Imipramine 50mg Tablets

Manufacturer PAR Active Ingredient Imipramine Tablets(im IP ra meen) Pronunciation im-IP-ra-meen
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.
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Drug Class
Tricyclic Antidepressant (TCA)
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Pharmacologic Class
Norepinephrine and Serotonin Reuptake Inhibitor; Anticholinergic
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Pregnancy Category
Category D
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FDA Approved
Mar 1959
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Imipramine is a medication used to treat depression, panic disorder, and bedwetting (nocturnal enuresis) in children. It works by helping to restore the balance of certain natural substances (neurotransmitters) in the brain, which can improve mood and reduce anxiety. For bedwetting, it helps control bladder function.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, it's essential to use it as directed by your doctor. 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 prescribed 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 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.
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Lifestyle & Tips

  • Avoid alcohol and other CNS depressants (e.g., sedatives, tranquilizers) 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 sudden changes in position (e.g., standing up quickly from a sitting or lying position) to prevent dizziness or fainting due to orthostatic hypotension.
  • Protect yourself from the sun, as imipramine can increase sensitivity to sunlight. Use sunscreen and wear protective clothing.
  • Maintain good oral hygiene and drink plenty of water to help with dry mouth, a common side effect.
  • Do not stop taking this medication suddenly without consulting your doctor, as it can lead to withdrawal symptoms.

Dosing & Administration

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Adult Dosing

Standard Dose: Depression: Initial 75 mg/day in divided doses, gradually increased to 150-200 mg/day. Max 300 mg/day for hospitalized patients. Panic Disorder: Initial 10-25 mg/day at bedtime, gradually increased to 75-150 mg/day.
Dose Range: 10 - 300 mg

Condition-Specific Dosing:

depression: Initial 75 mg/day, maintenance 150-200 mg/day (max 300 mg/day for inpatients)
panic_disorder: Initial 10-25 mg/day, maintenance 75-150 mg/day
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Nocturnal Enuresis (6-12 years): 25-50 mg at bedtime. (12+ years): 50-75 mg at bedtime. Not FDA approved for depression in children; Black Box Warning for suicidality.
Adolescent: Nocturnal Enuresis: 50-75 mg at bedtime. Not FDA approved for depression; Black Box Warning for suicidality.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, use with caution
Moderate: No specific adjustment, use with caution
Severe: Use with caution, consider lower doses and close monitoring due to potential accumulation of active metabolites
Dialysis: Not well studied, use with caution; Imipramine is highly protein-bound and not readily dialyzable.

Hepatic Impairment:

Mild: Consider lower initial doses and titrate slowly
Moderate: Reduced dose recommended (e.g., 50% of usual dose) due to extensive hepatic metabolism
Severe: Contraindicated or use with extreme caution; significant dose reduction required with close monitoring

Pharmacology

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Mechanism of Action

Imipramine inhibits the reuptake of norepinephrine (NE) and serotonin (5-HT) at the presynaptic neuronal membrane, thereby increasing the concentration of these neurotransmitters in the synaptic cleft. It also possesses significant anticholinergic, antihistaminic, and alpha-1 adrenergic blocking properties.
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Pharmacokinetics

Absorption:

Bioavailability: 29-77%
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
ProteinBinding: 85-95%
CnssPenetration: Yes

Elimination:

HalfLife: Imipramine: 9-24 hours; Desipramine: 12-54 hours
Clearance: Not available
ExcretionRoute: Renal (approximately 80%), Fecal (approximately 20%)
Unchanged: <5%
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Pharmacodynamics

OnsetOfAction: Antidepressant effect: 2-4 weeks; Sedative effect: within hours; Enuresis effect: within days to 1-2 weeks.
PeakEffect: Antidepressant effect: 4-6 weeks
DurationOfAction: Related to half-life, effects persist for 24 hours with once-daily dosing.

Safety & Warnings

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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. 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 except for patients with nocturnal enuresis.
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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, 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 Blood Sugar Changes

Inform your doctor if you experience any signs of high or low blood sugar, including:
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 individuals 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, especially when taking certain other medications. Seek medical help right away if you experience:
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's essential to be aware of the following potential 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.
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Seek Immediate Medical Attention If You Experience:

  • Worsening depression or 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 extreme restlessness.
  • Symptoms of serotonin syndrome: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness or twitching, loss of coordination, nausea, vomiting, diarrhea.
  • Signs of heart problems: fast or irregular heartbeat, chest pain, shortness of breath, fainting, severe dizziness.
  • Seizures.
  • Severe anticholinergic effects: severe constipation, difficulty urinating, severe blurred vision, confusion, hallucinations.
  • Allergic reaction: rash, itching/swelling (especially of face/tongue/throat), severe dizziness, trouble breathing.
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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 symptoms 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 issues with your doctor and pharmacist. They will help determine if it is safe for you 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.
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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 down position, and exercise caution when climbing stairs.

