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    Sertraline is a member of the medication class called Selective Serotonin Reuptake Inhibitors (SSRIs). This family of drugs also includes fluoxetine (Prozac), paroxetine (Paxil), citalopram (Celexa), escitalopram (Lexapro), and others. These medications are FDA approved for the treatment of depression and anxiety. One of the side effects of these medications is that men who use them require more time and stimulation to ejaculate. This “side effect” has been studied in men with Premature Ejaculation (PE) and found to be an effective therapy. These medications are recommended by the American Urological Association as a first-line treatment for P. Ejaculation is a complex phenomenon that is controlled by the nervous system. Various neurotransmitters are involved in the neural pathways that mediate ejaculation. ciprofloxacin hydrocortisone otic WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. In addition to the contraindications for all ZOLOFT formulations listed above, ZOLOFT oral solution is contraindicated in patients taking disulfiram. ZOLOFT oral solution contains alcohol, and concomitant use of ZOLOFT and disulfiram may result in a disulfiram-alcohol reaction. Serotonin Syndrome: Patients on ZOLOFT should be monitored for the emergence of a potentially life-threatening serotonin syndrome, particularly with concomitant use of serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). If concomitant use of ZOLOFT with other serotonergic drugs is clinically warranted, inform patients of the increased risk of serotonin syndrome and monitor for symptoms.

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    WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS ZOLOFT and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Watch for these changes and call your healthcare provider right away if you notice new or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. Pay particular attention to such changes when ZOLOFT is started or when the dose is changed. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. Watch for these changes and call your healthcare provider right away if you notice new or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. Before taking ZOLOFT, tell your doctor and pharmacist about all prescription and over-the-counter medications and supplements you take or plan to take including: those to treat migraines, psychiatric disorders (including other antidepressants or amphetamines) to avoid a potentially life-threatening condition called serotonin syndrome; aspirin, other NSAID pain relievers, or other blood thinners because they may increase the risk of bleeding. Initial: 50 mg q Day PO given continuously throughout menstrual cycle or given during luteal phase only May increase by 50 mg at the onset of each new menstrual cycle; no more than 150 mg q Day when administered continuously or 100 mg q Day when administered during luteal phase only 25 mg PO q Day initially; may increase by 25 mg every 2-3 days; not to exceed 200 mg q Day Alzheimer dementia related depression: Start at 12.5 mg/day and titrate every 1-2 weeks to response; not to exceed 150-200 mg Renal impairment: Dose adjustment not necessary Mild hepatic impairment (Child-Pugh 5-6): Decrease recommended starting dose and therapeutic dose by 50% Moderate-to-severe hepatic impairment (Child-Pugh 7-15): Not recommended; sertraline is extensively metabolized, and the effects in patients with moderate and severe hepatic impairment have not been studied Clinical worsening and suicide ideation may occur despite medication Use caution in patients with seizure disorders May worsen mania symptoms or precipitate mania in patients with bipolar disorder Increases risk of hyponatremia and impairment of cognitive/motor functions in the elderly Increases risk of bleeding in patients taking anticoagulants/antiplatelets concomitantly Risk of mydriasis; may trigger angle closure attack in patients with angle closure glaucoma with anatomically narrow angles without a patent iridectomy Pregnancy: Conflicting evidence regarding use of SSRIs during pregnancy and increased risk of persistent pulmonary hypertension of the newborn (see Pregnancy) In neonates exposed to SNRIs/SSRIs late in third trimester: Risk of complications such as feeding difficulties, irritability, and respiratory problems Avoid abrupt withdrawal Bone fractures reported with antidepressant therapy; consider the possibility if patient presents with bone pain, bruising, or point of tenderness Coadministration with other drugs that enhance the effects of serotonergic neurotransmission (eg, tryptophan, fenfluramine, fentanyl, 5-HT agonists, St. John’s Wort) should be undertaken with caution and avoided whenever possible due to the potential for pharmacodynamic interaction (see Contraindications) May cause false-positive urine immunoassay screening tests for benzodiazepines SSRIs and SNRIs are associated with development of SIADH; hyponatremia reported Several SSRIs (eg, fluoxetine, fluvoxamine, paroxetine, sertraline) are metabolized by CYP2D6 CYP2D6 is involved in the metabolism of approximately 20% of drugs in clinical use and displays large individual-to-individual variability in activity due to genetic polymorphisms More than 80 CYP2D6 variant alleles have been identified; however, 4 of the most prevalent alleles, CYP2D6*3, *4, *5, and *6, account for 93-97% of CYP2D6 poor metabolizers CYP2D6*4, the most common variant (~25% frequency in whites), causes a splicing defect; CYP2D6*3 (2.7% frequency) causes a frameshift mutation; and CYP3D6*5 (2.6%) is an entire deletion of the CYP2D6 gene; individuals homozygous for these alleles have no CYP2D6 activity The impact of CYP2D6 activity is further complicated in some SSRIs (eg, fluoxetine, fluvoxamine, paroxetine, sertraline) because in addition to being substrates for CYP2D6, they are also known to moderately inhibit CYP2D6 activity 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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