Chemical Name DULOXETINE (doo-LOX-e-teen)CYMBALTA is a prescription serotonin-norepinephrine reuptake inhibitor (SNRI) medication effectively used for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) mental depression. It is also used for pain caused by nerve damage associated with diabetes, diabetic peripheral neuropathic pain, fibromyalgia and chronic musculoskeletal pain due to chronic osteoarthritis pain and chronic low back pain. IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. Some patients may think CYMBALTA can be used for stress urinary incontinence; however the FDA failed the approval due to concerns over liver toxicity and suicidal events. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. In contrast, it is approved for this purpose in Europe, where it is used as an Take CYMBALTA exactly as directed by your health professional. See your health care professional for medical advice and treatment. A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body. The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. US residents can call their local poison control center at 1-800-222-1222. Properly discard this product when it is expired or no longer needed.
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. 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.
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