Duloxetine Duloxetine Hydrochloride

Get an overview of DULOXETINE (duloxetine hydrochloride capsule, delayed release), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Duloxetine can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Duloxetine.

Drug Basics

Brand Name: Duloxetine

Generic Name: DULOXETINE HYDROCHLORIDE

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: CAPSULE, DELAYED RELEASE

Data Current As Of: 2018-10-05

indications & usage

major depressive disorder

Duloxetine delayed-release capsules USP are indicated for the treatment of major depressive disorder (MDD). The efficacy of duloxetine delayed-release capsules USP was established in four short-term and one maintenance trial in adults [see Clinical Studies (14.1)].

A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation.

generalized anxiety disorder

Duloxetine delayed-release capsules USP are indicated for the treatment of generalized anxiety disorder (GAD). The efficacy of duloxetine delayed-release capsules USP was established in three short-term trials and one maintenance trial in adults [see Clinical Studies (14.2)].

Generalized anxiety disorder is defined by the DSM-IV as excessive anxiety and worry, present more days than not, for at least 6 months. The excessive anxiety and worry must be difficult to control and must cause significant distress or impairment in normal functioning. It must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and/or sleep disturbance.

diabetic peripheral neuropathic pain

Duloxetine delayed-release capsules USP are indicated for the management of neuropathic pain (DPNP) associated with diabetic peripheral neuropathy [see Clinical Studies (14.3)].

drug abuse & dependence

abuse

In animal studies, duloxetine did not demonstrate barbiturate-like (depressant) abuse potential.

While duloxetine delayed-release capsules have not been systematically studied in humans for their potential for abuse, there was no indication of drug-seeking behavior in the clinical trials. However, it is not possible to predict on the basis of premarketing experience the extent to which a CNS active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of duloxetine delayed-release capsules (e.g., development of tolerance, incrementation of dose, drug-seeking behavior).

dependence

In drug dependence studies, duloxetine did not demonstrate dependence-producing potential in rats.

patient counseling information

See FDA-approved patient labeling (Medication Guide).

information on medication guide

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with duloxetine delayed-release capsules and should counsel them in its appropriate use. A patient Medication Guide is available for duloxetine delayed-release capsules. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide before starting duloxetine delayed-release capsules and each time their prescription is renewed, and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking duloxetine delayed-release capsules.

suicidal thoughts & behaviors

Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication [see Boxed Warning, and Warnings and Precautions (5.1)].

medication administration

Duloxetine delayed-release capsules should be swallowed whole and should not be chewed or crushed, nor should the capsule be opened and its contents be sprinkled on food or mixed with liquids. All of these might affect the enteric coating.

continuing the therapy prescribed

While patients may notice improvement with duloxetine delayed-release capsules therapy in 1 to 4 weeks, they should be advised to continue therapy as directed.

hepatotoxicity

Patients should be informed that severe liver problems, sometimes fatal, have been reported in patients treated with duloxetine delayed-release capsules. Patients should be instructed to talk to their healthcare provider if they develop itching, right upper belly pain, dark urine, or yellow skin/eyes while taking duloxetine delayed-release capsules, which may be signs of liver problems. Patients should talk to their healthcare provider about their alcohol consumption. Use of duloxetine delayed-release capsules with heavy alcohol intake may be associated with severe liver injury [see Warnings and Precautions (5.2)].

alcohol

Although duloxetine delayed-release capsules do not increase the impairment of mental and motor skills caused by alcohol, use of duloxetine delayed-release capsules concomitantly with heavy alcohol intake may be associated with severe liver injury. For this reason, duloxetine delayed-release capsules should not be prescribed for patients with substantial alcohol use [see Warnings and Precautions (5.2) and Drug Interactions (7.15)].

orthostatic hypotension & syncope

Patients should be advised of the risk of orthostatic hypotension and syncope, especially during the period of initial use and subsequent dose escalation, and in association with the use of concomitant drugs that might potentiate the orthostatic effect of duloxetine [see Warnings and Precautions (5.3)].

serotonin syndrome

Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of duloxetine delayed-release capsules and other serotonergic agents including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan and St. John’s Wort [see Contraindications (4.1), Warnings and Precautions (5.4), and Drug Interactions (7.14)].

