Label: CYMBALTA- duloxetine hcl capsule, delayed release pellets

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 16, 2020

If you are a consumer or patient please visit this version.

  • Medication Guide

    MEDICATION GUIDE

    Duloxetine (doo lox' e teen)
    Delayed-Release Capsules

    Read this Medication Guide before you start taking duloxetine delayed-release capsules and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

    Talk to your healthcare provider about:

    all risks and benefits of treatment with antidepressant medicines
    all treatment choices for depression or other serious mental illness

    What is the most important information I should know about antidepressant medicines, depression, other serious mental illnesses, and suicidal thoughts or actions?

    1. Duloxetine delayed-release capsules and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.

    2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts or actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness).

    3. How can I watch for and try to prevent suicidal thoughts and actions?

    Pay close attention to any changes in mood, behavior, actions, thoughts, or feelings, especially sudden changes. This is very important when an antidepressant medicine is started or when the dose is changed.
    Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
    Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

    Call your healthcare provider right away if you have any of the following symptoms or feelings, especially if they are new, worse, or worry you. In an emergency, call 911.

    attempts to commit suicide
    acting on dangerous impulses
    acting aggressive, being angry, or violent
    thoughts about suicide or dying
    new or worse depression
    new or worse anxiety
    panic attacks
    feeling very agitated or restless
    new or worse irritability
    trouble sleeping
    an extreme increase in activity or talking (mania)
    other unusual changes in behavior or mood

    What else do I need to know about antidepressant medicines?

    Never stop an antidepressant medicine without first talking to a healthcare provider.

    Stopping an antidepressant medicine suddenly can cause other symptoms.

    Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients should discuss all treatment choices with your healthcare provider, not just the use of antidepressants.
    Antidepressant medicines have other side effects. Talk to your healthcare provider about the side effects of the medicine prescribed for you or your family member.
    Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show your healthcare provider. Do not start new medicines without first checking with your healthcare provider.

    What are duloxetine delayed-release capsules?

    Duloxetine delayed-release capsules are a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD). Duloxetine delayed-release capsules belong to a class of medicines known as SNRIs (or serotonin-norepinephrine reuptake inhibitors).

    Duloxetine delayed-release capsules are also used to treat or manage:

    Generalized Anxiety Disorder (GAD)
    Diabetic Peripheral Neuropathic Pain (DPNP)
    Fibromyalgia (FM)
    Chronic Musculoskeletal Pain

    Who should not take duloxetine delayed-release capsules?

    Do Not take duloxetine delayed-release capsules if you:

    take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid or intravenous methylene blue.

    Do not take an MAOI within 5 days of stopping duloxetine delayed-release capsules unless directed to do so by your healthcare provider.
    Do not start duloxetine delayed-release capsules if you stopped taking an MAOI in the last 14 days unless directed to do so by your healthcare provider.

    People who take duloxetine delayed-release capsules close in time to an MAOI may have a serious problem called Serotonin Syndrome (see “What are the possible side effects of duloxetine delayed-release capsules?”).

    What should I tell my healthcare provider before taking duloxetine delayed-release capsules?

    Before starting duloxetine delayed-release capsules, tell your healthcare provider if you:

    have heart problems or high blood pressure
    have diabetes (duloxetine delayed-release capsules treatment makes it harder for some people with diabetes to control their blood sugar)
    have liver problems
    have kidney problems
    have glaucoma
    have or had seizures or convulsions
    have bipolar disorder or mania
    have low sodium levels in your blood
    have delayed stomach emptying
    have or had bleeding problems
    are pregnant or plan to become pregnant. Duloxetine delayed-release capsules may harm your unborn baby. Talk to your healthcare provider about the risk to your unborn baby if you take duloxetine delayed-release capsules during pregnancy.

    Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with duloxetine delayed-release capsules.

    are breastfeeding or plan to breastfeed. Duloxetine hydrochloride passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby while taking duloxetine delayed-release capsules.

    Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Duloxetine delayed-release capsules and some medicines may interact with each other, may not work as well, or may cause serious side effects.

