Duloxetine Delayed-Release CapsulesGeneric Name:
Duloxetine (doo-LOX-e-teen)Brand Name:
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 (DPNP). It may also be used for other conditions as determined by your doctor.
Duloxetine Delayed-Release Capsules are a serotonin and 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.
Do NOT use Duloxetine Delayed-Release Capsules if:
- you are allergic to any ingredient in Duloxetine Delayed-Release Capsules
- you have uncontrolled narrow-angle glaucoma
- you have liver problems or severe kidney problems, or you are having dialysis
- you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days
- you are taking a quinolone antibiotic (eg, ciprofloxacin), a selective serotonin reuptake inhibitor (SSRI) (eg, fluoxetine, fluvoxamine), an SNRI (eg, venlafaxine), thioridazine, or tryptophan
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), recent heart attack, high blood pressure, kidney problems, diabetes, stomach or bowel problems (eg, slowed emptying), or increased eye pressure (eg, glaucoma)
- if you are dehydrated, have trouble urinating, have low blood sodium levels, or drink alcohol
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), linezolid, lithium, MAOIs (eg, phenelzine), quinidine, rasagiline, SNRIs (eg, venlafaxine), SSRIs (eg, fluoxetine, fluvoxamine), St. John's wort, tramadol, 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), phenothiazines (eg, chlorpromazine, thioridazine), or tricyclic antidepressants (eg, amitriptyline) because the risk of their side effects may be increased 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 mental or mood changes, numbness or tingling of the skin, diarrhea, dizziness, confusion, headache, increased sweating, nausea, nightmare, ringing in the ears, seizures, trouble sleeping, unusual tiredness, or vomiting. You will be closely monitored when you start Duloxetine Delayed-Release Capsules and whenever a change in dose is made.
- 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, lightheadedness, 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.
- 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 for 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; tremor. Contact your doctor at once if you have any of these symptoms.
- Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Duloxetine Delayed-Release Capsules. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
- 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 should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Duloxetine Delayed-Release Capsules may cause harm to the fetus if it is used during the last 3 months of pregnancy. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Duloxetine Delayed-Release Capsules while you are pregnant. Duloxetine Delayed-Release Capsules are found in breast milk. Do not breast-feed while taking Duloxetine Delayed-Release Capsules.
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:
Constipation; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; headache; increased sweating; loss of appetite; nausea; sore throat; tiredness; trouble sleeping; vomiting; weakness.Seek medical attention right away if any of these SEVERE side effects occur:
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; blurred vision; confusion; dark urine; decreased concentration; decreased coordination; excessive sweating; fainting; fast or irregular heartbeat; fever or chills; hallucinations; memory loss; new or worsening aggressiveness, agitation, anxiety, hostility, impulsiveness, irritability, panic attacks, restlessness, or inability to sit still; pale stools; red, swollen, blistered, or peeling skin; 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; 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 mental or mood changes; unusual weakness; vomit that looks like coffee grounds; worsening of depression; yellowing of the skin or eyes.
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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include agitation; blurred vision; coma; confusion; excessive sweating; fainting; fast or irregular heartbeat; fever; hallucinations; seizures; severe or persistent diarrhea, dizziness, drowsiness, headache, nausea, or vomiting; severe or persistent tiredness or weakness.Proper storage of Duloxetine Delayed-Release Capsules:
Store Duloxetine Delayed-Release Capsules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. 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.
This information is a summary only. It does not contain all information about Duloxetine Delayed-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.