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Duloxetine package insert pdf

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    Duloxetine package insert pdf


    Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. Therefore, it is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition. Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed. Duloxetine is used to treat depression and anxiety. buy erythromycin ointment online Indications and Usage, Generalized Anxiety Disorder (1.2) 11/2009 Dosage and Administration, Maintenance/Continuation/Extended Treatment (2.2) 11/2009 Warnings and Precautions, Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions (5.4) 01/2009 Although Cymbalta does not increase the impairment of mental and motor skills caused by alcohol, use of Cymbalta concomitantly with heavy alcohol intake may be associated with severe liver injury. For this reason, Cymbalta should ordinarily not be prescribed for patients with substantial alcohol use Patients should be advised of the risk of orthostatic hypotension and syncope, especially during the period of initial use and subsequent dose escalation, and in association with the use of concomitant drugs that might potentiate the orthostatic effect of duloxetine Any psychoactive drug may impair judgment, thinking, or motor skills. Although in controlled studies Cymbalta has not been shown to impair psychomotor performance, cognitive function, or memory, it may be associated with sedation and dizziness. Therefore, patients should be cautioned about operating hazardous machinery including automobiles, until they are reasonably certain that Cymbalta therapy does not affect their ability to engage in such activities.

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    HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CYMBALTA safely and effectively. See full. buy dapoxetine uk Gilead Sciences. 4. completion of hemodialysis treatment see Use in Specific Populations 8.6 and Clinical Pharmacology 12.3. 2.3 Not Recommended in Patients with Severe Renal Impairment CYMBALTAsafely and effectively. See full prescribing information for CYMBALTA. CYMBALTADuloxetine Delayed-Release Capsulesfor Oral Use. Initial U. S. Approval 2004 WARNING SUICIDALTHOUGHTSAND BEHAVIORS See full prescribing information for complete boxed warning. • Increased risk of suicidal thinking and behavior in children,

    Usually, 2–6 weeks at a therapeutic-dose level are needed to observe a clinical response. The choice of medication should be guided by anticipated safety and tolerability, which aid in compliance; physician familiarity, which aids in patient education and anticipation of adverse effects; and history of previous treatments. Often, treatment failures are caused not by clinical resistance but by medication noncompliance, inadequate duration of therapy, or inadequate dosing. Antidepressants can have central and peripheral anticholinergic effects, as well as sedative effects, and can block the active reuptake of norepinephrine (NE), serotonin (5-HT), and dopamine. SSRIs are metabolized via the cytochrome P-450 system and may have drug interactions on that basis. The degree of enzyme inhibition varies among SSRIs. Effects on blood levels and bioavailability of coadministered drugs, as well as pharmacodynamic interactions, account for most clinically significant SSRI-drug interactions. 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 . 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 . 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. Cymbalta is indicated for the treatment of generalized anxiety disorder (GAD). The efficacy of Cymbalta was established in three short-term trials and one maintenance trial in adults .

    Duloxetine package insert pdf

    Cymbalta duloxetine hydrochloride capsules - FDA, HIGHLIGHTS OF PRESCRIBING INFORMATION.

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  6. Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes

    • [email protected] FDA Approved Drug Products
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    CYMBALTA Duloxetine Delayed-Release Capsules for Oral Use. Initial U. S. See full prescribing information for complete boxed warning. •. Increased risk of. clonidine used for withdrawal The American Journal of GASTROENTEROLOGY VOLUME 104 XXX 2014 Chalasani et al. data have begun to blur the distinction between these two catego- CYMBALTA — duloxetine hydrochloride capsule, delayed release REMEDYREPACK INC. BOXED WARNING. provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by

     
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