Description
Duloxetine is used to treat depression and anxiety. It is also used for pain caused by nerve damage associated with diabetes (diabetic peripheral neuropathy).
Duloxetine is also used to treat fibromyalgia (muscle pain and stiffness) and chronic (long-lasting) pain that is related to muscles and bones.
Duloxetine belongs to a group of medicines known as selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). These medicines are thought to work by increasing the activity of chemicals called serotonin and norepinephrine in the brain.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule, Delayed Release
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of duloxetine in children to treat anxiety in children 7 years of age and older. However, safety and efficacy have not been established in children younger than 7 years of age.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of duloxetine in children to treat fibromyalgia in children 13 years of age and older. However, safety and efficacy have not been established in children younger than 13 years of age.
Appropriate studies have not been performed on the relationship of age to the effects of duloxetine for other indications in the pediatric population. Safety and efficacy have not been established for other indications.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of duloxetine in the elderly. However, elderly patients may be more sensitive to the effects of this medicine than younger adults, and are more likely to have hyponatremia (low sodium in the blood) and increase risk for falls, which may require caution in patients receiving duloxetine.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bromopride
- Isocarboxazid
- Linezolid
- Mavorixafor
- Methylene Blue
- Metoclopramide
- Ozanimod
- Phenelzine
- Procarbazine
- Rasagiline
- Safinamide
- Selegiline
- Thioridazine
- Tranylcypromine
- Viloxazine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abciximab
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Aceclofenac
- Acemetacin
- Alfentanil
- Almotriptan
- Amineptine
- Amitriptyline
- Amitriptylinoxide
- Amoxapine
- Amphetamine
- Amtolmetin Guacil
- Anagrelide
- Anileridine
- Apixaban
- Ardeparin
- Aripiprazole
- Asenapine
- Aspirin
- Atomoxetine
- Benzhydrocodone
- Benzphetamine
- Betrixaban
- Brexpiprazole
- Bromfenac
- Brompheniramine
- Bufexamac
- Buprenorphine
- Bupropion
- Buspirone
- Butorphanol
- Cangrelor
- Capmatinib
- Carbamazepine
- Carvedilol
- Celecoxib
- Certoparin
- Chlorpheniramine
- Chlorpromazine
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acenocoumarol
- Phenprocoumon
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
- Tobacco
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol abuse, history of or
- Kidney disease, severe or
- Liver disease (including cirrhosis)—Should not be used in patients with these conditions.
- Bipolar disorder (mood disorder with mania and depression), or risk of or
- Bleeding problems or
- Diabetes or
- Digestion problems or
- Glaucoma (angle-closure) or
- Heart or blood vessel disease or
- Hypertension (high blood pressure) or
- Hyponatremia (low sodium in the blood) or
- Mania, history of or
- Seizures, history of or
- Urinating problems (eg, urinary retention or trouble urinating)—Use with caution. May make these conditions worse.
- Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Swallow the delayed-release capsule whole with or without food. Do not chew, crush, or break the capsule. Do not open the Cymbalta® delayed-release capsule and sprinkle the contents on food or in liquids.
If you cannot swallow the Drizalma Sprinkle™ delayed-release capsule whole, you may do the following:
- You may open the capsule and sprinkle the contents over one tablespoon (15 mL) of applesauce. Swallow the mixture right away and do not save any of the mixture to use later.
- You may open the capsule and pour the contents to an all plastic catheter tip syringe and add 50 mL of water. Do not use other liquids. Gently shake it for 10 seconds, and then use it through a nasogastric tube. Rinse with additional water (about 15 mL) if needed.
You will need to use this medicine for several weeks before you begin to feel better. Keep using the medicine even if you feel you are not getting better, and talk to your doctor if you have any questions.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (delayed-release capsules):
- For treatment of anxiety:
- Adults—At first, 60 milligrams (mg) once a day. Some patients may start at 30 mg once a day for 1 week before increasing the dose to 60 mg once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 120 mg per day.
- Older adults—At first, 30 mg once a day for 2 weeks before increasing the dose to 60 mg once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 120 mg per day.
- Children 7 years of age and older—At first, 30 mg once a day for 2 weeks before increasing the dose to 60 mg once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 120 mg per day.
- Children younger than 7 years of age—Use and dose must be determined by your doctor.
- For treatment of chronic muscle pain:
- Adults—60 milligrams (mg) once a day. Some patients may start at 30 mg once a day for 1 week before increasing the dose to 60 mg once a day.
- Children—Use and dose must be determined by your doctor.
- For treatment of depression:
- Adults—40 milligrams (mg) per day (given as 20 mg two times per day) to 60 mg per day (given either once a day or as 30 mg two times per day). Your doctor may increase your dose as needed. However, the dose is usually not more than 120 mg per day.
- Children—Use and dose must be determined by your doctor.
- For treatment of diabetic peripheral neuropathy:
- Adults—60 milligrams (mg) once a day.
- Children—Use and dose must be determined by your doctor.
- For treatment of fibromyalgia:
- Adults—60 milligrams (mg) once a day. Some patients may start at 30 mg once a day for 1 week before increasing the dose to 60 mg once a day.
