Duloxetine fda approved indications

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    Duloxetine fda approved indications


    The Food and Drug Administration has approved the antidepressant duloxetine for the management of chronic musculoskeletal pain in adults, the agency announced Nov. Duloxetine, marketed as Cymbalta, was first approved in 2004 to treat depression, and later the drug gained indications for generalized anxiety disorder, diabetic neuropathy, and fibromyalgia. licensed indications to date and its third for treatment of pain. All of the indications are for people aged 18 years and older. The drug has received European Union marketing authorization for depression, anxiety, and diabetic neuropathy only. The mechanism by which duloxetine, a serotonin and norepinephrine reuptake inhibitor, works on pain is uncertain, Eli Lilly said in a press statement accompanying the announcement. However, it is believed to increase the availability of both neurotransmitters, enhancing the body’ natural pain-suppressing system. In August the FDA’s Anesthetic and Life Support Drugs Advisory Committee had voted 8 to 6 to recommend the extension of indication for duloxetine, a vote that was considered too narrow to predict what the agency would ultimately decide. Eli Lilly and Company (NYSE: LLY) announced that the U. Food and Drug Administration (FDA) has approved Cymbalta® (duloxetine HCl) for the management of chronic musculoskeletal pain. This has been established in studies in patients with chronic low back pain and chronic pain due to osteoarthritis. This is the fifth indication the FDA has approved for Cymbalta. Cymbalta, which has been shown to significantly reduce chronic low back pain and chronic pain due to osteoarthritis, is a non-narcotic pain reliever that is meant to be taken once a day, every day by people with these pain conditions."People with chronic musculoskeletal pain often struggle to find a medication that works for them. The approval of Cymbalta for chronic musculoskeletal pain by the FDA gives doctors another option to help an underserved and suffering group of patients," said Michael Clark, M. D., MPH, director, Chronic Pain Treatment Program, Department of Psychiatry and Behavioral Sciences, The Johns Hopkins Medical Institutions. Although the exact way that Cymbalta works to reduce chronic musculoskeletal pain is unknown, it is believed that Cymbalta helps lessen pain by enhancing the body's natural pain suppressing system by increasing the activity of serotonin and norepinephrine in the brain and spinal cord.

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    Generic. duloxetine. Status CVS Caremark Criteria. Type Initial Prior Authorization. POLICY. FDA-APPROVED INDICATIONS. Major Depressive Disorder. The Food and Drug Administration has approved the antidepressant duloxetine for the management of chronic musculoskeletal pain in adults. Nov 5, 2010. The Food and Drug Administration has approved the antidepressant duloxetine for the management of chronic musculoskeletal pain in adults.