    Especially tell your healthcare provider if you take:

    triptans used to treat migraine headache
    medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, buspirone, SSRIs, SNRIs or MAOIs
    tramadol and fentanyl
    amphetamines
    cimetidine
    the antibiotics ciprofloxacin, enoxacin
    medicine to treat irregular heart rate (like propafenone, flecainide, quinidine)
    theophylline
    the blood thinner warfarin (Coumadin, Jantoven)
    non-steroidal anti-inflammatory drug (NSAID)(like ibuprofen, naproxen or aspirin).
    over-the-counter supplements such as tryptophan or St. John’s Wort
    thioridazine (Mellaril). Mellaril together with duloxetine delayed-release capsules can cause serious heart rhythm problems or sudden death.

    Ask your healthcare provider for a list of these medicines if you are not sure. Do not take duloxetine delayed-release capsules with any other medicine that contain duloxetine.

    How should I take duloxetine delayed-release capsules?

    Take duloxetine delayed-release capsules exactly as your healthcare provider tells you to take it. Your healthcare provider may need to change the dose of duloxetine delayed-release capsules until it is the right dose for you.
    Swallow duloxetine delayed-release capsules whole. Do not chew or crush duloxetine delayed-release capsules.
    Do not open the capsule and sprinkle on food or mix with liquids. Opening the capsule may affect how well duloxetine delayed-release capsules work.
    Duloxetine delayed-release capsules may be taken with or without food.
    If you miss a dose of duloxetine delayed-release capsules, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of duloxetine delayed-release capsules at the same time.
    If you take too many duloxetine delayed-release capsules, call your healthcare provider or poison control center at 1-800-222-1222 right away, or get emergency treatment.
    When switching from another antidepressant to duloxetine delayed-release capsules your healthcare provider may want to lower the dose of the initial antidepressant first to potentially avoid side effects.

    What should I avoid while taking duloxetine delayed-release capsules?

    Duloxetine delayed-release capsules can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how duloxetine delayed-release capsules affect you.
    Use of duloxetine delayed-release capsules concomitantly with heavy alcohol intake may be associated with severe liver injury. Avoid heavy alcohol use while taking duloxetine delayed-release capsules.

    What are the possible side effects of duloxetine delayed-release capsules?

    Duloxetine delayed-release capsules may cause serious side effects, including: See “What is the most important information I should know about duloxetine delayed-release capsules?”

    Common possible side effects in people who take duloxetine delayed-release capsules include:

    1. liver damage. Symptoms may include:

    itching
    right upper abdominal pain
    dark urine
    yellow skin or eyes
    enlarged liver
    increased liver enzymes

    2. changes in blood pressure and falls. Monitor your blood pressure before starting and throughout treatment.

    Duloxetine delayed-release capsules may:

    increase your blood pressure.
    decrease your blood pressure when standing and cause dizziness or fainting, mostly when first starting duloxetine delayed-release capsules or when increasing the dose.
    increase risk of falls, especially in elderly.

    3. Serotonin Syndrome: This condition can be life-threatening and symptoms may include:

    agitation, hallucinations, coma or other changes in mental status
    coordination problems or muscle twitching (overactive reflexes)
    racing heartbeat, high or low blood pressure
    sweating or fever
    nausea, vomiting, or diarrhea
    muscle rigidity
    dizziness
    flushing
    tremor
    seizures

    4. abnormal bleeding: Duloxetine delayed-release capsules and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin, Jantoven), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.

    5. severe skin reactions: Duloxetine delayed-release capsules may cause serious skin reactions that may require stopping its use. This may need to be treated in a hospital and may be life-threatening. Call your healthcare provider right away or get emergency help if you have skin blisters, peeling rash, sores in the mouth, hives or any other allergic reactions.

    6. discontinuation symptoms: Do not stop duloxetine delayed-release capsules without first talking to your healthcare provider. Stopping duloxetine delayed-release capsules too quickly or changing from another antidepressant too quickly may result in serious symptoms including:

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

    7. manic episodes:

    greatly increased energy
    severe trouble sleeping
    racing thoughts
    reckless behavior
    unusually grand ideas
    excessive happiness or irritability
    talking more or faster than usual

    8. visual problems:

    eye pain
    changes in vision
    swelling or redness in or around the eye

    Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

    9. seizures or convulsions

    10. low salt (sodium) levels in the blood. Elderly people may be at greater risk for this.