- Children 13 years of age and older—At first, 30 mg once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mg per day.
- Children younger than 13 years of age—Use and dose must be determined by your doctor.
- For treatment of anxiety:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is important that your doctor check your progress at regular visits to allow for changes in your dose and to help prevent any unwanted effects.
Do not take duloxetine with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]) in the past 2 weeks. Do not start taking an MAO inhibitor within 5 days of stopping duloxetine. If you do, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, or severe convulsions. Ask your doctor if you are not sure if you take an MAOI, including linezolid (Zyvox®) or methylene blue injection.
Duloxetine may cause some teenagers and young adults to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you or your caregiver notice any of these unwanted effects, tell your doctor right away. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Duloxetine may cause a serious condition called serotonin syndrome if taken together with some medicines. Do not use duloxetine with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), tryptophan, St. John's wort, amphetamines, or some pain or migraine medicines (eg, meperidine, methadone, rizatriptan, sumatriptan, tramadol, Demerol®, Methadose®, Frova®, Imitrex®, Maxalt®, Relpax®, Ultram®, Zomig®). Check with your doctor first before using any other medicines with duloxetine.
This medicine may increase your risk for bleeding problems. Make sure your doctor knows if you are also taking other medicines that thin the blood, such as aspirin, NSAID pain medicines (eg, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, or Motrin®) or warfarin (Coumadin®).
Serious skin reactions (eg, erythema multiforme, Stevens-Johnson syndrome) can occur during treatment with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness while you are using this medicine.
Do not suddenly stop taking this medicine without checking first with your doctor. If you have been instructed to stop taking duloxetine, ask your doctor how to slowly decrease the dose. This will decrease your chance of having withdrawal symptoms such as dizziness, nausea, headaches, vomiting, increased sweating, irritability, nightmares, trouble with sleeping, or prickling or tingling feelings.
This medicine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.
This medicine may cause blurred vision, dizziness, drowsiness, trouble with thinking, or trouble with controlling body movements, which may lead to falls, fractures, or other injuries. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see clearly. You may also feel lightheaded or you may fall or faint when getting up suddenly from a lying or sitting position, so get up slowly. If these symptoms are bothering you or keeping you from doing your daily activities, tell your doctor right away.
You will need to measure your blood pressure before starting this medicine and while you are using it. If you notice any change to your recommended blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.
Hyponatremia (low sodium in the blood) may occur with this medicine. Check with your doctor right away if you have confusion, decreased urine output, difficulty concentrating, fast or irregular heartbeat, headaches, memory problems, nausea or vomiting, swelling of the face, ankles, or hands, trouble breathing, or unusual tiredness or weakness.
This medicine may cause sexual problems. Check with your doctor right away if you have decreased interest in sexual intercourse, inability to have or keep an erection, or loss in sexual ability, desire, drive, or performance.
Avoid smoking while you are using this medicine. If you have any questions about this, check with your doctor.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Incidence not known
- Area rash
- blindness
- blistering, peeling, or loosening of the skin
- blurred vision
- change in consciousness
- chest tightness
- chills
- clay-colored stools
- cold sweats
- confusion
- dark urine
- decreased urine output
- decreased vision
- difficulty with swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- eye pain
- fainting
- fast or irregular heartbeat
- general tiredness or weakness
- hives or welts, itching, or skin rash
- hives, itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
- increased thirst
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- light-colored stools
- loss of consciousness
- red skin lesions, often with a purple center
- red, irritated eyes
- redness of the skin
- seizures
- sores, ulcers, or white spots in the mouth or on the lips
- stomach pain
- swelling of the face, ankles, or hands
- tearing
- unpleasant breath odor
- upper right stomach pain
- vomiting of blood
- yellow eyes and skin
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Agitation
- diarrhea
- fever
- loss of bladder control
- muscle spasm or jerking of all extremities
- overactive reflexes
- poor coordination
- restlessness
- shivering
- sleepiness or unusual drowsiness
- sudden loss of consciousness
- sweating
- talking or acting with excitement you cannot control
- trembling or shaking
- twitching
- unusual tiredness or weakness
- vomiting
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Body aches or pain
- cough
- difficulty having a bowel movement (stool)
- dry mouth
- ear congestion
- frequent urination
- headache
- lack or loss of strength
- loss of appetite
- loss of voice
- muscle aches
- nausea
- sleepiness or unusual drowsiness
- sneezing
- sore throat
- stuffy or runny nose
- sweating increased
- trouble sleeping
- weight loss
Less common
- Abnormal ejaculation
- abnormal orgasm
- acid or sour stomach
- belching
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in taste
- change or problem with discharge of semen
- decreased interest in sexual intercourse
- difficulty with moving
- feeling of warmth or redness of the face, neck, arms, and occasionally, upper chest
- heartburn
- inability to have or keep an erection
- indigestion
- longer than usual time to ejaculation of semen
- loose stools
- loss in sexual ability, desire, drive, or performance
- loss of taste
- muscle cramps, pains, or stiffness
- shakiness in the legs, arms, hands, or feet
- stomach discomfort or upset
- sudden sweating
- swollen joints
- trembling or shaking of the hands or feet
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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