Zoloft - Dosage sertraline hydrochloride

ZOLOFT (sertraline hydrochloride solution, concentrate) comes in different strengths and amounts, which is referred to as the dosing of Zoloft. The appearance of Zoloft can differ based on the dosing. Your doctor may change the dosage and prescription of Zoloft to get you the best results possible.

Dosage & 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)

dosage in patients with mdd, ocd, pd, ptsd, & sad

The recommended initial dosage and maximum ZOLOFT dosage in patients with MDD, OCD, PD, PTSD, and SAD are displayed in Table 1 below. A dosage of 25 mg or 50 mg per day is the initial therapeutic dosage.

For adults and pediatric patients, subsequent dosages may be increased in case of an inadequate response in 25 to 50 mg per day increments once a week, depending on tolerability, up to a maximum of 200 mg per day. Given the 24-hour elimination half-life of ZOLOFT, the recommended interval between dose changes is one week.

Table 1: Recommended Daily Dosage of ZOLOFT in Patients with MDD, OCD, PD, PTSD, and SAD
Indication Starting Dose Therapeutic Range
Adults
  MDD 50 mg 50–200 mg
  OCD 50 mg
  PD, PTSD, SAD 25 mg
Pediatric Patients
  OCD (ages 6–12 years old) 25 mg 50–200 mg
  OCD (ages 13–17 years old) 50 mg

dosage in patients with pmdd

The recommended starting ZOLOFT dosage in adult women with PMDD is 50 mg per day. ZOLOFT may be administered either continuously (every day throughout the menstrual cycle) or intermittently (only during the luteal phase of the menstrual cycle, i.e., starting the daily dosage 14 days prior to the anticipated onset of menstruation and continuing through the onset of menses). Intermittent dosing would be repeated with each new cycle.

  • When dosing continuously, patients not responding to a 50 mg dosage may benefit from dosage increases at 50 mg increments per menstrual cycle up to 150 mg per day.
  • When dosing intermittently, patients not responding to a 50 mg dosage may benefit from increasing the dosage up to a maximum of 100 mg per day during the next menstrual cycle (and subsequent cycles) as follows: 50 mg per day during the first 3 days of dosing followed by 100 mg per day during the remaining days in the dosing cycle.

screen for bipolar disorder prior to starting zoloft

Prior to initiating treatment with ZOLOFT or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [See Warnings and Precautions (5.4)].

dosage modifications in patients with hepatic impairment

Both the recommended starting dosage and therapeutic range in patients with mild hepatic impairment (Child Pugh scores 5 or 6) are half the recommended daily dosage [See Dosage and Administration (2.1, 2.2)]. The use of ZOLOFT in patients with moderate (Child Pugh scores 7 to 9) or severe hepatic impairment (Child Pugh scores 10–15) is not recommended [See Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

switching patients to or from a monoamine oxidase inhibitor antidepressant

At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of ZOLOFT. In addition, at least 14 days must elapse after stopping ZOLOFT before starting an MAOI antidepressant [See Contraindications (4), Warnings and Precautions (5.2)].

discontinuation of treatment with zoloft

Adverse reactions may occur upon discontinuation of ZOLOFT [See Warnings and Precautions (5.5)]. Gradually reduce the dosage rather than stopping ZOLOFT abruptly whenever possible.

preparation of zoloft oral solution

ZOLOFT oral solution must be diluted before use.

  • Use the supplied calibrated dropper to measure the amount of ZOLOFT oral solution needed
  • Note: The supplied calibrated dropper has 25 mg and 50 mg graduation marks only
  • Mix with 4 ounces (1/2 cup) of water, ginger ale, lemon/lime soda, lemonade or orange juice ONLY. After mixing, a slight haze may appear, which is normal.

Instruct patients or caregivers to immediately take the dose after mixing.

Dosage Form & Strengths

25 mg tablets: light green film-coated, engraved on one side with "ZOLOFT" and on the other side scored and engraved with "25 mg"

50 mg tablets: light blue film-coated, engraved on one side with "ZOLOFT" and on the other side scored and engraved with "50 mg"

100 mg tablets: light yellow film-coated, engraved on one side with "ZOLOFT" and on the other side scored and engraved with "100 mg"

Oral solution: a clear, colorless solution with a menthol scent containing sertraline hydrochloride equivalent to 20 mg of sertraline per mL and 12% alcohol. It is supplied as a 60 mL bottle with an accompanying calibrated dropper that has 25 mg and 50 mg graduation marks.

  • Tablets: 25 mg, 50 mg and 100 mg (3)
  • Oral solution: 20 mg/mL (3)

Overdosage

Human Experience

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.

Storage & Handling

ZOLOFT 25 mg tablets: light green, film-coated, capsular-shaped tablets engraved on one side with "ZOLOFT" and on the other side scored and engraved with "25 mg"

NDC 0049-4960-30 Bottles of 30
NDC 0049-4960-50 Bottles of 50

ZOLOFT 50 mg tablets: light blue, film-coated, capsular-shaped tablets engraved on one side with "ZOLOFT" and on the other side scored and engraved with "50 mg"

NDC 0049-4900-30 Bottles of 30
NDC 0049-4900-66 Bottles of 100
NDC 0049-4900-73 Bottles of 500
NDC 0049-4900-94 Bottles of 5000
NDC 0049-4900-41 Unit Dose Packages of 100

ZOLOFT 100 mg tablets: light yellow, film-coated, capsular-shaped, tablets engraved on one side with "ZOLOFT" and on the other side scored and engraved with "100 mg"

NDC 0049-4910-30 Bottles of 30
NDC 0049-4910-66 Bottles of 100
NDC 0049-4910-73 Bottles of 500
NDC 0049-4910-94 Bottles of 5000
NDC 0049-4910-41 Unit Dose Packages of 100

ZOLOFT oral solution: clear, colorless solution with a menthol scent containing sertraline hydrochloride equivalent to 20 mg of sertraline per mL and 12% alcohol

NDC 0049-0050-01 Bottles containing 60 mL, each with an accompanying calibrated dropper that has 25 mg and 50 mg graduation marks.

Store ZOLOFT at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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