    Symptoms may include:
    headache
    weakness or feeling unsteady
    confusion, problems concentrating or thinking or memory problems

    11. problems with urination. Symptoms may include:

    decreased urine flow
    unable to pass any urine

    The most common side effects of duloxetine delayed-release capsules include:

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

    Common possible side effects in children and adolescents who take duloxetine delayed-release capsules include:

    nausea
    decreased weight
    dizziness

    Side effects in adults may also occur in children and adolescents who take duloxetine delayed-release capsules. Children and adolescents should have height and weight monitored during treatment.

    Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

    These are not all the possible side effects of duloxetine delayed-release capsules. For more information, ask your healthcare provider or pharmacist.

    Call your doctor for medical advice about side effects. You may report side effects to 1-800-FDA-1088.

    How should I store duloxetine delayed-release capsules?

    Store duloxetine delayed-release capsules at room temperature between 68°F to 77°F (20°C to 25°C).

    Keep duloxetine delayed-release capsules and all medicines out of the reach of children.

    General information about the safe and effective use of duloxetine delayed-release capsules.

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use duloxetine delayed-release capsules for a condition for which it was not prescribed. Do not give duloxetine delayed-release capsules to other people, even if they have the same symptoms that you have. It may harm them.

    This Medication Guide summarizes the most important information about duloxetine delayed-release capsules. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about duloxetine delayed-release capsules that is written for healthcare professionals.

    For more information about duloxetine delayed-release capsules call Actavis at 1-800-432-8534.

    What are the ingredients in duloxetine delayed-release capsules?

    Active ingredient: duloxetine hydrochloride

    Inactive ingredients: ammonium hydroxide, black iron oxide, gelatin, hydroxypropyl cellulose, hydroxypropyl methylcellulose phthalate, hypromellose, potassium hydroxide, propylene glycol, shellac, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. The 20 mg and 30 mg capsules also contain FD&C Blue #1 Aluminum Lake.

    This Medication Guide has been approved by the U.S. Food and Drug Administration.

    Brands listed are trademarks of their respective owners.

    Manufactured by:
    Actavis Elizabeth LLC
    Elizabeth, NJ 07207 USA

    Distributed by:
    Actavis Pharma, Inc.
    Parsippany, NJ 07054 USA

    Rev. A 10/2019

  • Dosage and Administration

    2 DOSAGE AND ADMINISTRATION

    Swallow duloxetine delayed-release capsules whole. Do not chew or crush. Do not open the capsule and sprinkle its contents on food or mix with liquids. All of these might affect the enteric coating. Duloxetine delayed-release capsules can be given without regard to meals. If a dose of duloxetine delayed-release capsules is missed, take the missed dose as soon as it is remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses of duloxetine delayed-release capsules at the same time.

    2.1 Dosage for Treatment of Major Depressive Disorder

    Administer duloxetine delayed-release capsules at a total dose of 40 mg/day (given as 20 mg twice daily) to 60 mg/day (given either once daily or as 30 mg twice daily). For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg/day dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer any additional benefits. The safety of doses above 120 mg/day has not been adequately evaluated. Periodically reassess to determine the need for maintenance treatment and the appropriate dose for such treatment [see CLINICAL STUDIES (14.1)].

    2.2 Dosage for Treatment of Generalized Anxiety Disorder

    Adults - For most patients, initiate duloxetine delayed-release capsules 60 mg once daily. For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg once daily dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer additional benefit. Nevertheless, if a decision is made to increase the dose beyond 60 mg once daily, increase dose in increments of 30 mg once daily. The safety of doses above 120 mg once daily has not been adequately evaluated. Periodically reassess to determine the continued need for maintenance treatment and the appropriate dose for such treatment [see CLINICAL STUDIES (14.2)].

    Pediatric use information for patients ages 7 to 17 years is approved for Eli Lilly and Company, Inc.'s CYMBALTA® (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

    2.3 Dosage for Treatment of Diabetic Peripheral Neuropathic Pain

    Administer duloxetine delayed-release capsules 60 mg once daily. There is no evidence that doses higher than 60 mg confer additional significant benefit and the higher dose is clearly less well tolerated [see CLINICAL STUDIES (14.3)]. For patients for whom tolerability is a concern, a lower starting dose may be considered.

