What are the main uses of duloxetine. How does duloxetine work in the body. What are the most common side effects of duloxetine. What serious side effects should you watch out for with duloxetine. How should duloxetine be taken safely.

Understanding Duloxetine: An Overview of the Medication

Duloxetine, commonly known by its brand name Cymbalta, is a versatile prescription medication that belongs to a class of drugs called serotonin-norepinephrine reuptake inhibitors (SNRIs). This oral capsule is widely used to treat various conditions, ranging from mental health disorders to chronic pain syndromes. As with any medication, it’s crucial to understand its uses, mechanisms, and potential side effects to ensure safe and effective treatment.

What is Duloxetine Used For?

Duloxetine is prescribed for several conditions:

• Generalized anxiety disorder
• Major depressive disorder
• Diabetic neuropathy (nerve pain caused by diabetes)
• Fibromyalgia
• Chronic muscle and joint pain

Its versatility in treating both mental health and pain-related conditions makes it a valuable option for many patients. However, it’s essential to use duloxetine only under the guidance of a healthcare professional.

The Science Behind Duloxetine: How It Works in Your Body

Understanding how duloxetine functions in the body can provide insight into its effectiveness and potential side effects. Duloxetine primarily works by influencing the balance of certain chemicals in the brain.

How Does Duloxetine Affect Brain Chemistry?

Duloxetine acts by balancing two key neurotransmitters in the brain: serotonin and norepinephrine. These chemicals play crucial roles in mood regulation, pain perception, and overall mental well-being. By inhibiting the reuptake of these neurotransmitters, duloxetine increases their availability in the brain, which can help alleviate symptoms of depression and anxiety.

Duloxetine’s Role in Pain Management

In addition to its effects on mood, duloxetine also helps manage chronic pain conditions. It achieves this by inhibiting pain signals from nerves to the brain. This dual action on both mood and pain pathways makes duloxetine particularly effective for conditions like fibromyalgia, where both pain and mood disturbances are present.

Common Side Effects of Duloxetine: What to Expect

Like all medications, duloxetine can cause side effects. While not everyone experiences these, it’s important to be aware of potential reactions.

What Are the Most Frequently Reported Side Effects in Adults?

Common side effects in adults taking duloxetine include:

• Nausea
• Dry mouth
• Sleepiness
• Fatigue
• Constipation
• Loss of appetite
• Increased sweating
• Dizziness

These side effects are usually mild and often subside as your body adjusts to the medication. However, if they persist or become bothersome, it’s important to consult your healthcare provider.

Are Side Effects Different in Children?

Children may experience slightly different side effects when taking duloxetine. The most common side effects in pediatric patients include:

• Nausea
• Decreased weight
• Dizziness
• Diarrhea
• Stomach pain

Parents and caregivers should monitor children closely when they start taking duloxetine and report any concerning symptoms to their healthcare provider.

Serious Side Effects and Warnings: When to Seek Medical Attention

While most side effects of duloxetine are mild, some can be serious and require immediate medical attention. It’s crucial to be aware of these potential risks and know when to seek help.

What Serious Side Effects Should You Watch For?

Some serious side effects that may occur with duloxetine use include:

• Liver damage
• Significant changes in blood pressure
• Serotonin syndrome
• Abnormal bleeding
• Severe skin reactions
• Manic episodes (in people with depression or bipolar disorder)
• Vision problems
• Seizures or convulsions
• Low sodium levels in the blood
• Problems with urination

If you experience symptoms associated with any of these conditions, such as yellowing of the skin or eyes, severe dizziness, hallucinations, or unusual bleeding or bruising, seek medical attention immediately.

Understanding the Black Box Warning

Duloxetine carries a Black Box Warning, the most serious warning from the Food and Drug Administration (FDA). This warning pertains to an increased risk of suicidal thoughts and behaviors, particularly in young adults aged 24 years and younger. It’s crucial for patients, especially those in this age group, to be monitored closely for worsening depression or emergence of suicidal ideation, especially in the early stages of treatment or during dosage adjustments.

Duloxetine Dosage and Administration: Guidelines for Safe Use

Proper administration of duloxetine is crucial for its effectiveness and safety. The dosage can vary depending on the condition being treated and individual patient factors.

How Should Duloxetine Be Taken?

Duloxetine is available as an oral capsule and should be taken exactly as prescribed by your healthcare provider. Generally, it’s taken once or twice daily, with or without food. The capsules should be swallowed whole and not crushed, chewed, or opened.

What Are the Typical Dosages for Different Conditions?

