Duloxetine DR 60mg 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, Analgesic
Pharmacologic Class
Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
Pregnancy Category
Not available
FDA Approved
Aug 2004
DEA Schedule
Not Controlled
Overview
What is this medicine?
Duloxetine is a medication that helps balance certain natural chemicals in your brain, like serotonin and norepinephrine. This can help improve your mood, reduce anxiety, and lessen certain types of chronic pain, such as nerve pain from diabetes or pain from fibromyalgia.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. You can take this medication with or without food.
It's essential to take your medication consistently and not stop suddenly without consulting your doctor, as this may increase your risk of side effects. If you need to stop taking this medication, your doctor will advise you on how to gradually discontinue it.
When taking your medication, swallow the tablet whole. Do not chew, crush, or open it.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of any unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult your pharmacist, who may be aware of 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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. You can take this medication with or without food.
It's essential to take your medication consistently and not stop suddenly without consulting your doctor, as this may increase your risk of side effects. If you need to stop taking this medication, your doctor will advise you on how to gradually discontinue it.
When taking your medication, swallow the tablet whole. Do not chew, crush, or open it.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of any unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult your pharmacist, who may be aware of 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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Avoid or limit alcohol consumption due to increased risk of liver problems.
- Be cautious when driving or operating machinery until you know how this medication affects you, as it can cause dizziness or drowsiness.
- Do not stop taking duloxetine suddenly without talking to your doctor, as this can lead to withdrawal symptoms.
- Report any new or worsening symptoms of depression, suicidal thoughts, or unusual changes in behavior to your doctor immediately.
- Maintain regular follow-up appointments with your doctor to monitor your progress and any potential side effects.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
60 mg once daily
Dose Range:
20 - 120 mg
Condition-Specific Dosing:
Major Depressive Disorder (MDD):
Initial 40-60 mg/day (20 mg BID or 60 mg QD), target 60 mg QD. Max 120 mg/day.
Generalized Anxiety Disorder (GAD):
Initial 30-60 mg/day, target 60 mg QD. Max 120 mg/day.
Diabetic Peripheral Neuropathic Pain (DPNP):
Initial 60 mg QD. Max 120 mg/day (no additional benefit over 60 mg QD).
Fibromyalgia (FM):
Initial 30 mg QD for 1 week, then 60 mg QD. Max 60 mg QD.
Chronic Musculoskeletal Pain (CMP):
Initial 30 mg QD for 1 week, then 60 mg QD. Max 60 mg QD.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
GAD: Initial 30 mg QD for 2 weeks, then 60 mg QD. Max 120 mg/day. MDD: Not FDA approved for pediatric MDD.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl 60-89 mL/min)
Moderate:
No adjustment needed (CrCl 30-59 mL/min)
Severe:
Contraindicated (CrCl <30 mL/min)
Dialysis:
Contraindicated in End-Stage Renal Disease (ESRD)
Hepatic Impairment:
Mild:
Not available
Moderate:
Contraindicated
Severe:
Contraindicated in hepatic insufficiency or end-stage liver disease
Pharmacology
Mechanism of Action
Duloxetine is a potent and selective inhibitor of serotonin (5-HT) and norepinephrine (NE) reuptake in the central nervous system (CNS). It has a weak inhibitory effect on dopamine reuptake. The antidepressant, anxiolytic, and pain inhibitory actions are believed to be related to the potentiation of serotonergic and noradrenergic activity in the CNS.
Pharmacokinetics
Absorption:
Bioavailability:
32-80% (mean 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:
Urine (approximately 70%), Feces (approximately 20%)
Unchanged:
Less than 1% in urine
Pharmacodynamics
OnsetOfAction:
1-2 weeks for antidepressant/anxiolytic effects; pain relief may take 2-4 weeks.
PeakEffect:
4-6 weeks for full therapeutic effect in depression/anxiety.
DurationOfAction:
24 hours (due to once-daily dosing)
Safety & Warnings
BLACK BOX WARNING
Antidepressants increased the risk compared to placebo of suicidal thoughts and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Duloxetine is not approved for use in pediatric patients except for Generalized Anxiety Disorder (GAD) in patients 7 to 17 years of age. This risk must be balanced 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. Duloxetine is not approved for use in pediatric patients with MDD.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
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, trouble 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, feeling confused, 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.
Sex-related problems, including decreased libido, trouble achieving orgasm, ejaculation issues, or erectile dysfunction. If you have concerns, discuss them with your doctor.
Liver problems, which can be life-threatening. Seek immediate medical attention if you experience dark urine, fatigue, decreased appetite, nausea or stomach pain, pale-colored stools, vomiting, or yellowing of the skin or eyes.
