Duloxetine DR 20mg 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
Category C
FDA Approved
Aug 2004
DEA Schedule
Not Controlled
Overview
What is this medicine?
Duloxetine is a medication that works by increasing the levels of two natural chemicals in your brain, serotonin and norepinephrine. These chemicals help regulate mood and pain. It is used to treat depression, anxiety, and certain types of nerve pain or chronic muscle and 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 advise 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. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
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 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 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 advise 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. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
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 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
- Take exactly as prescribed. Do not crush, chew, or open the capsules, as this will destroy the special coating that protects the medicine from stomach acid.
- Do not stop taking duloxetine suddenly without talking to your doctor, as this can cause withdrawal symptoms.
- 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 bleeding or bruising to your doctor.
- 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:
Varies by indication. For Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD): 60 mg once daily. For Diabetic Peripheral Neuropathic Pain (DPNP), Fibromyalgia (FM), Chronic Musculoskeletal Pain (CMP), Chronic Low Back Pain (CLBP), Osteoarthritis Pain (OA): 60 mg once daily (after initial titration).
Dose Range:
20 - 120 mg
Condition-Specific Dosing:
Major Depressive Disorder (MDD):
Initial: 20 mg twice daily or 60 mg once daily. Target: 60 mg once daily. Max: 120 mg/day (doses above 60 mg/day not shown to provide additional benefit).
Generalized Anxiety Disorder (GAD):
Initial: 20-30 mg once daily for 2 weeks, then 60 mg once daily. Max: 120 mg/day (doses above 60 mg/day not shown to provide additional benefit).
Diabetic Peripheral Neuropathic Pain (DPNP):
Initial: 60 mg once daily. Max: 120 mg/day (doses above 60 mg/day not shown to provide additional benefit).
Fibromyalgia (FM):
Initial: 30 mg once daily for 1 week, then 60 mg once daily. Max: 60 mg/day.
Chronic Musculoskeletal Pain (CMP):
Initial: 30 mg once daily for 1 week, then 60 mg once daily. Max: 60 mg/day.
Chronic Low Back Pain (CLBP):
Initial: 30 mg once daily for 1 week, then 60 mg once daily. Max: 60 mg/day.
Osteoarthritis Pain (OA):
Initial: 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:
For GAD (7-17 years): Initial 20 mg once daily for 2 weeks, then 30 mg once daily. May increase to 60 mg once daily. Max 120 mg/day.
Adolescent:
For GAD (7-17 years): Initial 20 mg once daily for 2 weeks, then 30 mg once daily. May increase to 60 mg once daily. Max 120 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl 50-80 mL/min).
Moderate:
No adjustment needed (CrCl 30-49 mL/min).
Severe:
Not recommended (CrCl <30 mL/min).
Dialysis:
Not recommended in patients with End-Stage Renal Disease (ESRD) or severe renal impairment.
Hepatic Impairment:
Mild:
Use with caution. No specific dose adjustment, but monitor closely.
Moderate:
Contraindicated in patients with hepatic insufficiency or end-stage renal disease.
Severe:
Contraindicated in patients with hepatic insufficiency or end-stage renal 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 weakly inhibits dopamine reuptake. The antidepressant and pain-relieving actions are thought to be related to the potentiation of serotonergic and noradrenergic activity in the CNS.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 50%
Tmax:
6 hours (range 4-10 hours) after oral administration of the enteric-coated pellet formulation.
FoodEffect:
Food delays Tmax by 6-10 hours and slightly decreases Cmax, but does not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
Approximately 1640 L
ProteinBinding:
>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 renal (approximately 70% as metabolites), fecal (approximately 20% as metabolites)
Unchanged:
<1% in urine
Pharmacodynamics
OnsetOfAction:
Antidepressant effects typically 2-4 weeks; pain relief may be observed earlier (within 1-2 weeks for some indications).
PeakEffect:
Steady-state plasma concentrations are typically achieved within 3 days of dosing.
DurationOfAction:
Due to its half-life, once-daily dosing is effective for most indications.