Dosages can vary, but some common starting doses include:

• Major Depressive Disorder: 40-60 mg/day
• Generalized Anxiety Disorder: 60 mg/day
• Diabetic Peripheral Neuropathic Pain: 60 mg/day
• Fibromyalgia: 60 mg/day
• Chronic Musculoskeletal Pain: 60 mg/day

Your doctor may adjust your dose based on your response to the medication and any side effects you experience. Never change your dose without consulting your healthcare provider.

Drug Interactions: Medications to Avoid While Taking Duloxetine

Duloxetine can interact with various medications, potentially altering its effectiveness or increasing the risk of side effects. It’s crucial to inform your healthcare provider about all medications, supplements, and herbal products you’re taking.

Which Medications Can Interact with Duloxetine?

Some medications that may interact with duloxetine include:

• Monoamine oxidase inhibitors (MAOIs)
• Other antidepressants, particularly SSRIs and SNRIs
• Triptans (used for migraine treatment)
• Certain pain medications, including tramadol and fentanyl
• Certain medications used to treat mental health conditions, such as lithium or antipsychotics
• Blood thinners like warfarin
• Nonsteroidal anti-inflammatory drugs (NSAIDs)

This list is not exhaustive, and other drugs may also interact with duloxetine. Always consult with your healthcare provider or pharmacist about potential drug interactions.

How Can You Minimize the Risk of Drug Interactions?

To reduce the risk of potentially harmful drug interactions:

1. Keep an up-to-date list of all medications, supplements, and herbal products you’re taking
2. Inform all healthcare providers about your current medications before starting any new treatment
3. Avoid starting or stopping any medication without consulting your doctor
4. Be cautious about using over-the-counter medications, particularly NSAIDs, without medical advice

Special Considerations: Duloxetine Use in Specific Populations

Certain groups of people may need special consideration when using duloxetine. These include pregnant women, breastfeeding mothers, elderly patients, and those with certain medical conditions.

Is Duloxetine Safe During Pregnancy and Breastfeeding?

The safety of duloxetine during pregnancy and breastfeeding is not fully established. Some studies suggest a potential risk of complications, particularly when used in late pregnancy. If you’re pregnant, planning to become pregnant, or breastfeeding, discuss the potential risks and benefits of duloxetine use with your healthcare provider. They can help you make an informed decision based on your individual circumstances.

How Should Elderly Patients Use Duloxetine?

Elderly patients may be more sensitive to the effects of duloxetine and may have an increased risk of certain side effects, such as falls due to dizziness or low blood pressure. Dosage adjustments may be necessary, and closer monitoring is often required. If you’re an older adult taking duloxetine, regular check-ins with your healthcare provider are important to ensure the medication remains safe and effective for you.

What Precautions Should Patients with Liver or Kidney Problems Take?

Duloxetine is primarily metabolized by the liver and excreted by the kidneys. Patients with liver or kidney problems may need dosage adjustments or may not be suitable candidates for duloxetine treatment. Regular liver function tests may be recommended for patients taking duloxetine, especially those with a history of liver problems.

Discontinuing Duloxetine: Managing Withdrawal Symptoms

Abruptly stopping duloxetine can lead to withdrawal symptoms, also known as discontinuation syndrome. It’s important to understand how to safely discontinue the medication if necessary.

What Are Common Withdrawal Symptoms?

Withdrawal symptoms from duloxetine can include:

• Dizziness
• Nausea
• Headache
• Irritability
• Fatigue
• Insomnia
• Sensory disturbances (such as “brain zaps”)
• Anxiety

These symptoms are usually mild and temporary but can be uncomfortable.

How Can You Safely Discontinue Duloxetine?

To minimize withdrawal symptoms:

1. Never stop taking duloxetine abruptly without medical supervision
2. Work with your healthcare provider to develop a tapering plan
3. Gradually reduce your dose over several weeks or months as directed by your doctor
4. Monitor for withdrawal symptoms and report any concerns to your healthcare provider
5. Consider lifestyle changes that may help manage symptoms, such as regular exercise and stress reduction techniques

Remember, the goal is to minimize discomfort while safely discontinuing the medication. Your healthcare provider can guide you through this process and adjust the plan as needed.

In conclusion, duloxetine is a powerful medication that can be highly effective in treating various conditions, from depression and anxiety to chronic pain. However, like all medications, it comes with potential risks and side effects. Understanding how to use duloxetine safely, recognizing potential side effects, and knowing when to seek medical attention are crucial for optimal treatment outcomes. Always work closely with your healthcare provider to ensure that duloxetine is the right choice for you and that you’re using it safely and effectively. Regular check-ins, open communication about any concerns or side effects, and adherence to prescribed dosages and guidelines can help you maximize the benefits of duloxetine while minimizing potential risks.

