Cymbalta (Page 13 of 13)

14.6 Chronic Musculoskeletal Pain in Adults

CYMBALTA is indicated for the treatment of chronic musculoskeletal pain in adults. This has been established in trials in adult patients with chronic low back pain and chronic pain due to osteoarthritis.

Trials in Chronic Low Back Pain in Adults

The efficacy of CYMBALTA in chronic low back pain (CLBP) in adults was assessed in two double-blind, placebo-controlled, randomized clinical trials of 13-weeks duration (Studies CLBP-1 and CLBP-2), and one of 12-weeks duration (CLBP-3). Studies CLBP-1 and CLBP-3 demonstrated efficacy of CYMBALTA in the treatment of CLBP. Patients in all trials had no signs of radiculopathy or spinal stenosis.

Study CLBP-1: Two hundred thirty-six adult patients (N=115 on CYMBALTA, N=121 on placebo) enrolled and 182 (77%) completed 13-week treatment phase. After 7 weeks of treatment, CYMBALTA-treated patients with less than 30% reduction in average daily pain and who were able to tolerate 60 mg once daily had their CYMBALTA dosage, in a double-blinded fashion, increased to 120 mg once daily for the remainder of the trial. Patients had a mean baseline pain rating of 6 on a numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain). After 13 weeks of treatment, patients taking CYMBALTA 60-120 mg daily had a significantly greater pain reduction compared to patients taking placebo. Randomization was stratified by the patients’ baseline NSAIDs use status. Subgroup analyses did not indicate that there were differences in treatment outcomes as a function of NSAIDs use.

Study CLBP-2: Four hundred and four patients were randomized to receive fixed dosages of CYMBALTA daily or a matching placebo (N=59 on CYMBALTA 20 mg, N=116 on CYMBALTA 60 mg, N=112 on CYMBALTA 120 mg, N=117 on placebo) and 267 (66%) completed the entire 13-week trial. After 13 weeks of treatment, none of the three CYMBALTA dosages showed a statistically significant difference in pain reduction compared to placebo.

Study CLBP-3: Four hundred and one patients were randomized to receive fixed doses of CYMBALTA 60 mg daily or placebo (N=198 on CYMBALTA, N=203 on placebo), and 303 (76%) completed the trial. Patients had a mean baseline pain rating of 6 on a numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain). After 12 weeks of treatment, patients taking CYMBALTA 60 mg daily had significantly greater pain reduction compared to patients taking placebo.

For various degrees of improvement in pain from baseline to study endpoint, Figures 8 and 9 show the fraction of patients in Studies CLBP-1 and CLBP-3 achieving that degree of improvement, respectively. The figures are cumulative, so that patients whose change from baseline is, for example, 50%, are also included at every level of improvement below 50%. Patients who did not complete the trial were assigned the value of 0% improvement.

Figure 8: Percentage of Adult Patients with CLBP Achieving Various Levels of Pain Relief as Measured by 24-Hour Average Pain Severity (Study CLBP-1)

Figure 8
(click image for full-size original)

Figure 9: Percentage of Adult Patients with CLBP Achieving Various Levels of Pain Relief as Measured by 24-Hour Average Pain Severity (Study CLBP-3)

Figure 9
(click image for full-size original)

Trials in Chronic Pain Due to Osteoarthritis in Adults

The efficacy of CYMBALTA in chronic pain due to osteoarthritis (OA) in adults was assessed in 2 double-blind, placebo-controlled, randomized clinical trials of 13-weeks duration (Study OA-1 and Study OA-2). All patients in both trials fulfilled the ACR clinical and radiographic criteria for classification of idiopathic OA of the knee. Randomization was stratified by the patients’ baseline NSAIDs-use status.

