Provided by You Health for patients

Generic for Cymbalta® (Duloxetine)

In this medication overview

Duloxetine is a prescription medicine used to treat major depressive disorder (MDD), generalized anxiety disorder (GAD), diabetic peripheral neuropathic pain (DPNP), fibromyalgia, and chronic musculoskeletal pain.

Usage

1. To get started, review the directions on your prescription label and follow your provider's dosing instructions. Swallow the capsule whole. Do not break, crush or chew it.

2. Miss a dose? If you miss a dose of duloxetine take it as soon as you remember, unless it is closer to the time of your next dose. Discuss this with your healthcare provider. Do not double your next dose or take more than what is prescribed.

3. Continue medication as prescribed Do not abruptly stop taking duloxetine or change your dose without talking with your healthcare provider first, even when you feel better. Studies have shown that a taper can reduce possible side-effects caused by stopping the medication abruptly. Abruptly stopping can cause discontinuation symptoms including: vomiting, irritability, dizziness, headaches, sensation of tingling skin, or nightmares. Studies have shown that a taper can reduce possible discontinuation symptoms. Your healthcare provider can provide individualized guidance on tapering your medication. Here are some general guidelines. Duloxetine is more difficult to taper on your own because it comes in capsules that can’t be split. You will probably need your provider to send in a prescription of the smallest pills (20 mg) to help with your taper. With some dosages, though, it’s easier. If you are taking 90 mg of duloxetine (three 30 mg capsules), take two capsules (60 mg) for a week, then one capsule (30 mg) for a week, then you may stop your medication. If you are taking 40 mg of duloxetine (two 20 mg capsules), take one capsule (20 mg) for a week, then you may stop your medication. If you are taking 30 mg or 20 mg of duloxetine, you can stop your medication without a taper. If you are taking 120 mg or 60 mg, you’ll need your provider to give you a prescription for 20 mg capsules to manage your taper. Your healthcare provider can also provide individualized guidance for tapering your medication.

4. Monitor for improvements Sleep, energy, or appetite may show some improvement within the first 1-2 weeks. Improvement in these physical symptoms can be an important early signal that the medication is working. Depressed mood and lack of interest in activities may need up to 6-8 weeks to fully improve.

Warnings

SUICIDALITY AND ANTIDEPRESSANT DRUGS

Duloxetine and other antidepressant medicines may increase suicidal thoughts or actions, especially in some people 24 years of age and younger within the first few months of treatment or when the dose is changed. If you are experiencing a mental health crisis, please call or text 988 to be connected with help, or go to your nearest hospital emergency department. Pay particular attention to such changes when duloxetine is started or when the dose is changed.

Patients, their families, and caregivers should be alert to the emergence of anxiety, restlessness, irritability, aggressiveness and insomnia. If these symptoms emerge, they should be reported to the patient’s prescriber or healthcare professional. All patients being treated with antidepressants for any indication should watch for and notify their healthcare provider for worsening symptoms, suicidality and unusual changes in behavior, especially during the first few months of treatment.

IMPORTANT SAFETY INFORMATION

Do not take duloxetine if you:

• Are allergic to duloxetine, or any of the ingredients in Duloxetine

• Take any medication for Parkinson’s Disease or depression called monoamine oxidase inhibitors (MAOI), or if you have stopped taking an MAOI in the last 14 days as they may cause a dangerous increase in blood pressure. MAOIs include, but are not limited to: isocarboxazid, phenelzine, rasagiline, selegiline, tranylcypromine

• Take other medication that may cause an increase in serotonin levels such as linezolid, methylene blue, tryptophan

• Take St John’s Wort or 5-Hydroxytryptophan (5-HTP)

• Have a medical history of a liver disease

• Are drinking large amounts of alcohol

• Are using or abusing recreation drugs or prescription medications

Before you take duloxetine, tell your healthcare provider if you:

• Have high blood pressure

• Have thoughts of suicide or harming yourself

• Have a history of psychiatric or medical problems, including bipolar disorder

• Have taken any medication in the past for your condition, whether effective or not

• Have suffered adverse or side effects from previous medication therapies

• Are pregnant, plan to become pregnant, or are breastfeeding

• Drink alcohol or use/abuse recreational or prescription drugs

Inform your healthcare provider

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and recreational drugs.

Duloxetine may affect the way other medicines work, and other medicines may affect the way duloxetine works, causing side effects. Especially tell your healthcare provider if you take any of the following:

• Aspirin or nonsteroidal anti-inflammatory drugs (e.g. ibuprofen, naproxen, celecoxib, diclofenac)

• Any other serotonergic medications including: trazodone, migraine medications (triptans), pain medications (tramadol), antibiotic linezolid, amphetamines, or methylene blue

• Warfarin or other anticoagulants

• Cimetidine (Tagamet®)

• Ciprofloxacin (Cipro®)

Duloxetine may increase the risk of bleeding when taking blood thinners or nonsteroidal anti-inflammatory drugs (NSAIDs). If you are currently taking blood thinners or NSAIDs, we strongly recommend that you inform your primary care provider that you have started taking this mental health medication and be sure to report any signs of abnormal bleeding to your provider, such as bleeding gums, unexplained bruising, or black, tarry stools.

Medication disposal

If you no longer need your medication, the best way to dispose of most types of old, unused, unwanted, or expired medicines (both prescription and over the counter) is to drop off the medicine at a drug take back site, location, or program immediately. You can use the DEA DIVERSION CONTROL DIVISION LOOKUP to find your nearest drug disposal site.

If no drug take back sites, locations, or programs are available in your area, and there are no specific disposal instructions (such as flushing) in the medication guide or package insert, you can visit FDA- Disposal of Unused Medicines for more information or follow these simple steps to dispose of most medicines in your trash at home:

• Mix medicines (liquid or pills; do not crush tablets or capsules) with an unappealing substance such as dirt, cat litter, or used coffee grounds;

• Place the mixture in a container such as a sealed plastic bag;

• Throw away the container in your trash at home; and

• Delete all personal information on the prescription label of empty medicine bottles or medicine packaging, then trash or recycle the empty bottle or packaging.

Side effects

Duloxetine can cause serious side effects and should be reported to your provider immediately. These side effects are rare and include:

• Liver failure, sometimes fatal

• Orthostatic hypotension,a drop in blood pressure when standing or getting up from sleep

• Increased risk of bleeding

• Increased heart rate

• Irregular menstrual cycle

• Frequency of urination or difficulty urinating

• Angle closure glaucoma (symptoms of angle closure glaucoma may include eye pain, changes in vision, swelling or redness in or around eye)

• Serotonin syndrome (symptoms may include shivering, diarrhea, confusion, severe muscle tightness, fever, seizures, and death)

• Hypertensive crisis

• Stevens-Johnson syndrome (rash)

• Pancreatitis

During treatment with this medication, common side effects of this medication may go away as your body adjusts to the medication. The most common side effects of duloxetine are:

• Headache

• Dizziness

• Nausea

• Vomiting

• Upset stomach

• Diarrhea

• Dry mouth

• Constipation

• Loss of appetite

• Weight loss

• Increased sweating

• Feeling nervous

• Restless

• Fatigued

• Unusual dreams

• Sleepiness or trouble sleeping (insomnia).

The following common side effects may not improve over time:

• Sexual side effects (such as problems with desire, orgasm or ejaculatory delay)

• Increased blood pressure