Side effects, dosage, uses, and more

1. Duloxetine oral capsule is available as both a generic and a brand-name drug. Brand name: Cymbalta.
2. Duloxetine only comes as a capsule you take by mouth.
3. Duloxetine oral capsule is used to treat anxiety, depression, diabetic nerve pain, fibromyalgia, and chronic (long-lasting) muscle and joint pain.

FDA warning: Suicidal thoughts and behaviors

• This drug has a Black Box Warning. This is the most serious warning from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients to potentially dangerous effects.
• This drug may increase the risk of suicidal thoughts and behaviors in people aged 24 years and younger. This drug can make depression worse in the early stages of treatment. Tell your doctor right away if your depression gets worse or if you have thoughts about suicide.

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• Drowsiness warning: This drug can cause sleepiness or affect your ability to make decisions, think clearly, or react quickly. You shouldn’t drive, use heavy machinery, or do other dangerous activities until you know how the drug affects you.
• Serotonin syndrome warning: This drug affects a chemical in your brain called serotonin. Taking this drug with other medications that affect serotonin may result in increased risk of a serious side effect called serotonin syndrome. Symptoms may include:
  • agitation
  • confusion
  • increased blood pressure or heart rate
  • sweating
  • loss of coordination
• Dizziness and falling warning: This drug can cause a sudden drop in blood pressure if you stand up too fast. This can cause dizziness and increase your risk of falling.

Duloxetine is a prescription drug. It only comes in the form of an oral capsule.

Duloxetine oral capsule is available as the brand-name drugs Cymbalta and Irenka. It’s also available as a generic drug. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in all strengths or forms as the brand-name drug.

Why it’s used

Duloxetine oral capsule is used to treat:

• generalized anxiety disorder
• major depressive disorder
• nerve pain caused by diabetes
• fibromyalgia pain
• chronic muscle and joint pain

How it works

Duloxetine belongs to a class of drugs called serotonin-norepinephrine reuptake inhibitors (SNRIs).

It works by balancing chemicals in your brain that cause depression and anxiety. By balancing these chemicals, this drug also helps inhibit pain signals from your nerves to your brain.

Duloxetine oral capsule can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You shouldn’t drive, use heavy machinery, or do other dangerous activities until you know how it affects you. It can also cause other side effects.

More common side effects

In adults, the more common side effects of duloxetine can include:

• nausea
• dry mouth
• sleepiness
• fatigue
• constipation
• loss of appetite
• increased sweating
• dizziness

In children, the more common side effects of duloxetine can include:

• nausea
• decreased weight
• dizziness
• diarrhea
• stomach pain

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Liver damage. Symptoms can include:
  • itching
  • pain in the right side of your upper abdomen
  • dark-colored urine
  • yellowing of your skin or the whites of your eyes
• Changes in blood pressure. Symptoms can include:
  • dizziness or fainting when standing. This may occur more often when you first start duloxetine or when you increase the dose.
• Serotonin syndrome. Symptoms can include:
  • agitation
  • hallucinations
  • coma
  • coordination problems or muscle twitching
  • racing heart
  • high or low blood pressure
  • sweating or fever
  • nausea, vomiting, or diarrhea
  • muscle rigidity
  • dizziness
  • flushing
  • tremor
  • seizures
• Abnormal bleeding. Duloxetine may increase your risk of bleeding or bruising, especially if you take warfarin or nonsteroidal anti-inflammatory drugs.
• Severe skin reactions. Symptoms can include:
  • skin blisters
  • peeling rash
  • sores in your mouth
  • hives
• Manic episodes in people with depression or bipolar disorder. Symptoms can include:
  • greatly increased energy
  • severe trouble sleeping
  • racing thoughts
  • reckless behavior
  • unusually grand ideas
  • excessive happiness or irritability
  • talking more or faster than usual
• Vision problems. Symptoms can include:
  • eye pain
  • changes in vision
  • swelling or redness in or around your eye
• Seizures or convulsions
• Low salt (sodium) levels in your blood. Symptoms can include:
  • headache
  • weakness or feeling unsteady
  • confusion, problems concentrating, or thinking or memory problems
• Problems with urination. Symptoms can include:
  • decrease in your urine flow
  • trouble passing urine

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.

Duloxetine oral capsule can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Examples of drugs that can cause interactions with duloxetine are listed below.