    Since diabetes is frequently complicated by renal disease, consider a lower starting dose and gradual increase in dose for patients with renal impairment [see DOSAGE AND ADMINISTRATION (2.6), USE IN SPECIFIC POPULATIONS (8.10), and CLINICAL PHARMACOLOGY (12.3)].

    2.4 Dosage for Treatment of Fibromyalgia

    Administer duloxetine delayed-release capsules 60 mg once daily. Begin treatment at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. Some patients may respond to the starting dose. There is no evidence that doses greater than 60 mg/day confer additional benefit, even in patients who do not respond to a 60 mg dose, and higher doses are associated with a higher rate of adverse reactions [see CLINICAL STUDIES (14.4)].

    2.5 Dosage for Treatment of Chronic Musculoskeletal Pain

    Administer duloxetine delayed-release capsules 60 mg once daily. Begin treatment at 30 mg for one week, to allow patients to adjust to the medication before increasing to 60 mg once daily. There is no evidence that higher doses confer additional benefit, even in patients who do not respond to a 60 mg dose, and higher doses are associated with a higher rate of adverse reactions [see CLINICAL STUDIES (14.5)].

    2.6 Dosing in Special Populations

    Hepatic Impairment - Avoid use in patients with chronic liver disease or cirrhosis [see WARNINGS AND PRECAUTIONS (5.14) and USE IN SPECIFIC POPULATIONS (8.9)].

    Severe Renal Impairment - Avoid use in patients with severe renal impairment, GFR less than 30 mL/min [see WARNINGS AND PRECAUTIONS (5.14) and USE IN SPECIFIC POPULATIONS (8.10)].

    2.7 Discontinuing Duloxetine Delayed-Release Capsules

    Adverse reactions after discontinuation of duloxetine delayed-release capsules, after abrupt or tapered discontinuation, include: dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible [see WARNINGS AND PRECAUTIONS (5.7)].

    2.8 Switching a Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

    At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with duloxetine delayed-release capsules. Conversely, at least 5 days should be allowed after stopping duloxetine delayed-release capsules before starting an MAOI intended to treat psychiatric disorders [see CONTRAINDICATIONS (4)].

    2.9 Use of Duloxetine Delayed-Release Capsules with Other MAOIs such as Linezolid or Methylene Blue

    Do not start duloxetine delayed-release capsules in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see CONTRAINDICATIONS (4)].

    In some cases, a patient already receiving duloxetine delayed-release capsules therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, duloxetine delayed-release capsules should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 5 days or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with duloxetine delayed-release capsules may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see WARNINGS AND PRECAUTIONS (5.4)].

    The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with duloxetine delayed-release capsules is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see WARNINGS AND PRECAUTIONS (5.4)].

  • Indications and Usage Section

    1 INDICATIONS AND USAGE

    Duloxetine delayed-release capsules are indicated for the treatment of:

    Major Depressive Disorder [see CLINICAL STUDIES (14.1)]
    Generalized Anxiety Disorder [see CLINICAL STUDIES (14.2)]
    Diabetic Peripheral Neuropathy [see CLINICAL STUDIES (14.3)]
    Fibromyalgia [see CLINICAL STUDIES (14.4)]
    Chronic Musculoskeletal Pain [see CLINICAL STUDIES (14.5)]

  • Principal Display Panel

    Duloxetine 30mg Capsule

  • INGREDIENTS AND APPEARANCE
    CYMBALTA 
    duloxetine hcl capsule, delayed release pellets
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:80425-0086(NDC:0228-2891)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DULOXETINE HYDROCHLORIDE (UNII: 9044SC542W) (DULOXETINE - UNII:O5TNM5N07U) DULOXETINE30 mg
    Product Characteristics
    Colorblue, grayScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code 2891;2891
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80425-0086-260 in 1 BOTTLE; Type 0: Not a Combination Product12/17/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09077612/17/2013
    Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advanced Rx Pharmacy of Tennessee, LLC117023142repack(80425-0086)