Discontinuing the Medication

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

Special Considerations

If you have diabetes (high blood sugar), closely monitor your blood sugar levels 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. Be aware that 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 require you to undergo 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.
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Overdose Information

Overdose Symptoms:

  • Cardiac arrhythmias (e.g., tachycardia, ventricular fibrillation, asystole)
  • Severe hypotension
  • Seizures
  • Coma
  • Respiratory depression
  • Dilated pupils
  • Hyperthermia
  • Agitation, confusion, hallucinations
  • Severe anticholinergic effects (e.g., urinary retention, paralytic ileus)

What to Do:

Seek immediate emergency medical attention. Call 911 or your local poison control center (1-800-222-1222 in the US). Treatment is supportive and symptomatic, often involving gastric lavage, activated charcoal, continuous ECG monitoring, and management of arrhythmias, hypotension, and seizures.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - risk of serotonin syndrome, hypertensive crisis
  • Cisapride - risk of QT prolongation and arrhythmias
  • Pimozide - risk of QT prolongation and arrhythmias
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Major Interactions

  • Other QT-prolonging drugs (e.g., antiarrhythmics like quinidine, procainamide; some antipsychotics like thioridazine, ziprasidone)
  • CNS depressants (e.g., alcohol, benzodiazepines, opioids, sedatives) - additive CNS depression
  • Sympathomimetics (e.g., epinephrine, norepinephrine, phenylephrine) - potentiated pressor response
  • Anticholinergic agents (e.g., atropine, benztropine, antihistamines) - additive anticholinergic effects
  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, cimetidine) - significantly increase imipramine and desipramine plasma levels
  • Thyroid hormones - increased risk of cardiac toxicity
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Moderate Interactions

  • Anticoagulants (e.g., warfarin) - increased risk of bleeding due to inhibition of metabolism
  • Antihypertensives (e.g., guanethidine, clonidine) - imipramine may block the antihypertensive effect
  • Barbiturates - may decrease imipramine levels due to enzyme induction
  • Methylphenidate - may increase imipramine levels
  • Oral contraceptives - may increase imipramine levels
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Electrocardiogram (ECG)

Rationale: To assess for pre-existing cardiac conduction abnormalities, especially in elderly patients or those with cardiac history, due to risk of QT prolongation and arrhythmias.

Timing: Prior to initiation of therapy

Liver Function Tests (LFTs)

Rationale: Imipramine is extensively metabolized by the liver; to assess baseline hepatic function.

Timing: Prior to initiation of therapy

Renal Function Tests (RFTs)

Rationale: To assess baseline renal function, as metabolites are renally excreted.

Timing: Prior to initiation of therapy

Blood Pressure (BP) and Heart Rate (HR)

Rationale: To establish baseline and monitor for orthostatic hypotension and tachycardia.

Timing: Prior to initiation of therapy (supine and standing BP)

Psychiatric Evaluation (mood, suicidality)

Rationale: To establish baseline symptom severity and monitor for worsening depression or emergence of suicidal thoughts/behaviors.

Timing: Prior to initiation of therapy

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Routine Monitoring

Electrocardiogram (ECG)

Frequency: Periodically, especially with dose increases, in elderly patients, or those with cardiac risk factors

Target: Normal PR, QRS, and QTc intervals (QTc <450 ms for males, <470 ms for females)

Action Threshold: Significant prolongation of PR, QRS, or QTc interval; new arrhythmias. Consider dose reduction or discontinuation.

Blood Pressure (BP) and Heart Rate (HR)

Frequency: Regularly, especially during dose titration and in early treatment

Target: Within patient's normal range, without significant orthostatic drop

Action Threshold: Significant orthostatic hypotension (e.g., >20 mmHg systolic drop) or persistent tachycardia. Consider dose reduction or intervention.

Therapeutic Drug Monitoring (TDM) for Imipramine and Desipramine levels

Frequency: If poor response, suspected toxicity, or to confirm adherence

Target: Combined imipramine + desipramine plasma levels: 150-300 ng/mL (for depression)

Action Threshold: Levels outside therapeutic range; adjust dose accordingly.

Mental Status (mood, suicidality, adverse effects)

Frequency: Weekly during initial treatment, then periodically

Target: Improvement in target symptoms, absence of suicidal ideation or new/worsening adverse effects

Action Threshold: Worsening depression, emergence of suicidal thoughts/behaviors, significant agitation, or severe adverse effects. Re-evaluate treatment plan.

