Duloxetine delayed-release capsulesPronunciation
Generic Name: duloxetine (doo-LOX-e-teen)
Brand Name: Cymbalta
Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using duloxetine delayed-release capsules outweigh the risks.
Families and caregivers must closely watch patients who take duloxetine delayed-release capsules. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor.
Duloxetine delayed-release capsules are used for:
Treating depression and generalized anxiety disorder. It is used for managing pain caused by fibromyalgia and diabetic peripheral neuropathy (DPN). Duloxetine delayed-release capsules are used for managing chronic musculoskeletal pain, including osteoarthritis and chronic low back pain. It may also be used for other conditions as determined by your doctor.
Duloxetine delayed-release capsules are a serotonin-norepinephrine reuptake inhibitor (SNRI). It works by restoring the balance of certain natural substances in the brain (serotonin and norepinephrine), which helps to improve certain mood problems and manage pain.
Do NOT use duloxetine delayed-release capsules if:
- you are allergic to any ingredient in duloxetine delayed-release capsules
- you have severe kidney problems, chronic liver disease, or cirrhosis
- you are taking or have taken linezolid or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days
- you are taking thioridazine
Contact your doctor or health care provider right away if any of these apply to you.
Before using duloxetine delayed-release capsules:
Some medical conditions may interact with duloxetine delayed-release capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you or a family member has a history of bipolar disorder (manic-depression), other mental or mood problems, suicidal thoughts or attempts, or alcohol or substance abuse
- if you have a history of seizures, heart problems (eg, heart failure, irregular heartbeat), a recent heart attack, high blood pressure, blood or bleeding problems, kidney or liver problems, diabetes, stomach or bowel problems (eg, slowed emptying), or increased eye pressure or glaucoma
- if you are dehydrated, have trouble urinating, have low blood sodium levels, or drink alcohol
- if you are taking a medicine that contains methylene blue
Some MEDICINES MAY INTERACT with duloxetine delayed-release capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:
- 5-HT1 receptor agonists (eg, sumatriptan), buspirone, fentanyl, linezolid, lithium, lorcaserin, MAOIs (eg, phenelzine, rasagiline), quinidine, SNRIs (eg, venlafaxine), SSRIs (eg, fluoxetine, fluvoxamine), St. John's wort, tramadol, tricyclic antidepressants (eg, amitriptyline), or tryptophan because severe side effects, such as a reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, or coma, may occur
- Anticoagulants (eg, warfarin), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of bleeding, including stomach bleeding, may be increased
- Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood sodium levels may be increased
- Cimetidine, medicines for high blood pressure, or quinolone antibiotics (eg, ciprofloxacin) because they may increase the risk of duloxetine delayed-release capsules's side effects
- Certain antiarrhythmics (eg, flecainide, propafenone), desipramine, phenothiazines (eg, chlorpromazine, thioridazine), or theophylline because the risk of their side effects may be increased by duloxetine delayed-release capsules
- Tamoxifen because its effectiveness may be decreased by duloxetine delayed-release capsules
This may not be a complete list of all interactions that may occur. Ask your health care provider if duloxetine delayed-release capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use duloxetine delayed-release capsules:
Use duloxetine delayed-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Duloxetine delayed-release capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get duloxetine delayed-release capsules refilled.
- Take duloxetine delayed-release capsules by mouth with or without food. Taking it with food may help to decrease the chance of nausea or stomach upset.
- Swallow duloxetine delayed-release capsules whole. Do not break, crush, or chew before swallowing. Do not open the capsule and sprinkle the contents on food or in liquid.
- Take duloxetine delayed-release capsules on a regular schedule to get the most benefit from it. Taking duloxetine delayed-release capsules at the same time each day will help you remember to take it.
- Continue to take duloxetine delayed-release capsules even if you feel well. Do not miss any doses.
- Do not suddenly stop taking duloxetine delayed-release capsules without checking with your doctor. Side effects may occur. They may include anxiety, numbness or tingling of the skin, diarrhea, dizziness, headache, increased sweating, irritability, nausea, trouble sleeping, unusual tiredness, or vomiting. If you need to stop duloxetine delayed-release capsules, your doctor may need to gradually lower your dose.
- If you miss a dose of duloxetine delayed-release capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use duloxetine delayed-release capsules.
Important safety information:
- Duloxetine delayed-release capsules may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use duloxetine delayed-release capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Duloxetine delayed-release capsules may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
- Low blood pressure, falls, and fainting have happened with duloxetine delayed-release capsules. Falls may lead to problems like broken bones and the need to go to the hospital. The risk of falling is increased in older people. Discuss any questions or concerns with your doctor.
- Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using duloxetine delayed-release capsules; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Several weeks may pass before your symptoms improve. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Do not suddenly stop taking duloxetine delayed-release capsules. Some conditions may become worse when the medicine is suddenly stopped or the dose of duloxetine delayed-release capsules are decreased. Your dose may need to be slowly lowered to decrease the risk of side effects.
- Children and teenagers who take duloxetine delayed-release capsules may be at increased risk of suicidal thoughts or actions. Adults may also be affected. The risk may be greater in patients who have had suicidal thoughts or actions in the past. The risk may also be greater in patients who have had bipolar (manic-depressive) illness, or if their family members have had it. Watch patients who take duloxetine delayed-release capsules closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
- Serotonin syndrome is a possibly fatal syndrome that can be caused by duloxetine delayed-release capsules. Your risk may be greater if you take duloxetine delayed-release capsules with certain other medicines (eg, MAOIs, SSRIs, "triptans"). Symptoms may include agitation; coma; confusion; excessive sweating; fast or irregular heartbeat; fever; hallucinations; nausea, vomiting, or diarrhea; or tremor. Contact your doctor at once if you have any of these symptoms.
- Certain antidepressants, including duloxetine delayed-release capsules, may increase the risk of bleeding. Sometimes, bleeding can be life-threatening. Discuss any questions or concerns with your doctor.
- Some people may be at risk for eye problems from duloxetine delayed-release capsules. Your doctor may want you to have an eye exam to see if you are at risk for these eye problems. Call your doctor right away if you have eye pain, vision changes, or swelling or redness in or around the eye.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
- Serious and sometimes fatal liver problems have happened with duloxetine delayed-release capsules. Call your doctor right away if you have symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, right-upper stomach pain, yellowing of the skin or eyes).
- Tell your doctor or dentist that you take duloxetine delayed-release capsules before you receive any medical or dental care, emergency care, or surgery.
- Diabetes patients - Duloxetine delayed-release capsules may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- If your doctor tells you to stop taking duloxetine delayed-release capsules, you will need to wait for at least 5 days before beginning to take certain other medicines (eg, MAOIs). Ask your doctor when you should start to take your new medicines after you have stopped taking duloxetine delayed-release capsules.
- Lab tests, including blood pressure and liver function, may be performed while you use duloxetine delayed-release capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use duloxetine delayed-release capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium levels.
- Caution is advised when using duloxetine delayed-release capsules in CHILDREN; they may be more sensitive to its effects, especially increased risk of suicidal thoughts or actions.
- Duloxetine delayed-release capsules may cause weight changes. CHILDREN and teenagers may need regular weight and growth checks while they take duloxetine delayed-release capsules.
- PREGNANCY and BREAST-FEEDING: It is not known if duloxetine delayed-release capsules can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking duloxetine delayed-release capsules while you are pregnant. Duloxetine delayed-release capsules are found in breast milk. If you are or will be breast-feeding while you use duloxetine delayed-release capsules, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of duloxetine delayed-release capsules:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; increased sweating; loss of appetite; nausea; stomach pain; tiredness; trouble sleeping; vomiting; weakness; weight loss.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bizarre behavior; bloody or black, tarry stools; confusion; decreased concentration; decreased coordination; decreased sexual desire or ability; excessive sweating; fainting; fast or irregular heartbeat; fever or chills; hallucinations; memory loss; new or worsening mental or mood changes (eg, aggressiveness, agitation, anxiety, depression, hostility, impulsiveness, irritability, panic attacks, restlessness); ringing in the ears; seizures; severe or persistent dizziness or headache; severe or persistent nausea, vomiting, or diarrhea; severe or persistent tiredness or weakness; severe or persistent trouble sleeping; sluggishness; stiff muscles; stomach pain; suicidal thoughts or attempts; tremor; trouble urinating or change in the amount of urine produced; unusual bruising or bleeding; unusual or severe weight changes; vomit that looks like coffee grounds.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of duloxetine delayed-release capsules:
Store duloxetine delayed-release capsules at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep duloxetine delayed-release capsules out of the reach of children and away from pets.
- If you have any questions about duloxetine delayed-release capsules, please talk with your doctor, pharmacist, or other health care provider.
- Duloxetine delayed-release capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take duloxetine delayed-release capsules or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about duloxetine delayed-release capsules. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to duloxetine delayed-release capsules. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using duloxetine delayed-release capsules.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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- Drug class: serotonin-norepinephrine reuptake inhibitors