Patients assigned to CYMBALTA started treatment in both trials at a dose of 30 mg once daily for one week. After the first week, the dose of CYMBALTA was increased to 60 mg once daily. After 7 weeks of treatment with CYMBALTA 60 mg once daily, in Study OA-1 patients with sub-optimal response to treatment (<30% pain reduction) and tolerated CYMBALTA 60 mg once daily had their dose increased to 120 mg. However, in Study OA-2, all patients, regardless of their response to treatment after 7 weeks, were re-randomized to either continue receiving CYMBALTA 60 mg once daily or have their dosage increased to 120 mg once daily for the remainder of the trial. Patients in the placebo treatment groups in both trials received a matching placebo for the entire duration of trials. For both trials, efficacy analyses were conducted using 13-week data from the combined CYMBALTA 60 mg and 120 mg once daily treatment groups compared to the placebo group.

Study OA-1: Two hundred fifty-six patients (N=128 on CYMBALTA, N=128 on placebo) enrolled and 204 (80%) completed the trial. Patients had a mean baseline pain rating of 6 on a numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain). After 13 weeks of treatment, patients taking CYMBALTA had significantly greater pain reduction than patients taking placebo. Subgroup analyses did not indicate that there were differences in treatment outcomes as a function of NSAIDs use.

Study OA-2: Two hundred thirty-one patients (N=111 on CYMBALTA, N=120 on placebo) enrolled and 173 (75%) completed the trial. Patients had a mean baseline pain of 6 on a numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain). After 13 weeks of treatment, patients taking CYMBALTA did not show a significantly greater pain reduction than patients taking placebo.

In Study OA-1, for various degrees of improvement in pain from baseline to study endpoint, Figure 10 shows the fraction of patients achieving that degree of improvement. The figure is cumulative, so that patients whose change from baseline is, for example, 50%, are also included at every level of improvement below 50%. Patients who did not complete the trial were assigned the value of 0% improvement.

Figure 10: Percentage of Adult Patients with OA Achieving Various Levels of Pain Relief as Measured by 24-Hour Average Pain Severity (Study OA-1)

Figure 10
(click image for full-size original)

