INDICATION AND USES:
ZOLOFT is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of (1):
- Major depressive disorder (MDD)
- Obsessive-compulsive disorder (OCD)
- Panic disorder (PD)
- Post-traumatic stress disorder (PTSD)
- Social anxiety disorder (SAD)
- Premenstrual dysphoric disorder (PMDD)
DOSAGE AND ADMINISTRATION
| Indication | Starting Dosage | Maximum Dosage |
| MDD (2.1) | 50 mg per day | 200 mg per day |
| OCD (2.1) | 25 mg per day (ages 6-12) 50 mg per day (ages > 13) |
200 mg per day |
| PD, PTSD, SAD (2.1) | 25 mg per day | 200 mg per day |
| PMDD (2.2) continuous dosing |
50 mg per day | 150 mg per day |
| PMDD (2.2) intermittent dosing |
50 mg per day during luteal phase only |
100 mg per day during luteal phase only |
- If inadequate response to starting dosage, titrate in 25-50 mg per day increments once weekly in MDD, OCD, PD, PTSD, and SAD (2.1)
- See Full Prescribing Information for titration in PMDD (2.2)
- Hepatic impairment:
- Mild: Recommended starting and maximum dosage is half recommended dosage (2.4)
- Moderate or severe: Not recommended (2.4)
- When discontinuing ZOLOFT, reduce dose gradually (2.6, 5.4)
- Oral solution: Must be diluted before administration (2.7)
SIDE EFFECTS:
Most common adverse reactions (>5% and twice placebo) in pooled placebo controlled MDD, OCD, PD, PTSD, SAD and PMDD clinical trials were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido (6.1)
CONTRAINDICATIONS:
- Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs (4, 7.1)
- Concomitant use of pimozide (4, 7.1)
- Known hypersensitivity to sertraline or excipients (4, 5.4)
- ZOLOFT oral solution only: Concomitant use of disulfiram (4)
WARNINGS AND PRECAUTIONS:
- Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue ZOLOFT and initiate supportive treatment. (5.2)
- Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk. (5.3)
- Activation of Mania/Hypomania: Screen patients for bipolar disorder. (5.4)
- Seizures: Use with caution in patients with seizure disorders. (5.6)
- Angle Closure Glaucoma: Avoid use of antidepressants, including ZOLOFT, in patients with untreated anatomically narrow angles. (5.7)
- QTc Prolongation: ZOLOFT should be used with caution in patients with risk factors for QTc prolongation. (5.10)
DRUG INTERACTIONS:
- Protein-bound drugs: Monitor for adverse reactions and reduce dosage of ZOLOFT or other protein-bound drugs (e.g., warfarin) as warranted. (7.1, 12.3)
- CYP2D6 substrates: Reduce dosage of drugs metabolized by CYP2D6 (7.1, 12.3)
OVERDOSE:
The most common signs and symptoms associated with non-fatal ZOLOFT overdosage were somnolence, vomiting, tachycardia, nausea, dizziness, agitation and tremor. No cases of fatal overdosage with only sertraline have been reported.
Other important adverse events reported with ZOLOFT overdose (single or multiple drugs) include bradycardia, bundle branch block, coma, convulsions, delirium, hallucinations, hypertension, hypotension, manic reaction, pancreatitis, QTc-interval prolongation, Torsade de Pointes, serotonin syndrome, stupor, and syncope [See Clinical Pharmacology (12.2)].
Overdose Management: No specific antidotes for ZOLOFT are known. Contact Poison Control (1-800-222-1222) for latest recommendations.
- Uses
-
INDICATION AND USES:
ZOLOFT is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of (1):
- Major depressive disorder (MDD)
- Obsessive-compulsive disorder (OCD)
- Panic disorder (PD)
- Post-traumatic stress disorder (PTSD)
- Social anxiety disorder (SAD)
- Premenstrual dysphoric disorder (PMDD)
DOSAGE AND ADMINISTRATION
Indication Starting Dosage Maximum Dosage MDD (2.1) 50 mg per day 200 mg per day OCD (2.1) 25 mg per day (ages 6-12)
50 mg per day (ages > 13)200 mg per day PD, PTSD, SAD (2.1) 25 mg per day 200 mg per day PMDD (2.2)
continuous dosing50 mg per day 150 mg per day PMDD (2.2)
intermittent dosing50 mg per day during
luteal phase only100 mg per day during
luteal phase only- If inadequate response to starting dosage, titrate in 25-50 mg per day increments once weekly in MDD, OCD, PD, PTSD, and SAD (2.1)
- See Full Prescribing Information for titration in PMDD (2.2)
- Hepatic impairment:
- Mild: Recommended starting and maximum dosage is half recommended dosage (2.4)
- Moderate or severe: Not recommended (2.4)
- When discontinuing ZOLOFT, reduce dose gradually (2.6, 5.4)
- Oral solution: Must be diluted before administration (2.7)
- Side Effects
-
SIDE EFFECTS:
Most common adverse reactions (>5% and twice placebo) in pooled placebo controlled MDD, OCD, PD, PTSD, SAD and PMDD clinical trials were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido (6.1)
- Precautions
-
CONTRAINDICATIONS:
- Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs (4, 7.1)
- Concomitant use of pimozide (4, 7.1)
- Known hypersensitivity to sertraline or excipients (4, 5.4)
- ZOLOFT oral solution only: Concomitant use of disulfiram (4)
WARNINGS AND PRECAUTIONS:
- Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue ZOLOFT and initiate supportive treatment. (5.2)
- Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk. (5.3)
- Activation of Mania/Hypomania: Screen patients for bipolar disorder. (5.4)
- Seizures: Use with caution in patients with seizure disorders. (5.6)
- Angle Closure Glaucoma: Avoid use of antidepressants, including ZOLOFT, in patients with untreated anatomically narrow angles. (5.7)
- QTc Prolongation: ZOLOFT should be used with caution in patients with risk factors for QTc prolongation. (5.10)
- Interactions
-
DRUG INTERACTIONS:
- Protein-bound drugs: Monitor for adverse reactions and reduce dosage of ZOLOFT or other protein-bound drugs (e.g., warfarin) as warranted. (7.1, 12.3)
- CYP2D6 substrates: Reduce dosage of drugs metabolized by CYP2D6 (7.1, 12.3)
- Overdose
-
OVERDOSE:
The most common signs and symptoms associated with non-fatal ZOLOFT overdosage were somnolence, vomiting, tachycardia, nausea, dizziness, agitation and tremor. No cases of fatal overdosage with only sertraline have been reported.
Other important adverse events reported with ZOLOFT overdose (single or multiple drugs) include bradycardia, bundle branch block, coma, convulsions, delirium, hallucinations, hypertension, hypotension, manic reaction, pancreatitis, QTc-interval prolongation, Torsade de Pointes, serotonin syndrome, stupor, and syncope [See Clinical Pharmacology (12.2)].
Overdose Management: No specific antidotes for ZOLOFT are known. Contact Poison Control (1-800-222-1222) for latest recommendations.