Serotonergic drugs

Taking these drugs with duloxetine may increase your risk of serotonin syndrome, which can be fatal. If you take any of these drugs, your doctor will start you on a lowered dosage of duloxetine and monitor you for signs of serotonin syndrome. Symptoms can include agitation, sweating, muscle twitches, and confusion.

Examples of serotonergic drugs include:

• selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine and sertraline
• serotonin-norepinephrine reuptake inhibitors (SSNRIs) such as venlafaxine
• tricyclic antidepressants (TCAs) such as amitriptyline and clomipramine
• monoamine oxidase inhibitors (MAOIs) such as selegiline and phenelzine
• the opioids fentanyl and tramadol
• the anxiolytic buspirone
• triptans
• lithium
• tryptophan
• amphetamines
• St. John’s wort

Schizophrenia drug

Taking thioridazine with duloxetine can increase the amount of thioridazine in your body. This may increase your risk of arrhythmia (abnormal heart rate).

Nonsteroidal anti-inflammatory drugs (NSAIDs)

Taking duloxetine with NSAIDs may increase your risk of abnormal bleeding. Examples of NSAIDs include:

• ibuprofen
• indomethacin
• naproxen

Mental health drug

Taking aripiprazole with duloxetine may increase the amount of aripiprazole in your body. This can lead to increased side effects.

Anticoagulants (blood thinners)

Taking blood thinners with duloxetine may increase your risk of abnormal bleeding. Examples of blood thinners include:

• apixaban
• warfarin
• clopidogrel
• dabigatran
• edoxaban
• prasugrel
• rivaroxaban
• ticagrelor

Gaucher disease drug

Taking eliglustat with duloxetine can increase the amount of eliglustat in your body. This may cause side effects on your heart.

Drug for depression and stopping smoking

Taking bupropion with duloxetine may increase the amount of duloxetine in your body. This may increase your risk of seizures.

Cancer drug

Taking doxorubicin with duloxetine may increase the amount of doxorubicin in your body. This can cause increased side effects.

Antibiotic

Taking ciprofloxacin with duloxetine may increase the amount of duloxetine in your body. Avoid taking these drugs together.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

Duloxetine oral capsule drug comes with several warnings.

Alcohol interaction warning

Drinking heavily while taking this drug increases your risk of severe liver injury. Talk to your doctor about how much alcohol you drink before starting duloxetine.

Allergy warning

This drug can cause a severe allergic reaction. Symptoms may include:

• trouble breathing
• swelling of your throat or tongue
• hives

If you develop these symptoms, call 911 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

Warnings for people with certain health conditions

For people with liver disease: Avoid taking this drug if you have chronic liver disease or cirrhosis of the liver. You may have trouble clearing the drug from your body. This can lead to further liver damage.

For people with kidney disease: Avoid taking this drug if you have severe kidney disease or if you receive dialysis. Your kidneys may have trouble removing the drug from your body. This could lead to a buildup of the drug and increase your risk of side effects.

For people with diabetes: This drug may affect your blood sugar levels. If you have diabetes, your doctor may want you to monitor your levels more closely and may need to change the dosage of your diabetes medication.

For people with bladder problems: This drug may affect your ability to urinate. Talk to your doctor if you have any problems with urine flow.

For people with bipolar disorder: This drug may cause mania or hypomania. If you or someone in your family has bipolar disorder, tell your doctor before starting duloxetine.

For people with bleeding problems: This drug may increase your risk of bleeding or bruising. If you already have bleeding problems or take certain medications, your risk may be higher. Before taking this drug, tell your doctor if you have any bleeding problems.

For people with glaucoma: This drug can increase your risk of having a glaucoma attack. If you have glaucoma, tell your doctor before starting this drug.

For people with high blood pressure: This drug may increase your blood pressure. If you already have high blood pressure, let your doctor know before starting duloxetine.

For people with a history of seizures or convulsions: This drug may cause seizures or convulsions. If you already experience these, your risk may be even higher if you take this drug. Tell your doctor about any seizures or convulsions before starting duloxetine.

For people with low sodium levels in the blood: This drug can cause very low sodium levels in your blood. If you already have a low sodium level, talk with your doctor before starting duloxetine.

Warnings for other groups

For pregnant women: This drug is a category C pregnancy drug. That means two things:

1. Research in animals has shown adverse effects to the fetus when the mother takes the drug.
2. There haven’t been enough studies done in humans to be certain how the drug might affect the fetus.

Talk to your doctor if you’re pregnant or plan to become pregnant. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

If you take this drug during pregnancy, you can take part in a registry that monitors outcomes in women exposed to duloxetine during pregnancy. To enroll, talk to your doctor or call 1-866-814-6975.