16 HOW SUPPLIED/STORAGE AND HANDLING

30 mg,

Body color: opaque white

Cap color: opaque blue

Cap imprint: Lilly 3240

Body imprint: 30mg

Capsule number: PU3240

NDC: 70518-2099-00

PACKAGING: 30 in 1 BLISTER PACK

a equivalent to duloxetine base

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

16.2 Storage and Handling

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

  • Suicidal Thoughts and Behaviors — Advise patients, their families, and their caregivers to look for the emergence of suicidal ideation and behavior, especially during treatment and when the dose is adjusted up or down and instruct them to report such symptoms to their healthcare provider [see Boxed Warning and Warnings and Precautions ( 5.1)] .
  • Administration — Advise patients to swallow CYMBALTA whole and to not chew, crush, or open the capsule (do not sprinkle contents on food or mixed with liquids) because these actions might affect the enteric coating.
  • Hepatotoxicity — Inform patients that severe liver problems, sometimes fatal, have been reported in patients treated with CYMBALTA. Instruct patients to talk to their healthcare provider if they develop itching, right upper belly pain, dark urine, or yellow skin/eyes while taking CYMBALTA, which may be signs of liver problems. Instruct patients to talk to their healthcare provider about their alcohol consumption. Use of CYMBALTA with heavy alcohol intake may be associated with severe liver injury [see Warnings and Precautions ( 5.2)] .
  • Alcohol — Although CYMBALTA does not increase the impairment of mental and motor skills caused by alcohol, use of CYMBALTA concomitantly with heavy alcohol intake may be associated with severe liver injury [see Warnings and Precautions ( 5.2) and Drug Interactions ( 7.15)] .
  • Orthostatic Hypotension, Falls and Syncope — Advise patients of the risk of orthostatic hypotension, falls 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 CYMBALTA [see Warnings and Precautions ( 5.3)] .
  • Serotonin Syndrome — Caution patients about the risk of serotonin syndrome with the concomitant use of CYMBALTA and other serotonergic agents including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, amphetamines, and St. John’s Wort [see Contraindications ( 4), Warnings and Precautions ( 5.4), and Drug Interactions ( 7.14)] . Advise patients 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). Caution patients to seek medical care immediately if they experience these symptoms.
  • Increased Risk of Bleeding — Caution patients about the concomitant use of CYMBALTA 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) and Use in Specific Populations ( 8.1)] .
  • Severe Skin Reactions — Caution patients that CYMBALTA may cause serious skin reactions. This may need to be treated in a hospital and may be life-threatening. Counsel patients 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 — Instruct patients that discontinuation of CYMBALTA 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 CYMBALTA without consulting their healthcare provider [see Warnings and Precautions ( 5.7)] .
  • Activation of Mania or Hypomania — Adequately screen patients with depressive symptoms for risk of bipolar disorder (e.g. family history of suicide, bipolar disorder, and depression) prior to initiating treatment with CYMBALTA. Advise patients 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)] .
  • Angle-Closure Glaucoma — Advise patients that taking CYMBALTA can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle-closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible [see Warnings and Precautions ( 5.9)] .
  • Seizures — Advise patients to inform their healthcare provider if they have a history of seizure disorder [see Warnings and Precautions ( 5.10)] .
  • Effects on Blood Pressure — Caution patients that CYMBALTA may cause an increase in blood pressure [see Warnings and Precautions ( 5.11)] .
  • Concomitant Medications — Advise patients to inform their healthcare provider 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 ( 2.9, 2.10), Contraindications ( 4), Warnings and Precautions ( 5.4, 5.12), and Drug Interactions ( 7)] .
  • Hyponatremia — Advise patients that hyponatremia has been reported as a result of treatment with SNRIs and SSRIs, including CYMBALTA. Advise patients of the signs and symptoms of hyponatremia [see Warnings and Precautions ( 5.13)] .
  • Concomitant Illnesses — Advise patients to inform their healthcare provider about all of their medical conditions [see Warnings and Precautions ( 5.14)] .
  • Urinary Hesitation and Retention — CYMBALTA is in a class of medicines that may affect urination. Instruct patients to consult with their healthcare provider if they develop any problems with urine flow [see Warnings and Precautions ( 5.15)] .
  • Pregnancy
    • Advise women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with CYMBALTA.
    • Advise pregnant women or patients who intend to become pregnant that CYMBALTA use during the month before delivery may lead to an increased risk for postpartum hemorrhage and may increase the risk of neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding.
    • Advise pregnant women that there is a risk of relapse with discontinuation of antidepressants.
    • Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to duloxetine during pregnancy [see Use in Specific Populations ( 8.1)] .
  • Lactation — Advise breastfeeding women using CYMBALTA to monitor infants for sedation, poor feeding and poor weight gain and to seek medical care if they notice these signs [see Use in Specific Populations ( 8.2)] .
  • Interference with Psychomotor Performance — CYMBALTA may be associated with sedation and dizziness. Therefore, caution patients about operating hazardous machinery including automobiles, until they are reasonably certain that CYMBALTA therapy does not affect their ability to engage in such activities.

Repackaged By / Distributed By: RemedyRepack Inc.

625 Kolter Drive, Indiana, PA 15701

(724) 465-8762

Medication Guide

Cymbalta ®
[sim-BALL-tah] (duloxetine delayed-release capsules)

Read this Medication Guide before you start taking Cymbalta ® 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. Cymbalta 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 is Cymbalta?

Cymbalta is a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD). Cymbalta belongs to a class of medicines known as SNRIs (or serotonin-norepinephrine reuptake inhibitors).

Cymbalta is also used to treat or manage:

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

Who should not take Cymbalta?

Do Not take Cymbalta 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 Cymbalta unless directed to do so by your healthcare provider.
    • Do not start Cymbalta if you stopped taking an MAOI in the last 14 days unless directed to do so by your healthcare provider.

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

What should I tell my healthcare provider before taking Cymbalta?

Before starting Cymbalta, tell your healthcare provider if you:

  • have heart problems or high blood pressure
  • have diabetes (Cymbalta 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. Cymbalta may harm your unborn baby. Talk to your healthcare provider about the risk to your unborn baby if you take Cymbalta during pregnancy.
    • Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Cymbalta.
    • If you become pregnant while taking Cymbalta, talk to your healthcare provider about registering with the Cymbalta Pregnancy Registry. You can register by calling 1-866-814-6975 or by visiting www.cymbaltapregnancyregistry.com. The purpose of this registry is to monitor the pregnancy outcomes in women who have been treated with Cymbalta at any time during pregnancy.
  • are breastfeeding or plan to breastfeed. Cymbalta 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 Cymbalta.

