ExcretionRoute:
Renal (approximately 80% as metabolites), Fecal (approximately 20%)
Unchanged:
<5%
Pharmacodynamics
OnsetOfAction:
Antidepressant effects: 1-4 weeks; Sedative effects: within hours
PeakEffect:
Antidepressant effects: 4-6 weeks
DurationOfAction:
Due to long half-life of parent drug and active metabolite, effects persist for 24 hours, allowing once-daily dosing.
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.
Side Effects
Important Side Effects to Report to Your Doctor Right Away
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 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 or hallucinations (seeing or hearing things that are not there)
Sleep disturbances, such as 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
Trouble swallowing or speaking
Seizures
Severe constipation or stomach pain (may be signs of a severe bowel problem)
Trouble passing urine
Swelling
Mouth irritation or mouth sores
Enlarged breasts or nipple discharge
Swelling of the testicles
Hair loss
Monitoring for Blood Sugar Changes
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
Feeling confused, sleepy, or weak
Flushing
Headache
Unusual thirst or hunger
Passing urine more often
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 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. 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, 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 report any of the following symptoms to your doctor if they bother you or do not go away:
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.
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 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 or hallucinations (seeing or hearing things that are not there)
Sleep disturbances, such as 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
Trouble swallowing or speaking
Seizures
Severe constipation or stomach pain (may be signs of a severe bowel problem)
Trouble passing urine
Swelling
Mouth irritation or mouth sores
Enlarged breasts or nipple discharge
Swelling of the testicles
Hair loss
Monitoring for Blood Sugar Changes
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
Feeling confused, sleepy, or weak
Flushing
Headache
Unusual thirst or hunger
Passing urine more often
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 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. 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, 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 report any of the following symptoms to your doctor if they bother you or do not go away:
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.
Seek Immediate Medical Attention If You Experience:
- Worsening depression or new suicidal thoughts/behavior, especially at the beginning of treatment or after a dose change.
- New or worsening anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, or restlessness.
- Signs of an allergic reaction (rash, itching/swelling, severe dizziness, trouble breathing).
- Fast, pounding, or irregular heartbeat.
- Severe dizziness or fainting.
- Seizures.
- Difficulty urinating or severe constipation.
- Yellowing of skin or eyes (jaundice).
- Unusual bleeding or bruising.
- Fever, sore throat, or other signs of infection (may indicate blood problems).
- Eye pain, vision changes, or swelling/redness around the eye (may indicate acute narrow-angle glaucoma).
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 severely 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 dosage 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 severely 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 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 are aware of 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 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, 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, and use protective measures such as sunscreen, clothing, and eyewear. In hot weather or during physical activity, drink plenty of fluids to prevent dehydration.
Monitoring and Follow-up
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.
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 are aware of 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 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, 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, and use protective measures such as sunscreen, clothing, and eyewear. In hot weather or during physical activity, drink plenty of fluids to prevent dehydration.
Monitoring and Follow-up
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.
Overdose Information
Overdose Symptoms:
- Severe drowsiness or confusion
- Hallucinations
- Fast, irregular, or pounding heartbeat (arrhythmias)
- Severe low blood pressure (hypotension)
- Seizures
- Coma
- Respiratory depression (slow, shallow breathing)
- Dilated pupils
- Muscle rigidity
- Fever
What to Do:
Seek immediate emergency medical attention. Call 911 or your local emergency number. In the US, you can also call Poison Control at 1-800-222-1222. Overdose can be fatal, especially in children.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - risk of serotonin syndrome, hyperpyretic crises, convulsions, and death.
- Cisapride - risk of QT prolongation and arrhythmias.
Major Interactions
- Other CNS depressants (e.g., alcohol, benzodiazepines, opioids, sedatives) - additive CNS depression.
- Anticholinergic agents (e.g., atropine, antihistamines, antipsychotics) - additive anticholinergic effects (severe constipation, urinary retention, paralytic ileus, hyperthermia).