For women who are breastfeeding: This drug may pass into breast milk. If you take this drug while you breastfeed, your baby may have side effects of the drug. Tell your doctor if you wish to breastfeed. You may need to decide whether to breastfeed or take this drug.

For seniors: If you’re aged 65 years or older and you take this drug, you may be at a greater risk of falls due to blood pressure changes. You may also be at greater risk of low sodium (salt) in your blood. Symptoms may include:

• headache
• weakness or feeling unsteady
• confusion, problems concentrating, or thinking or memory problems

For children: This drug hasn’t been proved to be safe or effective in treating generalized anxiety disorder in children younger than 7 years. It hasn’t been proved to be safe or effective in treating other conditions in children younger than 18 years.

This dosage information is for duloxetine oral capsule. All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:

• your age
• the condition being treated
• the severity of your condition
• other medical conditions you have
• how you react to the first dose

Forms and strengths

Generic: Duloxetine

• Form: oral delayed-release capsule
• Strengths: 20 milligrams (mg), 30 mg, 40 mg, and 60 mg

Brand: Cymbalta

• Form: oral delayed-release capsule
• Strengths: 20 mg, 30 mg, 60 mg

Dosage for major depressive disorder

Adult dosage (ages 18 years and older)

• Typical starting dosage: 30–60 mg per day.
• Typical maintenance dosage: Total daily dose of 40 mg (given as 20-mg doses twice daily) or 60 mg (given either once daily or as 30-mg doses twice daily).
• Maximum dosage: 120 mg per day.

Child dosage (ages 0–17 years)

Dosage for people younger than 18 years hasn’t been established.

Dosage for generalized anxiety disorder

Adult dosage (ages 18–64 years)

• Typical starting dosage: 30–60 mg per day.
• Typical maintenance dosage: 60 mg per day.
• Maximum dosage: 120 mg per day.

Child dosage (ages 7–17 years)

• Typical starting dosage: 30 mg per day for 2 weeks.
• Typical maintenance dosage: 30–60 mg per day.
• Maximum dosage: 120 mg per day.

Child dosage (ages 0–6 years)

Dosage for people younger than 7 years hasn’t been established.

Senior dosage (ages 65 years and older)

• Typical starting dosage: 30 mg per day for 2 weeks.
• Typical maintenance dosage: 60 mg per day.
• Maximum dosage: 120 mg per day.

Nerve pain caused by diabetes

Adult dosage (ages 18–64 years)

• Typical starting dosage: 60 mg per day.
• Maximum dosage: 60 mg per day.

Child dosage (ages 0–17 years)

Dosage for people younger than 18 years hasn’t been established.

Dosage for fibromyalgia

Adult dosage (ages 18 years and older)

• Typical starting dosage: 30 mg per day for 1 week.
• Typical maintenance dosage: 30–60 mg per day.
• Maximum dosage: 60 mg per day.

Child dosage (ages 13–17 years)

• Typical starting dosage: 30 mg per day for 1 week.
• Typical maintenance dosage: 30–60 mg per day.
• Maximum dosage: 60 mg per day.

Child dosage (ages 0–12 years)

Dosage for people younger than 13 years hasn’t been established.

Dosage for chronic muscle and joint pain

Adult dosage (ages 18 years and older)

• Typical starting dosage: 30 mg per day for 1 week.
• Typical maintenance dosage: 60 mg per day.
• Maximum dosage: 60 mg per day.

Child dosage (ages 0–17 years)

Dosage for people younger than 18 years hasn’t been established.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.

Duloxetine oral capsule is a long-term medication. It comes with risks if you don’t take it as prescribed by your doctor.

If you stop taking the drug or don’t take it at all: If you don’t take the drug, your symptoms won’t get better and could get worse. If you stop this drug quickly, you may have serious side effects, including:

• anxiety
• irritability
• feeling tired or problems sleeping
• headache
• sweating
• dizziness
• electric shock-like sensations
• vomiting or nausea
• diarrhea

If you miss doses or don’t take the drug on schedule: Your medication may not work as well or may stop working completely. For this drug to work well, a certain amount needs to be in your body at all times.

If you take too much: You could have dangerous levels of the drug in your body. Symptoms of an overdose of this drug can include:

• tiredness
• seizures
• dizziness
• increased heart rate
• high blood pressure
• vomiting

If you think you’ve taken too much of this drug, call your doctor or seek guidance from the American Association of Poison Control Centers at 1-800-222-1222 or through their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

What to do if you miss a dose: If you miss a dose, take it as soon as you remember. However, if it’s just a few hours until your next dose, skip the missed dose and take your next dose on schedule. Never try to catch up by taking two doses at once. This could result in dangerous side effects.

