Duloxetine DR 40mg 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. @ COMMON USES: It is used to treat depression.It is used to treat anxiety.It is used to help painful nerve diseases and diabetic nerve problems.It is used to ease long-term pain problems.It is used to treat fibromyalgia.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antidepressant
Pharmacologic Class
Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
Pregnancy Category
Category C
FDA Approved
Aug 2004
DEA Schedule
Not Controlled
Overview
What is this medicine?
Duloxetine is a medication that works by affecting certain natural chemicals in the brain, serotonin and norepinephrine, which are involved in mood and pain. It's used to treat depression, anxiety, and certain types of chronic pain, including nerve pain from diabetes, fibromyalgia, and chronic muscle or joint pain.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue taking the medication as directed by your doctor or healthcare provider, even if you're feeling well. You can take this medication with or without food. It's essential to take the medication as prescribed and not stop suddenly without consulting your doctor, as this may increase the risk of side effects. If you need to stop taking the medication, your doctor will instruct you on how to gradually discontinue it. Swallow the medication whole; do not chew, open, or crush it.
Storing and Disposing of Your Medication
Store the medication at room temperature in a dry place, avoiding bathrooms. Keep all medications in a safe 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 by your pharmacist. If you're unsure about the best way to dispose of your medication, consult your pharmacist or look into local drug take-back programs.
Missing 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. Do not take two doses at the same time or take extra doses to make up for the missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue taking the medication as directed by your doctor or healthcare provider, even if you're feeling well. You can take this medication with or without food. It's essential to take the medication as prescribed and not stop suddenly without consulting your doctor, as this may increase the risk of side effects. If you need to stop taking the medication, your doctor will instruct you on how to gradually discontinue it. Swallow the medication whole; do not chew, open, or crush it.
Storing and Disposing of Your Medication
Store the medication at room temperature in a dry place, avoiding bathrooms. Keep all medications in a safe 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 by your pharmacist. If you're unsure about the best way to dispose of your medication, consult your pharmacist or look into local drug take-back programs.
Missing 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. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take exactly as prescribed, usually once daily, with or without food. Do not chew, crush, or open the capsule.
- Do not stop taking duloxetine suddenly, as this can cause withdrawal symptoms. Your doctor will guide you on how to slowly reduce the dose if needed.
- Avoid or limit alcohol consumption, as it can increase the risk of liver problems.
- Be cautious when driving or operating machinery until you know how duloxetine affects you, as it can cause dizziness or drowsiness.
- Report any unusual changes in mood or behavior, especially at the beginning of treatment or after dose changes, to your doctor immediately.
- Inform your doctor and pharmacist about all other medications, supplements, and herbal products you are taking to avoid potential drug interactions.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
For most indications (MDD, GAD, DPNP, FM, CMP): 60 mg once daily. For some, may start at 20-30 mg once daily for 1 week to allow adjustment to the medication before increasing to 60 mg. Max 120 mg/day for DPNP, but 60 mg/day is often sufficient.
Dose Range:
20 - 120 mg
Condition-Specific Dosing:
Major Depressive Disorder (MDD):
Starting: 20-30 mg once daily for 1 week, then 60 mg once daily. Max: 60 mg/day.
Generalized Anxiety Disorder (GAD):
Starting: 20-30 mg once daily for 1 week, then 60 mg once daily. Max: 120 mg/day (though 60 mg/day is effective for many).
Diabetic Peripheral Neuropathic Pain (DPNP):
Starting: 60 mg once daily. Max: 120 mg/day (given as 60 mg twice daily, though 60 mg once daily is effective for many).
Fibromyalgia (FM):
Starting: 30 mg once daily for 1 week, then 60 mg once daily. Max: 60 mg/day.
Chronic Musculoskeletal Pain (CMP):
Starting: 30 mg once daily for 1 week, then 60 mg once daily. Max: 60 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for MDD/GAD in children under 7 years. For GAD in children 7-17 years: Starting 30 mg once daily for 2 weeks, then 30-60 mg once daily. Max 120 mg/day.
