Author: Charles Frank

Duloxetine Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Cymbalta can cause withdrawal if treatment is stopped abruptly. Withdrawal symptoms are side effects that can occur when you stop taking a drug that your body has become dependent on. And with dependence, your body needs the drug to function as usual. The expiration date helps guarantee that the medication is effective during this time.

1. The dosage is based on your age, medical condition and response to treatment.
2. Cymbalta can cause withdrawal if treatment is stopped abruptly.
3. You may wonder how often certain side effects occur with this drug.
4. However, it’s important to note that in clinical studies, researchers didn’t notice any benefit when the Cymbalta dose was increased above 60 mg per day.
5. For most adults less than 65 years of age with GAD, initiate CYMBALTA 60 mg once daily.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Your family or caregivers should also watch for sudden changes in your behavior. Cymbalta is a selective serotonin and norepinephrine reuptake inhibitor antidepressant (SSNRI). Duloxetine affects chemicals in the brain that may be unbalanced in people with depression.

What Are Warnings and Precautions for Duloxetine?

Nevertheless, if a decision is made to increase the dosage beyond 60 mg once daily, increase dosage in increments of 30 mg once daily. Periodically reassess to determine the continued need for maintenance treatment and the appropriate dosage for such treatment. The recommended starting dosage in adults with MDD is 40 mg/day (given as 20 mg twice daily) to 60 mg/day (given either once daily or as 30 mg twice daily). While a 120 mg/day dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer any additional benefits. Periodically reassess to determine the need for maintenance treatment and the appropriate dosage for such treatment.

The recommended starting CYMBALTA dosage in pediatric patients years of age with fibromyalgia is 30 mg once daily. The dosage may be increased to 60 mg once daily based on response and tolerability. Administer 60 mg once daily in adults with diabetic peripheral neuropathic pain. There is no evidence that doses higher than 60 mg once daily confer additional significant benefit and the higher dosage is clearly less well tolerated. For patients for whom tolerability is a concern, a lower starting dose may be considered. Duloxetine may improve your mood, sleep, appetite, and energy level, and decrease nervousness.

Increased sweating

In Study MDD-5, patients on CYMBALTA experienced a statistically significantly longer time to relapse of depression than did patients on placebo (see Figure 1). There is no specific antidote to a CYMBALTA overdosage, but if serotonin syndrome ensues, specific treatment (such as with cyproheptadine and/or temperature control) may be considered. Patients with clinically evident hepatic impairment have decreased duloxetine metabolism and elimination. Although Cmax was similar to normals in the cirrhotic patients, the half-life was about 3 times longer [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS]. It is not known if these adverse maternal and fetal outcomes are a direct result of fibromyalgia or other comorbid factors. Advise patients that use of CYMBALTA may cause symptoms of sexual dysfunction in both male and female patients.

Duloxetine belongs to a class of drugs known as serotonin-norepinephrine reuptake inhibitors (SNRIs). It works by helping to restore the balance of certain natural substances (serotonin and norepinephrine) in the brain. In adult placebo-controlled trials in patients with MDD, activation of mania or hypomania was reported in 0.1% (4/3779) of CYMBALTA-treated patients and 0.04% (1/2536) of placebo-treated patients. No activation of mania or hypomania was reported in DPNP, GAD, fibromyalgia, or chronic musculoskeletal pain placebo-controlled trials. Activation of mania or hypomania has been reported in a small proportion of patients with mood disorders who were treated with other marketed drugs effective in the treatment of major depressive disorder.

Fibromyalgia and chronic pain

Biotransformation and disposition of duloxetine in humans have been determined following oral administration of 14C-labeled duloxetine. Duloxetine comprises about 3% of the total radiolabeled material in the plasma, indicating that it undergoes extensive metabolism to numerous metabolites. The major biotransformation pathways for duloxetine involve oxidation of the naphthyl ring followed by conjugation and further oxidation. Both CYP1A2 and CYP2D6 catalyze the oxidation of the naphthyl ring in vitro. Metabolites found in plasma include 4-hydroxy duloxetine glucuronide and 5hydroxy, 6-methoxy duloxetine sulfate. Food does not affect the Cmax of duloxetine, but delays the time to reach peak concentration from 6 to 10 hours and it marginally decreases the extent of absorption (AUC) by about 10%.

The researchers used the Hamilton Anxiety Scale (HAM-A) and the Clinical Global Impressions of Improvement scale to assess people’s anxiety before the study began. They used increases in these scores to determine when someone in the study had a GAD relapse. However, it’s thought that the drug changes levels of certain chemicals in your brain that affect your mood and well-being. There isn’t a recommended length of time your taper should last.

Dosage for chronic musculoskeletal pain

Discontinuation of CYMBALTA should be considered in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted. Patients should be monitored for these symptoms when discontinuing treatment with CYMBALTA. A gradual reduction in the dose rather than abrupt cessation is recommended 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 healthcare provider may continue decreasing the dose but at a more gradual rate [see DOSAGE AND ADMINISTRATION].

“Narcotics” is another term for opioids, which are a type of pain reliever. Controlled substances are medications that could cause either physical or mental dependence. With dependence, your body needs the drug to function as usual.

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with CYMBALTA is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see WARNINGS AND PRECAUTIONS]. The recommended dose of Cymbalta for treating depression is 20 or 30 mg twice daily or 60 mg once daily. Cymbalta may interact with any medicine for pain, arthritis, fever, or swelling, including aspirin, ibuprofen, naproxen, celecoxib, diclofenac, indomethacin, piroxicam, nabumetone, etodolac, and others.

Do not take Cymbalta within 5 days before or 14 days after you have used a MAO inhibitor, such as isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, or tranylcypromine, or methylene blue injection. RxList does not provide medical advice, diagnosis or treatment. Concomitant use of duloxetine with MAOIs intended to treat psychiatric disorders. Duloxetine is also used to treat fibromyalgia (muscle pain and stiffness) and chronic (long-lasting) pain that is related to muscles and bones. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed.

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. For more information, ask your healthcare provider or pharmacist. Study GAD-3 had a starting dose of 30 mg once daily for 1 week before increasing it to 60 mg once daily.

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]. 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. Avoid use in patients with chronic liver disease or cirrhosis [see DOSAGE AND ADMINISTRATION , Hepatotoxicity , and Use In Specific Populations]. Because it is possible that CYMBALTA and alcohol may interact to cause liver injury or that CYMBALTA may aggravate pre-existing liver disease, CYMBALTA should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease. In drug dependence studies, duloxetine did not demonstrate dependence-producing potential in rats.