How to tell if the drug is working: The symptoms of the condition being treated should improve.

Keep these considerations in mind if your doctor prescribes duloxetine oral capsule for you.

General

Don’t crush or chew the delayed-release capsule.

Storage

• Store this drug at room temperature between 68°F and 77°F (20°C and 25°C).
• Keep this drug away from light.
• Don’t store this medication in moist or damp areas, such as bathrooms.

Refills

A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

• Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
• Don’t worry about airport X-ray machines. They won’t damage your medication.
• You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled container with you.
• Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Clinical monitoring

Your doctor may monitor you for new or worsening suicidal thoughts or behaviors.

Prior authorization

Many insurance companies require prior authorization for this drug. This means your doctor will need to get approval from your insurance company before your insurance company will pay for the prescription.

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk to your doctor about other drug options that may work for you.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Duloxetine (Cymbalta) | NAMI: National Alliance on Mental Illness

Generic name: Duloxetine (doo LOX e teen)

• Duloxetine
  • Capsules (delayed release): 20 mg, 30 mg, 40 mg, 60 mg

Brand names:

• Cymbalta®
  • Capsules (delayed release): 20 mg, 30 mg, 60 mg
• Drizalma Sprinkle™
  • Capsules (delayed release sprinkle): 20 mg, 30 mg, 40 mg, 60mg

All FDA black box warnings are at the end of this fact sheet. Please review before taking this medication.

What Is Duloxetine And What Does It Treat?

Duloxetine is an antidepressant medication that works in the brain. It is approved for the treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD), diabetic peripheral neuropathic pain (DPNP), fibromyalgia, and chronic musculoskeletal pain.

Symptoms of depression include:

• Depressed mood – feeling sad, empty, or tearful
• Feeling worthless, guilty, hopeless, and helpless
• Loss of interest or pleasure in your usual activities
• Sleep and eat more or less than usual (for most people it is less)
• Low energy, trouble concentrating, or thoughts of death (suicidal thinking)
• Psychomotor agitation (‘nervous energy’)
• Psychomotor retardation (feeling like you are moving and thinking in slow motion)
• Suicidal thoughts or behaviors

Generalized Anxiety Disorder (GAD) occurs when a person experiences excessive anxiety or worry for at least six months. Other symptoms include:

• Restlessness
• Fatigue (low energy, feeling tired all the time)
• Difficulty concentrating
• Irritability
• Muscle tension
• Sleep disturbance (difficulty falling asleep or waking up in the middle of the night)

What Is The Most Important Information I Should Know About Duloxetine?

Do not stop taking duloxetine, even when you feel better. With input from you, your health care provider will assess how long you will need to take the medicine.

Missing doses of duloxetine may increase your risk for relapse in your symptoms.

Stopping duloxetine abruptly may result in one or more of the following withdrawal symptoms: irritability, nausea, feeling dizzy, vomiting, nightmares, headache, and/or paresthesias (prickling, tingling sensation on the skin).

Depression is also a part of bipolar illness. People with bipolar disorder who take antidepressants may be at risk for “switching” from depression into mania. Symptoms of mania include “high” or irritable mood, very high self-esteem, decreased need for sleep, pressure to keep talking, racing thoughts, being easily distracted, frequently involved in activities with a large risk for bad consequences (for example, excessive buying sprees).

Medical attention should be sought if serotonin syndrome is suspected. Please refer to serious side effects for signs/symptoms.

Are There Specific Concerns About Duloxetine And Pregnancy?

If you are planning on becoming pregnant, notify your health care provider to best manage your medications. People living with MDD who wish to become pregnant face important decisions. Untreated MDD has risks to the fetus, as well as the mother. It is important to discuss the risks and benefits of treatment with your doctor and caregivers. For women who take antidepressant medications during weeks 13 through the end of their pregnancy (second and third trimesters), there is a risk that the baby can be born before it is fully developed (before 37 weeks).

Caution is advised with breastfeeding since duloxetine does pass into breast milk.

What Should I Discuss With My Health Care Provider Before Taking Duloxetine?

