SERTRALIN® 50

Composition: Each film-coated tablet contains:

Sertraline hydrochloride: equivalent to 50 mg Sertraline

Excipients: Calcium phosphate dihydrate, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol 6000, titanium dioxide, talc.

Dosage Form: Film-coated tablet
Packaging: Box of 3 blisters x 10 tablets
Indication: Sertraline is indicated for the treatment of:

  • Major depressive disorder, and for the prevention of relapse of major depressive episodes.
  • Panic disorder with or without agoraphobia.
  • Obsessive-compulsive disorder (OCD) in adults and pediatric patients aged 6-17 years.
  • Social anxiety disorder.
  • Post-traumatic stress disorder (PTSD).
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Indications & Usage

  • Administration: Take once daily, either in the morning or evening. Food has minimal effect on absorption, so it can be taken with or without food.
  • Dosage:
    • Depression and OCD: Initial dose of 50 mg/day.
    • Panic disorder, PTSD, and social anxiety disorder: Initial dose of 25 mg/day. After one week, this can be increased to 50 mg/day. This dosage has been shown to reduce the frequency of acute side effects typical of panic disorder at the start of treatment.
    • Depression, OCD, panic disorder, social anxiety disorder, and PTSD: If there is no clinical response after at least one week, the dose can be increased in 50 mg increments up to a maximum of 200 mg/day. Dose changes should only be made once per week due to sertraline’s 24-hour half-life. Therapeutic effects are typically observed within 7 days, but a longer period may be necessary to demonstrate a therapeutic response, especially for OCD.
    • Maintenance Treatment: The dose should be adjusted to maintain the patient at the lowest effective dose.
    • Children and adolescents with OCD:
      • 13-17 years: Initial dose of 50 mg/day.
      • 6-12 years: Initial dose of 25 mg/day. After 1 week, if there is no improvement, the dose can be increased to 50 mg/day up to a maximum of 200 mg/day.
  • Elderly: Dosing should be done with caution due to the increased risk of hyponatremia.
  • Hepatic Impairment: Use sertraline with caution in patients with liver disease. A lower dose or reduced dosing frequency should be used. Sertraline should not be used in severe hepatic impairment.
  • Renal Impairment: No dose adjustment is needed.

Contraindications

  • Hypersensitivity to sertraline or any component of the medication.
  • Concurrent treatment with monoamine oxidase inhibitors (MAOIs) due to the risk of serotonin syndrome, which can cause agitation, tremor, and hyperthermia. Sertraline should not be used concurrently with or within 14 days of discontinuing an MAOI. An interval of at least 7 days must pass after stopping sertraline before starting an MAOI.
  • Concurrent use with pimozide.

Storage & Quality

  • Storage: Store in a cool, dry place at a temperature below 30°C, away from light.
  • Shelf Life: 36 months from the manufacturing date.
  • Quality Standard: Manufacturer’s Standard.
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