Safety & Warnings
BLACK BOX WARNING
Antidepressants increased the risk compared to placebo of suicidal thoughts and behaviors 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 aged 65 and older. Monitor all patients for clinical worsening, and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dose changes. Counsel family members or caregivers to also monitor and communicate with the prescriber.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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 low sodium levels, including:
+ Headache
+ Difficulty focusing
+ Memory problems
+ Confusion
+ Weakness
+ Seizures
+ Changes in balance
Signs of bleeding, such as:
+ 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
+ Uncontrollable bleeding
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Fainting
+ Changes in vision
Seizures
Difficulty urinating
Sexual problems, such as:
+ Decreased libido
+ Difficulty achieving orgasm
+ Ejaculation problems
+ Erectile dysfunction
Liver problems, which can be life-threatening. If you experience any of the following symptoms, contact your doctor immediately:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Nausea or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may occur, which can cause severe 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
+ Sores in your mouth, throat, nose, or eyes
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following symptoms or if they persist or bother you, contact your doctor:
Constipation
Diarrhea
Stomach pain
Nausea
Vomiting
Decreased appetite
Headache
Dry mouth
Difficulty sleeping
Dizziness
Drowsiness
Fatigue
Weakness
Excessive sweating
Weight loss
* Nose or throat irritation
This is not an exhaustive list of possible side effects. If you have 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 notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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 low sodium levels, including:
+ Headache
+ Difficulty focusing
+ Memory problems
+ Confusion
+ Weakness
+ Seizures
+ Changes in balance
Signs of bleeding, such as:
+ 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
+ Uncontrollable bleeding
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Fainting
+ Changes in vision
Seizures
Difficulty urinating
Sexual problems, such as:
+ Decreased libido
+ Difficulty achieving orgasm
+ Ejaculation problems
+ Erectile dysfunction
Liver problems, which can be life-threatening. If you experience any of the following symptoms, contact your doctor immediately:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Nausea or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may occur, which can cause severe 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
+ Sores in your mouth, throat, nose, or eyes
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following symptoms or if they persist or bother you, contact your doctor:
Constipation
Diarrhea
Stomach pain
Nausea
Vomiting
Decreased appetite
Headache
Dry mouth
Difficulty sleeping
Dizziness
Drowsiness
Fatigue
Weakness
Excessive sweating
Weight loss
* Nose or throat irritation
This is not an exhaustive list of possible side effects. If you have 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:
- 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 the skin or eyes (jaundice), dark urine, severe stomach pain, persistent nausea or vomiting, unusual tiredness.
- New or worsening suicidal thoughts or behaviors, especially in young adults.
- Severe allergic reaction: rash, hives, swelling of the face/lips/tongue/throat, difficulty breathing.
- Unusual bleeding or bruising.
- Eye pain, changes in vision, or swelling or redness in or 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.
Certain health conditions, including kidney disease or liver disease.
If you are currently taking thioridazine.
If you are taking any of the following medications: ciprofloxacin, fluvoxamine, linezolid, or methylene blue.
* If you have taken specific medications for depression or Parkinson's disease within the last 14 days, including 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. Therefore, it is crucial to inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure your safety while taking this medication. Do not 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.
Certain health conditions, including kidney disease or liver disease.
If you are currently taking thioridazine.
If you are taking any of the following medications: ciprofloxacin, fluvoxamine, linezolid, or methylene blue.
* If you have taken specific medications for depression or Parkinson's disease within the last 14 days, including 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. Therefore, it is crucial to inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure your safety while taking this medication. Do not start, stop, or change the dose 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
Until you know how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, 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 forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, consult with 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 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 in or 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
Until you know how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, 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 forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, consult with 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 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 in or 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 (drowsiness)
- Seizures
- Serotonin syndrome (agitation, hyperthermia, hyperreflexia)
- Vomiting
- Tachycardia
- Dizziness
- Tremor
- Mydriasis (dilated pupils)
What to Do:
Seek immediate medical attention or call 911. Contact a poison control center at 1-800-222-1222. Management should include treatment of symptoms and supportive care. There is no specific antidote.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs): Risk of serious, sometimes fatal, serotonin syndrome.
- Potent CYP1A2 Inhibitors (e.g., fluvoxamine, ciprofloxacin, enoxacin): Significantly increases duloxetine exposure.
- Thioridazine: Due to CYP2D6 inhibition by duloxetine, which can increase thioridazine levels and risk of serious ventricular arrhythmias and sudden death.
Major Interactions
- Other Serotonergic Drugs (e.g., SSRIs, SNRIs, triptans, TCAs, fentanyl, lithium, tramadol, tryptophan, St. John's Wort): Increased risk of serotonin syndrome.
- Drugs that Affect Hemostasis (e.g., NSAIDs, aspirin, warfarin, other anticoagulants/antiplatelets): Increased risk of bleeding.
- Drugs Metabolized by CYP2D6 (e.g., tricyclic antidepressants, phenothiazines, Type 1C antiarrhythmics): Duloxetine is a moderate CYP2D6 inhibitor and can increase concentrations of these drugs.
- CNS Depressants (e.g., alcohol, benzodiazepines, opioids): Enhanced CNS depressant effects.
Moderate Interactions
- Alcohol: Increased risk of liver injury.
- Antihypertensives: Potential for additive hypotensive effects, though duloxetine can also cause orthostatic hypotension.
- Drugs that cause hyponatremia: Increased risk of hyponatremia.
Minor Interactions
- None specifically categorized as minor with significant clinical impact, but general caution with other CNS-active drugs.
Monitoring
Baseline Monitoring
Liver Function Tests (ALT, AST, bilirubin)
Rationale: To assess baseline hepatic function, as duloxetine can cause liver injury.
Timing: Prior to initiation.
Blood Pressure and Heart Rate
Rationale: Duloxetine can cause increases in blood pressure and orthostatic hypotension.
Timing: Prior to initiation.
