What is/are Cymbalta?
DULOXETINE is an antidepressant. It is used to treat depression. It is also used to treat pain caused by complications of diabetes or pain caused by fibromyalgia. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care providers before I take this medicine?
They need to know if you have any of these conditions:
- bipolar disorder or a family history of bipolar disorder
- kidney or liver disease
- narrow- angle glaucoma
- suicidal thoughts or a previous suicide attempt
- taken medicines called MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate within 14 days
- an unusual reaction to duloxetine, other medicines, foods, dyes, or preservatives
- pregnant or trying to get pregnant
How should I use this medicine?
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. You can take this medicine with or without food. Take your medicine at regular intervals. Do not take your medicine more often than directed. If you have been taking this medicine regularly for some time, do not suddenly stop taking it. You must gradually reduce the dose, or your symptoms may get worse. Ask your doctor or health care professional for advice.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
Note: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following:
- certain diet drugs like dexfenfluramine, fenfluramine, phentermine, sibutramine
- MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
- SSRIs like citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline
- St. John's Wort
This medicine may also interact with the following:
- certain antibiotics like ciprofloxacin and enoxacin
- medicines for heart rhythm or blood pressure
- other medicines for mental depression, mania, psychosis, or anxiety
This list may not describe all possible interactions. Give your health care providers a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What side effects may I notice from this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
- allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
- changes in blood pressure
- fast talking and excited feelings or actions that are out of control
- fast, irregular heartbeat
- hallucination, loss of contact with reality
- stomach flu-like symptoms of diarrhea, vomiting
- suicidal thoughts or other mood changes
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
- blurred vision
- change in appetite
- change in sex drive or performance
- increased sweating
This list may not describe all possible side effects.
What should I watch for while using this medicine?
Visit your doctor or health care professional for regular checks on your progress. Continue to take your medicine even if you do not feel better right away. It can take about 4 weeks before you feel the full effect of this medicine.
Patients and their families should watch out for worsening depression or thoughts of suicide. Also watch out for sudden or severe changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of treatment or after a change in dose, call your health care professional.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.
Do not treat yourself for coughs, colds, or allergies without asking your doctor or health care professional for advice. Some ingredients can increase possible side effects.
Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.
This medicine may cause an increase in blood pressure. Check with your doctor or health care professional, you may be able to measure your own blood pressure and pulse. Find out what your blood pressure and heart rate should be and when you should contact him or her.
Where should I keep this medicine?
Keep out of the reach of children.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.
Nausea, somnolence, insomnia, and dizziness are the main side effects, reported by about 10% to 20% of patients.
In a trial for major depressive disorder (MDD), the most commonly reported treatment-emergent adverse events among duloxetine-treated patients were nausea (34.7%), dry mouth (22.7%), headache (20.0%) and dizziness (18.7%), and except for headache, these were reported significantly more often than in the placebo group.
Sexual dysfunction is often a side effect of drugs that inhibit serotonin reuptake; this is known as post-SSRI sexual dysfunction. Specifically, common side effects include difficulty becoming aroused, lack of interest in sex, and anorgasmia (trouble achieving orgasm). Loss of or decreased response to sexual stimuli and ejaculatory anhedonia are also possible. Although usually reversible, there are some who report sexual side effects persisting after the drug has been withdrawn.
Postmarketing spontaneous reports
Reported adverse events which were temporally correlated to Cymbalta therapy include rash, reported rarely, and the following adverse events, reported very rarely: alanine aminotransferase increased, alkaline phosphatase increased, anaphylactic reaction, angioneurotic edema, aspartate aminotransferase increased, bilirubin increased, glaucoma, hepatitis, hyponatremia, jaundice, orthostatic hypotension (especially at the initiation of treatment), Stevens–Johnson syndrome, syncope (especially at initiation of treatment), and urticaria.
During marketing of other SSRIs and SNRIs, there have been spontaneous reports of adverse events occurring upon discontinuation of these drugs, particularly when abrupt, including the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. The withdrawal syndrome from duloxetine resembles the SSRI discontinuation syndrome.
When discontinuing treatment with duloxetine, the manufacturer recommends a gradual reduction in the dose, rather than abrupt cessation, whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate. The use of a liquid form of the drug may facilitate more gradual tapering."
In MDD placebo-controlled clinical trials of up to nine weeks' duration, systematically evaluating discontinuation symptoms in patients taking duloxetine following abrupt discontinuation found the following symptoms occurring at a rate greater than or equal to 2% and at a significantly higher rate in duloxetine-treated patients compared to those discontinuing from placebo: dizziness, nausea, headache, paresthesia, vomiting, irritability, and nightmare.
The FDA requires all antidepressants, including duloxetine, to carry a black box warning stating that antidepressants may increase the risk of suicide in persons younger than 25. This warning is based on statistical analyses conducted by two independent groups of the FDA experts that found a 2-fold increase of the suicidal ideation and behavior in children and adolescents, and 1.5-fold increase of suicidality in the 18–24 age group.
To obtain statistically significant results the FDA had to combine the results of 295 trials of 11 antidepressants for psychiatric indications. As suicidal ideation and behavior in clinical trials are rare, the results for any drug taken separately usually do not reach statistical significance. There have been no trials of duloxetine in minors.
Several commentators noted that the data FDA used in their analysis of duloxetine-associated suicidality may have been incomplete. According to Arif Khan, the Summary Basis of Approval used by the FDA to approve duloxetine for depression contained only the mention of two completed suicides out of 3490 patients, and the rest of the data was not sufficient to "conduct any meaningful analysis." Jeanne Lenzer wrote in The Independent and Slate Magazine, and this fact was also confirmed by a Lilly spokesman, that another two completed suicides, which occurred in the depression studies ran by the Lilly's Japanese partner Shionogi, have not been reported to the FDA. According to Lenzer, four completed suicides also occurred in the trials of duloxetine for stress urinary incontinence (SUI). As these trials failed, the FDA initially insisted that any information about them is a commercial secret and cannot be released. Later, in a short statement the FDA acknowledged that in SUI trials eleven suicide attempts occurred in persons taking duloxetine vs none in the placebo group.
A series of four cases of duloxetine-associated suicidality has been reported. In all four cases depressed patients began having suicidal thoughts after starting on duloxetine or increasing its dose. These thoughts stopped, and the patients returned to normal after duloxetine was discontinued, and they were switched to another antidepressant.
A suicide of 19-year-old Traci Johnson, a healthy volunteer in a duloxetine clinical pharmacology study, was highly publicized. For about a month she had been given high doses of duloxetine, and then she was switched to placebo. Four days after the switch, she hanged herself in the bathroom of Lilly Laboratory for Clinical Research. The New York Times article mentioned a withdrawal syndrome as a possible reason for this suicide.
This article uses material from the Wikipedia article Duloxetine, which is released under the Creative Commons Attribution-Share-Alike License 3.0.