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Cymbalta 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 Cymbalta 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 Cymbalta with any other medicine that contain duloxetine.

How should I take Cymbalta?

  • Take Cymbalta exactly as your healthcare provider tells you to take it. Your healthcare provider may need to change the dose of Cymbalta until it is the right dose for you.
  • Swallow Cymbalta whole. Do not chew or crush Cymbalta.
  • Do not open the capsule and sprinkle on food or mix with liquids. Opening the capsule may affect how well Cymbalta works.
  • Cymbalta may be taken with or without food.
  • If you miss a dose of Cymbalta, 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 Cymbalta at the same time.
  • If you take too much Cymbalta, 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 Cymbalta 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 Cymbalta?

  • Cymbalta 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 Cymbalta affects you.
  • Use of Cymbalta concomitantly with heavy alcohol intake may be associated with severe liver injury. Avoid heavy alcohol use while taking Cymbalta.

What are the possible side effects of Cymbalta?

Cymbalta may cause serious side effects, including: See “ What is the most important information I should know about Cymbalta?”

Common possible side effects in people who take Cymbalta 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. Cymbalta may:

  • increase your blood pressure.
  • decrease your blood pressure when standing and cause dizziness or fainting, mostly when first starting Cymbalta 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: Cymbalta 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: Cymbalta 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 Cymbalta without first talking to your healthcare provider. Stopping Cymbalta 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 Cymbalta include:

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

Common possible side effects in children and adolescents who take Cymbalta include:

  • nausea
  • decreased weight
  • dizziness

Side effects in adults may also occur in children and adolescents who take Cymbalta. 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 Cymbalta. 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 Cymbalta?

Store Cymbalta at room temperature between 68°F to 77°F (20°C to 25°C).

Keep Cymbalta and all medicines out of the reach of children.

General information about the safe and effective use of Cymbalta.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Cymbalta for a condition for which it was not prescribed. Do not give Cymbalta 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 Cymbalta. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about Cymbalta that is written for healthcare professionals.

For more information, call 1-800-545-5979.

What are the ingredients in Cymbalta?

Active ingredient: duloxetine hydrochloride

Inactive ingredients:

FD&C Blue No. 2, gelatin, hypromellose, hydroxypropyl methylcellulose acetate succinate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow.

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

Medication Guide revised: 10/2019

Repackaged By / Distributed By: RemedyRepack Inc.

625 Kolter Drive, Indiana, PA 15701

(724) 465-8762

DRUG: Cymbalta

GENERIC: Duloxetine hydrochloride

DOSAGE: CAPSULE, DELAYED RELEASE

ADMINSTRATION: ORAL

NDC: 70518-2099-0

COLOR: blue

SHAPE: CAPSULE

SCORE: No score

SIZE: 16 mm

IMPRINT: LILLY;3240;30;mg

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • Duloxetine hydrochloride 30mg in 1

INACTIVE INGREDIENT(S):

  • Gelatin, Unspecified
  • Hypromellose, Unspecified
  • Hypromellose Acetate Succinate 16070722 (3 MM2/S)
  • Sodium lauryl sulfate
  • Sucrose
  • Talc
  • Titanium dioxide
  • Triethyl citrate
  • FD&C Blue No. 2
Remedy_Label
(click image for full-size original)
CYMBALTA duloxetine hydrochloride capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-2099(NDC:0002-3240)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DULOXETINE HYDROCHLORIDE (DULOXETINE) DULOXETINE 30 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)
SODIUM LAURYL SULFATE
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
FD&C BLUE NO. 2
Product Characteristics
Color blue (opaque blue) , white (opaque white) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code LILLY;3240;30;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-2099-0 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021427 05/22/2019
Labeler — REMEDYREPACK INC. (829572556)

Revised: 07/2021 REMEDYREPACK INC.

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