• Symptoms of your condition that bother you the most
• If you have thoughts of suicide or harming yourself
• Medications you have taken in the past for your condition, whether they were effective or caused any adverse effects
• If you experience side effects from your medications, discuss them with your provider. Some side effects may pass with time, but others may require changes to the medication.
• Any other psychiatric or medical problems you have, including a history of bipolar disorder, kidney or liver disease
• All other medications you are currently taking (including over the counter products, herbal and nutritional supplements) and any medication allergies you have
• Other non-medication treatment you are receiving, such as talk therapy or substance abuse treatment. Your provider can explain how these different treatments work with the medication.
• If you are pregnant, plan to become pregnant, or are breastfeeding
• If you drink alcohol or use drugs

How Should I Take Duloxetine?

Duloxetine is usually taken 1 or 2 times per day with or without food.

Typically, patients begin at a low dose of medicine and the dose is increased slowly over several weeks.

The dose usually ranges from 20 mg to 120 mg. Only your health care provider can determine the correct dose for you.

The duloxetine delayed release capsule (Cymbalta® or generic duloxetine) should be swallowed whole. It should not be chewed, crushed, or broken. Drizalma Sprinkle™ delayed release capsules may be opened and sprinkled on applesauce, if needed.

Consider using a calendar, pillbox, alarm clock, or cell phone alert to help you remember to take your medication. You may also ask a family member or a friend to remind you or check in with you to be sure you are taking your medication.

What Happens If I Miss A Dose Of Duloxetine?

If you miss a dose of duloxetine take it as soon as you remember, unless it is closer to the time of your next dose. Discuss this with your health care provider. Do not double your next dose or take more than what is prescribed.

What Should I Avoid While Taking Duloxetine?

Avoid drinking alcohol or using illegal drugs while you are taking antidepressant medications. They may decrease the benefits (e.g., worsen your condition) and increase adverse effects (e.g., sedation) of the medication. Alcohol increases the risk of liver problems with duloxetine.

What Happens If I Overdose With Duloxetine?

If an overdose occurs, call your doctor or 911. You may need urgent medical care. You may also contact the poison control center at 1-800-222-1222.

A specific treatment to reverse the effects of duloxetine does not exist.

What Are Possible Side Effects Of Duloxetine?

Common side effects

Headache, nausea, diarrhea, dry mouth, decreased appetite, increased sweating, feeling nervous, restless, fatigued, sleepy or having trouble sleeping (insomnia). These will often improve over the first week or two as you continue to take the medication.

Sexual side effects, such as problems with orgasm or ejaculatory delay, and blood pressure increases often do not improve over time.

Rare/serious side effects

There have been rare reports of liver failure (sometimes fatal) with duloxetine. This risk is increased in those with substantial alcohol use or chronic liver disease.

Orthostatic hypotension, or a drop in blood pressure when standing or getting up from sleeping, has been reported in patients taking duloxetine. The risk may be greater in patients also taking medications for high blood pressure.

Increased heart rate, irregular menstrual cycle, increased frequency of urination or difficulty urinating, increased liver enzymes, teeth grinding, low sodium (symptoms of low sodium levels may include headache, weakness, difficulty concentrating and remembering), angle closure glaucoma (symptoms of angle closure glaucoma may include eye pain, changes in vision, swelling or redness in or around eye), serotonin syndrome (symptoms may include shivering, diarrhea, confusion, severe muscle tightness, fever, seizures, and death), hypertensive crisis (severely elevated blood pressure), myocardial infarction (heart attack), Stevens-Johnson Syndrome (rash), pancreatitis

SNRI antidepressants, including duloxetine, may increase the risk of bleeding events. Combined use of aspirin, nonsteroidal anti-inflammatory drugs (e.g., ibuprofen, naproxen), warfarin, and other anti-coagulants may increase this risk. This may include gums that bleed more easily, nose bleed, or gastrointestinal bleeding. Some cases have been life threatening.
 

Are There Any Risks For Taking Duloxetine For Long Periods Of Time?

To date, there are no known problems associated with long term use of duloxetine. It is a safe and effective medication when used as directed.

What Other Medications May Interact With Duloxetine?

Duloxetine should not be taken with or within 2 weeks of taking monoamine oxidase inhibitors (MAOIs). These include phenelzine (Nardil®), tranylcypromine (Parnate®), isocarboxazid (Marplan®), rasagiline (Azalect®) and selegiline (Emsam®).

Although rare, there is an increased risk of serotonin syndrome when duloxetine is used with other medications that increase serotonin, such as other antidepressants, migraine medications called “triptans” (e. g., Imitrex®), some pain medications (e.g., tramadol (Ultram®), the antibiotic linezolid (Zyvox®), and amphetamines.