- Adrenergic neuron blockers (e.g., guanethidine, clonidine) - may decrease antihypertensive effect.
- Direct-acting sympathomimetics (e.g., epinephrine, norepinephrine) - potentiation of cardiovascular effects (hypertension, arrhythmias).
- CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, cimetidine) - increased imipramine plasma levels and toxicity.
- Thioridazine - increased risk of arrhythmias and sudden death.
- QT-prolonging drugs (e.g., antiarrhythmics, certain antipsychotics, macrolide antibiotics) - additive QT prolongation risk.
Moderate Interactions
- Thyroid hormones - increased risk of cardiac arrhythmias.
- Anticoagulants (e.g., warfarin) - potential for increased anticoagulant effect (monitor INR).
- Barbiturates - may decrease imipramine plasma levels.
- Phenytoin - altered phenytoin levels (increased or decreased).
- Oral contraceptives - may increase or decrease imipramine levels.
- Nicotine - may decrease imipramine levels.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Complete Blood Count (CBC)
Rationale: To establish baseline and monitor for blood dyscrasias (e.g., agranulocytosis, thrombocytopenia), though rare.
Timing: Prior to initiation
Liver Function Tests (LFTs)
Rationale: To establish baseline and monitor for hepatic impairment, as imipramine is extensively metabolized by the liver.
Timing: Prior to initiation
Electrocardiogram (ECG)
Rationale: To assess cardiac conduction and rule out pre-existing abnormalities, especially in patients with cardiac disease or elderly.
Timing: Prior to initiation, especially for doses >100 mg/day or in patients with cardiac risk factors.
Blood Pressure (BP) and Heart Rate (HR)
Rationale: To establish baseline and monitor for orthostatic hypotension and tachycardia.
Timing: Prior to initiation
Renal Function (BUN, Creatinine)
Rationale: To establish baseline, especially in elderly or those with suspected renal impairment.
Timing: Prior to initiation
Ophthalmologic exam (intraocular pressure)
Rationale: To assess for narrow-angle glaucoma, as anticholinergic effects can precipitate an acute attack.
Timing: Prior to initiation in at-risk patients
Routine Monitoring
Mental Status (mood, suicidal ideation, anxiety, agitation)
Frequency: Weekly during initial titration, then monthly or as clinically indicated.
Target: Improvement in target symptoms, absence of suicidal ideation.
Action Threshold: Worsening depression, emergence of suicidal thoughts, or unusual behavioral changes require immediate assessment and intervention.
Blood Pressure (BP) and Heart Rate (HR)
Frequency: Weekly during initial titration, then periodically.
Target: Within normal limits, or acceptable for patient. Orthostatic drop <20 mmHg systolic, <10 mmHg diastolic.
Action Threshold: Significant orthostatic hypotension (symptomatic or >20/10 mmHg drop), persistent tachycardia, or new arrhythmias.
ECG
Frequency: Periodically, especially with dose increases, in elderly, or patients with cardiac risk factors.
Target: Normal sinus rhythm, QTc <450 ms (men), <470 ms (women).
Action Threshold: Significant QTc prolongation (>500 ms or >60 ms increase from baseline), new arrhythmias, or conduction abnormalities.
Plasma Imipramine/Desipramine Levels (Therapeutic Drug Monitoring)
Frequency: Not routinely required, but useful in cases of non-response, suspected toxicity, or drug interactions.
Target: Imipramine + Desipramine: 150-300 ng/mL (for depression).
Action Threshold: Levels outside therapeutic range, especially high levels associated with toxicity.
Weight
Frequency: Monthly during initial treatment, then periodically.
Target: Stable weight or within acceptable range.
Action Threshold: Significant or rapid weight gain.
Anticholinergic side effects (dry mouth, constipation, urinary retention, blurred vision)
Frequency: Daily patient inquiry.
Target: Tolerable or manageable.
Action Threshold: Severe or unmanageable symptoms impacting quality of life or indicating serious complications (e.g., urinary retention).