Adolescent:
For GAD in adolescents 7-17 years: Starting 30 mg once daily for 2 weeks, then 30-60 mg once daily. Max 120 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment needed (CrCl 30-80 mL/min).
Moderate:
No dosage adjustment needed (CrCl 30-80 mL/min).
Severe:
Contraindicated (CrCl <30 mL/min).
Dialysis:
Contraindicated in patients with end-stage renal disease (ESRD) or severe renal impairment (CrCl <30 mL/min).
Hepatic Impairment:
Mild:
Use with caution.
Moderate:
Contraindicated in patients with chronic liver disease or cirrhosis.
Severe:
Contraindicated in patients with chronic liver disease or cirrhosis.
Pharmacology
Mechanism of Action
Duloxetine is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI). It weakly inhibits dopamine reuptake. Duloxetine's antidepressant, anxiolytic, and pain-relieving actions are presumed to be related to its potentiation of serotonergic and noradrenergic activity in the central nervous system.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 50%
Tmax:
6 hours
FoodEffect:
Food delays Tmax by 6-10 hours and decreases Cmax by approximately 11%, but does not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
Approximately 1640 L
ProteinBinding:
Greater than 90% (primarily to albumin and alpha-1 acid glycoprotein)
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 12 hours (range 8-17 hours)
Clearance:
Approximately 101 L/hour
ExcretionRoute:
Primarily urine (approximately 70% as metabolites), feces (approximately 20% as metabolites)
Unchanged:
Less than 1% in urine
Pharmacodynamics
OnsetOfAction:
Antidepressant/Anxiolytic effects: 1-4 weeks; Pain relief: 1-2 weeks
PeakEffect:
Antidepressant/Anxiolytic effects: 4-6 weeks; Pain relief: 4-8 weeks
DurationOfAction:
24 hours (due to once-daily dosing)
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. This risk must be balanced 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 65 years of age 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. Duloxetine is not approved for use in pediatric patients less than 7 years of age.
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 immediate medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of low sodium levels: headache, trouble focusing, memory problems, confusion, weakness, seizures, or changes in balance.
Signs of bleeding: vomiting or coughing up blood, vomit that resembles coffee grounds, blood in the urine, black, red, or tarry stools, bleeding from the gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrollable bleeding.
Signs of high or low blood pressure: severe headache or dizziness, fainting, or changes in vision.
Seizures.
Difficulty urinating.
Sexual problems, including decreased libido, trouble achieving orgasm, ejaculation problems, or erectile dysfunction. If you have concerns, discuss them with your doctor.
Liver problems, which can be life-threatening. If you experience symptoms such as dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin or eyes, contact your doctor immediately.
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may occur, potentially causing long-term health problems or death. Seek medical help right away if you notice red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in your mouth, throat, nose, or eyes.
Other Possible Side Effects
Like all medications, this drug may cause side effects. Many people experience no side effects or only mild ones. If you encounter any of the following side effects or any other symptoms that bother you or persist, contact your doctor or seek medical attention:
Gastrointestinal symptoms: constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite.
Headache.
Dry mouth.
Sleep disturbances.
Dizziness, drowsiness, fatigue, or weakness.
Excessive sweating.
Weight loss.
* Nose or throat irritation.
This list is not exhaustive. If you have questions or concerns about side effects, consult 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 notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of low sodium levels: headache, trouble focusing, memory problems, confusion, weakness, seizures, or changes in balance.
Signs of bleeding: vomiting or coughing up blood, vomit that resembles coffee grounds, blood in the urine, black, red, or tarry stools, bleeding from the gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrollable bleeding.
Signs of high or low blood pressure: severe headache or dizziness, fainting, or changes in vision.
Seizures.
Difficulty urinating.