Patients should be advised of the signs and symptoms associated with serotonin syndrome that may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular changes (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be cautioned to seek medical care immediately if they experience these symptoms.

abnormal bleeding

Patients should be cautioned about the concomitant use of duloxetine and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation since combined use of psychotropic drugs that interfere with serotonin reuptake and these agents has been associated with an increased risk of bleeding [see Warnings and Precautions (5.5)].

severe skin reactions

Patients should be cautioned that duloxetine delayed-release capsules may cause serious skin reactions. This may need to be treated in a hospital and may be life-threatening. Patients should be counseled to call their doctor right away or get emergency help if they have skin blisters, peeling rash, sores in their mouth, hives, or any other allergic reactions [see Warnings and Precautions (5.6)].

discontinuation of treatment

Patients should be instructed that discontinuation of duloxetine delayed-release capsules may be associated with symptoms such as dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue, and should be advised not to alter their dosing regimen, or stop taking duloxetine delayed-release capsules without consulting their physician [see Warnings and Precautions (5.7)].

activation of mania or hypomania

Patients with depressive symptoms should be adequately screened for risk of bipolar disorder (e.g., family history of suicide, bipolar disorder, and depression) prior to initiating treatment with duloxetine delayed-release capsules. Patients should be advised to report any signs or symptoms of a manic reaction such as greatly increased energy, severe trouble sleeping, racing thoughts, reckless behavior, talking more or faster than usual, unusually grand ideas, and excessive happiness or irritability [see Warnings and Precautions (5.8)].

seizures

Patients should be advised to inform their physician if they have a history of seizure disorder [see Warnings and Precautions (5.9)].

effects on blood pressure

Patients should be cautioned that duloxetine delayed-release capsules may cause an increase in blood pressure [see Warnings and Precautions (5.10)].

concomitant medications

Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter medications, since there is a potential for interactions [see Dosage and Administration (2.5), Contraindications (4.1)Warnings and Precautions (5.4 and 5.11), and Drug Interactions (7)].

hyponatremia

Patients should be advised that hyponatremia has been reported as a result of treatment with SNRIs and SSRIs, including duloxetine delayed-release capsules. Patients should be advised of the signs and symptoms of hyponatremia [see Warnings and Precautions (5.12)].

concomitant illnesses

Patients should be advised to inform their physicians about all of their medical conditions [see Warnings and Precautions (5.13)].

urinary hesitancy & retention

Duloxetine delayed-release capsules are in a class of medicines that may affect urination. Patients should be instructed to consult with their healthcare provider if they develop any problems with urine flow [see Warnings and Precautions (5.14)].

pregnancy & breast feeding

Patients should be advised to notify their physician if they

interference with psychomotor performance

Any psychoactive drug may impair judgment, thinking, or motor skills. Although in controlled studies duloxetine delayed-release capsules have not been shown to impair psychomotor performance, cognitive function, or memory, it may be associated with sedation and dizziness. Therefore, patients should be cautioned about operating hazardous machinery including automobiles, until they are reasonably certain that duloxetine delayed-release capsules therapy does not affect their ability to engage in such activities.

Distributed by:
Citron Pharma LLC
Suite -1101
2 Tower Center Blvd
East Brunswick NJ 08816

Code No.: DRUGS/AP/19/1993

Made in India

Issued: November 2013

Repackaged By:
Kaiser Foundation Hospitals
Livermore, CA 94551

medication guide

Duloxetine Delayed-Release Capsules USP

Read the Medication Guide that comes with duloxetine delayed-release capsules before you start taking them and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about.

What is the most important information I should know about duloxetine delayed-release capsules? 

Duloxetine delayed-release capsules and other antidepressant medicines may cause serious side effects, including: 

1.  Suicidal thoughts or actions:

  • 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.
  • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
  • Watch for these changes and call your healthcare provider right away if you notice:
    • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
    • Pay particular attention to such changes when duloxetine delayed-release capsules are started or when the dose is changed.
Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

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

  • attempts to commit suicide
  • acting on dangerous impulses
  • acting aggressive or violent
  • thoughts about suicide or dying
  • new or worse depression
  • new or worse anxiety or panic attacks
  • feeling agitated, restless, angry or irritable
  • trouble sleeping
  • an increase in activity or talking more than what is normal for you
  • other unusual changes in behavior or mood

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Duloxetine delayed-release capsules may be associated with these serious side effects:

2.
Liver damage - symptoms may include:

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

3.  Serotonin Syndrome - This condition can be life-threatening and 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 doctor right away or get emergency help if you have skin blisters, peeling rash, sores in the mouth, hives or any other allergic reactions. 

