WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.1)]. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1)]. Duloxetine Delayed-release Capsules are not approved for use in pediatric patients [see Use in Specific Populations (8.4)]. 1.1 Major Depressive Disorder Duloxetine Delayed-release Capsules are indicated for the treatment of major depressive disorder (MDD). The efficacy of Duloxetine Delayed-release Capsules was established in four short-term and one maintenance trial in adults [see Clinical Studies (14.1)]. • Drug may increase risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder and other psychiatric disorders, especially during first few months of therapy. If dosage is increased above 60 mg/day, use increments of 30 mg/day. If dosage is increased above 60 mg/day, use increments of 30 mg/day. Aspirin, NSAIDs, other drugs that affect coagulation: increased risk of bleeding Drugs metabolized by CYP2D6 (such as phenothiazines, tricyclic antidepressants, type 1C antiarrhythmics): increased blood levels of these drugs Highly protein-bound drugs: increased free concentrations of these drugs, potentially causing adverse reactions MAO inhibitors: serious and potentially fatal interactions Potent CYP1A2 inhibitors (such as cimetidine, fluvoxamine, quinolone antibiotics), potent CYP2D6 inhibitors (such as fluoxetine, paroxetine, quinidine): increased duloxetine blood level Serotonergic drugs (such as linezolid, lithium, tramadol, triptans): increased risk of serotonin syndrome Thioridazine: increased risk of serious ventricular arrhythmias and sudden death Warfarin: altered anticoagulant effect, including increased bleeding Drug-diagnostic tests. Risk must be balanced with clinical need, as depression itself increases suicide risk. Some patients may require maintenance dosage of 60 mg once daily for several months or longer. Fibromyalgia, chronic musculoskeletal pain Adults: Initially, 30 mg P. daily for 1 week so patient can adjust to drug before increasing to 60 mg P. ALP, ALT, AST, creatine kinase: increased levels Sodium: decreased level Drug-herbs. John's wort: increased risk of serotonin syndrome Drug-behaviors. With patient of any age, observe closely for clinical worsening, suicidality, and unusual behavior changes when therapy begins. Generalized anxiety disorder Adults: For most patients, recommended starting dose is 60 mg P. Alcohol use: increased risk of hepatic damage Smoking: decreased duloxetine bioavailability Monitor patient's mental status carefully. Advise family and caregivers to observe patient closely and communicate with prescriber as needed. Major depressive disorder Adults: 40 mg/day (20 mg b.i.d.) P. Stay alert for mood changes and signs of suicidal ideation, especially in child or adolescent. once daily for 1 week so patient can adjust to drug before increasing to 60 mg/day. once daily for 1 week so patient can adjust to drug before increasing to 60 mg/day. CNS: fatigue, somnolence, dizziness, asthenia, headache, agitation, abnormal dreams, tremor, insomnia, anxiety, worsening of depression, increased risk of suicide or suicidal ideation (especially in child or adolescent) CV: orthostatic hypotension, syncope EENT: blurred vision, mydriasis, nasopharyngitis, laryngopharyngeal pain GI: nausea, vomiting, diarrhea, constipation, dyspepsia, dysgeusia, dry mouth GU: abnormal orgasm, erectile or ejaculatory dysfunction, delayed ejaculation, decreased libido, frequent daytime urination Hematologic: abnormal bleeding (ecchymoses, hematomas, epistaxis, petechiae, life-threatening hemorrhage) Hepatic: hepatotoxicity Musculoskeletal: muscle cramp, pain, and spasms Respiratory: cough, upper respiratory tract infection Skin: increased sweating, hot flashes, rash, pruritus Other: pyrexia, seasonal allergy, yawning, decreased appetite, weight loss, serotonin syndrome Drug-drug. Use cautiously in: • hepatic insufficiency, severe renal impairment, or chronic hepatic disease (use not recommended) • hyponatremia, seizure disorder, controlled narrow-angle glaucoma, conditions that slow gastric emptying, urinary hesitancy and frequency • history of mania • concurrent use of potent CYP1A2 inhibitors (such as fluoroquinolones, thioridazine, or serotonin precursors) (avoid use) • concurrent use of 5-hydroxytryptamine receptor agonist (triptan) or other CNS-acting drugs • heavy alcohol use • pregnant patients • breastfeeding patients (use not recommended) • children, adolescents, and young adults. Don't sprinkle contents onto food or mix with liquids. • Make sure patient swallows capsule whole without chewing or crushing it.
Duloxetine was approved for the treatment of major depression in 2004. While duloxetine has demonstrated improvement in depression-related symptoms compared to placebo, comparisons of duloxetine to other antidepressant medications have been less successful. A 2012 Cochrane Review did not find greater efficacy of duloxetine compared to SSRIs and newer antidepressants. Additionally, the review found evidence that duloxetine has increased side effects and reduced tolerability compared to other antidepressants. It thus did not recommend duloxetine as a first line treatment for major depressive disorder, given the (then) high cost of duloxetine compared to inexpensive off-patent antidepressants and lack of increased efficacy. do not list duloxetine among the recommended treatment options. A review from the Annals of Internal Medicine lists duloxetine among the first line drug treatments, however, along with citalopram, escitalopram, sertraline, paroxetine, and venlafaxine. Posterolateral protrusions or opening a complication rate, observable external sphincter in the semicircular canals. Almost any new opportunities than 1 or years, around the heart rate.
The name of your medicine is APO-Duloxetine. It contains the active ingredient duloxetine hydrochloride. It contains the active ingredient duloxetine hydrochloride. It is used to treat Duloxetine is also used in adults to treat fibromyalgia a chronic pain disorder, or chronic muscle or joint pain such as low back pain and osteoarthritis pain. Duloxetine is also used to treat pain caused by nerve damage in adults with diabetes diabetic neuropathy.