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may occur, potentially causing long-term health issues or death. Seek medical help right away if you experience 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 can cause side effects. While many people may not experience any significant side effects, others may have mild or moderate issues. If you encounter any of the following side effects or any other concerns, contact your doctor or seek medical attention:
Gastrointestinal issues: constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite.
Headache.
Dry mouth.
Sleep disturbances.
Feeling dizzy, drowsy, tired, or weak.
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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
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, trouble 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, feeling confused, 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.
Sex-related problems, including decreased libido, trouble achieving orgasm, ejaculation issues, or erectile dysfunction. If you have concerns, discuss them with your doctor.
Liver problems, which can be life-threatening. Seek immediate medical attention if you experience dark urine, fatigue, decreased appetite, nausea or stomach pain, pale-colored stools, vomiting, or yellowing of the skin or eyes.
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may occur, potentially causing long-term health issues or death. Seek medical help right away if you experience 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 can cause side effects. While many people may not experience any significant side effects, others may have mild or moderate issues. If you encounter any of the following side effects or any other concerns, contact your doctor or seek medical attention:
Gastrointestinal issues: constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite.
Headache.
Dry mouth.
Sleep disturbances.
Feeling dizzy, drowsy, tired, or weak.
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
- Thoughts about harming yourself or others
- Unusual changes in behavior (e.g., agitation, restlessness, panic attacks, irritability, aggression, impulsivity, severe insomnia, hypomania, mania)
- Signs of liver problems (e.g., yellowing of skin or eyes, dark urine, severe stomach pain, persistent nausea/vomiting)
- Signs of serotonin syndrome (e.g., confusion, hallucinations, rapid heart rate, sweating, muscle stiffness or twitching, tremors, fever, nausea, vomiting, diarrhea)
- Severe allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
- Significant increase in blood pressure
- Difficulty urinating or painful urination
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.
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. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe use. Never start, stop, or adjust 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 symptoms 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. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe use. 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.
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 exercise caution 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. This medication can also cause high blood pressure, so follow your doctor's instructions for regular blood pressure checks.
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 potentially life-threatening condition called serotonin syndrome can occur, especially when taking certain other medications. Seek immediate medical attention if you experience symptoms such as 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 eye problems when 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, plan to become pregnant, or are breastfeeding, inform your doctor. Taking this medication in 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 exercise caution 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. This medication can also cause high blood pressure, so follow your doctor's instructions for regular blood pressure checks.
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 potentially life-threatening condition called serotonin syndrome can occur, especially when taking certain other medications. Seek immediate medical attention if you experience symptoms such as 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 eye problems when 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, plan to become pregnant, or are breastfeeding, inform your doctor. Taking this medication in 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
- Seizures
- Tachycardia
- Vomiting
- Dizziness
- Tremor
- Mydriasis
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Management should include supportive care, monitoring of vital signs, and management of specific symptoms (e.g., benzodiazepines for seizures, cyproheptadine for serotonin syndrome).
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - risk of serotonin syndrome
- Thioridazine - risk of QT prolongation and ventricular arrhythmias
- Potent CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin, enoxacin) - significantly increases duloxetine levels
Major Interactions
- Other serotonergic drugs (e.g., SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome
- Drugs that affect hemostasis (e.g., NSAIDs, aspirin, warfarin) - increased risk of bleeding
- CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine) - may increase duloxetine levels
- Drugs metabolized by CYP2D6 (e.g., tricyclic antidepressants, phenothiazines, Type 1C antiarrhythmics) - duloxetine may increase their levels
Moderate Interactions
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Liver function tests (ALT, AST, bilirubin)
Rationale: Duloxetine can cause hepatic injury, especially in patients with pre-existing liver disease or heavy alcohol use.
Timing: Prior to initiation
Renal function (CrCl)
Rationale: Duloxetine is contraindicated in severe renal impairment.
Timing: Prior to initiation
Blood pressure
Rationale: Duloxetine can cause an increase in blood pressure.
Timing: Prior to initiation
Suicidal ideation/behavior assessment
Rationale: Risk of suicidality, especially in young adults and during initial treatment/dose changes.