6.  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
7.  Seizures or convulsions

8.  Changes in blood pressure.

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.

 9. 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

10.       Problems with urination include:

  • decreased urine flow
  • unable to pass any urine

11.       Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.

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, nausea, diarrhea

What are duloxetine delayed-release capsules? 

Duloxetine delayed-release capsules are a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider. Duloxetine delayed-release capsules are also used to treat or manage:

  • Major Depressive Disorder (MDD) 
  • Generalized Anxiety Disorder (GAD)
  • Diabetic Peripheral Neuropathic Pain (DPNP)

Talk to your healthcare provider if you do not think that your condition is getting better with duloxetine delayed-release capsules treatment.

Who should not take duloxetine delayed-release capsules?

Do NOT take duloxetine delayed-release capsules if you:

  • have uncontrolled narrow-angle glaucoma 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.
  • Do not take an MAOI within 5 days of stopping duloxetine delayed-release capsules unless directed to do so by your physician.
  • Do not start duloxetine delayed-release capsules if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

People who take duloxetine delayed-release capsules close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:

 

  • high fever
  • uncontrolled muscle spasms
  • stiff muscles
  • rapid changes in heart rate or blood pressure
  • confusion
  • loss of consciousness (pass out)
  • take Mellaril* (thioridazine) because this can cause serious heart rhythm problems or sudden death.

What should I tell my healthcare provider before taking duloxetine delayed-release capsules? Ask if you are not sure.

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

  • Are taking certain drugs such as: 
    • 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
    • Cimetidine
    • The antibiotics ciprofloxacin, enoxacin
    • Medicine to control heart rate such as 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
    • have heart problems or high blood pressure
    • have diabetes (duloxetine delayed-release capsules treatment worsens the control of blood sugar in some patients with diabetes)
    • 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. It is not known if duloxetine delayed-release capsules will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression or other conditions with duloxetine delayed-release capsules during pregnancy.
    • are breast-feeding or plan to breast-feed. Some duloxetine hydrochloride may pass into your breast milk. 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 non-prescription 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. 

Your healthcare provider or pharmacist can tell you if it is safe to take duloxetine delayed-release capsules with your other medicines. Do not start or stop any medicine while taking duloxetine delayed-release capsules without talking to your healthcare provider first.

If you take duloxetine delayed-release capsules, you should not take any other medicines that contain duloxetine.

How should I take duloxetine delayed-release capsules?

  • Take duloxetine delayed-release capsules exactly as prescribed. Your healthcare provider may need to change the dose of duloxetine delayed-release capsules until it is the right dose for you.
  • Do not open, break or chew the capsule; it must be swallowed whole.
  • 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 much duloxetine hydrochloride, call your healthcare provider or poison control center right away, or get emergency treatment.
  • When switching from another antidepressant to duloxetine delayed-release capsules your doctor 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 all of those described in the section entitled “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:

  • nausea
  • dry mouth
  • sleepiness
  • fatigue
  • loss of appetite
  • increased sweating
  • dizziness
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 THE FDA AT 1-800-FDA­-1088.

H

ow should I store duloxetine delayed-release capsules? 

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

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

General information about 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 condition. They 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 Citron Pharma LLC. at 1-855-5-CITRON (1-855-524-8766).

What are the ingredients in duloxetine delayed-release capsules? 

Active ingredient: duloxetine hydrochloride 

Inactive ingredients:

  • Delayed-Release Capsules: crospovidone, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, methylene chloride, sugar spheres, talc, titanium dioxide, and triethylcitrate. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulphate. In addition, the 20 mg and 60 mg contain FD&C Blue No. 2 and iron oxide yellow and 30 mg contains FD&C Blue No. 2. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.

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

*The brands listed are trademarks of their respective owners and not trademarks Aurobindo Pharma limited.

Distributed by:
Citron Pharma LLC
Suite -1101
2 Tower Center Blvd
East Brunswick NJ 08816

Code No.: DRUGS/AP/19/1993

Made in India

Issued: November 2013

Repackaged By:
Kaiser Foundation Hospitals
Livermore, CA 94551

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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