Sexual problems, including decreased libido, trouble achieving orgasm, ejaculation problems, or erectile dysfunction. If you have concerns, discuss them with your doctor.
Liver problems, which can be life-threatening. If you experience symptoms such as dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin or eyes, contact your doctor immediately.
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may occur, potentially causing long-term health problems or death. Seek medical help right away if you notice red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in your mouth, throat, nose, or eyes.
Other Possible Side Effects
Like all medications, this drug may cause side effects. Many people experience no side effects or only mild ones. If you encounter any of the following side effects or any other symptoms that bother you or persist, contact your doctor or seek medical attention:
Gastrointestinal symptoms: constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite.
Headache.
Dry mouth.
Sleep disturbances.
Dizziness, drowsiness, fatigue, or weakness.
Excessive sweating.
Weight loss.
* Nose or throat irritation.
This list is not exhaustive. If you have questions or concerns about side effects, consult 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 anxiety
- New or worsening thoughts of self-harm or suicide
- Extreme agitation, restlessness, or irritability
- Panic attacks
- Difficulty sleeping (insomnia)
- Unusual changes in behavior
- Signs of serotonin syndrome: agitation, hallucinations, rapid heart rate, fever, sweating, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea
- Signs of liver problems: yellowing of skin or eyes (jaundice), dark urine, severe stomach pain, unexplained flu-like symptoms
- New or worsening high blood pressure
- Eye pain, changes in vision, or swelling or redness in or around the eye (may indicate acute angle-closure 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.
Existing health conditions, including kidney disease or liver disease.
Current medications, particularly:
+ Thioridazine
+ Ciprofloxacin or fluvoxamine
+ Linezolid or methylene blue
If you have taken certain medications for depression or Parkinson's disease within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of very high blood pressure.
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to disclose all of your:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Health problems
Your doctor and pharmacist need this information to determine whether it is safe for you to take this medication with your existing medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
Existing health conditions, including kidney disease or liver disease.
Current medications, particularly:
+ Thioridazine
+ Ciprofloxacin or fluvoxamine
+ Linezolid or methylene blue
If you have taken certain medications for depression or Parkinson's disease within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of very high blood pressure.
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to disclose all of your:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Health problems
Your doctor and pharmacist need this information to determine whether it is safe for you to take this medication with your existing medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
Important Warnings and Precautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and be cautious when climbing stairs.
Risk of Falls and Low Blood Pressure
This medication can cause low blood pressure, falls, and fainting, which may lead to serious injuries, such as broken bones, and hospitalization. Older adults are at a higher risk of falls. Discuss this risk with your doctor.
Monitoring Blood Sugar and Blood Pressure
If you have diabetes, closely monitor your blood sugar levels. Additionally, have your blood pressure checked regularly, as prescribed by your doctor, since this medication can cause high blood pressure.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other cannabis products, or taking prescription or over-the-counter medications that may impair your actions, consult your doctor.
Bleeding Risk
This medication may increase the risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor.
Serotonin Syndrome
A rare but potentially life-threatening condition called serotonin syndrome can occur, especially when taking certain other medications. Seek immediate medical attention if you experience agitation, balance problems, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, vomiting, or a severe headache.
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 this risk. If you experience eye pain, changes in vision, or swelling and redness around the eye, contact your doctor promptly.
Low Sodium Levels
This medication can cause low sodium levels, which can be life-threatening and lead to seizures, fainting, breathing difficulties, or death.
Lab Tests and Age-Related Considerations
Inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab tests. If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. In children and adolescents, this medication may affect growth in some cases, and regular growth checks may be necessary. Discuss this with your doctor.
Pregnancy and Breastfeeding
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor. Taking this medication during the third trimester of pregnancy may increase the risk of bleeding after delivery and cause health problems in the newborn. This medication passes into breast milk and may harm your baby. Discuss the benefits and risks with your doctor.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and be cautious when climbing stairs.