Timing: Prior to initiation
Routine Monitoring
Blood pressure
Frequency: Periodically, especially during dose titration
Target: Individualized, within normal limits
Action Threshold: Significant or sustained elevation requiring intervention
Liver function tests (ALT, AST, bilirubin)
Frequency: Periodically, especially if symptoms of liver injury develop or in patients with risk factors
Target: Within normal limits
Action Threshold: Significant elevation (e.g., >3x ULN) or clinical signs of liver injury
Weight
Frequency: Periodically
Target: Stable
Action Threshold: Significant or undesirable weight changes
Mental status, mood, behavior (especially for suicidality, agitation, mania)
Frequency: Frequently during initial therapy (first few months) and with dose changes, then periodically
Target: Improvement in target symptoms without adverse behavioral changes
Action Threshold: Worsening depression, emergence of suicidal thoughts/behavior, unusual changes in behavior, agitation, or signs of mania/hypomania
Urinary symptoms (e.g., hesitancy, retention)
Frequency: Periodically
Target: Normal urinary function
Action Threshold: Development or worsening of urinary retention
Symptom Monitoring
- Nausea
- Dry mouth
- Constipation
- Dizziness
- Insomnia
- Fatigue
- Sweating
- Sexual dysfunction
- Headache
- Anxiety
- Agitation
- Restlessness
- Panic attacks
- Insomnia
- Irritability
- Hostility
- Impulsivity
- Akathisia (psychomotor restlessness)
- Hypomania
- Mania
- New or worsening depression
- Suicidal thoughts or behavior
- Signs of liver injury (e.g., jaundice, dark urine, abdominal pain, persistent nausea/vomiting)
- Signs of serotonin syndrome (e.g., agitation, hallucinations, delirium, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea)
Special Patient Groups
Pregnancy
Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Exposure during late pregnancy may be associated with complications in the neonate requiring prolonged hospitalization, respiratory support, and tube feeding (persistent pulmonary hypertension of the newborn, PPHN, has been reported with SSRIs/SNRIs).
Trimester-Specific Risks:
First Trimester:
Limited data, but generally not associated with major congenital malformations.
Second Trimester:
Not available
Third Trimester:
Risk of PPHN and neonatal withdrawal symptoms (e.g., respiratory distress, feeding difficulties, jitteriness, hypotonia, persistent crying) if exposed late in the third trimester.
Lactation
Duloxetine is excreted into human milk. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for duloxetine, and any potential adverse effects on the breastfed infant from duloxetine or from the underlying maternal condition. Monitor infants for sedation, poor feeding, and poor weight gain.
Infant Risk:
Low to moderate risk. Infant exposure is relatively low. Monitor for drowsiness, irritability, poor feeding, and weight gain.
Pediatric Use
Not approved for MDD in pediatric patients. Approved for GAD in adolescents (7-17 years). Black Box Warning regarding suicidality in children, adolescents, and young adults. Close monitoring for behavioral changes is crucial.
Geriatric Use
No overall differences in safety or effectiveness were observed between geriatric and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Use with caution due to potential for increased falls, hyponatremia, and urinary retention. Start with lower doses and titrate slowly.
Clinical Information
Clinical Pearls
- Duloxetine is a delayed-release capsule; it should be swallowed whole and not chewed, crushed, or opened, as this will affect the enteric coating and drug release.
- Discontinuation syndrome (withdrawal symptoms) can occur if duloxetine is stopped abruptly. Symptoms include dizziness, headache, nausea, diarrhea, paresthesia, irritability, anxiety, and insomnia. Tapering the dose gradually over at least 2 weeks is recommended.
- Monitor blood pressure regularly, as duloxetine can cause dose-related increases in blood pressure.
- Be aware of the risk of liver injury, especially in patients with pre-existing liver disease or heavy alcohol use. Discontinue if signs of liver injury develop.
- Duloxetine can cause or worsen urinary hesitancy or retention, particularly in men with benign prostatic hyperplasia (BPH).
- Consider the potential for sexual dysfunction, a common side effect of SNRIs, and discuss with patients.
- For pain indications, the full analgesic effect may take several weeks to develop.
Alternative Therapies
- Other SNRIs (e.g., venlafaxine, desvenlafaxine, levomilnacipran)
- SSRIs (e.g., escitalopram, sertraline, fluoxetine, paroxetine, citalopram)
- Tricyclic Antidepressants (TCAs) (e.g., amitriptyline, nortriptyline) for pain or depression
- Other antidepressants (e.g., bupropion, mirtazapine)
- Gabapentin or pregabalin for neuropathic pain or fibromyalgia
- Physical therapy, cognitive behavioral therapy (CBT), psychotherapy for mood/anxiety disorders and chronic pain.
Cost & Coverage
Average Cost:
Varies widely, typically $30-$200+ per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic), Tier 3 or higher (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, contact your doctor immediately. It is essential to use your prescribed medication responsibly: do not share it with others, and never take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider. In the event of a suspected overdose, promptly call the poison control center or seek immediate medical attention. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.