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ZOLOFT ORAL CONCENTRATE
Anxiety/OCD
Mood disorders
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Drug Name:

ZOLOFT ORAL CONCENTRATE Rx

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

Company:
Pfizer Inc.

Therapeutic Use:

Indications for ZOLOFT ORAL CONCENTRATE:

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

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.

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.

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. Monitor for serotonin syndrome; discontinue if occurs. History of seizures, mania/hypomania. Angle-closure glaucoma; avoid. Monitor weight and growth in children. Volume-depleted. Hepatic impairment. Write ℞ for smallest practical amount. Avoid abrupt cessation. Reevaluate periodically. Elderly. Labor & delivery. Pregnancy. Nursing mothers.

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, and others that affect coagulation. Monitor phenytoin, warfarin. May cause false-positive urine test for benzodiazepines.

See Also:

ZOLOFT

Pharmacological Class:

SSRI.

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.

How Supplied:

Tabs 25mg—30, 50; 50mg, 100mg—30, 100, 500, 5000; Soln—60mL (w. dropper)

Indications for ZOLOFT ORAL CONCENTRATE:

Depression. Premenstrual dysphoric disorder (PMDD).

Adult:

Give once daily (AM or PM). Depression: 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.

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.

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. Monitor for serotonin syndrome; discontinue if occurs. History of seizures, mania/hypomania. Angle-closure glaucoma; avoid. Monitor weight and growth in children. Volume-depleted. Hepatic impairment. Write ℞ for smallest practical amount. Avoid abrupt cessation. Reevaluate periodically. Elderly. Labor & delivery. Pregnancy. Nursing mothers.

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, and others that affect coagulation. Monitor phenytoin, warfarin. May cause false-positive urine test for benzodiazepines.

See Also:

ZOLOFT

Pharmacological Class:

SSRI.

Adverse Reactions:

Diarrhea, nausea, insomnia, somnolence, sexual dysfunction, tremor, dry mouth, sweating, anorexia, weight loss, anxiety, decreased libido, hyponatremia, weak uricosuric effect.

How Supplied:

Tabs 25mg—30, 50; 50mg, 100mg—30, 100, 500, 5000; Soln—60mL (w. dropper)

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