Risk of Falls and Low Blood Pressure
This medication can cause low blood pressure, falls, and fainting, which may lead to serious injuries, such as broken bones, and hospitalization. Older adults are at a higher risk of falls. Discuss this risk with your doctor.
Monitoring Blood Sugar and Blood Pressure
If you have diabetes, closely monitor your blood sugar levels. Additionally, have your blood pressure checked regularly, as prescribed by your doctor, since this medication can cause high blood pressure.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other cannabis products, or taking prescription or over-the-counter medications that may impair your actions, consult your doctor.
Bleeding Risk
This medication may increase the risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor.
Serotonin Syndrome
A rare but potentially life-threatening condition called serotonin syndrome can occur, especially when taking certain other medications. Seek immediate medical attention if you experience agitation, balance problems, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, vomiting, or a severe headache.
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 this risk. If you experience eye pain, changes in vision, or swelling and redness around the eye, contact your doctor promptly.
Low Sodium Levels
This medication can cause low sodium levels, which can be life-threatening and lead to seizures, fainting, breathing difficulties, or death.
Lab Tests and Age-Related Considerations
Inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab tests. If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. In children and adolescents, this medication may affect growth in some cases, and regular growth checks may be necessary. Discuss this with your doctor.
Pregnancy and Breastfeeding
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor. Taking this medication during the third trimester of pregnancy may increase the risk of bleeding after delivery and cause health problems in the newborn. This medication passes into breast milk and may harm your baby. Discuss the benefits and risks with your doctor.
Overdose Information
Overdose Symptoms:
- Somnolence
- Coma
- Serotonin syndrome (agitation, hyperthermia, hyperreflexia, myoclonus, tremor, diarrhea)
- Seizures
- Tachycardia
- Hypertension
- Vomiting
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management should include supportive care, monitoring of vital signs, and management of specific symptoms. There is no specific antidote.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - risk of serotonin syndrome
- Thioridazine - risk of serious ventricular arrhythmia and sudden death
- Fluvoxamine, Ciprofloxacin, Enoxacin (potent CYP1A2 inhibitors) - significantly increase duloxetine levels
Major Interactions
- Other serotonergic drugs (e.g., SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, St. John's Wort) - increased risk of serotonin syndrome
- Drugs metabolized by CYP2D6 (e.g., tricyclic antidepressants, phenothiazines, Type 1C antiarrhythmics like propafenone, flecainide) - duloxetine is a moderate CYP2D6 inhibitor, may increase levels of these drugs
- Warfarin and other anticoagulants/antiplatelets (e.g., NSAIDs, aspirin) - increased risk of bleeding
Moderate Interactions
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Renal function (CrCl)
Rationale: Duloxetine is contraindicated in severe renal impairment (CrCl <30 mL/min).
Timing: Prior to initiation
Hepatic function (ALT, AST, bilirubin)
Rationale: Duloxetine is contraindicated in chronic liver disease or cirrhosis; liver injury has been reported.
Timing: Prior to initiation
Blood pressure
Rationale: Duloxetine can cause an increase in blood pressure.
Timing: Prior to initiation
History of mania/hypomania or bipolar disorder
Rationale: Risk of activating mania/hypomania in susceptible individuals.
Timing: Prior to initiation
History of narrow-angle glaucoma
Rationale: Risk of mydriasis and acute angle-closure glaucoma.