Weight

Frequency: Periodically

Target: Stable weight or within healthy range

Action Threshold: Significant weight gain. Counsel on diet and exercise.

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Symptom Monitoring

  • Worsening depression
  • Emergence of suicidal thoughts or behaviors
  • Unusual changes in behavior (e.g., agitation, irritability, anxiety, panic attacks, insomnia, impulsivity, aggression, mania/hypomania)
  • Cardiac symptoms (e.g., palpitations, chest pain, dizziness, fainting)
  • Anticholinergic effects (e.g., dry mouth, blurred vision, constipation, urinary retention)
  • Orthostatic hypotension (dizziness upon standing)
  • Seizures
  • Symptoms of serotonin syndrome (e.g., agitation, hallucinations, rapid heart beat, fever, overactive reflexes, nausea, vomiting, diarrhea, muscle rigidity, incoordination)
  • Allergic reactions (e.g., rash, hives, swelling)

Special Patient Groups

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Pregnancy

Category D. Imipramine crosses the placenta. Use during pregnancy is generally not recommended unless the potential benefit outweighs the potential risk to the fetus. Neonates exposed to TCAs in the third trimester may experience withdrawal symptoms (e.g., respiratory distress, cyanosis, apnea, seizures, feeding difficulties, hypotonia, hypertonia, tremor, irritability) and/or anticholinergic effects.

Trimester-Specific Risks:

First Trimester: Some studies suggest a possible association with congenital malformations (e.g., limb reduction defects, cardiovascular defects), but data are inconsistent and causality is not definitively established.
Second Trimester: Potential for fetal growth restriction and increased risk of preterm birth.
Third Trimester: Risk of neonatal withdrawal syndrome and anticholinergic effects in the newborn.
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Lactation

L3 (Moderately Safe). Imipramine and its active metabolite, desipramine, are excreted into breast milk. While levels in breast milk are generally low, potential for adverse effects in the infant exists. Monitor breastfed infants for sedation, poor feeding, irritability, and weight gain. Consider alternative therapies or close monitoring if breastfeeding.

Infant Risk: Low to moderate risk. Potential for sedation, poor feeding, irritability, and weight gain in the infant. Long-term effects are unknown.
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Pediatric Use

Imipramine is FDA approved for nocturnal enuresis in children aged 6 years and older. It is NOT FDA approved for depression in pediatric patients, and carries a Black Box Warning for increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults when used for depression or other psychiatric disorders. Close monitoring is essential if used off-label for depression.

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Geriatric Use

Elderly patients are more sensitive to the anticholinergic, sedative, and cardiovascular effects of imipramine (e.g., orthostatic hypotension, tachycardia, arrhythmias, confusion, urinary retention, constipation). Start with lower doses (e.g., 25-50 mg/day) and titrate slowly. Close monitoring for adverse effects is crucial. Consider alternative antidepressants with a more favorable side effect profile.

Clinical Information

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Clinical Pearls

  • Imipramine has a narrow therapeutic index; therapeutic drug monitoring (TDM) of combined imipramine and desipramine levels can be useful, especially in cases of non-response or suspected toxicity.
  • Antidepressant effects typically take 2-4 weeks to manifest, while sedative and anticholinergic side effects may occur sooner.
  • Due to its significant anticholinergic properties, imipramine should be used with caution or avoided in patients with benign prostatic hyperplasia, narrow-angle glaucoma, or severe constipation.
  • Abrupt discontinuation can lead to withdrawal symptoms (e.g., nausea, vomiting, dizziness, headache, malaise, sleep disturbance, irritability); taper dose gradually.
  • Cardiac toxicity, particularly arrhythmias, is a major concern in overdose and requires immediate medical attention.
  • Orthostatic hypotension is common, especially at the start of treatment; advise patients to rise slowly from sitting or lying positions.
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Alternative Therapies

  • Other Tricyclic Antidepressants (TCAs): Amitriptyline, Nortriptyline, Doxepin, Desipramine
  • Selective Serotonin Reuptake Inhibitors (SSRIs): Fluoxetine, Sertraline, Escitalopram, Paroxetine, Citalopram
  • Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs): Venlafaxine, Duloxetine, Desvenlafaxine
  • Atypical Antidepressants: Bupropion, Mirtazapine, Trazodone
  • For Nocturnal Enuresis: Desmopressin, Oxybutynin, behavioral therapies (e.g., enuresis alarms)
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Cost & Coverage

Average Cost: $15 - $50 per 30 tablets (50mg generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, 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 receive a refill of this medication. 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.