Duloxetine prescribing information

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  1. Allar Well-Known Member

    Duloxetine prescribing information


    Restricted benefit Duloxetine (Cymbalta) 30 mg and 60 mg capsules can be prescribed on the Pharmaceutical Benefit Scheme (PBS) for people with a major depressive disorder.1 The 30 mg capsule is listed as a month's supply with no repeats. People with renal impairment who require this strength on an ongoing basis will need an authority for any repeats. The Pharmaceutical Benefits Advisory Committee (PBAC) considered duloxetine to be as effective as venlafaxine (Efexor-XR), but with more adverse effects in the first 6 weeks of therapy. In the following 6 weeks the incidence of adverse effects was similar for the two drugs.2 The PBAC had previously accepted as plausible the argument that the discontinuation rate with duloxetine could be reduced by slower dose titration. However, it remained concerned that in trials twice as many people stopped taking duloxetine because of adverse events as stopped taking venlafaxine. 3 Antidepressants are effective in moderate or severe major depressive disorder. There are many different antidepressants available in a number of classes, with similar efficacy but differences in adverse effects. Indications and Usage Dosage and Administration Dosage Forms and Strengths Contraindications Warnings and Precautions Adverse Reactions Drug Interactions Use in Specific Populations Drug Abuse and Dependence Overdosage Description Clinical Pharmacology Nonclinical Toxicology Clinical Studies How Supplied/Storage Patient Counseling Information Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Cymbalta or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Cymbalta is not approved for use in pediatric patients. A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation.

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    Cymbalta safely and effectively. See full prescribing information for. Cymbalta. Cymbalta duloxetine hydrochloride Delayed-Release Capsules for Oral. Use. Cymbalta is approved for treatment of depression, generalized anxiety disorder and management of diabetic nerve pain and fibromyalgia. Uses, dosage, side-effects of. Cymbalta duloxetine, a drug prescribed for neuropathic pain associated with diabetic peripheral neuropathy, depression, and anxiety. Side effect, dosage, and drug.

    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. A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants (''mood elevators'') such as duloxetine during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. Children younger than 18 years of age should not normally take duloxetine, but in some cases, a doctor may decide that duloxetine is the best medication to treat a child's condition. You should know that your mental health may change in unexpected ways when you take duloxetine or other antidepressants even if you are an adult over 24 years of age. These changes may occur even if you do not have a mental illness and you are taking duloxetine to treat a different type of condition. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased.

    Duloxetine prescribing information

    Duloxetine Cymbalta for major depressive disorder RADAR, Duloxetine HCl Full Prescribing Information HealthyPlace

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  4. Prescribing Cymbalta to patients with increased intraocular pressure. See section 4.2 for information on patients with mild or moderate renal dysfunction.

    • CYMBALTA, INN-duloxetine - European Medicines Agency - europa.eu.
    • Duloxetine - MedicineNet - Health and Medical Information..
    • Duloxetine marketed as Cymbalta Information.

    CYMBALTA safely and effectively. See full prescribing information for CYMBALTA. CYMBALTA Duloxetine Delayed-Release Capsules for Oral Use. Initial U. S. See full prescribing information for complete boxed warning. Among Duloxetine-Treated Patients in Placebo-Controlled. 17.1 Information on Medication Guide Jan 22, 2009. Cymbalta duloxetine hydrochloride Delayed-Release Capsules for Oral. Use. See full prescribing information for complete boxed warning.

     
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