The following medications may increase the levels and effects of duloxetine: cimetidine (Tagamet®), ciprofloxacin (Cipro®), fluoxetine (Prozac®), fluvoxamine (Luvox®), paroxetine (Paxil®)

Duloxetine may increase the effects of other medications that can cause bleeding (e.g., ibuprofen (Advil®, Motrin®), warfarin (Coumadin®) and aspirin).

How Long Does It Take For Duloxetine To Work?

Sleep, energy, or appetite may show some improvement within the first 1-2 weeks. Improvement in these physical symptoms can be an important early signal that the medication is working. Depressed mood and lack of interest in activities may need up to 6-8 weeks to fully improve.

Summary of FDA Black Box Warnings

Suicidal thoughts or actions in children and adults

Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications. This risk may persist until significant remission occurs.

In short-term studies, antidepressants increased the risk of suicidality in children, adolescents, and young adults when compared to placebo. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24. Adults age 65 and older taking antidepressants have a decreased risk of suicidality. Patients, their families, and caregivers should be alert to the emergence of anxiety, restlessness, irritability, aggressiveness and insomnia. If these symptoms emerge, they should be reported to the patient’s prescriber or health care professional. All patients being treated with antidepressants for any indication should watch for and notify their health care provider for worsening symptoms, suicidality and unusual changes in behavior, especially during the first few months of treatment.

Provided by

(January 2023)

©2020 The American Association of Psychiatric Pharmacists (AAPP) and the National Alliance on Mental Illness (NAMI). AAPP and NAMI make this document available under the Creative Commons Attribution-No Derivatives 4.0 International License. Last Updated: January 2016.

This information is being provided as a community outreach effort of the American Association of Psychiatric Pharmacists. This information is for educational and informational purposes only and is not medical advice. This information contains a summary of important points and is not an exhaustive review of information about the medication. Always seek the advice of a physician or other qualified medical professional with any questions you may have regarding medications or medical conditions. Never delay seeking professional medical advice or disregard medical professional advice as a result of any information provided herein. The American Association of Psychiatric Pharmacists disclaims any and all liability alleged as a result of the information provided herein.

Duloxetine testing, drug monitoring in St. Petersburg

Biomaterial and method of sampling

9 0015

Deadline: up to 5 days.

Synonyms (rus)

Intriv, Cymbalta

Synonyms (eng)

Duloxetine, Cymbalta

Download sample analysis

Duloxetine belongs to the group of antidepressants. The mechanism of action of the drug is based on the ability to slow down the reuptake of serotonin and norepinephrine, which leads to the accumulation of these mediators in synapses and the development of an antidepressant effect. Duloxetine is active in the treatment of not only mild depressive disorders, but also severe depression with symptoms of melancholia. Also, the drug has a pronounced analgesic effect, which is used to relieve neuropathic pain, for example, with fibromyalgia.

Duloxetine has a high oral bioavailability. After absorption into the blood, most of the drug molecules bind to plasma proteins. Metabolism of duloxetine is carried out in the liver, during which inactive metabolites are formed, which are excreted by the kidneys in the urine. Thus, in patients with liver and kidney diseases, there is a slowdown in the metabolism and excretion of the drug and an increase in its content in the blood. Taking duloxetine is accompanied by the development of side effects: dizziness, headache, dry mouth, nausea, sleep disturbances, loss of appetite, blurred vision, decreased libido, increased blood pressure and blood glucose levels. There may be suicidal thoughts.

With a sharp cessation of taking the drug, a “withdrawal syndrome” develops, the main manifestations of which are dizziness, headache, anxiety, insomnia, nausea, tremor, and increased sweating. Overdose in patients is manifested by vomiting, tremor, clonic convulsions, ataxia.

Drug monitoring of duloxetine is prescribed in the presence of pathology of the liver and kidneys and the need to select an individual therapeutic dose, the development of symptoms of an overdose, the absence of the expected effect of treatment and suspicion of a violation of the drug regimen.

• do not eat fatty foods a few hours before the test, preferably not eat for 4 hours;
• shortly before taking blood, drink 1-2 glasses of ordinary non-carbonated water;
• do not play sports on the day of the test;
• exclude increased emotional stress;
• a few minutes before taking blood, take a comfortable position (sit down), relax, calm down;
• do not smoke for at least 30 min. before taking blood;
• refrain from drinking alcohol for 72 hours prior to testing;

Important!
If an examination is to be carried out using the CITO service, pack the sample in a separate bag and label it with the CITO sticker.

Clot Activator Gel Vacuum Tube (red cap), 6 ml + transport tube

Sample processing

• Mix 5-6 times
• Clotting at room temperature (35-40 min.