    40-60 mg/day PO initially (in single daily dose or divided q12hr for 1 week if patient needs to adjust to therapy) Titrate dose in increments of 30 mg/day over 1 week as tolerated Target dosage: 60 mg/day PO (in single daily dose or divided q12hr); not to exceed 120 mg/day (safety of dosages Treatment of chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain 30 mg/day PO initially for 1 week to allow for therapy adjustment Target dosage: 60 mg/day PO; not to exceed 60 mg/day Dosages ≥60 mg/day have not been shown to offer additional benefits Major depressive disorder and generalized anxiety disorder: Acute episodes often necessitate several months of sustained therapy Diabetic peripheral neuropathic pain: Efficacy for 12 weeks has not been studied; if diabetes is complicated by renal disease, consider lower starting dosage with gradual increase to effective dosage Fibromyalgia: Efficacy for ≥12 weeks has not been studied; continue treatment on basis of individual patient response Chronic musculoskeletal pain: Efficacy for ≥13 weeks has not been studied Uncontrolled narrow-angle glaucoma: Use not recommended due to increased risk of mydriasis Constipation (10%) Dizziness (10%) Insomnia (10%) Diarrhea (9-10%) Anorexia (8%) Decreased appetite (7-8%) Abdominal pain (6%) Hyperhidrosis (6%) Increased sweating (6%) Agitation (5%) Nasopharyngitis (5%) Vomiting (3-5%) Male sexual dysfunction (2-5%) Abdominal pain (4%) Decreased libido (4%) Musculoskeletal pain (4%) Upper respiratory tract infection (URTI) (4%) Abnormal orgasm (3%) Agitation (3%) Anxiety (3%) Blurred vision (3%) Cough (3%) Influenza (3%) Muscle spasms (3%) Tremor (3%) Abnormal dreams (2%) Dyspepsia (2%) Hot flushes (2%) Nausea (2%) Oropharyngeal pain (2%) Palpitations (2%) Paresthesia (2%) Weight loss (2%) Yawning (2%) Dysuria ( General: Anaphylactic reaction, angioneurotic edema, hypersensitivity Cardiovascular: Hypertensive crisis, supraventricular arrhythmia, myocardial infarction, tachycardia, Takotsubo cardiomyopathy Endocrine: Galactorrhea, gynecologic bleeding, hyperglycemia, hyperprolactinemia Neurologic: Restless legs syndrome, seizures upon treatment discontinuance, extrapyramidal disorders Ophthalmic: Glaucoma Otic: Tinnitus (upon treatment discontinuance) Psychiatric: Aggression and anger (particularly early in treatment or after treatment discontinuance), hallucinations Musculoskeletal: Trismus, muscle spasm Skin: Serious skin reactions (eg, erythema multiforme and Stevens-Johnson syndrome) necessitating drug discontinuance or hospitalization, urticaria, rash Gastrointestinal: Colitis (microscopic or unspecified),cutaneous vasculitis (sometimes associated with systemic involvement), acute pancreatitis 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 24 yr There was a reduction in risk with antidepressant use in patients ≥65 yr 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 CYP1A2 inhibitors or thioridazine should not be coadministered Use caution in severe renal impairment, ESRD Heavy alcohol use Suicidality; monitor for clinical worsening and suicide risk, especially in children, adolescents and young adults (18-24 years) during early phases of treatment and alterations in dosage Serotonin syndrome or neuroleptic malignant syndrome-like reactions may occur; discontinue and initiate supportive therapy; closely monitor patients concomitantly receiving triptans, antipsychotics and serotonin precursors Neonates exposed to serotonin-noreponephrine reuptake inhibitors (SNRIs) or selective serotonin reuptake inhibitors (SSRIs) late in 3rd trimester of pregnancy have developed complications necessitating prolonged hospitalization, respiratory support, and tube feeding Screen patients for bipolar disorder; risk of mixed/manic episodes is increased in patients treated with antidepressants May cause activation of mania or hypomania Increased risk of hepatotoxicity, sometimes fatal; monitor for abdominal pain, hepatomegaly, elevations in hepatic transaminases exceeding 20 times upper limit of normal; jaundice; cholestatic jaundice with minimal elevations of hepatic transaminases have also been reported; use not recommended in patients with substantial alcohol use or chronic liver disease SSRIs and SNRIs may impair platelet aggregation and increase the risk of bleeding events, ranging from ecchymoses, hematomas, epistaxis, petechiae, and GI hemorrhage to life-threatening hemorrhage; concomitant use of aspirin, NSAIDs, warfarin, other anticoagulants, or other drugs known to affect platelet function may add to this risk Severe skin reactions (eg, erythema multiforme and Stevens-Johnson syndrome); discontinue at first appearance of blisters, peeling rash, mucosal erosions, or any other sign of hypersensitivity if no other etiology can be identified Orthostatic hypotension and syncope, especially during week 1 of therapy; monitor patients taking drugs that increase risk of orthostatic hypotension; consider dose reduction or discontinue therapy in patients who experience symptomatic orthostatic hypotension, falls and/or syncope Hyponatremia due to syndrome of inappropriate antidiuretic hormone (SIADH); cases of serum sodium Exact mechanism of action unknown; inhibits reuptake of serotonin and norepinephrine; weakly inhibits reuptake of dopamine; has no MAOI activity; has no significant activity for histaminergic H1 receptor or alpha2-adrenergic receptor The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. 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.

    Duloxetine fda approved indications

    Cymbalta New FDA Drug Approval CenterWatch, FDA Adds New Pain Indication for Cymbalta MDedge Internal.

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  7. Cymbalta is was initially approved August 4, 2004. It is approved for the following indications Major Depressive Disorder, Diabetic Peripheral Neuropathic Pain, and, most recently, General Anxiety

    • Division of Medication Errors and Technical Support..
    • FDA Adds New Pain Indication for Cymbalta MDedge Internal Medicine.
    • Sertraline - Wikipedia.

    Cymbalta is not approved for use in pediatric patients. other psychiatric indications obsessive compulsive disorder and social anxiety disorder as well. For acute hypertensive episodes including hypertensive urgency and hypertensive emergency in pediatric patients†. NOTE Per the FDA and manufacturers, immediate-release nifedipine dosage forms should not be used to treat hypertension and should only be used to treat patients with chronic stable angina or vasospastic angina. Two doses of CYMBALTA at the same time. 2. Indication. Starting. Dose. Target Dose. It should be noted that CYMBALTA is not approved for use in.

     
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