Timing: Prior to initiation
Routine Monitoring
Blood pressure
Frequency: Periodically, especially during dose titration
Target: Within patient's normal range
Action Threshold: Significant or sustained elevation requiring intervention
Weight
Frequency: Periodically
Target: Stable or within healthy range
Action Threshold: Clinically significant weight gain or loss
Symptoms of depression/anxiety/pain
Frequency: Regularly, especially during initial treatment and dose changes
Target: Improvement in symptoms
Action Threshold: Lack of improvement, worsening symptoms, or emergence of new symptoms
Suicidality (especially in young adults)
Frequency: Closely monitor, especially during initial treatment and dose changes
Target: Absence of suicidal ideation or behavior
Action Threshold: Emergence or worsening of suicidal thoughts/behaviors
Signs/symptoms of serotonin syndrome
Frequency: Monitor, especially when co-administered with other serotonergic drugs
Target: Absence of symptoms (e.g., agitation, hallucinations, tachycardia, fever, hyperreflexia)
Action Threshold: Presence of any symptoms
Liver function tests (ALT, AST, bilirubin)
Frequency: If clinically indicated (e.g., signs of liver injury, history of liver issues)
Target: Within normal limits
Action Threshold: Significant elevation
Symptom Monitoring
- Worsening depression
- Suicidal thoughts or behavior
- Unusual changes in behavior or mood (e.g., agitation, irritability, panic attacks, insomnia, impulsivity, aggression, severe restlessness, hypomania, mania)
- Signs of serotonin syndrome (e.g., agitation, confusion, hallucinations, rapid heart rate, fever, sweating, muscle rigidity, tremor, twitching, nausea, vomiting, diarrhea)
- Signs of liver injury (e.g., dark urine, yellowing of skin/eyes, right upper quadrant pain, unexplained flu-like symptoms)
- New or worsening hypertension
- Dizziness or lightheadedness (orthostatic hypotension)
- Nausea, dry mouth, constipation, insomnia, fatigue, sweating
Special Patient Groups
Pregnancy
Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally not associated with major congenital malformations.
Second Trimester:
Limited data.
Third Trimester:
Risk of persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal syndrome (e.g., respiratory distress, feeding difficulties, irritability, tremor, hypotonia, constant crying).
Lactation
Duloxetine is excreted into breast milk. The amount is low, but potential for adverse effects on the infant exists. Weigh benefits of breastfeeding against potential risks to the infant. Monitor infant for sedation, poor feeding, and poor weight gain.
Infant Risk:
Low to moderate risk. Monitor for drowsiness, irritability, poor feeding, and weight gain.
Pediatric Use
Safety and efficacy not established for MDD in children under 7 years. For GAD, approved for children 7-17 years. Black Box Warning regarding suicidality applies to children and adolescents. Close monitoring is essential.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Use with caution due to increased risk of hyponatremia, falls, and potential for drug interactions. Lower starting doses and slower titration may be considered.
Clinical Information
Clinical Pearls
- Duloxetine is a dual-acting antidepressant (SNRI) effective for both mood disorders and various chronic pain conditions, making it a good choice for patients with comorbid depression/anxiety and pain.
- Always counsel patients on the importance of not abruptly discontinuing duloxetine due to the risk of SNRI discontinuation syndrome (e.g., dizziness, nausea, headache, paresthesias, anxiety, irritability). Tapering is crucial.
- Monitor blood pressure regularly, as duloxetine can cause dose-dependent increases in blood pressure.
- Be vigilant for signs of serotonin syndrome, especially when co-prescribing with other serotonergic agents.
- Contraindicated in patients with unmanaged narrow-angle glaucoma due to risk of mydriasis.
- Contraindicated in severe renal impairment (CrCl <30 mL/min) and hepatic insufficiency/cirrhosis.
- Counsel patients on the Black Box Warning regarding suicidality, especially in young adults, and the need for close monitoring.
Alternative Therapies
- SSRIs (e.g., escitalopram, sertraline, fluoxetine) for depression/anxiety
- Tricyclic Antidepressants (TCAs) (e.g., amitriptyline, nortriptyline) for depression/pain
- Gabapentin or Pregabalin for neuropathic pain/fibromyalgia
- Milnacipran for fibromyalgia
- Other pain management strategies (e.g., NSAIDs, opioids, physical therapy, cognitive behavioral therapy)
Cost & Coverage
Average Cost:
Not available per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for 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 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 quantity, 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 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 quantity, and the time it occurred.