ZOLOFT TABLET 50 mg

VIATRIS PRIVATE LIMITED

VIATRIS PRIVATE LIMITED

Therapeutic

Prescription Only

TABLET, FILM COATED

**4.2 Posology and Method of Administration** Sertraline should be administered once daily, either in the morning or evening. Sertraline tablets can be administered with or without food. **Initial Treatment** Depression and OCD – Sertraline treatment should be administered at a dose of 50 mg/day. Panic Disorder, PTSD and Social Phobia – Therapy should be initiated at 25 mg/day. After one week, the dose should be increased to 50 mg once daily. This dosage regimen has been shown to reduce the frequency of early treatment-emergent side effects characteristic of panic disorder. Pre-menstrual Dysphoric Disorder – Sertraline treatment should be initiated at a dose of 50 mg/day, either daily throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle, depending on physician assessment. **Titration** Depression, OCD, Panic Disorder, PTSD, and Social Phobia – Patients not responding to a 50 mg dose may benefit from dose increases. Dose changes should be made at intervals of at least one week, up to a maximum of 200 mg/day. Changes in dose should not be made more frequently than once per week given the 24-hour elimination half-life of sertraline. The onset of therapeutic effect may be seen within 7 days. However, longer periods are usually necessary to demonstrate therapeutic response, especially in OCD. Pre-menstrual Dysphoric Disorder – Patients not responding to a 50 mg/day dose may benefit from dose increases (at 50 mg increments/menstrual cycle) up to 150 mg/day when dosing daily throughout the menstrual cycle, or 100 mg/day when dosing during the luteal phase of the menstrual cycle. If a 100 mg/day dose has been established with luteal phase dosing, a 50 mg/day titration step for three days should be utilized at the beginning of each luteal phase dosing period. Maintenance – Dosage during long-term therapy should be kept at the lowest effective level, with subsequent adjustment depending on therapeutic response. Use in the Elderly – The same dose range as in younger patients may be used in the elderly. Over 700 elderly patients (>65 years) have participated in clinical studies that demonstrated the efficacy of sertraline in this patient population. The pattern and incidence of adverse reactions in the elderly were similar to that in younger patients. Use in Hepatic Insufficiency – The use of sertraline in patients with hepatic disease should be approached with caution. A lower or less frequent dose should be used in patients with hepatic impairment (see section **4.4 – Special Warnings and Precautions for Use** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Use in Renal Insufficiency – Sertraline is extensively metabolized. Excretion of unchanged drug in urine is a minor route of elimination. As expected from the low renal excretion of sertraline, sertraline dosing does not have to be adjusted based on the degree of renal impairment (see section **4.4 – Special Warnings and Precautions for Use** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Discontinuation** Patients currently taking sertraline should not be discontinued abruptly, due to risk of discontinuation symptoms. At the time that a medical decision is made to discontinue, a gradual reduction in the dose rather than an abrupt cessation is recommended.