Symptom Monitoring
- Worsening depression
- Suicidal thoughts or behavior
- Agitation
- Anxiety
- Panic attacks
- Insomnia
- Irritability
- Hostility
- Impulsivity
- Akathisia (psychomotor restlessness)
- Hypomania/Mania
- Dry mouth
- Constipation
- Blurred vision
- Urinary retention
- Dizziness or lightheadedness (especially on standing)
- Palpitations
- Tremor
- Seizures
- Skin rash
- Fever
- Sore throat (signs of blood dyscrasias)
Special Patient Groups
Pregnancy
Imipramine is classified as Pregnancy Category D. There are positive human fetal risk data, but the potential benefits may warrant use of the drug in pregnant women despite potential risks (e.g., life-threatening condition). Neonatal withdrawal symptoms (e.g., respiratory distress, cyanosis, irritability, seizures, tremors, feeding difficulties) have been reported when TCAs are used during the third trimester.
Trimester-Specific Risks:
First Trimester:
Limited data, but some studies suggest a possible association with congenital malformations (e.g., limb reduction defects, cardiovascular defects), though causality is not definitively established. Risk appears low.
Second Trimester:
Generally considered safer than first or third trimester, but continued monitoring is essential.
Third Trimester:
Risk of neonatal withdrawal syndrome (e.g., respiratory distress, cyanosis, irritability, seizures, tremors, feeding difficulties, hypotonia, hypertonia, vomiting, hypoglycemia) if exposed late in pregnancy. Use should be carefully weighed against the benefits.
Lactation
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. Monitor infants for sedation, poor feeding, and poor weight gain. Use with caution, or consider alternative therapies with better safety profiles during lactation.
Infant Risk:
L3 (Moderate risk) - Monitor infant for sedation, irritability, poor feeding, and weight gain. Consider therapeutic drug monitoring in the infant if concerns arise.
Pediatric Use
Imipramine is approved for nocturnal enuresis in children aged 6 years and older and for depression in adolescents. However, a black box warning exists regarding increased risk of suicidality in children, adolescents, and young adults. Close monitoring for clinical worsening and suicidality is crucial. Dosing must be carefully adjusted by age and weight.
Geriatric Use
Elderly patients are more sensitive to the anticholinergic, sedative, and cardiovascular (orthostatic hypotension, cardiac conduction abnormalities) effects of imipramine. Start with lower doses (e.g., 10-25 mg/day) and titrate slowly. Monitor closely for adverse effects, especially orthostatic hypotension, cognitive impairment, and cardiac effects. Consider lower target plasma levels if therapeutic drug monitoring is used.
Clinical Information
Clinical Pearls
- Imipramine is a potent TCA with significant anticholinergic and sedative effects, which can be beneficial for patients with insomnia or anxiety, but problematic for others.
- Due to its cardiac effects (QT prolongation, conduction delays), an ECG should be considered before starting treatment, especially in patients with pre-existing cardiac disease or elderly.
- Orthostatic hypotension is a common side effect; advise patients to rise slowly and ensure adequate hydration.
- The 10mg tablet is often used for initial titration, especially in sensitive patients or the elderly, or for specific low-dose indications like panic disorder.
- Therapeutic drug monitoring (TDM) for imipramine and desipramine levels can be useful in cases of non-response, suspected toxicity, or drug interactions, aiming for combined levels of 150-300 ng/mL for depression.
- Avoid abrupt discontinuation to prevent withdrawal symptoms (e.g., nausea, vomiting, dizziness, headache, anxiety, agitation, sleep disturbances).
Alternative Therapies
- Other Tricyclic Antidepressants (TCAs): Amitriptyline, Nortriptyline, Doxepin, Desipramine, Clomipramine
- 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, enuresis alarms.
Cost & Coverage
Average Cost:
Varies, typically $10-$50 per 30 tablets (10mg)
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 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 provides crucial information for patients. Please read this guide carefully and review it again whenever you refill your prescription. If you have any questions or concerns about this medication, consult 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.