Psychiatric Evaluation/Suicidal Ideation Assessment
Rationale: To assess baseline mental status and risk, especially in young adults.
Timing: Prior to initiation.
Glaucoma Screening
Rationale: Contraindicated in uncontrolled narrow-angle glaucoma.
Timing: Prior to initiation if risk factors present.
Routine Monitoring
Blood Pressure and Heart Rate
Frequency: Periodically, especially during dose titration.
Target: Maintain within normal limits or patient's target range.
Action Threshold: Significant or sustained increases warrant dose adjustment or discontinuation; symptomatic orthostatic hypotension.
Mood/Anxiety Symptoms
Frequency: Regularly, especially during initial weeks and dose changes.
Target: Improvement in symptoms.
Action Threshold: Worsening symptoms, emergence of new symptoms, or lack of efficacy.
Suicidal Ideation/Behavior
Frequency: Closely monitor, especially during initial weeks and dose changes, and when increasing or decreasing dose.
Target: Absence of suicidal thoughts/behaviors.
Action Threshold: Emergence or worsening of suicidal thoughts/behaviors, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, mania.
Liver Function Tests (ALT, AST, bilirubin)
Frequency: If symptoms of liver injury develop (e.g., unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, dark urine, jaundice).
Target: Within normal limits.
Action Threshold: Significant elevations (e.g., >3x ULN) or clinical signs of liver injury warrant discontinuation.
Weight
Frequency: Periodically.
Target: Stable or within healthy range.
Action Threshold: Significant or clinically concerning weight changes.
Symptom Monitoring
- Serotonin syndrome (agitation, hallucinations, delirium, coma, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia, tremor, rigidity, myoclonus, hyperreflexia, incoordination, nausea, vomiting, diarrhea)
- Suicidal thoughts or behaviors, worsening depression or anxiety, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, mania
- Signs of liver injury (jaundice, dark urine, abdominal pain, unexplained nausea/vomiting, fatigue)
- Unusual bleeding or bruising
- Urinary hesitancy or retention
- Orthostatic hypotension (dizziness upon standing)
- Hyponatremia (headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, falls; severe: hallucinations, syncope, seizures, coma, respiratory arrest)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy 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:
Potential for neonatal withdrawal syndrome (e.g., respiratory distress, cyanosis, apnea, seizures, feeding difficulty, tremor, hypotonia, hypertonia, hyperreflexia, irritability, constant crying) and persistent pulmonary hypertension of the newborn (PPHN).
Lactation
Excreted into breast milk. L3 (Moderately Safe). Monitor breastfed infants for adverse effects such as sedation, poor feeding, and poor weight gain. Consider risks vs. benefits.
Infant Risk:
Low to moderate risk. Monitor for drowsiness, irritability, poor feeding, and weight changes.
Pediatric Use
Approved for Generalized Anxiety Disorder (GAD) in children aged 7-17 years. Black Box Warning regarding increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults. Close monitoring is essential.
Geriatric Use
Increased risk of falls, hyponatremia, and orthostatic hypotension. Start with lower doses and titrate slowly. Monitor for adverse effects and drug interactions more closely.
Clinical Information
Clinical Pearls
- Duloxetine capsules are enteric-coated and must be swallowed whole. Do not crush, chew, or open the capsules, as this will affect the drug's release and absorption.
- Discontinuation syndrome (withdrawal symptoms) can be significant if duloxetine is stopped abruptly. Symptoms can include dizziness, nausea, headache, paresthesia, vomiting, irritability, nightmares, and insomnia. Taper dose gradually over at least 2 weeks, or longer if needed.
- Monitor blood pressure regularly, as duloxetine can cause dose-related increases in blood pressure.
- Contraindicated in patients with uncontrolled narrow-angle glaucoma due to the risk of mydriasis.
- Caution with patients who have a history of seizures or mania/hypomania.
- Can cause urinary hesitancy or retention, especially in men with prostatic hypertrophy.
Alternative Therapies
- Selective Serotonin Reuptake Inhibitors (SSRIs) for depression/anxiety (e.g., escitalopram, sertraline, fluoxetine).
- Tricyclic Antidepressants (TCAs) for depression/neuropathic pain (e.g., amitriptyline, nortriptyline).
- Atypical Antidepressants (e.g., bupropion, mirtazapine).
- Gabapentin or Pregabalin for neuropathic pain or fibromyalgia.
- Non-steroidal Anti-inflammatory Drugs (NSAIDs) for musculoskeletal pain.
- Physical therapy, cognitive behavioral therapy (CBT), other non-pharmacological interventions for chronic pain and mood disorders.
Cost & Coverage
Average Cost:
Varies widely by pharmacy and insurance plan, typically $10-$100 for generic 30-day supply. per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 for generic; Tier 3 or higher for brand.
General Drug Facts
If your symptoms or health problems 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, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.
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 detailed information, including the name of the medication taken, the quantity, and the time it occurred.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.
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 detailed information, including the name of the medication taken, the quantity, and the time it occurred.