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Zoloft Generic Name & Formulations
Legal Class
Rx
General Description
Sertraline (as HCl) 25mg, 50mg, 100mg; scored tabs.
Pharmacological Class
SSRI.
See Also
How Supplied
Tabs 25mg—30, 50; 50mg, 100mg—30, 100, 500, 5000; Soln—60mL (w. dropper)
Manufacturer
Generic Availability
YES
Zoloft Indications
Indications
Panic disorder (PD). Posttraumatic stress disorder (PTSD). Obsessive-compulsive disorder (OCD). Social anxiety disorder (SAD).
Zoloft Dosage and Administration
Adult
Give once daily (AM or PM). PD, PTSD, SAD: initially 25mg/day. OCD: initially 50mg/day. For all: may increase by 25–50mg/day at 1-week intervals; max 200mg/day. Hepatic impairment (mild): reduce dose by ½; (moderate to severe): not recommended.
Children
PD, PTSD, SAD: not established. OCD: <6yrs: not established. Give once daily (AM or PM). 6–12yrs: initially 25mg/day. 13–17yrs: initially 50mg/day. May increase by 25–50mg/day at 1-week intervals; max 200mg/day. Hepatic impairment (mild): reduce dose by ½; (moderate to severe): not recommended.
Zoloft Contraindications
Contraindications
During or within 14 days of MAOIs; do not start an MAOI during or within 14 days of sertraline. Concomitant pimozide, linezolid, IV methylene blue. Oral soln: concomitant disulfiram.
Zoloft Boxed Warnings
Boxed Warning
Suicidal thoughts and behaviors.
Zoloft Warnings/Precautions
Warnings/Precautions
Increased risk of suicidal thinking and behavior in children, adolescents, and young adults; monitor for clinical worsening or unusual changes. Screen for bipolar disorder, mania, or hypomania. Monitor for serotonin syndrome; discontinue if occurs. Seizure disorders. QT prolongation. Angle-closure glaucoma; avoid. Monitor weight and growth in children. Discontinue if symptomatic hyponatremia occurs. Volume-depleted. Sexual dysfunction. Hepatic impairment. Write ℞ for smallest practical amount. Avoid abrupt cessation. Reevaluate periodically. Elderly. Labor & delivery. Pregnancy. Nursing mothers.
Zoloft Pharmacokinetics
Distribution
98% serum protein bound.
Elimination
Renal, fecal. Half-life: ~26 hours.
Zoloft Interactions
Interactions
See Contraindications. Increased risk of serotonin syndrome with other serotonergic drugs (eg, other SSRIs, SNRIs, triptans, TCAs, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort) or with drugs that impair serotonin metabolism (eg, MAOIs, linezolid, IV methylene blue). Avoid alcohol. May potentiate or be potentiated by protein bound drugs (eg, warfarin); reduce dose if needed. May potentiate CYP2D6 substrates (eg, propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, thioridazine, tolterodine, venlafaxine); reduce dose of these. Increased risk of bleeding with concomitant NSAIDs, aspirin, warfarin, heparin, clopidogrel, and others that affect coagulation. Avoid concomitant drugs known to prolong the QT interval (eg, ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol, erythromycin, gatifloxacin, moxifloxacin, sparfloxacin, Class IA & III antiarrhythmics, pentamidine, methadone, mefloquine, and others). Monitor phenytoin, warfarin. May cause false (+) urine test for benzodiazepines.
Zoloft Adverse Reactions
Adverse Reactions
Nausea, diarrhea, tremor, dyspepsia, decreased appetite, sweating, ejaculation failure, decreased libido, insomnia, weight loss, dry mouth; hyponatremia (esp. elderly). Children: also, hyperkinesia, fever, urinary incontinence, aggression, epistaxis, purpura, arthralgia, muscle twitching, anxiety.
Zoloft Clinical Trials
See Literature
Zoloft Note
Not Applicable
Zoloft Patient Counseling
See Literature
Zoloft Generic Name & Formulations
Legal Class
Rx
General Description
Sertraline (as HCl) 25mg, 50mg, 100mg; scored tabs.
Pharmacological Class
SSRI.
See Also
How Supplied
Tabs 25mg—30, 50; 50mg, 100mg—30, 100, 500, 5000; Soln—60mL (w. dropper)
Manufacturer
Generic Availability
YES
Zoloft Indications
Indications
Major depressive disorder (MDD). Premenstrual dysphoric disorder (PMDD).
Zoloft Dosage and Administration
Adult
Give once daily (AM or PM). MDD: initially 50mg/day, may increase by 25–50mg/day at 1-week intervals; max 200mg/day. PMDD: give either for entire menstrual cycle or only during luteal phase. Luteal phase dosing: initially 50mg/day; if no response, may increase up to max 100mg/day, starting each cycle at 50mg/day for 3 days. Entire cycle dosing: initially 50mg/day, if no response, may increase by 50mg/cycle to max 150mg/day.
Children
Not established.
Zoloft Contraindications
Contraindications
During or within 14 days of MAOIs; do not start an MAOI during or within 14 days of sertraline. Concomitant pimozide, linezolid, IV methylene blue. Oral soln: concomitant disulfiram.
Zoloft Boxed Warnings
Boxed Warning
Suicidal thoughts and behaviors.
Zoloft Warnings/Precautions
Warnings/Precautions
Increased risk of suicidal thinking and behavior in children, adolescents, and young adults; monitor for clinical worsening or unusual changes. Screen for bipolar disorder, mania, or hypomania. Monitor for serotonin syndrome; discontinue if occurs. Seizure disorders. QT prolongation. Angle-closure glaucoma; avoid. Monitor weight and growth in children. Discontinue if symptomatic hyponatremia occurs. Volume-depleted. Sexual dysfunction. Hepatic impairment. Write ℞ for smallest practical amount. Avoid abrupt cessation. Reevaluate periodically. Elderly. Labor & delivery. Pregnancy. Nursing mothers.
Zoloft Pharmacokinetics
Distribution
98% serum protein bound.
Elimination
Renal, fecal. Half-life: ~26 hours.
Zoloft Interactions
Interactions
See Contraindications. Increased risk of serotonin syndrome with other serotonergic drugs (eg, other SSRIs, SNRIs, triptans, TCAs, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort) or with drugs that impair serotonin metabolism (eg, MAOIs, linezolid, IV methylene blue). Avoid alcohol. May potentiate or be potentiated by protein bound drugs (eg, warfarin); reduce dose if needed. May potentiate CYP2D6 substrates (eg, propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, thioridazine, tolterodine, venlafaxine); reduce dose of these. Increased risk of bleeding with concomitant NSAIDs, aspirin, warfarin, heparin, clopidogrel, and others that affect coagulation. Avoid concomitant drugs known to prolong the QT interval (eg, ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol, erythromycin, gatifloxacin, moxifloxacin, sparfloxacin, Class IA & III antiarrhythmics, pentamidine, methadone, mefloquine, and others). Monitor phenytoin, warfarin. May cause false (+) urine test for benzodiazepines.
Zoloft Adverse Reactions
Adverse Reactions
Nausea, diarrhea, tremor, dyspepsia, decreased appetite, sweating, ejaculation failure, decreased libido, insomnia, weight loss, dry mouth; hyponatremia (esp. elderly).
Zoloft Clinical Trials
See Literature
Zoloft Note
Not Applicable
Zoloft Patient Counseling
See Literature
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