Zoloft Oral Solution

— THERAPEUTIC CATEGORIES —
  • Anxiety/OCD
  • Mood disorders
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Zoloft Oral Solution Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Sertraline (as HCl) 20mg/mL; contains alcohol 12%. Dilute just before administering in 4oz water, ginger ale, lemon/lime soda, lemonade, or orange juice.

    Pharmacological Class

    SSRI.

    See Also

    How Supplied

    Tabs 25mg—30; 50mg, 100mg—30, 100; Soln—60mL (w. dropper)

    Manufacturer

    Pfizer Inc.

    Generic Availability

    YES

    Mechanism of Action

    Sertraline potentiates serotonergic activity in the central nervous system through inhibition of neuronal reuptake of serotonin (5-HT).

    Zoloft Oral Solution Indications

    Indications

    Panic disorder (PD). Posttraumatic stress disorder (PTSD). Obsessive-compulsive disorder (OCD). Social anxiety disorder (SAD).

    Zoloft Oral Solution 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 Oral Solution 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 Oral Solution Boxed Warnings

    Boxed Warning

    Suicidal thoughts and behaviors.

    Zoloft Oral Solution 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. Risk for bleeding events. 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 (during 3rd trimester; see full labeling for effects on neonates). Nursing mothers.

    Zoloft Oral Solution Pharmacokinetics

    Absorption

    Mean peak plasma concentrations (Cmax) of sertraline occurred between 4.5–8.4 hours post-dosing.

    Distribution

    Plasma protein bound: 98%.

    Metabolism

    Hepatic. 

    Elimination

    Renal, fecal. Half-life: ~26 hours.

    Zoloft Oral Solution Interactions

    Interactions

    See Contraindications. Increased risk of serotonin syndrome with other serotonergic drugs (eg, other SSRIs, SNRIs, triptans, TCAs, fentanyl, lithium, tramadol, meperidine, methadone, 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 aspirin, NSAIDs, clopidogrel, heparin, warfarin, 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 Oral Solution 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 Oral Solution Clinical Trials

    See Literature

    Zoloft Oral Solution Note

    Not Applicable

    Zoloft Oral Solution Patient Counseling

    See Literature

    Zoloft Oral Solution Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Sertraline (as HCl) 20mg/mL; contains alcohol 12%. Dilute just before administering in 4oz water, ginger ale, lemon/lime soda, lemonade, or orange juice.

    Pharmacological Class

    SSRI.

    See Also

    How Supplied

    Tabs 25mg—30; 50mg, 100mg—30, 100; Soln—60mL (w. dropper)

    Manufacturer

    Pfizer Inc.

    Generic Availability

    YES

    Mechanism of Action

    Sertraline potentiates serotonergic activity in the central nervous system through inhibition of neuronal reuptake of serotonin (5-HT).

    Zoloft Oral Solution Indications

    Indications

    Major depressive disorder (MDD). Premenstrual dysphoric disorder (PMDD).

    Zoloft Oral Solution 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 Oral Solution 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 Oral Solution Boxed Warnings

    Boxed Warning

    Suicidal thoughts and behaviors.

    Zoloft Oral Solution 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. Risk for bleeding events. 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 (during 3rd trimester; see full labeling for effects on neonates). Nursing mothers.

    Zoloft Oral Solution Pharmacokinetics

    Absorption

    Mean peak plasma concentrations (Cmax) of sertraline occurred between 4.5–8.4 hours post-dosing.

    Distribution

    Plasma protein bound: 98%.

    Metabolism

    Hepatic. 

    Elimination

    Renal, fecal. Half-life: ~26 hours.

    Zoloft Oral Solution Interactions

    Interactions

    See Contraindications. Increased risk of serotonin syndrome with other serotonergic drugs (eg, other SSRIs, SNRIs, triptans, TCAs, fentanyl, lithium, tramadol, meperidine, methadone, 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 aspirin, NSAIDs, clopidogrel, heparin, warfarin, 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 Oral Solution Adverse Reactions

    Adverse Reactions

    Nausea, diarrhea, tremor, dyspepsia, decreased appetite, sweating, ejaculation failure, decreased libido, insomnia, weight loss, dry mouth; hyponatremia (esp. elderly).

    Zoloft Oral Solution Clinical Trials

    See Literature

    Zoloft Oral Solution Note

    Not Applicable

    Zoloft Oral Solution Patient Counseling

    See Literature

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